Options for load release

Transcription

1 Approaches to Release of Sterile Goods from Steam Sterilization: Parametric Release and Routine Monitoring Craig Wallace Senior Technical Specialist 3M Infection Prevention Division Today s Topics 1. Options for load release Parametric release Validation and control Routine monitoring 2. Some things to consider Options for load release Quality Control options for release of sterilization loads Parametric release Routine monitoring with physical, biological, and chemical indicators 3 4 Key standards Key standards ISO (2006) Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices Sterilization of health care products Moist heat Part 2: Guidance 5 6 1

2 Key standards ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities Parametric release 7 8 Parametric release Parametric release Declaration that product is sterile, based on records demonstrating that the process parameters were delivered within specified tolerances. Declaration that product is sterile, based on records demonstrating that the process parameters were delivered within specified tolerances. ISO/TS 11139:2006 ISO/TS 11139:2006 All critical process parameters... Load release decision is based only on physical sensors Specified tolerances are determined in validation 9 10 Parametric Release If, and only if, validation of the entire sterilization process has been completed and maintained, and a quality system is in place to assure consistent operation, can parametric release be considered. General considerations for the use of parametric release Validation For each step of the sterilization process (e.g. cleaning definition, control and documentation) Documentation Written procedures Written evidence that procedures were completed Process control All process steps must be kept within the validated parameters (e.g. load configuration) Any changes to process, products, or packaging have to be assessed, and possibly re-validated Calibrations completed and documented 12 2

3 Validation and control P. Schneider, Parametric Release of Steam Sterilized Items, Managing Infection Control, April Validation Documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield a product complying with predetermined specifications. ISO TS Methodology used by medical device and pharmaceutical manufacturers to assure sterility per national and international standards Required by regulatory and auditing bodies, i.e., FDA, MOH, TÜV, etc. 15 Validation... the basics Rigorous testing to identify and verify critical process parameters Determines the boundaries of a process. As long as the daily process is within the boundaries set in the validation, the results should be good Validation of the worst case situation Most difficult instruments to reprocess Most difficult locations within the instruments Most challenging packaging Most challenging loads Worst case process (e.g. lowest acceptable temperature, shortest acceptable exposure time) 16 More on validation... The sterilization process... Daily verification (proof) that the entire process has been completed within the validated parameters Have to prove it - If its not written down, it didn t happen Cleaning Inspection and Assembly Packaging Loading Sterilization Storage and Distribution Can t vary from the validated conditions

4 Validation Equipment commissioning Installation Qualification (IQ) Obtaining and documenting evidence that equipment has been provided and installed in accordance with its specification. ISO TS Operational Qualification (OQ) Empty machine Usually assisted by manufacturer Obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational instructions. Measurements with independent sensors ISO TS Verify machine delivers expected conditions 19 Validation - Equipment Performance Qualification (PQ) Obtaining and documenting evidence that the equipment as installed and operated in accordance with operational procedures, consistently performs in accordance with predetermined criteria, and thereby yields a product meeting its specification. ISO TS Testing with actual product and loads MPQ Microbiological tests to verify kill PPQ - Physical measurements to verify the process Re-Qualification or Re-validation Periodic (annual) After changes 20 Validation Validation PQ Example Performance Re-Qualification Performance Re-Qualification Performance Re-Qualification Performance Qualification Operational Qualification Installation Qualification Elements of validation build upon each other... Example: Loadable space of a steam sterilizer Measurements inside and outside of load 21 PQ Example (cont.) PQ Example (cont.) Instrument Mixed load (%) (%) Textiles (%) Instrument Mixed load (%) (%) Textiles (%) Interpolation between loads 3 conditions 2 conditions 2 conditions X 3 replicates/set = 21 cycles = 7 conditions 4

5 Validation (cont.) Cleaning and decontamination Inspection / assembly Packaging (materials, technique) Sterilizer loading Sterilization process (sterilizer, cycle) Storage / distribution ALL STEPS (and critical equipment) OF THE STERILIZATION PROCESS MUST BE VALIDATED AND CONTROLLED 25 More validation requirements... Equipment calibration/recalibration Change control ISO ; 2006 Change control Any changes must be revalidated Product New devices Process Materials like cleaners New sterilizer cycle or setting Routine monitoring Packaging New containers Loading Standards Standards routine monitoring... ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities Sterilization of health care products Moist heat Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

