Approval Signature: Original signed by B. Postl. June 2007

Transcription

1 POLICY REGIONAL Applicable to all WRHA governed sites and facilities (including hospitals and personal care homes), and all funded hospitals and personal care homes. All other funded entities are excluded unless set out within a particular Service Purchase Agreement Policy Name: Policy Number: Sterilizer Quality Assurance Monitoring Approval Signature: Section: Date: Original signed by B. Postl June 2007 Level: 1 Page 1 of 5 INFECTION PREVENTION & CONTROL Supercedes: New 1.0 PURPOSE: To mitigate the risk of an unsterile Medical Device being used on a client, patient or resident. 2.0 DEFINITIONS: 2.1 Biological Indicator (BI) - A carrier that is inoculated with bacterial spores whose numbers and resistance to the sterilization process far exceed those of the micro-organisms expected to be present on devices for sterilization. 2.2 Biological Indicator Test Pack - A predefined pack that contains a biological indicator (BI) and a chemical indicator (CI) inside a pack designed to reduce penetration thereby creating a challenge for the sterilization process. The BI test pack is designed to monitor the effectiveness of the sterilization process. 2.3 Chemical Indicator (CI) - A system that reveals a change in one or more process variables by an alteration in state, colour, intensity, or shade. The change correlates with the sterilization process thereby allowing it to be a useful process to monitor as they provide results immediately after the cycle completion. CI s may be external or internal. External CI s differentiate between processed and unprocessed packs. Internal CI s detect potential sterilization failures due to factors such as incorrect packaging, incorrect loading of the sterilizer or equipment malfunctions assessed when the package is opened for use. CI s include chemical integrator s which are affected simultaneously by critical sterilization parameters. 2.4 Alternative Sterilization Technologies - Those sterilization technologies that are specific to one manufacturer and do not have a written standard to follow (i.e. Sterrad and Steris System I). 10.8

2 2.5 Emergency (Flash) Sterilization - A special steam sterilization cycle designed for the emergency sterilization of surgical goods. 2.6 Ethylene Oxide A gas used to sterilize heat sensitive Medical Devices. 2.7 Gravity Displacement Sterilizer A sterilization system in which incoming steam displaces residual air so that it is exhausted from the chamber through the port or drain that is situated at the lowest point of the sterilizer chamber. 2.8 Medical Device - any instrument or apparatus intended by the manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or handicap or for control of conception. Medical Devices will fall into one of the following three classes: Critical Medical Device - one that penetrates skin or invades normally sterile parts of the body (i.e. Medical Devices with blood contact, or invasive into sterile body cavities) Semi-critical Medical Device - one that touches the mucus membranes during use (i.e. Medical Devices with mucus membrane contact, or invasive into non-sterile body cavities) Non-critical Medical Device - one that does not normally make contact with the patient or with his or her body fluids (i.e. Medical Devices with either no direct patient contact or skin contact only). 2.9 Prevacuum Sterilizers - A steam sterilizer where the air is removed through mechanical means by pressure and vacuum excursions prior to the sterilization cycle Table Top Sterilizer - A steam sterilizer that has a chamber volume of not more than 42.5L. Steam is generated when distilled or deionized water is added to the water reservoir by the user Sterilization - A validated process used to render a Medical Device free from viable micro-organisms Medical Device Performance Testing Testing using sample packs representative of what packs are normally sterilized and that contain both a BI and a CI. 3.0 POLICY: All WRHA facilities and WRHA funded facilities shall follow, as a minimum, the following procedures developed and approved by the Regional Medical Device Reprocessing Team. 4.0 PROCEDURE: 10.9

