Published on February 22, 2014
Healthcare Reprocessing of Medical Devices and Human Factors Debrief Emily Mitzel, B.S., M.S. Laboratory Manager Nelson Laboratories, Inc. 801-290-7899 email@example.com
Reusable Devices Copyright Nelson Laboratories 2014
Human tissue found inside an arthroscopic cannula during infection outbreak investigation. Infection Control and Hospital Epidemiology, University of Chicago Press. 3
Bristle from a cleaning brush inside a ―clean‖ arthroscopic shaver. Infection Control and Hospital Epidemiology, University of Chicago Press. 4
Human tissue and other debris retained in surgical suction tubes. University of Michigan Health System. 5
Surgical suction device cut in half was found to be packed with debris. University of Michigan Health System 6
NBC Special Cleaning/disinfection/sterilization of reusable devices in a HCF. http://www.today.com/health/today-investigates-dirtysurgical-instruments-problem-or-1C9382187 http://video.today.msnbc.msn.com/today/46479070#464790 70 7
Overview Guidance for the Reusable Device Manufacturer Outcome of ―How Clean is Clean?‖ Round Table Discussion IFU Information Device Design for Human Factors Cleaning Validation Considerations for Human Factors Sterilization Validation Considerations for Human Factors Manufacturer’s Responsibilities and Considerations Copyright Nelson Laboratories 2014 8
Important Guidance Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling – May 2011 AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers AAMI TIR30:2011 A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices Copyright Nelson Laboratories 2014 9
Current AAMI Working Groups Related to Reprocessing • • • • • • • • • • • • • WG 6 – Chemical Indicators – ANSI/AAMI/ISO 11140 WG 10 – Liquid Chemical Sterilization - ANSI/AAMI/ISO 14160 WG 12 – Instructions for device reprocessing – TIR12, ST81, ISO 17664 WG 13 – Washer-disinfectors - ISO 15883 WG 40 – Steam Sterilization Hospital Practices - ST79 WG 60 – EO Sterilization Hospital Practices – ST41 WG 61 – Chemical Sterilants Hospital Practices - ST58 WG 84 – Endoscope Reprocessing WG 85 – Human Factors for Device Reprocessing WG86 – Quality Systems for Device Reprocessing – ST90 WG 93 – Cleaning of Reusable Medical Devices – TIR30 WG 94 – Rigid Sterilization Container Systems - ST77 WG 95 – Water Quality for Reprocessing Medical Devices - TIR34 Copyright Nelson Laboratories 2014 10
New Guidance New working groups from AAMI • • • • • • Human factors device reprocessing - draft Standardized instructions for use - draft Quality systems for device reprocessing - outline Endoscope reprocessing - comments Managing sterilization of loaner instrumentation – on hold Low and intermediate level disinfectants and their use - outline New working groups from ASTM • WK31799 – New Guide for Designing Medical Devices for Cleanability • WK33439 – New Guide for Standard test soils for validation of cleaning methods for reusable medical devices 11 Copyright Nelson Laboratories 2014
"How Clean is Clean?" 19 September 2013 Participants: • AAMI • FDA • Manufacturers • Test Labs • Hospital Staff What is the maximum amount of residual soil that can remain on a medical device after cleaning that will still render it safe for patient use? Copyright Nelson Laboratories 2014 12
Cleanability? Device Design Human Factors Cleaning Device Compatibility Instructions for Use Copyright Nelson Laboratories 2014 13
"How Clean is Clean?" Main Topics • How do we define ―clean‖? • 2 ways: – Manufacturers need to validate a cleaning method that will render the device safe for patient use – HCFs need a simple, cost-effective method to verify that the device has been cleaned to that standard. Copyright Nelson Laboratories 2014 14
"How Clean is Clean?" Validation of Cleanliness of Devices • One test soil cannot be used for all medical devices • Manufacturers should conduct validation testing on devices that are in a used state • Manufacturers should ensure that the HCF can correctly clean the device • Manufacturers’ instructions for cleaning should take into account limits within the HCF as well as limits with the device itself Copyright Nelson Laboratories 2014 15
Instructions for Use (IFU) • Grammatically correct • Legible • Presented in logical order - from the initial reprocessing step through the terminal reprocessing step • Short/concise – at 6th grade reading level • Positive/active voice • Number steps in Arabic numbers • Use images to show essential steps Copyright Nelson Laboratories 2014 16
IFU – Don’ts • Be Specific - Do not use: – – – – ―a ―if ―if ―if minimum of‖ appropriate‖ possible‖ necessary‖ This language has been discouraged and is no longer acceptable. It not only allows for misinterpretation, but steps may be missed during reprocessing resulting in inadequate cleaning. Copyright Nelson Laboratories 2014 17
