STANDARD 29: Sterilization and Decontamination Services

29.1 General

1. The healthcare organization shall establish and maintain policies and procedures to ensure an effective sterilization and decontamination service.

2. Measures required for sterilization and decontamination shall be identified, specified, implemented, monitored, reviewed, corrected and corrective actions taken (if required) for all relevant activities. This shall include consideration of infection prevention and control to include procedures to validate and/or verify achievement of the intended outcomes (See also 4.1.3-4.1.5).

3. There shall be a competent individual who directs and supervises this process.

4. Staff processing medical/surgical equipment, devices, and supplies shall be oriented, trained, and competent in the practices of cleaning, disinfection, and sterilization and receive proper supervision.

5. When a nonconforming process, product or output is identified within the sterilization and decontamination service, it shall take appropriate action commensurate with the risk of the nonconformance at hand. Actions taken shall include one or more the following:

a) correct/corrective action;

b) remove from service and segregate to prevent use or further non-conformance;

c) obtain permissive use authorization under concession accepting the risk identified;

d) inform all end-point users and/or customers so as to mitigate and control propagation of the unacceptable outcome. In all cases the healthcare organization shall ensure that requirements for acceptable output, including calibration, if necessary, are verified prior to a return to service.

6. If the sterilization and decontamination process is software controlled, the healthcare organization shall confirm that the software was validated.

7. The personnel shall be qualified and/or trained for the sterilization and decontamination process including the appropriate us of PPE.

8. Where the results of a process cannot be fully verified by subsequent inspection and tests, the process shall be validated with a high degree of assurance and approval according to established procedures. The validation activities to include results, equipment in question, date, and signature of the authorizing shall be documented.

NOTE 1 When planning and conducting sterilization and decontamination activities, the healthcare organization should consider issues including but not limited to:

a) potential health and safety hazards associated with processes adopted (e.g. exposure to harmful chemicals, excessive heat/pressure);

b) ensuring all disinfectants contain sufficient active compound for their intended use under a given circumstance (e.g. when organic matter may be present, loss of active ingredient over time);

c) ensuring adequate methods and resources are available to deal with routine work and any spillages or other incidents during handling and transport of waste and potentially infectious material inside and outside the healthcare facility.

NOTE 2 Validation measures should consider issues including but not limited to:

a) an ability to maintain adequate conditions throughout the cycle, including contact times;

b) manufacturer’s recommendations regarding materials used (agents used and materials to be subjected to treatment);

c) ensuring methods are available for effective decontamination of mixed waste (e.g. infectious waste that have radioactive materials);

d) material compatibility issues (e.g. interaction with stainless steel or rubber seal);

e) implementing monitoring measures to ensure the methods have been effective (e.g. cycle recording and use of indicators).

29.2 Selection of Medical Devices and Equipment

1. Purchase of medical devices and equipment requiring sterilization or decontamination shall be reported to sterile processing in order to confirm the ability of the service to adequately process the proposed equipment in question.

NOTE 1 When planning the purchase or medical devices, equipment or other items which may become contaminated, a formal specification and approval process should be adopted to ensure items will be fit-for-purpose with regard to infection risk.

NOTE 2 When planning and conducting selection of medical devices and equipment, the organization should consider issues including but not limited to:

a) ensuring that validation methodology is available for decontamination of sensitive equipment, especially if not suitable for autoclaving (e.g. sensitive medical devices);

b) engaging relevant internal and external parties (e.g. in-house decontamination specialists, suppliers) to ensure processes support selection of these items (e.g. appropriateness of available means of disinfection/sterilization);

c) ensuring process flow/timing, space, storage and transport requirements can be met with respect to need for adequate and validated disinfection and/or sterilization;

d) ensuring risk of transferring infection via medical instruments, equipment and other items is considered as part of assessment for selection, processing/reprocessing.

29.3 Storage, Segregation and Transport

1. The healthcare organization shall establish effective procedures for the handling and storage of processed/reprocessed medical devices and other equipment to ensure they remain fit-for- purpose with regard to infection risk.

2. Expiration parameters shall be established for all sterile and decontamination processed items. These shall be maintained as documented information.

3. Transport of processed items shall be carried out so as to prevent recontamination of sterile or decontaminated items.

NOTE 1 In order to prevent contamination, clean and sterile supplies are properly stored in designated storage areas that are clean and dry and protected from dust, moisture, and temperature extremes. Sterile supplies are stored separately from clean supplies, and sterile storage areas have limited access. Some disinfected items require specific drying and storage principles to ensure complete and thorough disinfection. For example, following disinfection, endoscopes must be able to hang freely without coming into contact with the floor in order to prevent fluid from accumulating in the bottom of the scope.