Baib12017-02 Guideline On Conceptual Design And Engineering Requirements For Cssu.pdf

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

Ministry of Health Malaysia Engineering Services Division Level 3-7, Block E3, Parcel E, Precinct 1 Federal Government Administrative Centre 62590 Putrajaya Tel: 603-8000 8000 | Fax: 603-8892 4855/4872 Website: http://engineering.moh.gov.my

AL TU P E L NC IDE GU CO

AL TU EP NC O C INE

N SIG DE

AL TU EP NC O C

N SIG DE

ING ER

E LIN IDE GU ENTS M IRE QU RE

E ING ER LIN IGN E E ID IN ES NG GU CEPTUAL D E N N

NE

GI EN

ING ER E IN

G EN

E LIN IDE U G

E LIN IDE U G

AL PTU DESIG CE N CO

TS EN M IRE QU E R

CO

TS EN M IRE QU E R

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

MINISTRY OF HEALTH MALAYSIA MOH/ESD/2017-02

Disclaimer: Any pictures of equipment, brand and model of equipment depicted in this guideline shall not be considered as an acceptance or approval from the Ministry of Health Malaysia. It shall only serve as an example or illustration for the relevant issues and matter of interest.

3

TABLE OF CONTENTS Message from The Director General of Health Preface by The Director of Engineering Services Division Acknowledgements List of Abbreviations Glossary Executive Summary

6 7 8 10 11 14

1.0

Introduction

15

2.0 2.1 2.2 2.3 2.3.1 2.3.2

Central Sterile Supply Unit (CSSU) Primary Function Location Sterilization Classification Types of Sterilization

16 16 17 18

3.0 3.1 3.2 3.3 3.3.1 3.3.2 3.3.3

General Function and Layout Basic CSSU Layout Staff Movement Material Movement Soiled Zone Clean Zone Sterile Zone

22 22 24 25

4.0 4.1 4.1.1 4.1.2 4.1.2.1 4.1.2.2 4.1.2.3 4.1.2.4 4.1.2.5 4.1.2.6 4.1.2.7

Service Area within Zone Soiled Zone Receiving Area Cleaning Area Decontamination Area Manual Cleaning Area Ultrasonic Cleaners Washer Disinfectors Cart Washer Transfer Hatch Medical Drying Cabinet

27 27

4

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

4.2 4.2.1 4.2.2 4.2.3 4.2.4 4.2.5 4.3 4.3.1 4.3.1.1 4.3.1.2 4.3.1.2 4.3.2 4.3.3 4.3.4 4.4 4.4.1 4.4.2 4.4.3 4.4.4 4.4.5 4.4.6 4.4.7 4.4.8 4.4.9

Clear Zone IAP Area Documentation and Label Printing Area Clean Stores Sterilizer Loading Area Sterilizer Room Sterilization Zone Sterilizers Steam Sterilizer Ethylene Oxide Sterilizer Hydrogen Peroxide Sterilizer Cooling Area Sterilized Product Storage Area Sterile Item Issuing Area Administrative and Staff Facilities Administrative (Matron/Sister) Office Meeting Room Change Room Staff Room Prayer Room Personnel Protective Equipment (PPE) Store Chemical Store Disposal Room Receive and Break Pack Room

36

5.0 5.1 5.2

General information Calculating the size of CSSU Information required in determining number of Sterilizers

57 57 57

6.0 6.1 6.1.1 6.1.2 6.1.3 6.1.4 6.1.5 6.1.6 6.1.7

Architectural and Engineering Services Architectural Finishes Wall Ceiling Flooring Doors Windows Worktops and Sinks Painting

59 59

44

50

5

6.2 6.2.1 6.2.2 6.2.3 6.2.4 6.2.5 6.2.6 6.2.7 6.3 6.3.1 6.3.2 6.3.3 6.3.4 6.4 6.4.1 6.4.2 6.5 6.6

Mechanical Services Air Conditioning and Ventilation Fire System Noise Water Steam Compressed Air Drainage Electrical Services Electrical Installation Lighting Switch Socket Outlets Emergency Supply Communication Internal Communication External Communication IT Link Security

62

Acquiring and Installing of Major CSSU Equipment Elements to consider prior to acquiring of equipment Roles and responsibilities of user during planning, installation, testing and commissioning of upgraded facilities or equipment replacement

69 69

8.0

Upgrading of Existing CSSU

71

9.0

References

72

7.0 7.1 7.2

66

67

68 68

70

6

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

MESSAGE THE DIRECTOR GENERAL OF HEALTH

The Central Sterile Supply Unit (CSSU) is the hub where contaminated re-usable medical devices are decontaminated, cleaned, disinfected, washed, packed, sterilized and stored before being delivered to the respective departments in a hospital to be used onto the next patient. In view of the emergence of many new viruses, the sterility of those medical devices must be assured at the highest level. To achieve this, the CSSU is designed and operated with the principle of stringent infection control measures in handling those medical devices from the receiving to the operation table. Good engineering practice in construction, selection of appropriate material and equipment, installation of suitable engineering systems and effective maintenance of the entire facility partly contribute to the achievement. Therefore, the formulation of this document is timely and serves as a practical guidance to whoever involved in the planning, constructing and maintaining of the CSSU. This guideline, hopefully, can be benefited by various interested parties within or outside the Ministry of Health to further enhance the sustainability of CSSU in continuously producing the highest sterility of re-usable medical devices.

Datuk Dr. Noor Hisham Bin Abdullah Director General of Health Ministry of Health Malaysia

7

PREFACE THE DIRECTOR OF ENGINEERING SERVICES DIVISION

Central Sterile Supply Unit (CSSU) is an integral part of the hospital and plays the role of processing re-usable medical devices and consumables that are used in operating theatres, emergency department and wards where surgical and non-surgical procedures are carried out. Properly designed, installed, operated and maintained CSSU facility and equipment will ensure that reprocessed medical devices and other sterilized products achieve high assurance levels of sterility, and eliminate any source of contaminant/infection for the personnel and patient. These guidelines are developed to ensure that CSSU at the hospitals comply to international requirements with a greater emphasize put on the engineering aspects as to address the issues and concerns raised during the construction and operation phases. These guidelines are also prepared to serve as a guiding document in establishing some basic requirements in the construction of a new CSSU and upgrading or converting an existing area in a CSSU. Apart from complying with the functionality requirements, the design should allow flexibility and creativity to cope with the minimum space of utilization as the way forward. These guidelines are intended for Ministry of Health personnel (the owners), the hospital administrators, health care workers, designers, maintenance personnel, and others concerning the CSSU in the healthcare facilities.

Haji Md. Jalal Bin Bongkik Director of Engineering Services Division Ministry of Health Malaysia

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

8

ACKNOWLEDGEMENTS The guidelines were prepared by the Engineering Services Division of the Ministry of Health Malaysia (MOH) and assisted by Healthcare Facilities Consultant, Sistem Hospital Awasan Taraf Sdn Bhd (SIHAT), who was appointed by the Government of Malaysia. We thank and acknowledge the following personnel who contributed to the preparation of this document, by taking part in discussions, reviews, providing feedbacks and being members in the committee meetings. Engineering Services Division, Ministry of Health Malaysia (MOH) 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.

Tn. Haji Md. Jalal Bin Bongkik Tn. Haji Tauran Zaidi Bin Ahmad Zaidi En. Mohd Azizi Bin Ibrahim Ir. Haji Suhaimi Bin Rashid Ir. Mohd Hisam Bin Sa’at En. Mohd Kamalluddin Bin Hashim En. Mohd Fairuz Bin Mohd En. Abu Bakar Bin Abdullah Ir. Rasyidi Bin Mohd Tahir En. Amir Ikram Bin Muhammad En. Adli Faiz Bin Ramli En. Mohd Haisa Bin Hafiz Ariffin Ir. Haji Rosmahadi Bin Ali (Editor) En. Alif Riduan Bin Khalid@Othman (Member of Editorial Board) En. Mohd Amirul Fahmi Bin Mohd Lazim (Member of Editorial Board)

Planning Division, Ministry of Health 1. Dr. Siti Sarah Binti Mohd Shukor 2. Pn. Katijah Binti Karim 3. Pn. Shaliza Binti Abd. Rahman Medical Development Division, Ministry of Health 1. Dr. Suraya Binti Amir Husin 2. Dr. Suriana Aishah Binti Zainal

9

Tengku Ampuan Rahimah Hospital 1. Pn. Jamilah Binti Jaafar 2. Pn. Ong Siew Wang 3. Pn. Nor Saffia Binti Badron Sungai Buloh Hospital 1. Pn. Khaslina Binti Kasbon Malaysian Sterile Service Association 1. Pn. Kamariah Binti Jusoh 2. Pn. Hjh. Mek Binti Jusoh 3. Pn. Rahijah Binti Abd. Rahman

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

10

LIST OF ABBREVIATIONS

MOH

ORGANIZATIONS American Society of Heating, Refrigerating and Air-Conditioning Engineers Jabatan Keselamatan dan Kesihatan Pekerjaan (Department of Occupational Safety and Health) Ministry of Health, Malaysia

ACMV AHU CSSU ICU MD UPS

TERMS Air Conditioning and Mechanical Ventilation Air Handling Unit Central Sterile Supply Unit Intensive Care Unit Medical Device Uninterruptible Power Supply

ASHRAE JKKP

11

GLOSSARY AirConditioning

A form of air treatment whereby temperature humidity and air cleanliness are all controlled within limits determined by the requirements of the air-conditioned enclosure.

Air Handling Unit (AHU)

AHU is a device that is used to filter, condition and circulate the air as part of a heating, ventilating, and air-conditioning (HVAC) system.

Carrier

A device that carries or transports the load through the decontamination process.

