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Reducing Risk: Validated Methods for Cleaning Reusable Medical Devices


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Reducing Risk: Validated Methods for Cleaning Reusable Medical Devices

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Reducing Risk: Validated Methods for Cleaning Reusable Medical Devices

  1. 1. Reducing Risk: Validated Methods for Cleaning Reusable Medical Devices
  2. 2.  This webinar will be available afterwards at & email  Q&A at the end of the presentation  Hashtag for this webinar: #DWwebinar Before We Start
  3. 3. Moderator Presenters Paul Heney Design World Emily Mitzel Nelson Laboratories Steve Twork Bal Seal Engineering
  4. 4. Cleaning Awareness • Eliminate Nosocomial Infections o Acquired in the hospital or other health care facility that was not present or incubating at the time of the client’s admission • MRSA #1 • Device Design o Bal Seal Canted Coil Springs used in over 500 types of medical devices today o Baseline testing on Canted Coil Springs in various Bal Seal groove configurations • Keeping up with new standards and methods o Various reprocessing methods
  5. 5. Cleaning Samples • Single housing with multiple groove types o “Typical” spring configuration o Enclosed groove o No flush ports • 5mm bore • Stainless steel
  6. 6. Cleaning Methods • Reusable Cleaning (Baseline test in accordance with AAMI TIR30: 2011) o Manual cleaning methods • Scrubbing and rinsing • Pressure washing
  7. 7. Cleaning Results
  8. 8. Cleaning Results
  9. 9. Cleaning Results
  10. 10. Next Step • Reusable cleaning (Baseline test in accordance with AAMI TIR30: 2011) o System cleaning methods (proposed baseline test) • Ultrasonic • Automated washer/disinfector
  11. 11. Alternative Solutions • OD or ID Flush Ports • Open grooves • Product alternatives
  12. 12. Healthcare Reprocessing of Medical Devices and Human Factors Debrief Emily Mitzel, B.S., M.S. Laboratory Manager Nelson Laboratories, Inc. 801.290.7899
  13. 13. Reusable Devices
  14. 14. Human tissue found inside an arthroscopic cannula during infection outbreak investigation. Infection Control and Hospital Epidemiology, University of Chicago Press.
  15. 15. Bristle from a cleaning brush inside a “clean” arthroscopic shaver. Infection Control and Hospital Epidemiology, University of Chicago Press.
  16. 16. Human tissue and other debris retained in surgical suction tubes. University of Michigan Health System.
  17. 17. Surgical suction device cut in half was found to be packed with debris. University of Michigan Health System
  18. 18. Cleaning/disinfection/sterilization of reusable devices in a HCF. instruments-problem-or-1C9382187 NBC Special
  19. 19. 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 Overview
  20. 20. 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 Important Guidance
  21. 21. • 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 • WG 86 – 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 Current AAMI Working Groups Related to Reprocessing
  22. 22. 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 New Guidance
  23. 23. •AAMI •FDA •Manufacturers •Test Labs •Hospital Staff Participants: 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? “How Clean is Clean?” 19 September 2013
  24. 24. Cleaning Device Design Device Compatibility Instructions for Use Human Factors Cleanability?
  25. 25. How do we define “clean”? • 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. 2 ways: "How Clean is Clean?" Main Topics
  26. 26. • 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 “How Clean is Clean?” Validation of Cleanliness of Devices
  27. 27. • 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 Instructions for Use (IFU)
  28. 28. Be Specific - Do not use: •“a minimum of” •“if appropriate” •“if possible” •“if 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. IFU – Don’ts
  29. 29. • 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. IFU – Disassembly and Reassembly
  30. 30. Specific instructions need to include: • Detergent dosage • Temperature • Water quality • Time • Brush type and size • Specialized supplies - include and part numbers IFU – Cleaning Information
  31. 31. 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. New FDA Expectation for Manufacturers
  32. 32. • 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 New FDA Expectation for Manufacturers – cont’d
  33. 33. In conjunction with designing devices o 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. Consider Reprocessing
  34. 34. 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 Design Features that Make Cleaning Difficult
  35. 35. •Aluminum based metals •Pliable materials such as: •Silicone •Rubber May have a significant effect on thermal conductance Material Design Features that Make Cleaning Difficult
  36. 36. More complex device = greater opportunity for errors •Devices might not be reassembled properly •Parts could be misplaced •Parts may be intermixed •Confusion which extends processing time Number of Components that Make Cleaning Difficult
  37. 37. = 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 Complex Devices
  38. 38. Worst case testing Appropriate test soil Appropriate residual testing Cleaning Validation Considerations
  39. 39. 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. Clinically Relevant Test Soils
  40. 40. Contamination method Does this device get immersed? Does the device just get handled by the physician? 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? Worst case dwell time should be used for validations Worst Case Contamination
  41. 41. Performed per Manufacturers IFU Manual: Most common method - Mandatory •soaking •brushing •flushing Mechanical: •ultrasonic cleaners Automated: Mandatory also if device appropriate •washer/disinfector Methods of Cleaning
  42. 42. Cleaning Protein Hemoglobin Total Organic Carbon Carbohydrates Detergent Residuals Endotoxin Bioburden Cleaning Markers
  43. 43. Cleaning Validation Acceptance Criteria For most devices there are no established performance criteria For validations, these should be pre-determined and justified by manufacturer AAMI TIR30 –benchmark criteria for endoscopes
  44. 44. 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
  45. 45. 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 7 Criteria for Reprocessing Instructions
  46. 46. Thank You! Emily Mitzel, B.S., M.S. Laboratory Manager Nelson Laboratories, Inc. 801.290.7899 General Information: Seminar Information:
  47. 47. Summary • Improved awareness on cleanability o Better understanding of cleaning methods and expectations o Bal Seal Canted Coil Spring - one solution shown to meet AAMI TIR30:2011 guidelines o Alternative hardware configurations (e.g., flush ports) may further enhance cleanability in more challenging conditions
  48. 48. Questions? Paul Heney Design World Phone: 440.234.4531 Twitter: @DW_Editor Emily Mitzel Nelson Laboratories Phone: 801.290.7802 Steve Twork Bal Seal Engineering Phone: 949.460.2160
  49. 49. Thank You  This webinar will be available at & email  Tweet with hashtag #DWwebinar  Connect with Design World  Discuss this on