3 4.1 Ethylene Oxide (ETO Sterilizer): A BI test pack shall be included in every load that is to be sterilized. The routine test pack shall be in the center of a normally loaded sterilizer. BI test packs prepared in-house shall be assembled according to Canadian Standards Association (CSA). Manufacturers directions for use shall be followed for commercially prepared routine BI test packs. After exposure to the sterilization cycle, which may include aeration, the biological indicator shall be removed from the load, its load traceability recorded and the BI incubated. A CI should be placed inside complex instrument sets. 4.2 Steam Prevacuum Steam Sterilizers: A BI test pack shall be used every day the sterilizer is used. o The routine BI test pack shall be placed in the bottom of the sterilizer near the drain of a fully loaded sterilizer. o BI test packs prepared in-house shall be assembled according to CSA standards and positioned horizontally in the sterilizer. o Manufacturers directions for use shall be followed for commercially prepared test pack(s). o After exposure to the sterilization cycle, the biological indicator shall be removed from the load, its load traceability recorded and the BI incubated. A daily air removal test (Bowie-Dyck) shall be performed prior to using the sterilizer for the day. A CI test pack may also be used in each load. The results of the CI shall be reviewed prior to release of the load. A CI should be placed inside complex instrument sets and linen packs Emergency (Flash) Steam Sterilization Cycles: Only non-porous items should be processed using the Emergency Sterilization cycle. Complex Medical Devices and devices with lumens are considered porous devices and written directions for sterilization shall be obtained from the device manufacturer prior to using this cycle. A biological test shall be conducted every day the sterilizer is used. Routine testing shall include both a BI appropriate for the cycle and a CI. After exposure to the sterilization cycle, the BI shall be removed and incubated. For purposes of unwrapped Emergency Sterilization cycles the BI is not in a test pack. Daily biological testing should include both the cycle for the unwrapped method as well as the cycle for the flash pack if both are used Tabletop Steam Sterilizers: 10.10

4 A BI test pack shall be used every day the sterilizer is used. BI test packs prepared in-house shall be assembled according to CSA standards and positioned horizontally in the sterilizer. If the standard test pack cannot fit into a tabletop sterilizer, the tray considered most difficult to sterilize shall be used. (Dressings and large metal mass make a package more difficult to sterilize.) A CI should be placed inside complex instrument sets and linen packs. 4.3 Alternative Low Temperature Sterilization Technologies: A BI test shall be conducted every day the sterilizer is used. Manufacturers directions for type of BI and composition of test pack (if required) shall be followed. 4.4 Each package for sterilization shall have an external visible CI for the purpose of differentiating between processed and unprocessed packs. This is located on the outside of the package. Indicator tape, which is an external CI, does not eliminate the need to include an internal CI where required. In sterilization pouches where the internal CI is visible through the plastic side, an external CI is not required. 4.5 Prior to release of a sterilization load, the following shall be performed: Prevac Cycles: Verification of parameters on computer printout or recording chart are checked and signed by the sterilizer operator or accepted on the computer screen that sterilization parameters are correct. Review of external CI to ensure the item has been exposed to a sterilization process. Assessment of prevac steam load for visible moisture. Assessment of integrity of package seal. Review results of BI test where possible Flash/Emergency Sterilization Cycles: Computer print out or recording chart shall be signed by the sterilizer operator that the specified temperature was attained and maintained for the specified exposure time. If a recording device is not available, the operator shall monitor the time and temperature indicating gauges during the cycle and at the end of the cycle record that the cycle parameters were met and initial the documentation. 4.6 Documentation for all Sterilization Technologies For recall purposes, a record is kept of all devices sterilized in each load. Documentation shall include the date, load number, sterilizer number (if applicable) and a list of all devices sterilized in the load

5 Each wrapped pack/tray sterilized shall be identified with the following: o Load Control Label: includes load number, sterilizer identification, and date of sterilization. o Device Identification: may include the name of the device or tray and the initial of the individual responsible for assembly of the tray. This is not necessary when using a see through pouch. All documentation including the results of the BI test, CI test, signed computer printout (where available), load content and daily air removal test (if applicable), shall be retained for two years for all acceptable sterilization cycles. Documentation from unacceptable loads shall be retained for 25 years. Documentation for flash sterilization shall include: o Date, o Time, o Description of load content, o Verification of correct exposure time and temperature, o Identification of operator and sterilizer, o Endpoint response of CI, o Results of BI monitoring, o Bowie Dyck Test if applicable, and o Identification of patient device was used on 4.7 Testing using sample packs shall occur when major changes are made in packaging, wrapping techniques or load configuration. 4.8 A written recall report shall be prepared for all sterilization loads that have been released for use and subsequently found to be unacceptable. Each recall report shall include circumstances that prompted the recall, corrective action, the total number of devices to be recalled and the actual number of devices located. The report shall be distributed to site Infection Prevention and Control and Director of Regional Medical Device Reprocessing. 5.0 REFERENCES: 5.1 CSA Effective Sterilization in Health Care Facilities by the Steam Process Z CSA Effective Sterilization in Health Care Facilities by the Ethylene Oxide Process Z CSA Infection Prevention and Control in Office-Based Healthcare and Allied Services, PLUS 1112 Mar CSA Recommended Standard Practice for Emergency (Flash) Sterilization Z Policy Contact: Susan Hadfield, Director, Regional Medical Device Reprocessing 10.12