Class 8

Class 8 is a classification number in the ISO 14644 clean-room standard on the classification of the air cleanliness. ISO Maximum concentration limits (particles/m3 of air) for particles equal to and Classification larger than the considered sizes shown below number = 0.1μm =0.2 μm = 0.3 μm = 0.5 μm = 1 μm = 5.0 μm ISO Class 1 10 2 ISO Class 2 100 24 10 4 ISO Class 3 1000 237 102 35 8 ISO Class 4 10,000 2370 1020 352 83 ISO Class 5 100,000 23,700 10,200 3520 832 29 ISO Class 6 1,000,000 237,000 102,000 35,200 8320 293 ISO Class 7 352,000 83,200 2930 ISO Class 8 3,520,000 832,000 29,300 ISO Class 9 35,200,000 8,320,000 293,000

HEPA filter

High Efficiency Particulate Air filters capable of removing 99.97% of particles 0.3 µm in diameter and may assist in controlling the transmission of airborne disease agents.

LAeq, Leq

It is the Total Sound Energy measured over a given period of time with an A weight-age measurement.

Load

Collectively, all the goods, equipment and materials that are put into a sterilizer or washer-disinfector at any one time for the purpose of processing it.

12

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

Medical device Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer, to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; investigation, replacement or modification of the anatomy or of a physiological process; and control of conception: and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. Microbial Deposition of viable or potentially viable elements of bacteria, fungi or contamination viruses onto or within articles previously rendered free of them. Porous-load A clinical sterilizer designed to process, by exposure to high temperature steam sterilizer steam under pressure, porous items such as towels, gowns and dressings, and also medical devices that are wrapped in porous materials such as paper or fabrics. Pressure Differential

The difference in air pressure of the room with respect to the surrounding. The surrounding here refers to the corridor or adjacent area where applicable.

Room Units

Room units here refer to the local air conditioning units that are used primarily for the cooling of air, and not disinfection of air.

Spore

A small, usually single cell that is dormant and resistant to adverse environmental conditions, chemical and enzymes.

Sterile

Free from viable micro-organisms, including bacterial spores and viruses.

Sterilization

A process undertaken to render a load sterile.

Sterilizer

An apparatus designed to achieve sterilization. (See also Porous-load sterilizer.)

13

Sterilization module

BS EN 285 specifies that a sterilizing module is a rectangular shape measuring 300 x 300 x 600 mm, of volume 54 L. A large sterilizer can accommodate one or more modules.

Tray

A container, usually with a flat base and upturned edges, used for containing an assembly of surgical instruments for packing to be used in an aseptic procedure.

Ultrasonic cleaner

A mechanical cleaner that generates sound waves that creates cavitation and is used to clean instruments.

Uninterruptible Power Supply (UPS)

UPS is a battery back power supply that provides emergency power for a specified duration during a power failure.

User

User is the person who uses the equipment or services e.g. nursing staff.

Washerdisinfector

Machine intended to clean and disinfect medical devices and other articles used in the context of medical, dental, pharmaceutical and veterinary practices.

14

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

EXECUTIVE SUMMARY The guidelines were prepared by the Engineering Services Division, Ministry of Health Malaysia and have eight (8) sections. Section 1 : Introduction This section explains the importance of CSSU in the hospital and the need for proper planning in design, build and maintain of the department. Section 2 : Central Sterile Supply Unit (CSSU) This section discusses the primary function, location, interaction between CSSU and other departments, and the internal processes. There is also a brief explanation of sterilization and the types of common sterilization processes in a hospital. Section 3 : General Function and Layout This section focuses on the basic layout, staff and material movement in CSSU to promote infection control protocol as well as to prevent cross contamination during processes. Section 4 : Service Area within Zone This section elaborates the various areas within the department and specifies the intended function, activities, requirements, fixtures, fittings, equipment, and engineering service requirements. Section 5 : General Information This section briefly describes the planning of the department in terms of sizing and selecting the major equipment. Section 6 : Architectural and Engineering Services This section explains the detailed requirements of architectural, mechanical, electrical, and communication aspects of the department. Section 7 : Acquiring and Installation of Major CSSU Equipment This section discusses the planning for acquiring and installation of a new major CSSU equipment. It also stresses the roles and responsibilities of the owner of the hospital during the planning, execution, testing & commissioning of the equipment. Section 8 : Upgrading of Existing CSSU The last section of the guideline discusses the elements to be closely considered and thought by the owner before embarking on a major upgrading of the CSSU.

15

1.

Introduction

Centralized Sterile Supply Unit (CSSU) in hospitals play an important role in providing sterile products to the various end users e.g. the operation theatres, emergency department, maternity, wards etc. through a series of strictly monitored cleaning, disinfecting, packing and sterilizing processes. Building the CSSU requires an in-depth knowledge of the operational of the department, relationship between the supplying and receiving departments in the hospital, compliance to the infection control protocol, cross contamination containment, the necessity of major processing and supporting working equipment, and the ability of the department to sustain the current and near future demands. As the design of the department becomes more complicated to address all the above mentioned requirements within the allowable space, the engineering systems installed in this department shall be relooked. Based on the experience from the construction of new or upgrading the existing of such department in hospitals as well as the operation and maintenance of the facility, there is the need to establish a quick reference on the various engineering issues concerning this department. This document is developed based on numerous established guidelines plus the input from the local CSSU practitioner and medical planners with the noble intention of reducing any operational and maintenance problems with regards to engineering systems and design. It covers the basic planning of the department, space and equipment requirements, and utilities requirements to support the equipment and department. Last but not least, the document also provides the basic roles of the hospital and instructions to be followed in planning and upgrading the process of existing facility and major equipment replacement in the department. Coupled with the inclusion of the latest construction and new policy requirements, this document shall be handy for all relevant parties.

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

16

2.

Central Sterile Supply Unit (CSSU)

Central Sterile Supply Unit (CSSU) is the center for processing reused medical devices and supplying sterilized products to various departments such as operation theatres, critical care departments, emergency department and wards. 2.1

Primary Functions 1) 2) 3) 4)

2.2

To receive, decontaminate, clean, dry, pack and sterilize contaminated reusable Medical Device (MD) to a level that provides an assurance of sterility. To sterilize soft goods before distributing to the relevant departments. To ensure that all decontamination and sterilization processes are carried out, monitored and adhered to the acceptable international standard. To manage all raw materials and sterilized MDs that are received/issued through CSSU to be continuously tracked, to ensure accountability and loss reduction in the most cost effective manner.

Location The location of the CSSU is dependent on the primary function i.e. to sterilize consumables and contaminated re-usable MDs. 1)

2) 3) 4) 5) 6)

CSSU shall be located near the main source of generation i.e. the operation theaters. It shall preferably be adjacent to and on the same floor of the operation theatres. CSSU shall also be close to critical care units and the emergency department. The potential risk of contamination of the sterile products shall be minimized by the shorter distance and travel time possible. There shall be a direct and easy access from the medical supplies store to the CSSU or from the CSSU to other users of departments via designated route(s). The routes for transporting dirty and sterile products shall, in any way or point, not be crossing each other. A designated route for maintenance activities shall be preferable. The CSSU shall not be placed in the inner part of the building to avoid complexity in the engineering system design and maintenance. Proper accessibility to the department and supporting engineering facilities shall be considered for maintenance and future equipment replacement activities.

17

Operation Theatres/ Critical Care Units/Wards/ ED

Receiving

Distribution

Decontamination Storing

CSSU Washing

Cooling

Inspection Sterilization Packing

Raw Material/ Linen/ MDs Figure 1- Primary Functions

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

18

2.3

Sterilization 2.3.1 Classification Reusable medical devices1 are classified based on device usage and their contact with body i.e. non-critical, semi-critical and critical. The classification is shown in the table below; Table 1 Spaulding Classification Non-Critical Semi-Critical Critical

Contact Level

Disinfection/ Sterilization

Skin, non-secretion membranes (e.g. bed pans, cuffs etc.) Mucous membrane or non-intact skin (some endoscopes, medical instrument blades etc.) Tissue or the vascular system (e.g. implants, invasive catheter etc.)

Low or Intermediate Level Disinfectant High Level Disinfectant Sterilization

Medical devices that have contact with sterile body tissues or fluids are considered critical items. These items shall be sterile when used because any microbial contamination could result in disease transmission. 2.3.2 Type of Sterilization Sterilization describes a process that destroys or eliminates all forms of microbial life and spores, and is carried out in health-care facilities by physical or chemical methods2. A product is said to be sterile when it is free from any viable microorganism present after it is sterilized. The level of sterility is referred as Sterility Assurance Level (SAL). SAL is expressed as 10-n. SAL of 10-6 is the probability of not more than one in a million microorganisms surviving after sterilization. There are three main parameters to be considered during sterilization i.e. temperature, pressure and time. Any change in one of the parameters affects the SAL. SAL (10-6) can still be achieved by manipulating the other two parameters within allowable limits i.e. increasing/decreasing the time, temperature or pressure. 1 Chemical disinfection of medical and surgical materials, Spaulding E.H. (Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, Page 10) 2 Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, Page 8

19

There are mainly two types of sterilization i.e. steam sterilization and low temperature sterilization used in hospitals. a.

High temperature (Steam) Sterilization

The steam sterilization process shall be applied for heat resistant medical devices because it has the largest margin of safety due to its reliability, consistency and lethality. There are two types of steam sterilizers i.e. gravity displacement type and prevacuum (dynamic-air-removal) type. The gravity displacement autoclaves are primarily used to process laboratory media, water, pharmaceutical products, regulated medical waste, and nonporous articles whose surfaces have direct steam contact. The high-speed pre-vacuum sterilizers, on the other hand, are fitted with a vacuum pump (or ejector) to ensure air removal from the sterilizing chamber and load before the steam is admitted. The advantage of using a vacuum pump is that there is a nearly instantaneous steam penetration, even into porous loads. Another design in steam sterilization is a steam flush-pressure pulsing process, which removes air rapidly by repeatedly alternating a steam flush and a pressure pulse above the atmospheric pressure. Typical sterilization temperatures and times are 132°C to 135°C with 3 to 4 minutes of exposure time for porous loads and instruments. The typical operating temperature and exposure times for the category of items sterilized in a gravity displacement and pre dynamic air removal (prevacuum) sterilizers are based on acceptable international standards. The medical devices shall be exposed to direct steam contact at the appropriate temperature and pressure for the specified time in order to accomplish sterilization. The ideal steam for sterilization shall be dry saturated steam and entrained water (dryness fraction ≥97%). The Bowie-Dick test shall be used to detect air leaks and inadequate air removal and consists of folded 100% cotton surgical towels that are clean and preconditioned. A commercially available Bowie-Dick-type test sheet shall be placed in the center of the pack.