IFU – Disassembly and Reassembly • Disassembly and Assembly step by step instructions should be included in the IFU. • This includes detailed illustrations, diagrams, descriptions, and videos to assist the end user. • Disassembly steps are vital to the cleaning process. Copyright Nelson Laboratories 2014 18
IFU – Cleaning Information Specific instructions need to include: • Detergent dosage • Temperature • Water quality • Time • Brush type and size • Specialized supplies - include and part numbers Copyright Nelson Laboratories 2014 19
New FDA Expectation for Manufacturers Manufacturers are encouraged to provide on-site training and education for sterile processing personnel. This opens communication and encourages collaboration on device designs that meet functional requirements, and also addresses human factor considerations. Copyright Nelson Laboratories 2014 20
New FDA Expectation for Manufacturers – cont’d • Consider feedback from HCF personnel, sales reps, etc. • Solicit input from individuals knowledgeable in processing equipment and methods to ensure complete and accurate analysis • Develop education, training, and competency verification materials for HCFs • Keep in mind PPE HCF need to use during cleaning when performing validation 21 Copyright Nelson Laboratories 2014
Consider Reprocessing • In conjunction with designing devices – Provisions for cleaning and sterilization should be considered during the first stages of device design. Goal is to achieve functional yet cleanable and sterilizable product designs. Copyright Nelson Laboratories 2014 22
Design Features that Make Cleaning Difficult May harbor unwanted organisms and/or organic material – difficult to clean and sterilize • Braided or twisted wires • Textured surfaces • Hinges • Springs • Dead end lumens and channels • Inaccessible cracks and crevices • Mated Surfaces • Sharp internal corners and angles • Lumens • O-Rings Copyright Nelson Laboratories 2014 23
Material Design Features that Make Cleaning Difficult May have a significant effect on thermal conductance • Aluminum based metals • Pliable materials such as: • Silicone • Rubber Copyright Nelson Laboratories 2014 24
80 60 Temperature(C) Metal Device 14:18:40 14:18:20 14:18:00 14:17:40 14:17:20 14:17:00 14:16:40 14:16:20 14:16:00 14:15:40 14:15:20 14:15:00 14:14:40 14:14:20 14:14:00 14:13:40 14:13:20 14:13:00 14:12:40 14:12:20 14:12:00 14:11:40 14:11:20 14:11:00 14:10:40 14:10:20 14:10:00 14:09:40 14:09:20 14:09:00 14:08:40 14:08:20 14:08:00 14:07:40 14:07:20 14:07:00 14:06:40 14:06:20 14:06:00 14:05:40 14:05:20 14:05:00 14:04:40 14:04:20 Time Copyright Nelson Laboratories 2014 25 Chamber Max Chamber Min Product Max Product Min Prevacuum, 132 degrees Celsius, 4/0 Metal Device (355.1 grams) PRODUCT & CHAMBER TEMPERATURE PROFILE Lab Number: Nelson Labs 140 120 100 40 20
70 Temperature(C) Silicone Device 14:18:40 14:18:20 14:18:00 14:17:40 14:17:20 14:17:00 14:16:40 14:16:20 14:16:00 14:15:40 14:15:20 14:15:00 14:14:40 14:14:20 14:14:00 14:13:40 14:13:20 14:13:00 14:12:40 14:12:20 14:12:00 14:11:40 14:11:20 14:11:00 14:10:40 14:10:20 14:10:00 14:09:40 14:09:20 14:09:00 14:08:40 14:08:20 14:08:00 14:07:40 14:07:20 14:07:00 14:06:40 14:06:20 14:06:00 14:05:40 14:05:20 14:05:00 14:04:40 14:04:20 26 Copyright Nelson Laboratories 2014 Time Chamber Max Chamber Min Product Max Product Min Prevacuum, 132 degrees Celsius, 4/0 Silicone Device (360.2 grams) PRODUCT & CHAMBER TEMPERATURE PROFILE Lab Number: Nelson Labs 130 110 90 50 30 10
Number of Components that Make Cleaning Difficult • Devices might not be reassembled properly • Parts could be More complex misplaced device = greater opportunity for • Parts may be intermixed • Confusion which errors extends processing time Copyright Nelson Laboratories 2014 27
Complex Devices = unavoidable problematic design features May require more stringent cleaning procedures such as mechanical or automated cleaning methods and increased sterilization cycle times or drying times Copyright Nelson Laboratories 2014 28
Cleaning Validation Considerations Worst case testing Appropriate test soil Appropriate residual testing 29 Copyright Nelson Laboratories 2014
Clinically Relevant Test Soils What test soil should be used? Will the device be in contact with blood, mucus, cerebral spinal fluid (CSF), brain tissue, etc.? Clinically relevant soils Soil contents, proportion of contents, viscosity and tenacity. Manufacturers must justify why the specific soil was used and make sure the test soil is appropriate for all markers to be measured. Copyright Nelson Laboratories 2014 30
Worst Case Contamination Contamination method Does this device get immersed? Simulated use How is the device actuated in surgery? Wet soil contact time How long is the surgery time? Contaminated device dwell time What is the wait time between the surgery and the cleaning process? Copyright Nelson Laboratories 2014 Does the device just get handled by the physician? Worst case dwell time should be used for validations 31
