STANDARD 17: Sterilization and Decontamination Services

17.1 General 

1. The dental 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.

3. The managing director shall appoint a competent individual who directs and supervises this process.

4. When a nonconforming process, product, or output is identified within the sterilization and decontamination service, the supervisor 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) removal from service and segregation to prevent use or further non-conformance; 

c) permissive under concession by the appropriate authority (accept the risk identified); 

d) informing all end-point users and/or customers so as to mitigate and control propagation of the unacceptable outcome. In all cases of a non-conformity, the dental organization shall ensure that requirements for acceptable use of the entity in question (including mechanical calibration if required) are performed and verified prior to that item’s/process return to service.

5. If the sterilization and decontamination process is software controlled, the dental organization shall confirm that the software is validated according to manufacturer’s instructions or national law.

6. The personnel performing the sterilization and decontamination process shall utilize the appropriate PPE.

7. In the case of decontamination, or where the results of a process cannot be fully verified by ongoing or subsequent inspection and tests, the process shall be validated with a high degree of assurance and approval according to established procedures. These validation efforts and activities may include but are not limited to: 

a) any testing results; 

b) a review of the associated processes; 

c) approval by an appropriate authority with signature, date, and time.

NOTE 1 When planning and conducting sterilization and decontamination activities, the dental 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 dental organization.

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

a) appropriate pre-cleaning and pre-sterilization packaging;

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

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

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

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

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

17.2 Selection of Medical Devices and Equipment 

1. Purchase of medical devices and equipment requiring sterilization or decontamination shall be compatible with the dental organization’s ability to appropriately sterilize or decontaminate the equipment in question.

NOTE 1 When planning and conducting selection of medical devices and equipment, the dental 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 external parties (suppliers) to ensure processes support for decontamination/ sterilization. ensuring process flow/timing, space, storage, and transport requirements can be met with respect to need for adequate and validated decontamination and/or sterilization; 

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

2. In no case shall a product labeled as “disposable or single use only” be reused or considered for sterilization and/or decontamination and subsequent patient use.

17.3 Storage, Segregation, and Transport 

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

2. Expiration parameters for processed material shall be established for all sterilized and/or decontaminated items. These parameters 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.