20

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

Portable (table-top) steam sterilizers shall be used in outpatient, dental, and rural clinics. These sterilizers are designed for small instruments, such as hypodermic syringes and needles and dental instruments. The ability of the sterilizer to reach physical parameters necessary to achieve sterilization shall be monitored by mechanical, chemical, and biological indicators. Similarity, the steam cycle shall be monitored by mechanical, chemical, and biological monitors. Steam sterilizers shall have a printout (or shown graphically) by measuring the temperature, the time at the temperature, and pressure. Typically, chemical indicators shall be affixed to the outside and incorporated into the pack to monitor the temperature or time and temperature. b.

Low temperature sterilization

There are a few types of low temperature sterilization i.e. Hydrogen Peroxide Gas Plasma, Ethylene Oxide Gas and Peracetic Acid. These low temperature sterilizers are used for MDs that are susceptible to heat and moisture e.g. plastic and electrical devices. Some of the common types are briefly described in the following paragraphs. 1)

Hydrogen Peroxide Gas Plasma The sterilant used in this sterilizer is Hydrogen Peroxide solution which vaporizes and comes in contact with the surface of the load. Electrical field created using radio frequency is applied to the vapor which generates microbicidal free radicals (hydroxyl and hydroperoxyl). These radicals inactivate the microorganisms. The advantage of this sterilizer is that the by-products of this type of sterilization are water vapor and oxygen. The process operates in the range of 37-44oC and has a cycle time of about 75 minutes.

2)

Ethylene Oxide (EtO) Gas Sterilizer The sterilant used in this sterilizer is EtO gas which is colorless, flammable and explosive. The distinct disadvantage of this sterilizer is the long processing time (1-6 hours) and aeration time (8-12 hours at 50-60oC).

21

Since EtO poses a potential health hazard to the staff and patient, a proper installation to prevent exposure and personnel monitoring mechanisms shall be applied. Local exhaust ventilation system shall be installed at this sterilizer. 3)

Peracetic Acid Peracetic acid is a highly biocidal oxidizer that maintains its efficacy in the presence of organic soil. Peracetic acid removes surface contaminants (primarily protein) on endoscopic tubing. The sterilant, 35% peracetic acid, and an anticorrosive agent are supplied in a single-dose container. The concentrated peracetic acid is diluted to 0.2% with filtered water (0.2 μm) at a temperature of approximately 50oC. The container is punctured at the time of use, immediately prior to closing the lid and initiating the cycle. The sterilant is pumped through the channels of the endoscope for 12 minutes, decontaminating the exterior surfaces, lumens, and accessories.

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

22

3.

General Function and Layout

The general function of the department shall be addressed by specifying the right flow of materials and personnel, proper areas zoning, sufficiently sized equipment, and provision for future expansion. The details of the departmental layout such as type of rooms, size, orientation, and location shall be strictly adhered to the guideline produced by the Planning Division, Ministry of Health. The provision of proper air movement, environmental parameters controlled and pressurization scheme shall be strictly adhered to in order to eliminate the potential risk of cross contamination. The actual details of rooms, size and orientation shall be finalized prior to the construction of the department involving all relevant parties subjected to the actual project area and complying with the requirements of standard. The use of newly advanced washing and sterilizing equipment utilizing energy/water efficient mechanisms shall be encouraged. Based on the available space area, the double doors version of equipment shall be preferable. The use of information technology in the process of registration, verification, validation, stock circulation and tracking mechanism shall be promoted for efficient management of CSSU. Proper intra route and adequate space between equipment or nearby installation/wall for maintenance access or activities shall be provided. 3.1

Basic CSSU Layout The basic layout shall be designed to meet the principle function of CSSU and be equipped with the proper supporting facilities in resulting infection-free sterilized medical devices. The design shall allow flexibility and creativity in space utilization and equipment sizing without compromising the principle of infection control and cross contamination prevention. A CSSU shall be made up of three clearly indicated zones namely the soiled zone, clean zone and sterile zone.

23

Figure 2: The Basic Zoning and Pressurization Trends in CSSU For the double doors equipment arrangement, the washer disinfectors and sterilizers shall act as the primary and secondary physical barriers. For the single door equipment set up, the soiled area shall be clearly separated from the clean or sterile area. The movement of personnel and material within the CSSU shall be properly designed to ensure no or minimum contamination of the sterile products. The layout and proposed workflow in CSSU shall comply with the latest safety requirements by Fire Department. Dedicated escape route for staff shall be established to accommodate safe evacuation in the event of fire or any other emergency incidents. The layout shall preferably allow adequate space for the future expansion of services by the department. The following chart shall serve as a basic guide for area distribution in the new CSSU. The actual percentage may differ at the site based on the specific requirement at a particular hospital.

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

24

15%

20%

15% 20% 30%

Auxilliary zone Cleaning area Preparation zone Steriled products storage Storage room

Figure 3: Proposed Area Distribution in CSSU 3.2

Staff Movement Staff safety and wellbeing is crucial as they constantly come in contact with contaminated re-usable medical devices. The safety aspects involve administrative controls i.e. controlling the staff movement and the donning of personnel protective gears. The staff movement shall be restricted within zones so as to minimize any cross contamination within the zones. The staff movement shall abide to the CSSU operational policies and/or by use of dedicated security passes. Staff entering the soiled zone shall go through a dedicated change room where they wear the appropriate clothing and Personnel Protective Equipment (PPE) e.g. gloves, face mask, wet boots etc. Staff working in clean zone shall enter the clean zone through a dedicated change room where they wear appropriate clothing and PPE, while staffs working in the sterile zone shall then proceed through a door between the clean and sterile zones.

25

3.3

Material Movement There are various types of material moving within the CSSU i.e. contaminated reusable medical devices, clean medical devices, linen and consumables. Contaminated re-usable medical devices arriving from various locations shall be processed from the most soiled (dirtiest) part of the CSSU to the cleanest part of the CSSU. 3.3.1 Soiled Zone The Soiled Zone is where soiled items are received from the user locations. Here, the items are decontaminated, cleaned and disinfected. Soiled Zone is made up of the following areas; 1) 2)

3) 4) 5) 6) 7)

Receiving Area Stainless steel tables counter Cleaning Area a. Decontaminating Area b. Manual Washing c. Ultrasonic cleaning area Disinfection a. Automated Washing Area b. Automated Cart Washer Hand washing facilities Bins or other containers for the disposal of waste Detergent Room Stainless cabinet Exhaust fan Cleaning equipment room / area

3.3.2 Clean Zone The Clean Zone is where items that have been cleaned are inspected, assembled and packed before they are sent for sterilization. Clean Zone is made up of the following areas;

26

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

1)

2) 3) 4) 5) 6)

Inspection, Assembly and Packing Stainless packing table with wheels and locking system Magnifying glass on each table Heat seal machine Digital weighing scale ( place on table) Documentation and Label Printing Area Clean Stores Sterilizer Loading Area Linen Room Inspection table with lamp Exhaust fan Soft Dressing Room Packing table and adjustable chair with back rest Exhaust fan

3.3.3 Sterile Zone The Sterile Zone is where the loads are sterilized, cooled, stored and prepared for dispatch to the end-user. The Sterile Zone is made up of the following areas; 1) 2) 3) 4)

Sterilizer Cooling Area Sterilized Products Storage Area and Sterile Item Issuing Area

27

4.

Service Area within Zone

4.1

Soiled Zone 4.1.1 Receiving Area This area is the entrance to the Soiled Zone. A.

Function 1) This area is where contaminated re-usable medical devices from various user locations are deposited for processing. 2) All items received shall be recorded.

Stainless steel tables

Computer and bar code scanner

B.

Activities carried out 1) Contaminated items are received at the counter where they are sorted out, scanned and logged. 2) The items are forwarded to the decontamination area and the trolleys are sent to the Cart Washer.

C.

Requirements 1) It shall be at the entrance to the CSSU. 2) The entrances shall be secured to prevent access by unauthorized people. 3) A “red-line” is to be drawn out on the floor to designate the beginning of the area, where soiled trolleys and materials are to enter.

28

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

D.

Fixtures, Fittings and Equipment 1) Computer with CSSU management software 2) Uninterruptable Power Supply for computer 3) Bar code scanner 4) Stainless steel tables 5) Moveable stools with back support

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) Switch socket outlets for computer, and scanner 3) Data ports for network connections 4) Door access control 5) Intercom and telephone connection

4.1.2 Cleaning Area Cleaning of MDs is the first step towards sterilizing re-usable MDs. The purpose is to clean and rinse the MDs so as to remove all visible debris and reduce the number of particulates, micro-organisms and potential pathogens. Thorough cleaning and rinsing are vital for the effectiveness of subsequent processes used for decontamination, disinfection and / or sterilization. Ineffective cleaning and rinsing of the MDs may result in foreign material on the device to interfere with the effectiveness of subsequent disinfection and / or sterilization. 4.1.2.1 Decontamination Area A.

Function 1) Some of the soiled MDs that are deemed unsafe to handle shall be decontaminated before they are further cleaned and processed. 2) Decontamination is carried out by immersing the soiled MDs in chemicals that will inactivate or destroy bloodborne pathogens on a surface or difficult to access locations on the MDs e.g. the joints; so that they are no longer capable of transmitting infections and are rendered safe for handling.

29

Stainless steel table tops with deep sink

Signage identify the area

B.

Activities carried out 1) Highly contaminated MDs are immersed in special stainless steel bowls with covers.

C.

