QUALITY ASSURANCE IN AN MDRD

QUALITY ASSURANCE IN AN MDRD

MAINTENANCE AND PREVENTATIVE MAINTENANCE MDRD is a machine dependent department washers, pasteurizers, cart washer, sterilizer, ultrasonic, heat sealers, RO water systems All of the above need regular, documented maintenance and preventative maintenance this could be something that is required to be done daily, weekly, monthly, quarterly, etc... Some PM tasks may be done by MDRD technicians wiping door gasket daily, cleaning sterilizer chamber, checking sterilizer drain screen, cleaning pasteurmatic basin, etc... these tasks are defined by the vendor s operator instruction manuals

QMS AND THE MDRD MAINTENANCE/PM A regular inspection and maintenance program for all machines must be completed on a schedule as defined by the equipment manufacturer and any work must documented according to the provisions in Article 14.3 of the CSA standard Z314.3-09 The maintenance work or PM work may be done through a service contract or by an in-house maintenance program. Regardless of how the service is provided, it must be done by personnel trained and qualified to provide the service. Z314.3-09. A record of all maintenance work must be current and be readily available to the MDRD manager. Z314.3-09

STERILITY ASSURANCE TESTING AND MONITORING PROGRAM CSA Standard Z314.3-09 states that sterility assurance is the integrated system of tests, controls and backup procedures intended to ensure that reprocessed medical devices are sterile when delivered for use. Testing and monitoring is to include: 1. Installation qualification 2. Operational qualification/requalification 3. Performance qualification 4. Routine monitoring

STERILITY ASSURANCE TESTING AND MONITORING PROGRAM So, what is involved in testing and monitoring that MDRT s are responsible for? >LEAK TESTS >DART or BOWIE & DICK TESTS PLUS OTHER TYPES OF CHEMICAL INDICATORS (CI s) >BIOLOGICAL CHALLENGE TESTS (BI s) CHEMICAL INDICATORS ARE DIVIDED INTO 6 CLASSES:

CI S CLASS I >are process indicators; demonstrate through a colour change that a device has been exposed to sterilization process ie: steam tape, peel pouch indicator (inside or outside), card type tip protectors CLASS II >are specific tests ie: DART or Bowie & Dick CLASS III >measure one parameter of the sterilization process ie: temperature CLASS IV >measure two or more critical parameters of the sterilization process indicated by a chemical or physical change after exposure to the sterilization process ie: the paper chemical indicators used in packages

CI S CLASS V >react to all critical parameters of the sterilization process >known as chemical integrators >cannot be used in place of BI s CLASS VI >known as emulators or emulating indicators >measure all critical parameters of a specific cycle >most closely mimic the performance of a BI, but cannot be used in place of a BI

CI S CLASS IV AND V INDICATORS >are generally used for pack monitoring >are put in pack in the most challenging area for sterilant to penetrate >do not indicate sterility of a product, just that sterilization conditions occurred at the most challenging area inside the pack >any failure of any CI is an indicator there was an issue in the sterilization process whether packaging, loading, sterilizer failure, etc don t use the item, quarantine the load, investigate failure

BIOLOGICAL INDICATORS Used as part of operational qualification, for requalification of sterilizer, daily monitoring and for load monitoring Can be made in-house or use a commercial single use pack What is it? >a small capped plastic vial containing millions of spores on a strip of paper and an ampoule of growth medium >vial and a chemical indicator is placed inside a specially designed pack to challenge the sterilant penetration

LEAK TESTS Can be done daily or weekly. Used to detect trends over a period of time. Measures how well sealed the sterilizer chamber and piping are against air leaking in during the vacuum stage of the sterilization cycle. How??? When a leak test is in progress, the sterilizer will draw a maximum vacuum. At the peak of that maximum vacuum, the cycle will be paused and sensors check how well the vacuum is being maintained. If a measurable amount of air is being pulled into the system, it is detected and this volume is translated as a number onto the paper mechanical printout. A reading of >1.0 needs requires maintenance.

BOWIE & DICK / D.A.R.T. TESTS These are both air removal tests that test the sterilizer s mechanical ability to remove air from the chamber. Can be assembled in-house or more commonly is a commercially prepared and purchased test pack (single use or ranier cube). This test is done as first load of the day after a warm up cycle (and after leak test if done) Warm up cycle is needed to purge all of the lines since sterilizer has been idle. Is done in an otherwise empty sterilizer chamber.

STERILITY ASSURANCE TESTING AND MONITORING PROGRAM 1. Installation qualification performed by the manufacturer Is required for commissioning of sterilizer Is documented and a record of the documents is kept by the facility (includes purchase, install and commissioning) Involves the actual install, assures the sterilizer operates to the specified performance criteria, confirm utilities connected as per specs, ensures install meets architectural drawings, water quality, steam quality, meets code, etc...

STERILITY ASSURANCE TESTING AND MONITORING PROGRAM 2. Operational qualification and requalification To verify the sterilizer is meeting the manufacturer s operating specs To verify the sterilizer is consistently producing sterilization conditions To verify the above again in the event major repairs or other occurences or annually

STERILITY ASSURANCE TESTING AND MONITORING PROGRAM Operational qualification entails running 3 consecutive BI challenge tests in an empty sterilizer chamber. If the sterilizer can perform both vacuum and gravity cycles, then the 3 tests must be done for both types of cycles. If the sterilizer is the dynamic air removal type (vacuum), then 3 consecutive air removal tests (DART, Bowie & Dick) must also be done. All results must be documented and retained. Operational re-qualification as above must be performed yearly by the facility, documented and retained.