6 Standards routine monitoring... Routine monitoring the basics China: WS310:2016 Colombia: #02183 Manual of good practices of sterilization of Colombia: 2004 Canada: Z : Effective Sterilization in Health Care Settings by the Steam Process (2014 ed.) Typically used in health care facilities that are not able to attain and maintain the high degree of validation and control required by the parametric release approach. Typically requires that a Quality System be established and maintained Data for the product release decision generated by indicators that test each sterilization cycle as a distinct event Sterilization Process Monitoring Tools Physical monitors Information from sensors in the sterilizer chamber wall (e.g. temperature, pressure) Can confirm that the correct cycle was selected Biological Indicators Chemical Indicators Physical Monitors Provides a record of the cycle Chemical indicators Biological indicators Exposure Indicators Examples: Indicator tapes; printed indicators on packages Special Equipment Tests Bowie-Dick Tests Test systems containing viable microorganisms providing a defined resistance to a specified sterilization process ISO Pack Indicators Used inside packs, or inside Process Challenge Devices

7 The basic principle of biological indicators Process challenge devices (PCD) 1. Contain a very large number of bacteria (test organisms) 2. The test organisms are spores, so they are very hard to kill If the process can kill the BI, it will kill the lower numbers of less resistant organisms on the medical devices BIOLOGICAL INDICATORS PROVIDE A DIRECT MEASURE OF LETHALITY 37 process challenge device (PCD): Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process. ISO Routine monitoring practices require that biological indicators used for load release be inside of a process challenge device 38 Process challenge devices Process challenge devices Practical consideration... indicators inside of the load or packages cannot be easily retrieved Process challenge devices are intended to restrict sterilant access to the indicator, as if it was inside the load The design of the PCD is related to increasing resistance to challenge the process 39 AAMI ST Routine monitoring Sterilized load release is based on: Routine monitoring Quality System Routine monitoring still requires that a quality control system be in place Integration all monitoring control results Biological Chemical Indicators Indicators Physical Monitors Verification of appropriate reprocessing procedures and documentation per the requirements of the Quality System 42 7

8 Parametric release vs. Routine monitoring Some considerations... How do health care facilities approach the issue of release of sterile goods? Americas Asia Europe 43 3M All Rights Reserved. Europe The myth... Europe The reality... A continent with a consistent approach to sterilization quality assurance in health care facilities in all countries... Approach to sterilization assurance is not uniform in the region, even within the European Union Facilities in some northern European countries follow a more industrial practice UK, Netherlands, Germany, Belgium, Sweden Driven by government regulation, and in many cases, investment Historical events (UK) Not all facilities comply Other European countries (southern, eastern Europe) are not actively using this approach Europe The reality... A validation survey of 197 hospital steam sterilizers in The Netherlands in 2001 and 2002 J.P.C.M. van Doornmalena,b,*, J. Dankerta, a Department of Medical Microbiology, Academic Medical Centre of Amsterdam, The Netherlands Received 12 June 2003; accepted 26 July 2004 Available online 13 October 2004 Summary: Steam sterilization is the most common method of sterilization used in hospitals and by companies sterilizing for hospitals. This study validated 197 steam sterilizers with respect to technical condition, various production processes and routine control tests, according to the European norms and standards for steam sterilization. Overall, only 40% of the validated steam sterilizers met the norms and standards. We recommend that adequate measures need to be taken, based on the comments in the validation reports, in order to guarantee the sterility of processed medical items. Other considerations steam quality Time - Satisfactory time at temperature Temperature - Satisfactory temperature as validated for load or device Saturated Steam - Water vapor in a state of equilibrium between condensation and evaporation

9 Saturated steam Steam quality is critical to effective steam sterilization Steam quality is difficult to test and control Summary Potential Sources of Poor Steam Quality Inadequate air removal sterilizer Air leaks (valves or gaskets) sterilizer Gasses entrapped in the supplied steam Boiler feed water Steam lines and valves Parametric release vs. Routine monitoring Both approaches require... A Quality System consisting of policies & procedures for reprocessing of medical items with provisions for appropriate documentation A sterility release mechanism based on monitoring results and evidence or reprocessing per specifications Parametric release requires... Rigorous and thorough validation of the entire process (including re-validation) Strict adherence to the validated process Rigorous calibration and maintenance of equipment Routine monitoring requires... Rigorous use of physical, chemical, and biological indicators A safe parametric release system REQUIRES an effective and tightly controlled validation program. Without validation, parametric release (releasing without use of other indicators) cannot effectively determine the effectiveness of the sterilization process. Is this realistic in hospitals??? Use of a sterile load release program integrating physical, chemical, and biological indicator information is a safe, effective, and commonly used approach worldwide. It accommodates the variability inherent in the demanding CSSD environment, without the expense of rigorous validation procedures