Medical Device Decontamination and Validation (Mr. Hugh O'Connor) Medical Device Decontamination and Validation Learning to Work Efficiently and Accurately With HSE COP PT 1 5 Introduction for HSE COP Look at how best to reduce risk of infections from the reprocessing of medical devices especially Surgical instruments/endoscopes Look at what is best practice for procedures on cleaning, disinfection, sterilisation of such devices A healthcare h instituution i i should do everthing to prevent spresding of infections within the institution 1
Bio-burden reduction required by cleaning MI s are used in wounds of patients,should have no micros or foreign particles Left on instruments can cause Sepsis or septicimia If such a dirt particle enters blood stream recovery and morbidity can be effected Leaving food(fungi)blood(hep B) pus (bacteria,gangerine) allows micro to divide and multiply Bio-burden reduction required for cleaning In Summay Remove all visable dust and dirt Removal of breeding ground for surviving micros Protection against corrosion Ensure safe free movement of equipment and material That s why we do efficacy tests 2
Bio-burden reduction required for sterilisation Process renedering an object (RIMD) free of all viable,reproducable micro-organism Process to treat a product (RIMD)in such a way that it is fit for its intended purpose Processes KPI s (SAL) should be achieved Process must be reproducable and verified Process must maintain sterility for packaging or aseptic further processing) Classifying a medical Device All devices placed on the market must meet the essential requirements of the legislation and not compromise the clinical condition and safety of the patient, user or other persons 3
Classifying a medical device Code of Practice states: Reprocessing units to meet the essential requirements of the legislation The same standard to be applied to industry and healthcare facilities Classifying a medical device Code of practice sets the standard Code of practice sets the standard Audits highlight where improvement is required Education is crucial Management of risk Good communication with stakeholders internally and externally 4
What are Rerpocessors Sterilizer is classed as a Class11a medical device Washer Disinfector is classed as a Class11a medical device Scope Washer is classed as a Class 11a medical Device Ultrasonic washer is a class 11 medcial device Bed pan washer are up for debate but probaly Class 11 Classification of Critical Medical Device Are manufacturers Instruction Available no Is processing possible based On previous knowledge no Do not process End process Skin or Mucosal Penetration Critical A Yes no Critical medical Device Yes Is documented Validated Process avaailable Alternative Method of Re-processing Manufacturer Instructions Available no Non-fixing pre-cleaning After use Steam Sterilization Possible Simple Design Cleaning/Automated Disinfection Limited No of Cycles no Yes Lumens L,Cannular u m e Yes n s L MIS Trolley u m e n Further processing based on QA13485 Alternative Method of Re-processing Alternative processes EO,FA,Plasma EN ISO 17664 Steam Sterilization and Label 5
Whats the Cost of implementing HSE COP Labour Costs for in house testing Labour Costs for in house user testing Labour costs for water sampling Labour costs for management of testing Labour costs for auditing of testing Labour costs for auditing of compliance Labour cost to read and understand code of pracxtice and standards Brief look at other Audits Healthcare Commision Report 2008 UK 90 % of acute hospitals failed to comply FULLY with Commisiond Hygen Code One in five failed to satify requiremnts of decontamination From April 2009 CQCwill enforce requiremnt of CHQ for infection control Care Quality Commision can impose conditions and fines 6
Average Cost of Testing in compliance with HSE COP Pt 3 (conservative) Machine Type TOTAL NUMBER Machines TOTAL NUMBER OF Annual Tests per Machine Total Cost For COP HSE Compliance Sterilizers 140 38 1.4 million Washer 145 52 1.8 million Disinfectors Scope Washer 100 66 1.2 million AER Bedpan washer 300 20.8 million Bench top WD N/a N/a N/a Benchtop A/C N/a N/a N/a Heat Sealer 200 6.2 million Ultra Sonic WD 100 30.8 million Total Cost of Validation 6.2 million Machine Type Average Labour Days in compliance with HSE COP Pt 3 (conservative) TOTAL NUMBER Machines TOTAL NUMBER OF Annual Labour days per Machine Total Labour Days Sterilizers 140 6 840 Washer 145 7 1015 Disinfectors Scope Washer 100 8 800 AER Bedpan washer 400 4 1600 Bench top WD N/a N/a N/a Benchtop A/C N/a N/a N/a Heat Sealer 200 2 400 Ultra Sonic WD 100 3 300 Total no of labour days 4955(5000) 7