Requirements 1) Area is identified and labeled as “BIOHAZARD INSTRUMENTS”. 2) There shall be space for foot operated clinical waste bins.

D.

Fixtures, Fittings and Equipment 1) Double Bowl Stainless Steel Deep Sink 2) Stainless steel table tops 3) Moveable stools

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) Cold water supply to the hand wash basin

4.1.2.2 Manual Cleaning Area A.

Function 1) Soiled MDs that are deemed unsuitable for automated cleaning are manually cleaned. Manual cleaning is recommended for MDs that are delicate or complex, such as micro-surgical devices, instruments having lenses (scopes) and air-powered drills.

B.

Activities carried out 1) Soiled MDs are sorted, cleaned and rinsed.

30

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

C.

Requirements 1) Adjacent to the decontamination area.

D.

Fixtures, Fittings and Equipment 1) Double Bowl Stainless Steel Deep Sink 2) Stainless steel tables 3) Moveable stools 4) Spray gun at sink to facilitate the cleaning of lumens (hollow, tubular instruments)

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) Cold water supply to deep sink 3) Medical air 4) Laparoscopic Insulation Tester

Laparoscopic Insulation Tester 4.1.2.3 Ultrasonic Cleaner A.

Function 1) Ultrasonic cleaner is the most effective and efficient way to clean instruments with small crevices, cavities, lumens, and between tightly spaced parts, where it is hard to reach during manual cleaning. It is able to remove debris from challenging areas of the instrument e.g. the box lock, jaw, ratchets, hinges, serrations, reamers and drills. To maximize its effectiveness, the instruments shall first be cleaned of all visible debris.

31

Ultrasonic Cleaners

Ultrasonic Cleaner with de-ionized water treatment system, hot water boiler and detergent dispenser

B.

Activities carried out 1) Cleaning is done using de-ionized water with detergents.

C.

Requirements 1) The ultrasonic cleaner shall have an interlocking lid and thermostatically controlled heaters/ hot water boiler.

D.

Fixtures, Fittings and Equipment 1) Rack with baskets

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) De-ionized water 3) Switch socket outlets 4) Water outlet 5) Hot water boiler

4.1.2.4 Washer Disinfector (WD) There are two types of WD i.e. single chamber and multi-chamber (tunnel washers). A.

Function 1) The WD’s primary function is to wash, disinfect and lubricate the instruments. 2) A typical wash cycle in a WD is pre-rinsing, cleaning (with detergent), post rinsing (with lubrication), thermal disinfectant, final rinse and the drying phase. 3) The whole cycle is automatically validated.

32

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

4) 5)

The WD forms a part of the primary physical barrier between the Soiled Zone and the IAP Zone. These washers form the primary physical barrier between the soiled and clean zones.

Washer disinfectors

Transfer trolley in front of washer disinfector

B.

Activities carried out 1) Disassembled and washed items are placed in wire mesh baskets which are then placed into the appropriate carriers that are loaded into the WD. 2) Cleaning detergent (enzymatic and non-enzymatic) and lubricant are loaded into the WD prior to the switching on the cycle.

C.

Requirements 1) Dedicated floor mounted conveyor line (to suit WDs). 2) The WDs shall be sufficiently ventilated to remove heat and smell from disinfecting agents.

D.

Fixtures, Fittings and Equipment 1) Transfer trolleys 2) Conveyor lines

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) Domestic hot and cold water supply 3) De-ionized water 4) Switch socket outlets 5) Water outlet 6) Intercom

33

4.1.2.5 Cart Washer A.

Function 1) The main functions of the washer are to wash, disinfect and dry the soiled carts (trolleys). 2) The wash cycle may consist of pre-rinsing, cleaning (with detergent), post rinsing (with lubrication), thermal disinfectant, final rinse and the drying phase. The whole process of the washing cycle is automatic.

Cart Washer

B.

Activities carried out 1) Trolleys are placed into the Cart Washer and the washing process is initiated. 2) Disinfectants need to be replenished.

C.

Requirements 1) There shall be a dedicated room adjoining the cart washer to accommodate the boiler and air compressor. This room can either come as part of the cart washer package or is dedicated to the facility. 2) There shall be sufficient space provided around the equipment for inspection and repairs, while the access doors shall be sized appropriately to allow a complete replacement of the equipment. 3) There shall be a water jet facility to be used to clean the washer disinfector.

D.

Fixtures, Fittings and Equipment 1) Dedicated steam boiler 2) Dedicated compressed air

34

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) Domestic hot and cold water supply 3) Switch socket outlets 4) Waste water outlet 5) Water jet facility 6) Compressed air to dry the trolley

Water jet facility

4.1.2.6 Transfer Hatch A.

Function 1) The transfer hatch is used to transfer large, manually cleaned and disinfected MDs and none-MDs to the next Zone (IAP Zone). The none-MDs that are transferred are baskets and instrument trays. 2) This hatch forms a part of the primary physical barrier between the Soiled Zone and the Clean Zone. 3) The transfer hatch door facing the Soiled Zoned and the one facing the IAP Zone shall be interlocked, allowing only one door to be opened at one time.

35

Transfer hatch

B.

Activities carried out 1) Large, cleaned and disinfected MDs and non-MDs are passed through this hatch.

C.

Requirements 1) The hatches shall be able to close so as to create an airlock to minimize the air movement between the Soiled Zone and the Clean Zone. 2) Dedicated floor mounted conveyor lines shall be placed at the Transfer Hatch.

D.

Fixtures, Fittings and Equipment 1) Stainless steel conveyor lines

E.

Engineering Services Required 1) For general requirements, refer to Section 6. 2) Intercom shall be installed for staff to communicate between the two zones.

4.1.2.7 Medical Drying Cabinet A.

Function 1) This cabinet generates hot air that is used to dry MDs such as anesthetic hoses, breathing bags, hollow ware and tubing.

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

36

Drying cabinets with utensils on rack

4.2

Drying cabinets with tube rack

B.

Activities carried out 1) MDs are placed in the drying cabinets for a period of time under fixed temperatures.

C.

Requirements 1) There shall be sufficient space at the back of the dryer for proper air circulation.

D.

Fixtures, Fittings and Equipment Not Applicable

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) Switch Socket Outlet

Clean Zone 4.2.1 Inspection, Assembly and Packing Area (IAP Area) A.

Function 1) In this area, MDs are Inspected, Assembled and Packed prior to sending them for sterilization.

37

Worktable at IAP

Rack with pouches

Worktable with bins

B.

Activities carried out 1) Here, the MDs are placed on a stainless steel table laid with wrapping sheets where they are inspected, assembled and packed. Stainless steel storage racks are also made available in this area to store paper wrapping sheets. 2) MDs are inspected to ensure that they are clean and not damaged. The instruments are also inspected for their functionality and are lubricated when required. 3) The MDs and consumables are assembled in sets or in trays based on the standard checklist for their final use (surgical procedures).

38

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

4)

The assembled packages are then packed in proper wrappers/ pouches, sealed, and labeled. Biological indicators are placed in the middle of the load and chemical indicators are placed inside and outside of the packing to validate the sterilization process.

C.

Requirements 1) IAP area shall be sufficiently sized and suitably arranged. 2) Minimum distance from the machine & working table shall be allowed for material and staff maneuverability. 3) Windows to the outside shall be encouraged; however, when installing, the windows need to be sealed. 4) Internal walls and doors shall have vision panels. 5) The area shall be under positive pressure differential with respect to adjacent areas.

D.

Fixtures, Fittings and Equipment 1) Adjustable height, stainless steel packing tables 2) Adjustable height, stools 3) Stainless steel storage racks 4) Stainless steel, wrapper racks 5) Stainless steel “wire” containers or plastic/polypropylene baskets. 6) Table lamp with light and magnifier 7) Mobile, high adjustable stools 8) Stainless steel trolleys 9) Rotary Heat Sealing Machine (2 different types) a. for sealing both types of high temperature and high pressure pouches and bags; and b. for sealing low temperature pouches and bags.

E.

Engineering Services Required 1) For general requirements, refer to Section 6. 2) IAP area shall be air conditioned and designed for appropriate class of clean room. 3) The area shall be under positive differential pressure with respect to adjacent areas. 4) Natural lighting from windows is encouraged. Task lighting shall be in place where items are inspected at IAP tables. 5) Switch socket outlets shall be required for the task lighting.

39

4.2.2 Documentation and Label Printing Area A.

Function 1) In this area, all the different packing checklists are printed so that the nursing staff can use this checklist to assemble the MDs sets based on the operation requirement. 2) Bar code labels are also printed and scanned to capture all relevant information.

Computer with printer

Scanner with label printer

B.

Activities Carried Out 1) Checklist for the assembly of sets are printed out 2) Labels are printed out 3) Labels are placed on the scanner and packed

C.

Requirements 1) Propriety software for CSSU management

D.

Fixtures, Fittings and Equipment 1) Computer 2) Printer for checklist 3) Label printer and scanner 4) Uninterruptible Power supply (UPS) 5) Stainless Steel Table 6) Movable stool

E.

Engineering Services Required 1) For general requirements, refer to Section 6. 2) Switch socket outlets for computer, printer, scanner.

40

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

3) 4)

Data line for network. Intercom and telephone connection.

4.2.3 Clean Stores There are basically four different types of clean stores i.e. “Stor Pukal (bulk store), “Stor Peralatan” (instrument store), “Stor Kain Kasa” (soft goods store) and “Stor Kain” (linen store). A.

Function 1) The bulk store is used to store items purchased in bulk, especially the bulky items e.g. sterilization wrapping paper, pouches and autoclave tape, etc. The instrument store is used to store medical devices to stock up on any deficiency in the packing or faulty device. The swab/gauze store is where gauze is repackaged into the desired packing e.g. gauze pad, gauze bandages, gauze sponge, swabs etc. The linen store is where clean linen is stored and packed as a part of the procedural accessories e.g. surgical towel, mayo stand cover, drape sheet etc. 2) These stores are used to store clean items (consumables) before there are sent to the packing area or directly to the sterile loading area for sterilization.