Methods of Cleaning Performed per Manufacturers IFU Manual: Most common method - Mandatory • soaking • brushing • flushing Mechanical: • ultrasonic cleaners Automated: Mandatory also if device appropriate • washer/disinfector Copyright Nelson Laboratories 2014
Cleaning Markers Cleaning Bioburden Protein Hemoglobin Carbohydrates Total Organic Carbon Detergent Residuals Endotoxin Copyright Nelson Laboratories 2014
Cleaning Validation Acceptance Criteria For most devices there are no established performance criteria For validations, these should be predetermined and justified by manufacturer AAMI TIR30 –benchmark criteria for endoscopes Copyright Nelson Laboratories 2014
Cleaning Validation Information Needed Description of all accessories required Techniques used including rinsing, brushing, flushing Water quality used for each process Concentration and type of chemicals/detergents Exposure time and temperature of each step ISO17664 Copyright Nelson Laboratories 2014
Methods of Sterilization STERRAD ® Liquid Chemical Steam Sterilization Copyright Nelson Laboratories 2014 Ethylene Oxide Dry Heat 36
Sterilization Validation Steps SAL validation with half cycle paramters Dry time validation with full cycle paramters Copyright Nelson Laboratories 2014 Temperature profiling 37
Inoculation Methods BIs placed in the most difficult-tosterilize areas: • Lumens • Mated surfaces First preference is an inoculated carrier •NOTE—Direct inoculation of a product with a liquid spore suspension can result in variable resistance of the inoculum because of the occlusion of the spores on or in the product, surface phenomena, and/or other environmental factors. (AAMI TIR39:2009) Copyright Nelson Laboratories 2014 38
Sterilization Validation Acceptance Criteria All media used for sterility testing the biological indicators must demonstrate growth promotion. All validation cycles must be within specifications. All SAL validation runs must demonstrate a minimum of a 6 log10 kill in the half cycle. Packaging and products must pass visual inspection with no moisture observed Packaging weight gain cannot exceed 3% Copyright Nelson Laboratories 2014 39
Recent Sterilization Guidance FDA-cleared Parameters • Sterilizers • Steam, EO, STERRAD, Dry Heat • Accessories • Biological Indicators, Chemical Indicators, Packaging • Parameters from AAMI TIR12, AAMI ST79, etc. • No more extended cycles Copyright Nelson Laboratories 2014 40
Cycle Parameters for Prevacuum Steam Sterilization Cycles 132°C (270°F) Item 135°C (275°F) 4 min Wrapped Instruments 20-30 min 3 min 4 min Textile Packs 16 min 5-20 min 3 min 4 min Wrapped Utensils Drying Times 3 min 20 min 3 min 16 min Unwrapped Nonporous Items (e.g. instruments) 3 min 3 min NA Unwrapped Nonporous and Porous Items in a Mixed Load 4 min 3 min NA ANSI/AAMI ST79:2010 and A1:2010 Copyright Nelson Laboratories 2014 41
Sterilization Considerations Device Design • Material of device heats up quickly and remains hot • Limit blind holes or dead-ended lumens • Use cannulas to allow for sterilant penetration • Ensure sterilant can flow through entire device Tray Design • Allow for adequate sterilant penetration • Tray material heats up quickly and remains hot • Reduce mass (<25 pounds) Copyright Nelson Laboratories 2014 42
Sterilization Considerations Tray Layout • Proper sterilant flow throughout tray • Holders have limited contact with device • Holders do not block steam • Holders allow devices to be in unlocked and open position • Mass is distributed throughout tray • Devices are not stacked on each other Copyright Nelson Laboratories 2014 43
Sterilization Considerations Dry Time Testing • Materials that stay hot do the best • Reduce mass • No surfaces that allow water to pool • Packaging material • Water to properly drain Copyright Nelson Laboratories 2014 44
Sterilization Validation Information Needed Description of techniques to be used All accessories required Description of process parameters Concentration of sterilant required Max values of contaminants in condensate from steam Required temperature of the sterilizing agent Humidity required for the sterilization process Min exposure time Pressure required Post-sterilization activities ISO17664 Copyright Nelson Laboratories 2014
7 Criteria for Reprocessing Instructions 1) Labeling reflects intended use 2) Thorough cleaning process 3) Microbiocidal process 4) Reprocessing steps are technically feasible 5) Use legally marketed detergents/disinfectants 6) Instructions are comprehensive – Reuse Life testing 7) Instructions are understandable Copyright Nelson Laboratories 2014
Thank You! Emily Mitzel, B.S., M.S. Laboratory Manager Nelson Laboratories, Inc. 801-290-7899 firstname.lastname@example.org Copyright Nelson Laboratories 2013 General Information: email@example.com Seminar Information: firstname.lastname@example.org
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