STERILITY ASSURANCE TESTING AND MONITORING PROGRAM Operational re-qualification must also be completed, documented and the documentation retained when: 1. There are major repairs to the sterilizer 2. If the sterilizer is relocated 3. If there is construction in the sterilizer area 4. With environmental changes (ie: to air handling system) 5. For unexplained sterility failures 6. For changes in steam supply or delivery Z314.3-09

STERILITY ASSURANCE TESTING AND MONITORING PROGRAM 3. The third part of the testing and monitoring program is performance qualification. Performed to confirm that the sterilizer will perform consistently and produce expected results (ie: actual testing of families of medical device packages to ensure the same packages will have the same results each time sterilized in the most challenging area of the sterilizer chamber) Sounds like a big job!! How is it done?

STERILITY ASSURANCE TESTING AND MONITORING PROGRAM To conduct performance qualification: 1. Assess instrumentation and determine commonalities that can be divided into similar families of instruments. Commonalities to consider: time to sterilize, required temp., weight, layering of tray, complexity of tray, implants, power equipment, mixed materials, lumen devices, MIS devices, implants, utensils, linen bundles, etc... 2. Assign each tray/bundle/device to a family- need to document rationale for defining a family and why device/tray/bundle assigned to that family. 3. Select the most challenging tray/bundle/devices in each family to be tested.

STERILITY ASSURANCE TESTING AND MONITORING PROGRAM 4. Each family to be tested using each type of wrapper used in dept. may need to test each family in disposable, reusable, single step, 2-step, containers 5. Biological and chemical indicators are to be placed in the selected test sets in specific patterns (see Z314.3-09) no tape is to be used to secure BI s into place 6. Test sets are to be the most challenging sets in the load and are to be placed in the area that presents the most challenge to steam penetration (over the drain). The cycle time and temp for that family of trays to be performed. Test each family in each sterilizer. **SAH took testing a step further- testing 5 trays from each family in 5 locations each cycle in each sterilizer (3M)

STERILITY ASSURANCE TESTING AND MONITORING PROGRAM 7. After sterilization, the test sets are to be retrieved and the BI s incubated and the chemical indicators read. 8. All info is to be recorded: Date, time, sterilizer number, operator initials Cycle time, temperature Family info, item name, weight, location in chamber Location of BI s and corresponding CI s Type of wrapper used Comment section re: wet load Results of BI s and CI s

STERILITY ASSURANCE TESTING AND MONITORING PROGRAM Any failure of any BI s and CI s indicates a sterilization failure and is to be documented. Imperative to find reason why. Check mechanical indicators. Were sterilization conditions achieved? Run tray again in same load configuration with BI s and CI s in same configuration. Pass? Test 2 more times. Send failed BI to lab for C&S. Failed again? Reconfigure tray. Reduce weight. Vary wrapper. FIND REASON FOR FAILURE AND CORRECT. **Any major changes to trays/bundles need to do performance testing of that tray/bundle & document

STERILITY ASSURANCE TESTING AND MONITORING PROGRAM BI s, CI s and Other Testing Sterilizers: Vacuum- shall have a DART/Bowie & Dick test run daily (or each day used) results documented and retained as per facility policy Vacuum & Gravity shall have a BI challenge test each day (or each day used) as a minimum Should be done at the beginning of the day before any loads are run results documented and retained as per facility policy A BI challenge test should be done for each type of cycle to be run that day (for both gravity & vacuum) A BI challenge test should be run for any implant load results documented each time

HIGH LEVEL DISINFECTANTS All high level disinfectant use must be monitored too Mechanical: >mechanical printout indicating time, temperature, concentration >a chemical indicator made for that specific HLD must be put in with every load >any scope should have traceability back to the pt >all must be recorded and kept as per facility policy

HIGH LEVEL DISINFECTANTS MANUAL (OR COLD) HLD >Temperature must be monitored and recorded >Contact time recorded >MEC (Minimally Effective Concentration) must be checked each time before soaking a device and this must be recorded >items cannot be added after the soak of one device has begun start over or wait until first soak is completed

ULTRASONIC Should be checked that they are functioning at least weekly Commercially prepared test vials that are immersed in the basin and a cycle is run >looking for a colour change to indicate successful cycle Small sheet of tinfoil may be used but not recommended >looking for small pin holes in foil after cycle >make a mess in the ultrasonic basin tiny bits of tinfoil in solution and kling to walls

PERFORMANCE VERIFICATION OF WASHERS Done by using a TOSI (Test Object Surgical Instrument) test Simulates dried blood on a difficult to clean area of an instrument Test soil is manufactured and applied to a metal plate, then covered Placed in specific levels/areas of a washer chamber & cycle is run Plates are checked after cycle and results recorded Failure indicates an issue with the washer arms, detergent concentration, water flow, temperature, etc.

OTHER TESTS Other tests available: >soil removal tests for AER s tests how well soil is removed by an automated scope reprocessor similar to the TOSI test >Cart wash checks check the efficacy of the cart washer >Scope checks usually a swab of the working channel of a flexible scope that is immersed in a solution that affects a colour change colour change indicates soil left in lumen

QUESTIONS?