Rack in bulk store

Rack in soft goods store

41

B.

Activities Carried Out 1) Items are stored in these stores and in some cases, packed prior to sending them for sterilization.

C.

Requirements 1) The swab/gauze cutting table in the store shall have a Local Exhaust Ventilation system. 2) Linen packing area shall be properly lit so that the user can clearly see and pick any frayed linen (loose thread).

D.

Fixtures, Fittings and Equipment 1) Stainless steel storage racks 2) Stainless steel table and movable stool 3) Rotary heat sealing machine 4) Illuminated linen inspection table 5) Gauze cutting machine

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) Switch socket outlets for rotary heat sealing machines and gauze cutting machine. 3) There shall be a Local Exhaust Ventilation (LEV) system in the swab/gauze store. This LEV is used to exhaust out any debris generated during the cutting and repackaging process. The LEV shall be so designed to take into account the fire hazard posed by lint and dust. 4) Data line for network

4.2.4 Sterilizer Loading Area A.

Function 1) Packed sets shall flow from the IAP area to the Sterilizer Loading Area. 2) Sterilizer Loading Area is where packed sets and trays are placed in baskets and mounted on trolleys, parked and awaiting to be loaded into sterilizers. 3) The loads entering this area are sorted based on the type of sterilization e.g. high pressure steam sterilization or those requiring low heat (plasma) sterilization. (Plasma sterilization is discussed as a separate topic). 4) In case of high pressure single-door sterilizers, this area is used to load and un-load packed items into and out of the sterilizers.

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

42

5) 6) 7)

In case of double-door sterilizers, the loading is done in this area while the un-loading is done in a separate area (cooling area) on the other end of the sterilizer (sterile zone). There shall be a dedicated area to hold visibly defective packs before the sterilization process. Proper extraction mechanism above the opening of sterilizer shall be provided.

Demarcated loading area

3

Trolley parking bay

B.

Activities carried out 1) Loads are received and held in this area before they are loaded into the sterilizer for sterilization and unloaded after sterilization.

C.

Requirements 1) Space requirement shall be based on the three elements i.e. number of trolleys used, the space required for the trolleys to move around and space for loading and unloading. Space requirements shall comply with the manufacturer’s requirements. A minimum of 2m3 space is required in front the sterilizers. This area shall be demarcated by a colored line. 2) The area shall be under positive differential pressure with respect to adjacent areas.

D.

Fixtures, Fittings and Equipment Not Applicable.

E.

Engineering Services Required 1) For general requirements, refer to Section 6.

IUSS Health Facility Guides, Central Sterile Service Department (Proposal V.1) 21st March 2014, Page 60

43

4.2.5 Sterilizer Room A.

Function 1) This room is used to accommodate sterilizers and its associated plant and equipment e.g. steam generator (boilers), compressor, water pump, test points for water etc.

Steam generator

B.

Activities carried out 1) Maintenance and repair works are carried out in this area. 2) Water quality is checked in this area at the test points.

C.

Requirements 1) There shall be sufficient space within the plant room to accommodate the sterilizers, its associated plants and equipment. Space requirement shall be based on the number of sterilizer and associated equipment. 2) Sufficient space shall also be provided to allow the maintenance personnel to carry out their maintenance works. 3) Manufacturer’s requirement shall be adopted. 4) The plant room shall be ventilated to remove heat released during the sterilization process and discharge from safety valves. An exhaust system shall be installed.

D.

Fixtures, Fittings and Equipment Not Applicable

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) High pressure steam sterilizers from a central boiler or localized steam generator.

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

44

3) 4) 4.3

Any autoclaves, steam generators and air compressors shall require the JKKP certificates. Exhaust system

Sterilization Zone 4.3.1 Sterilizers 4.3.1.1 Steam Sterilizers A.

Function 1) These steam sterilizers are also known as free standing autoclaves and are used to sterilize items that are able to withstand high temperature. 2) These sterilizers form the secondary physical barrier between the clean and sterilized zones.

Steam sterilizer-loading end

B.

Steam sterilizer- unloading end

Activities carried out 1) Packed sets and trays are placed onto carriers that are loaded into the sterilizer. 2) The autoclave operators need to ensure that the desired sterilizer program is initiated and that the sterilizer completes it sterilization cycle. 3) The autoclave operators will unload the sterilized products and validate that the sterilization cycle has been completed.

45

C.

Requirements 1) There shall be sufficient numbers of sterilizers to meet the demand of the hospital. 2) There shall be sufficient space for future expansions (additional sterilizers).

D.

Fixtures, Fittings and Equipment 1) Steam sterilizers 2) Steam generators 3) Air compressors

E.

Engineering Services Required 1) For general requirements, refer to Section 6. 2) There shall be sufficient numbers of switch socket outlets. 3) There shall be a drainage system to facilitate the discharge of condensate and dirty water arising from cleaning the sterilizer. 4) There shall be a dedicated or shared Local Exhaust Ventilation (LEV) hood just in front and at the other end of the sterilizer to exhaust the gush of steam whenever the sterilizer door is opened for loading and unloading. Exhaust system shall also be installed above the sterilizers. This exhaust system can be a part of the sterilizer plant room’s LEV system.

4.3.1.2 Ethylene Oxide (EtO) Sterilizers A.

Function 1) Heat sensitive loads are sterilized in these low temperature sterilizers.

Ethylene Oxide Sterilizer

46

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

B.

Activities carried out 1) Packed sets are placed into the sterilizing chamber. 2) The autoclave operators need to ensure that the desired sterilizer program is initiated and that the sterilizer completes its sterilization cycle. 3) The autoclave operators will unload the sterilized products and validate that the sterilization cycle has been completed.

C.

Requirements 1) There shall be sufficient numbers of sterilizers to meet the demand of the hospital. 2) There shall be sufficient space for future expansions (additional sterilizers).

D.

Fixtures, Fittings and Equipment 1) Ethylene Oxide Sterilizers (Low temperature sterilizer) 2) Aerator (new sterilizers may not have a separate aerator)

E.

Engineering Services Required 1) For general requirements, refer to Section 6. 2) There shall be sufficient numbers of switch socket outlets. 3) There shall be a dedicated Local Exhaust Ventilation (LEV) system to exhaust the residual Ethylene Oxide.

4.3.1.3 Hydrogen Peroxide (Plasma) Sterilizers A.

Function 1) Heat sensitive loads are sterilized in these low temperature sterilizers.

Plasma Sterilizer (Low Temperature Sterilizer or Hydrogen Peroxide (Plasma) Sterilizers )

47

B.

Activities carried out 1) Packed sets are placed into the sterilizing chamber. 2) The autoclave operators need to ensure that the desired sterilizer program is initiated and that the sterilizer completes it sterilization cycle. 3) The autoclave operators will unload the sterilized products and validate that the sterilization cycle has been completed.

C.

Requirements 1) There shall be sufficient numbers of sterilizers to meet the demand of the hospital. 2) There shall be sufficient space for future expansions (additional sterilizers).

D.

Fixtures, Fittings and Equipment Not Applicable.

E.

Engineering Services Required 1) For general requirements, refer to Section 6. 2) There shall be sufficient numbers of switch socket outlets.

4.3.2 Cooling Area A.

Function 1) This area is located on the unloading side of the double-door sterilizer. Here, items that have been sterilized are removed from the autoclaves and placed onto trolleys, where they are allowed to cool to room temperature.

Sterilized load in cooling area

48

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

B.

Activities carried out 1) Sterilized item are unloaded from the sterilizer onto trolleys, where they are allowed to cool to room temperature.

C.

Requirements Not Applicable.

D.

Fixtures, Fittings and Equipment 1) Sufficient number of trolleys are available.

E.

Engineering Services Required 1) For general requirements, refer to Section 6.

4.3.3 Sterilized Product Storage Area A.

Function 1) Once the items have been sterilized and cooled in the Cooling Area, they are transferred to the sterile store. The sterile store is the cleanest area in the CSSU. 2) Items are stored on open shelf stainless steel racks.

Sterilized products on racks in sterile store

B.

Activities carried out 1) Items are loaded and un-loaded onto or from the open shelf stainless steel racks.

49

C.

Requirements 1) There shall be no source of contamination e.g. wash areas, trash bins. 2) The store shall be in an area with minimum traffic flow.

D.

Fixtures, Fittings and Equipment 1) There shall be sufficient space around the racks for proper storing of the sterilized items. 2) The lowest shelf of the rack shall be 250mm above the floor; while the top part of the rack shall be 440mm from the ceiling4. 3) Air-conditioned.

E.

Engineering Services Required 1) For general requirements, refer to Section 6.

4.3.4 Sterile Item Issuing Area A.

Function 1) Sterilized items are issued from this sterile issue area to the users.

Computer with scanner

B.

Activities carried out 1) Sterilized items are issued at this area.

C.

Requirements Not Applicable

Issuing area

4 Guideline Storage Design for Sterile and Non-Sterile Stock for New and Refurbished Healthcare Facilities, Centre for Healthcare Related Infection Surveillance and Prevention & Tuberculosis Control, Queensland Government

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

50

4.4

D.

Fixtures, Fittings and Equipment 1) Counter top or table. 2) Computer with dedicated CSSU module 3) Printer 4) Uninterrupted Power Supply (UPS) 5) Label scanner. 6) Stainless shelves to store empty wire basket

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) Switch socket outlets for computer, printer and label scanner 3) Data ports for network connections 4) Intercom and telephone connection

Administrative and Staff Facilities 4.4.1 Administrative Office A.

Function 1) This office is to be used by the person in-charge of the CSSU. The setup shall be consistent with the setup of any office in the hospital.

B.

Activities carried out 1) Administrative works are carried by the person in-charge.

C.

Requirements 1) The office shall be located in the clean zone so as to allow the person in-charge to observe the various activities at this area. 2) The internal walls and doors shall have vision panels.

D.