What is HTM s, EN 15583 HTM s is a health technical memorandum covering the classification of washer/disinfectors provides recommendations for the cleaning, disinfection of instrumentation, provides guidance on the quality of water supply and sets out procedures for specification qualification, purchase and type of washer, installation qualification, acceptance qualification, commisioning and operational qualification. Procedures for routine monitoring. Great Document for Engineer Isomnia HTM & COP Requires from the Supplier Itemized list available for user requirements The manufacturer consult with the washer manufacturer for compatibility. Effect on device/scope life? Effect on device function? Material compatibility? Biocompatibility? Cycle validation to insure microbial efficacy 8
COP Recommends Centralise Centralise for patient safety Provide a quality process that is consistent, controlled and validated Dedicated trained staff Improve working environment Update equipment Cost efficiency The Team Manufacturer of the Health Estates machines t Test Person Clin Eng Sterile Services/ Endoscopy The User Contractors Testing/building Infection Control & Microbiologist Authorized Engineer Decomtam Estates /Management Planning Servicing/repair Routine testing 9
The Plan start like this The 2 nd stage of any centralize Plan dirty corridor Staff room Treatment room Returns and wash Treatment room Clean process Treatment room Patient ward/waiting area Office Storage clean corridor 10
The plan should develop like this Example of a Sterilzer Validation 11
Steam sterilization KPI s for product release Steam quantity Steam quality Temperature Time Moisture Air removal Moisture Initial validation PQ initial requirements Testing maintenance Printout Complete process(between use and re-use) Monitoring Documentation Steam-generation &distribution hg = hf + hfg (2164) 3abs 561 X CLEAN WATER hfg Latent heat Yhfg heat hf Hf 561 Point Z USER 12
List of Tests for Sterilizer/Autoclave COP/EN285 Test daily Weekly Annual Bowie Dick Test Weekly Tests Verification of instruments Vacuum Leak test Air Detector Test Small Load Test Full Load Test Pressure Tests BI+ Steam Quality commissioning Ap sign off List of Tests for Washer Disinfector EN15883-1-2 Test daily Weekly Quarterely Efficacy test Spray arms Verification of From printer instruments Sump strainers MIS lumen test Small Load Test Full Load Test Dose pump check Pump tests Final rinse water tests 13
Example of a Sterilizer PQ Validation Inject air into a sterilizer Measure the effect in 1 st Load in Empty chamber 2 nd Chamber loaded with a tray of surgical instruments 3 rd Chamber loaded with 4 trays of surgical instruments 4 th Chamber loaded with 7 kg towel pack 5 th Chamber loaded with Bowie Dick pack Empty Chamber Sterilizer for Air Dtector Function Test Chamber volume 600 litres Rather than leak air into the chamber, air was injected into the chamber at a defined point The quantity of air injected was gradually increased 14
Air Injection Point Air injection 10 milibar per min Empty Chamber air injection air injected Temperature and pressure were as dictated by steam tables i.e. correct for saturated steam As the volume of air was increased, no fault could be detected by temperature vs. pressure comparisons 15
Single Tray Sterilizer loaded with single tray of instruments used commonly in hospitals Trays wrapped in Non-woven paper (Westfield Medical) Woven PTFE textile S b d d l l (Ki b l Cl k) Spun-bonded polypropylene (Kimberly Clark) Wrapping techniques used as recommended by wrap manufacturer 16
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Conclusions for PQ The tray contents are drawing steam, and with it, air The concentrated air (rather than evenly distributed) would account for the non-dalton behaviour It is not uncommon that hydrophilic materials such as cotton and paper produce small amounts of exothermic superheat but Air Detctor works Test takes 8 hours to complete No more of this,without checks and balances 18
Its all about Documents & accountability 19