Fixtures, Fittings and Equipment 1) Office furniture e.g. table, chairs, cupboards and filing cabinets. 2) Whiteboard 3) Computer and printer 4) Uninterrupted Power Supply (UPS) 5) Waste bins

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) Switch Socket Outlets for computer and printer

51

3) 4)

Data ports for network connection Intercom and telephone connection

4.4.2 Meeting Room A.

Function 1) The meeting room can either be used specifically for the purpose of conducting a meeting or can also be used as a training room. The meeting room can also be used for departmental activities.

B.

Activities carried out 1) Meeting or trainings are conducted in this facility.

C.

Requirements 1) The meeting room shall be located in the clean zone and away from the all the work areas. 2) The internal walls and doors shall have vision panels.

D.

Fixtures, Fittings and Equipment 1) Meeting table and chairs 2) Whiteboard 3) Computer 4) Overhead/LCD projector cum with screen 5) Waste bins

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) Switch socket outlets for computer, printer and overhead/ LCD projector 3) Data ports for network connections 4) Intercom and telephone connection

4.4.3 Change Room Change Rooms shall be made available for staff to change their clothing to hospital gowns and wear Personnel Protective Equipment. There shall be a set of male and female change rooms with wash room facilities. These change rooms shall be located at the soiled zone and clean zone. A.

Function 1) This facility is for staff to change into or out of the protective clothing or gowning.

52

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

B.

Activities carried out 1) All staffs and visitors entering or leaving the CSSU are required to change into appropriate clothing.

C.

Requirements 1) There shall be separate change rooms for male and for female staff. 2) The facility shall have washrooms preferably with shower facilities. 3) There shall be a step-over-barrier to demarcate the clean and dirty areas within the change room. 4) There shall be sufficient lockers for the staff and spares for visitors. 5) There shall be shelves for clean gowns and PPE storage. 6) There shall be space for soiled linen bins and foot operated clinical waste bins.

D.

Fixtures, Fittings and Equipment 1) Shelves and lockers 2) Hand wash basin with no plug and overflow 3) Hands-free tap that do not discharge directly into the drain aperture 4) Footwear storage facility 5) Wall mounted mirror in the wash room for staff

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) Cold water supply to the hand wash basin, shower and washrooms 3) Intercom

4.4.4 Rest/Staff Room A.

Function 1) The rest room is used specifically by the staff to have a break, refreshing oneself, rest or have a meal

B.

Activities carried out 1) A place where staff discuss about work and socialize during breaks

53

C.

Requirements 1) Shall be away from processing area

D.

Fixtures, Fittings and Equipment 1) Table and chairs 2) Cabinets for storage 3) Lockers 4) Sinks 5) Refrigerator 6) Microwave oven

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) Cold water supply to the hand wash basin 3) Switch socket outlets 4) Intercom and telephone connection

4.4.5 Prayer Room A.

Function 1) The prayer room is a room where staff can perform their religious obligations

B.

Activities carried out 1) Staff can perform their prayer activities within this facility

C.

Requirements 1) There shall be separate prayer rooms for male and female staff with ablution facilities

D.

Fixtures, Fittings and Equipment 1) Prayer mats

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) Ablution facilities 3) Cold water supply for ablution

54

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

4.4.6 Personnel Protective Equipment (PPE) store A.

Function 1) Personnel Protective Equipment store is a store where safety attires such as gowns, boots, face masks etc. are stored

B.

Activities carried out 1) PPE are kept on racks and are withdrawn for use as and when required.

C.

Requirements 1) The PPE store shall be located in the clean zone. 2) This store shall be secured and only assigned staff shall have access to it.

D.

Fixtures, Fittings and Equipment 1) Stainless steel racks

E.

Engineering Services Required 1) For general requirements, refer to Section 6

4.4.7 Detergent and Disinfectant Store (Chemical Store) A.

Function 1) The store is used to store detergents and disinfectants used for decontamination, cleaning and washer disinfector processes 2) Housekeeping cleaning chemicals shall not be stored in this area

B.

Activities carried out 1) Detergents and disinfectants are stored on racks and are withdrawn based on the CSSU usage. 2) The detergents and disinfectants are topped-up based on their re-order level.

C.

Requirements Not Applicable

D.

Fixtures, Fittings and Equipment 1) Stainless steel shelves

55

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) Local exhaust ventilation will be required where chemicals are subjected to an occupational exposure limit as per OCCUPATIONAL SAFETY AND HEALTH (USE AND STANDARDS OF EXPOSURE OF CHEMICALS HAZARDOUS TO HEALTH) REGULATIONS 2000.

4.4.8 Disposal Room/Soiled Utility Room A.

Function 1) This room is used to hold clinical and non-clinical waste for collection and disposal

B.

Activities carried out 1) Clinical waste and non-clinical waste bags and bins are stored in this room and are collected by the Clinical Waste (CW) Disposal personnel for disposal and the consumables are replaced

C.

Requirements Not Applicable

D.

Fixtures, Fittings and Equipment 1) Stainless steel racking

E.

Engineering Services Required 1) For general requirements, refer to Section 6

4.4.9 Receive and Break Pack Room A.

Function 1) It is a room where all clean consumables and new MDs are received for further processing 2) Bulk items are also received here and unpacked before sending them to the clean rooms

B.

Activities carried out 1) Items are received and unpacked into small packs

56

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

C.

Requirements 1) The store shall be secured and only assigned staff shall have access to this store 2) Dedicated CSSU module

D.

Fixtures, Fittings and Equipment 1) Stainless steel racks 2) Counter top or table 3) Computer 4) Printer 5) Uninterrupted Power Supply (UPS) 6) Label scanner

E.

Engineering Services Required 1) For general requirements, refer to Section 6 2) Switch socket outlets for computer, printer and label scanner 3) Data ports for network connections 4) Intercom and telephone connection

57

5.

General Information

5.1

Calculating the size of the CSSU The size of a CSSU shall be generally determined by; 1) 2)

3) 4) 5)

The workload demand of sterile products from various departments within or outside the hospital. The footprint requirement for the placement of sterilizing and decontaminating equipment, supporting built-up (benches, cabinet etc.), administrative spaces, routes for achieving material and personnel flow, storage areas and so on. The circulation area for the handling of materials and sterilized goods to promote safe and effective working environment. The appropriate space for trolley and personnel maneuverability during operation. Proper clearance between the equipment and the working bench. The space for maintenance activities and for future expansion to cater to additional load demand.

The size of the CSSU shall be based on the maximum simultaneous demand. 5.2

Information required in determining the number and size of major equipment (sterilizers and washers) Sterilizers and washer disinfector are amongst the costly equipment in the CSSU. Due to the high initial capital cost, a proper decision making needs to be made during the purchase of this equipment. When designing a new or refurbishing an existing CSSU, it is best to engage the professional services of the sterilizer’s manufacturers/suppliers to determine the type, size and quantity of sterilizer required. Some of the information that may be requested include; 1) 2) 3) 4) 5) 6)

Number of hospital beds Number of operating theatres, ICU, HDW, and wards Number of delivery per day Average number and type of surgical procedures per day per operating theatre, or total surgical procedures for all the operating theatres Number of hours the CSSU will be in-operation per day and number of operating days per week Number of outside box

58

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

It is better to have two smaller sized equipment than having one large equipment to accommodate the services during maintenance and breakdown. The number of equipment shall be calculated on the basis of running and standby arrangement. All equipment shall be designed to be operated alternately at any times. Due to space utilization, the recommended size of sterilizer shall be 20cu.ft for district hospitals and 30cu.ft for general hospitals. For the general hospital, the designer shall consider the additional depth of the sterilizer in view of the maintenance area behind the equipment and the width of physical barrier for the double door type. The usable volume for washer disinfector shall be in the range of 280-300L for general hospitals and 180-200L for district hospitals. No gap between the equipment and the floor shall be permitted in the double door washer disinfector arrangement. The major equipment characteristics shall include the following consideration. 1) 2) 3) 4) 5)

Complimentary and functional Ergonomics, hygiene and safe Compatible Adapted to the production Complying to the applicable standards

59

6.

Architectural and Engineering Services

6.1

Architectural Finishes 6.1.1 Wall 1) Full heighted fire wall shall be provided for the washer and sterilizer room. 2) Walls shall be of solid construction so as to eliminate the risk of infestation. 3) Walls shall be washable, scrub-able, smooth, water resistant and not easily damaged by chemical and disinfectants e.g. tiled, epoxy painted or spray painted. Tiled walls shall be encouraged to be installed in soiled zone as they are easier to clean. 4) Walls shall be free of fissures, open joints, or crevices that may retain or permit the passage of dirt particles. 5) Walls penetrated by pipes, ducts and conduits shall be tightly sealed. 6) Joints shall be avoided as they can hold moisture, encouraging the growth of organisms. Joints of structural elements shall be sealed if necessary. 7) In processing areas, finishes shall be suitable for frequent cleaning and tolerant to surface-cleaning agents. 8) Proper insulation material shall be installed for areas served by the air conditioning system. The thickness of insulation shall be specified to meet the requirement of the 24 hours or 8 hours operation. 9) Walls shall be protected against accidental damage from wheeled traffic by buffer rails and corner guards, which shall be appropriately sited to reflect the specifications of trolleys in use. 6.1.2 Ceiling 1) Ceiling shall be monolithic from wall to wall without fissures; i.e. there shall be no open joints that may retain or permit the passage of dirt particles or supporting microbial growth. This type of ceiling is to be implemented at the IAP area and sterile store. 2) Proper insulation material shall be installed for areas served by the air conditioning system. The thickness of insulation shall be specified to meet the requirement of the 24 hours or 8 hours operation. 3) Seamless ceiling for packing and sterile store. Lighting casing in the ceiling shall match the ceiling for ease of cleaning and maintenance. 4) Ceiling shall be cleanable, impervious and of durable finishes. The ceiling shall be able to withstand disinfecting and cleaning agents without deterioration.

60

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

5) 6)

Ceilings shall be resistant to humidity where steam and moisture may be encountered. Light fittings shall be recessed, flush fitted and sealed to prevent dust ingress.

6.1.3 Flooring 1) The finish, the screed and sub-flooring in the CSSU shall be suitable for heavy trolley traffic. 2) The finishes shall be seamless, non-slip, easy to clean, resistant to the disinfection procedure and not physically affected by germicidal cleaning solution. 3) In processing areas, finishes shall be suitable for frequent cleaning and tolerant to surface-cleaning agents. 4) Joints shall be avoided as they can hold moisture, encouraging the growth of organisms. Joints of structural elements shall be sealed if necessary. 5) Proper insulation material shall be installed for areas served by the air conditioning system. The thickness of insulation shall be specified to meet the requirement of the 24 hours or 8 hours operation 6) The heavy duty, anti-slip, anti-septic vinyl sheet flooring shall be used in the IAP area, sterile area and stores. It shall be laid with all joints to be hot welded, and the skirting shall be backed by a coving and bent up to a height of 100mm high to prevent dust from collecting. 7) Skirting, floor and wall joints shall be made integral with the floor, tightly sealed against the wall, and constructed without voids. 8) Damp proof membrane shall be provided for the department if located at the ground level. 9) The washing and soiled areas shall be provided with seamless tiles. 10) The vinyl flooring can be of different colors to distinguish one area from another. 11) IAP area shall not be having any structural expansion joints. 12) The sterilizer room flooring shall fall naturally to a drain to facilitate cleaning. 6.1.4 Door 1) There shall be separate doors for staff and goods. 2) Doors shall be adequately sized to allow clear access for staff and trolleys to pass through. 3) The main door and exit door shall be the fire rated type. 4) All doors except in the change rooms shall have doors closer to reduce air movement.

61

5) 6) 7) 8) 9)

Doors shall open towards the higher pressure side where possible. Visible panels shall be provided at doors that are open to walkways and where privacy is not required and shall be of the double glazed type. Doors shall be provided with a kick-plate and push-plate All emergency exit doors shall have electro-mechanical locking mechanism to enable disengagement in the event of fire The doors shall be lockable.

6.1.5 Windows 1) The room shall have ample daylight. Distribution and location of windows shall take into account the need to prevent glare and excess solar gain. 2) To avoid loss of control of air movement by the ventilation system, all windows shall be fixed, non-openable, sealed and flush type. 3) Open-able windows may be considered for offices and staff rooms; provided that they are secured. 4) The windows shall be easily accessible for cleaning both internally and externally. 6.1.6 Worktops and sinks 1) The worktops are normally placed along the walls as to create space in the middle of the zones. These worktops shall be made of stainless steel. 2) The worktops shall be flushed to the wall and any gap shall be sealed; where this is not possible, the worktops shall have a sufficiently large gap to allow for easy cleaning. 3) Work table shall not be fixed so as to allow for easy cleaning of the work area. 6.1.7 Painting 1) The paint shall be of anti-fungal and of the chemical resistant type. 2) Epoxy paint shall be applied. 3) The surface shall be pre-treated and smoothed for a better paint finish. 4) The first layer of paint shall be completely dried before applying the epoxy on any surfaces.

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

62

6.2

Mechanical Services 6.2.1 Air conditioning and ventilation 1) All processing and storage areas shall be provided with the mechanical ventilation to provide cool, treated air for the comfort of the personnel and minimize cross contamination. 2) The air pressurization scheme flowing from the cleanest to the most soiled area shall be strictly complied. 3) A 100% exhaust ventilation shall be provided at all washer disinfectors, cart washer, sterilizers and sterilizer rooms where heat and humidity are generated. LEV shall be installed in the swab/gauze and linen storage facility. 4) The clean and sterile areas in the department shall have air recirculation to promote energy efficiency practice. 5) The air conditioning system installed shall have air filters to remove particulates from the air supply. ASHRAE5 only stipulates that sterilized products store shall have a minimum of one filter bed, having a minimum MERV rating of 13. 6) The IAP and Sterile Zones shall have positive pressure with respect to the adjoining areas. The air movement shall be from the IAP Zone towards the Sterile and Soiled Zones. 7) Sterilized products storage area located within the operating theatre shall be provided with HEPA filter. Separated sterilized products storage area shall be equipped with secondary filter. 8) The ductworks shall be rigid and meet the fire requirements. Flexible ductwork shall be avoided except for final connections to grilles and diffusers; provided they meet the fire requirements and the length shall not be more than 2.0 meter. 9) The ducts shall be adequately insulated to eliminate the risk of condensation and reduce the noise from air movement. Ducts shall also be well attenuated to minimize the noise transmission from AHU to other parts of the duct. 10) The area above the sterilizer opening shall be provided with the appropriate extractor system to capture hot and humid air that exit the equipment. 11) The major environmental parameters monitoring devices i.e. temperature and humidity meters shall be placed at suitable locations to avoid false readings.

5 ASHRAE Handbook—HVAC Applications, HEALTH-CARE FACILITIES, 2007, Chapter 7, Page 7.3

63

12) 13)

The air handling or fan coil unit shall be placed or installed at a suitable location to facilitate service and maintenance activities. The subsequent table below provides the various parameters for comfort and safe work environment. Table 4: Ventilation & Parameters Controlled in CSSU ETO-steriliz- Sterilizing er room equipment room

Pressure in respect to adjacent areas Minimum Outdoor Air Change Minimum Total Air Change All room air exhausted directly to outdoors Air re-circulated by means of room units Relative Humidity % Temperature 0C

Negative

Negative

Soiled or decontamination room (Soiled Zone) Negative

Clean work- Sterile storroom (IAP age (Sterile Zone) Zone)

N/R*

N/R*

2

2

2

10

10

6

4

4

Yes

Yes

Yes

N/R*

N/R*

No

No

No

R

R

Max.60

Max.60

Max.60

Max. 60

Max.60

22 to 24

22 to 24

22 to 24

22 to 24

22 to 24

Positive

Positive

*N/R- No requirement 6.2.2 Fire System 1) Prior to any installation or upgrading of a department, all documentation related to the proposed fire system in the department shall be forwarded to the Fire Department for approval. 2) The fire requirement of this department shall comply with the latest version of Malaysian “UNIFORM BUILDING BY-LAWS 3) Access hatch on the ceiling shall be suitably positioned to allow easy access to inspect fire dampers. 4) Fire safety policies including evacuation procedures shall be developed and implemented to promote awareness of the fire hazards and safety aspects of the place to the personnel.

64

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

6.2.3 Noise 1) The noise within the ventilation plant rooms shall not be greater than 85 dBA6. 2) The noise level within the department shall not be more than the values stipulated in the current version of the FACTORY AND MACHINERY ACT (NOISE EXPOSURE), REGULATIONS by the Malaysian Department of Health and Safety. 3) Proper acoustic ceiling tiles, soft floor (vinyl) and engineering controls shall be implemented to reduce the sound levels. 6.2.4 Water The detailed water requirements e.g. the pressure, flow rate and quality shall be determined to allow a smooth operation of the major washer and sterilizing equipment. There are three types of water used in CSSU. 6.2.4.1 Potable Water a) Potable water shall be supplied for use in the staff’s rest room, prayer ablution area and washrooms. Potable water shall also be used in normal rinsing of the medical devices in the washers as well as in the cart washers. b) Potable water shall be tapped directly from the normal water supply. 6.2.4.2 Hot Water a) Hot water shall either be from the central hot water supply or from dedicated hot water boilers. Water from the central supply shall be supplied to the CSSU at 60oC ± 2.5oC. b) Hot water is used at the manual washing area and in the washer disinfector. To prevent scalding, thermostatically mixing devices shall be installed at the taps. c) Hot water from the central supply shall be boosted at the washer disinfector if required 6.2.4.3 Treated Water a) The sediment filter shall be installed to prolong the life span of the water treatment system. b) The reverse osmosis (RO) water shall be installed for washers and sterilizer usage. The system capacity shall be able to cater to the day’s minimum operation of washing & sterilization.

6 Health Technical Memorandum 2025, Ventilation in healthcare premises, NHS, 1996

65

c) d)

The RO water system shall include storage tank & carbon filter. The system shall have a by-pass route to normal water for maintenance. The recommended flow rate shall be 20 L/min for washer & 50 L/min for the sterilizer.

6.2.5 Steam Saturated steam for the sterilizer can either come from the in-house central steam reticulation system or dedicated steam generators. There shall be sufficient and clean saturated steam supplied to the sterilizer. The recommended steam dryness shall not be below than 97% and the quantity of steam for the equipment shall strictly follow the manufacturer’s requirement. In case the steam supply is from dedicated steam generators, the water supplied to the steam generator shall be treated as discussed in the section on Treated Water. Steam generators shall be required to have JKKP certificate and regularly inspected for continuing validity. 6.2.6 Compressed Air 1) The compressed air shall come from dedicated air compressors. 2) Dedicated air compressors shall be placed in cool and clean plant room to prolong the life of the compressors as well as improve air quality (dryness). 3) Air compressors shall be required to have a fitness certificate from the Department of Health & Safety and regularly inspected for continuing validity. 6.2.7 Drainage 1) Effluents from the clinical sinks, ultrasonic cleaners, washer disinfectors and steam sterilizers shall be considered as potentially contaminated with chemical and microorganism; and shall be discharged to the sewerage treatment plant. 2) The drain shall be properly sized to accommodate simultaneous operation of the equipment. 3) Special drain pipe or drainage system shall be provided for the discharge of effluents from washer and sterilizer. 4) Exposed drains shall be avoided, especially in the clean zones.

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

66

5) 6.3

The steel material used in the construction of the drainage system shall be chosen to withstand a high temperature effluent.

Electrical Services 6.3.1 Electrical Installation 1) Electrical installation shall comply with the latest version of Malaysian standard for electrical installation of building and Energy Commission Requirements. 2) A dedicated switchboard shall be installed for the department, complete with surge protection devices. Energy sub-meter is to be installed. 3) Separate distribution boards shall be installed for normal and emergency circuits. 6.3.2 Lighting 1) The lighting intensity requirement for the various areas in the CSSU shall have the following values. Area Soiled Zone Clean Zone Stores Sterilizer and cart washer plant room Task lighting (IAP workstation)

2)

Luminance (lux)7 300 300 150 200 500

The type of luminaries used at various areas in CSSU shall be based on the degree by which it is protected against the ingress of moisture and dust, and this is provided below; Area

Luminaries8

Soiled Zone Clean Zone Stores Sterilizer and cart washer plant room

IP 65 IP 65 IP 65 IP 65

Description of Type of Luminaries Jet proof and dust tight Jet proof and dust tight Jet proof and dust tight Jet proof and dust tight

7 Chartered Institute of Building Services Engineers (CIBSE) Lighting Guide LG2, Hospitals and healthcare buildings, Page 60 8 Chartered Institute of Building Services Engineers (CIBSE) Lighting Guide LG2, Hospitals and healthcare buildings, Page 71

67

3) 4) 5)

Energy-efficient luminaries shall be used. Where areas are unoccupied for long periods e.g. office and store; suitable automatic/presence switching shall be considered. Appropriate color finishes and lighting in the CSSU shall be considered to ensure that the quality of work is not compromised.

6.3.3 Switch Socket Outlets 1) There shall be a sufficient number of 13-amp switch socket outlets (SSO). The number of SSO shall correspond to the number of equipment as listed in the schedule list of equipment in the CSSU e.g. for ultrasonic washer, sealers, table top light with magnifier, computers etc. 2) SSO shall also be provided at the corridors and individual rooms for cleaning equipment. 3) The type of SSO material and how it is mounted shall be consistent with the SSO installed throughout the hospital. 4) Isolators shall be installed for all heavy equipment within CSSU e.g. sterilizer, washer disinfectors, cart washers, air compressor, steam boilers etc. In wet areas, the isolators shall be of the water proof type. 5) The built-in steam generator shall consume higher ampere apart from the equipment and shall be duly allocated. 6) All SSO shall be labeled and preferably color coded based on the hospital norms. 6.3.4 Emergency Supply Equipment shall be connected to standby generator and include the following; 1) Security system, communication system, clock, alarm system, lighting and power sockets. 2) One unit of Washer disinfectors, one unit of ultrasonic disinfector and one unit of sterilizer. 3) The change-over switch shall be installed to allow any unit of the above major equipment (item 2) to be operated at any required time. 6.4

Communication 6.4.1 Internal communication Internal communication in the form of intercom shall be provided between the three zones i.e. soiled zone, clean zone and sterile zone.

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

68

6.4.2 External communication There shall be direct communication links (telephone) between CSSU and other support facilities (e.g. stores), user departments (e.g. OTs, CCU) and CSSU. 6.5

IT link Data points shall also be provided if the CSSU has its own IT module to track its inventory. Where available and required, the CSSU module can be integrated with the Hospital Management System.

6.6

Security All entrances and exits shall be secured to prevent unauthorized persons entering the CSSU. Basic security features e.g. intercom shall be installed at the entrances for unauthorized persons to seek access to CSSU. Card access facilities shall be installed at the CSSU for its authorized staff. Centrally monitored CCTV system shall be installed where possible.

69

7.

Acquiring and Installing of Major CSSU equipment

7.1

Elements to consider prior to acquiring of equipment 7.1.1 The type and quantity of load The type and quantity of load shall depend on the type and maximum number of operations carried out in a day and load from other sources of generation e.g. critical units. 7.1.2 The type and quantity of equipment The quantity of the sterilizer shall be determined by the total load, cycle time and the operating hours. Normally, this can be calculated from the load information. 7.1.3 Floor area requirement The space required by CSSU shall be determined by the size and number of the equipment, operational ancillary set-up sterilizer, auxiliary equipment and furniture, movement of staff and goods, space for servicing and heat dissipation, type of door configuration and plumbing requirement. 7.1.4 Quality of water supply Where high purity water is required for steam generation, Water Softeners, Reverse Osmosis or De-ionization or a combination of these water treatment solutions shall be considered. 7.1.5 The type of steam The steam supplied to the sterilizer shall come either from the in-house main central facility or dedicated steam generators for the sterilizers (additional power supply capacity required). 7.1.6 Utilities requirements All utilities requirement for the efficient functioning of major equipment i.e. electrical supply, water supply and steam shall be adequately provided as per the manufacturer’s requirement. 7.1.7 Energy and water saving features All major equipment shall preferably have energy and/or water saving features. 7.1.8 Accessibility to install and remove the sterilizer There shall be a sufficiently sized route to lift or cart the sterilizer from the outside to the final installation site. Proper planning can reduce installation time and costly knock-downs.

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

70

7.1.9 Warranty Manufacturers do provide warranty. However, the type and period of warranty shall be established during the specification requirements. 7.1.10 About the manufacturer and supplier The basic information about the brand and manufacturer of major equipment shall be obtained to determine the reliability of the equipment. Any feedback from other users shall be considered during the evaluation or selection of equipment. 7.1.11 Spare parts availability The availability of spare parts for a certain period of time shall be specified in the purchasing document. The preferred genuine part shall be readily available and competitive in price. 7.2

Roles and responsibilities of user during planning, installation, testing and commissioning of upgraded facilities or equipment replacement. The following are some of the roles and responsibilities of the users during the upgrading of existing facilities or replacement of equipment. It shall serve as a guidance to ensure proper execution of the project. 1) 2) 3) 4) 5)

6) 7) 8) 9) 10)

The upgrading contractor shall provide the complete implementation schedule of the project to enable proper planning of service continuity. The hospital shall appoint a representative from the CSSU to participate in all relevant meetings to keep abreast on the development of the project. The appointed representative shall participate in the planning of facility shutdown and redeployment of service. For equipment replacement, the anticipated new equipment shall fit the existing space as well as meet the load demand. The information of availability of the utilities required to support the equipment shall be obtained from the maintenance company. All upgrading of identified scope of utilities to support the new equipment shall be done prior to the installation to avoid any purchasing/contractual problems. The existing equipment to be replaced shall be processed for BER certification. The representative shall participate in the testing and commissioning of the upgraded facility or new equipment. The proper training program for CSSU personnel upon completion of the project/installation shall be carried out by the contractor/supplier. The representative shall ensure all relevant statutory certification and the test result shall be submitted during the handing over. All defects shall be addressed to the relevant parties and all rectification work shall be rectified.

71

8.

Upgrading of Existing CSSU Some common reasons for upgrading are increase in demands, compliance to new requirement and poor existing facilities. To meet the above requirements, there is a need to make a decision to either build a new facility or upgrade an existing facility or premise. The following need to be considered when upgrading an existing facility: 1) The structural building and space area’s ability to take additional loads. Most existing units are insufficient in space and designed to cater extra loads. 2) Suitability of the facility with respect to the location in view of transporting and circulation of items within the allowable environment. 3) Adequacy of required space (height and floor area) to satisfy the addition of equipment, infection control protocol compliance, workflow, ventilation requirement and maintenance activities. 4) Physical constraints that hamper installation e.g. alcoves, bends, columns etc. shall be observed prior to proper planning. 5) The age and state of the building, condition and adequacy and safety of its engineering facilities e.g. electrical, plumbing, fire and steam system to support additional equipment. Upgrading of existing engineering system may be necessary and has to be completed before the arrival of equipment. 6) The possibilities of achieving a full compliance to the standard or otherwise, few adjustments shall be made especially when dealing with the existing space area. 7) The proper projected loads shall be included as to ensure the department is undersized. 8) Accessibility for bringing in operational consumables/goods to be used by the department and the maneuverability of vehicle from other facilities. 9) The possibilities of providing reserved space for future expansion and addition of equipment and the availability of extra loading capacities of the engineering system. Another critical element to be considered during upgrading is the disruption of the operations of existing services. The department and hospital management shall plan and execute the appropriate decontamination & sterilization activities during the period of upgrading. An earlier engagement with the nearest health facility shall be organized and the mode of transporting the dirty and clean products shall be fully established to avoid interruption to the service.

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

72

9.

References AFS Association Francaise de Sterilisation. 2008. Architecture and Sterilisation Premises – Part 2. Central Service Vol. 16 AIA Guidelines for design and Construction of Hospital and Healthcare facilities, 2001 Edition HVAC Design Manual for Hospitals and Clinics (Second Edition) ASHRAE, 2013 AS/NZS 2107:2000 ACOUSTICS REQUIREMENTS FOR HEALTHCARE BUILDINGS BS EN 285 Sterilisation – Steam Sterilisers – Large Sterilisers Chartered Institute of Building Services Engineers (CIBSE) Lighting Guide LG2, Hospitals and healthcare buildings Chemical disinfection of medical and surgical materials. In: Lawrence C. Block SS eds., 1968, Spaulding E.H. Guidelines for Community Noise, World Health Organization, Geneva, 1999 Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 HTM 01-01: Decontamination of reusable medical devices Part C- Sterilizers HTM 2025, Ventilation in Healthcare Premises - Design Considerations, Reprint with Amendments, 1999 HBN 13-Sterile Services Department, NHS Estate Health Technical Memorandum 05-02: Firecode Guidance in support of functional provisions (Fire safety in the design of health care premises) 2014 edition IUSS Health Facility Guides, Central Sterile Service Department (Proposal V.1) 2014 UNIFORM BUILDING BY-LAWS, 1984” (revised version 2013)

GUIDELINE ON CONCEPTUAL DESIGN AND ENGINEERING REQUIREMENTS FOR CENTRAL STERILE SUPPLY UNIT (CSSU)

Ministry of Health Malaysia Engineering Services Division Level 3-7, Block E3, Parcel E, Precinct 1 Federal Government Administrative Centre 62590 Putrajaya Tel: 603-8000 8000 | Fax: 603-8892 4855/4872 Website: http://engineering.moh.gov.my