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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

Reducing Risk: Validated Methods for Cleaning Reusable Medical Devices

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  • In this talk I’ll be discussing the newly published guidance, new working group guidance from the AAMI groups, and important information from the FDA guidance document. At that point I will go into how to perform a sterilization validation and also how to perform a cleaning validation on a reusable device.
  • We are seeing changes in the development and design of the devices due to human factor considerations and more changes are on the horizon. IFU developers also need to design instructions with end users in mind. The FDA draft guidance contains a section specific to the content of IFUs. This section outlines what the reprocessing instructions should encompass and how they should be presented.

    This section suggests that all instructions be grammatically correct, legible, and presented in logical order, from the initial reprocessing step through the terminal reprocessing step. Each step should be well written and in simple language when possible.

    Language is the correct, succinct, and clear use of words


  • Use of language such as, “a minimum of”, “if appropriate”, “if possible”, or “if necessary” has been discouraged and is no longer acceptable. It not only allows for interpretation, but steps may be missed during reprocessing resulting in inadequate cleaning.
     
  • The step by step instructions for adequate disassembly and the supplies used for disassembly should be included in the IFU. Detailed illustrations, diagrams, and descriptions should also be used to assist the end user, especially for disassembly steps which are vital to the cleaning process.
     
  •  
    Details such as detergent dosage/temperature/water quality or type/ time/ brush type and size used in the validation should be outlined in the IFU. If specialized supplies are needed for cleaning, the product manufacturer and part numbers should be documented in the IFU. This may seem unreasonable to many, but the need for this information is necessary for effective reprocessing.
     
  • Inaccessible areas of a device pose a potential challenge for effective reprocessing simply due to the physical restriction for accessing those areas. When designing devices, consider finding alternatives to the following:
    Textured surfaces
    Hinges
    Springs
    Narrow or dead end lumens
    Cracks and crevices
    Mated surfaces
  • The type of materials chosen for the device or device container can have a significant effect on thermal conductance which, in turn, can affect optimal sterilization conditions. Materials such as braided cables, aluminum based metals, and pliable materials (silicone and rubber) may decrease the ability to clean a device. Material compatibility with sterilization methods, alkaline detergents, or chemical disinfectants must also be considered.
  • The type of materials chosen for the device or device container can have a significant effect on thermal conductance which, in turn, can affect optimal sterilization conditions. Materials such as braided cables, aluminum based metals, and pliable materials (silicone and rubber) may decrease the ability to clean a device. Material compatibility with sterilization methods, alkaline detergents, or chemical disinfectants must also be considered.

Transcript

  • 1. Reducing Risk: Validated Methods for Cleaning Reusable Medical Devices
  • 2.  This webinar will be available afterwards at www.designworldonline.com & email  Q&A at the end of the presentation  Hashtag for this webinar: #DWwebinar Before We Start
  • 3. Moderator Presenters Paul Heney Design World Emily Mitzel Nelson Laboratories Steve Twork Bal Seal Engineering
  • 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. Cleaning Samples • Single housing with multiple groove types o “Typical” spring configuration o Enclosed groove o No flush ports • 5mm bore • Stainless steel
  • 6. Cleaning Methods • Reusable Cleaning (Baseline test in accordance with AAMI TIR30: 2011) o Manual cleaning methods • Scrubbing and rinsing • Pressure washing
  • 7. Cleaning Results
  • 8. Cleaning Results
  • 9. Cleaning Results
  • 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. Alternative Solutions • OD or ID Flush Ports • Open grooves • Product alternatives
  • 12. Healthcare Reprocessing of Medical Devices and Human Factors Debrief Emily Mitzel, B.S., M.S. Laboratory Manager Nelson Laboratories, Inc. 801.290.7899 emitzel@nelsonlabs.com
  • 13. Reusable Devices
  • 14. Human tissue found inside an arthroscopic cannula during infection outbreak investigation. Infection Control and Hospital Epidemiology, University of Chicago Press.
  • 15. Bristle from a cleaning brush inside a “clean” arthroscopic shaver. Infection Control and Hospital Epidemiology, University of Chicago Press.
  • 16. Human tissue and other debris retained in surgical suction tubes. University of Michigan Health System.
  • 17. Surgical suction device cut in half was found to be packed with debris. University of Michigan Health System
  • 18. Cleaning/disinfection/sterilization of reusable devices in a HCF. http://www.today.com/health/today-investigates-dirty-surgical- instruments-problem-or-1C9382187 http://video.today.msnbc.msn.com/today/46479070#46479070 NBC Special
  • 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. 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. • 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. 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. •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. Cleaning Device Design Device Compatibility Instructions for Use Human Factors Cleanability?
  • 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. • 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. • 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. 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. • 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. 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. 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. • 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. 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. 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. •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. 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. = 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. Worst case testing Appropriate test soil Appropriate residual testing Cleaning Validation Considerations
  • 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. 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. 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. Cleaning Protein Hemoglobin Total Organic Carbon Carbohydrates Detergent Residuals Endotoxin Bioburden Cleaning Markers
  • 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. 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. 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. Thank You! Emily Mitzel, B.S., M.S. Laboratory Manager Nelson Laboratories, Inc. 801.290.7899 emitzel@nelsonlabs.com General Information: sales@nelsonlabs.com Seminar Information: seminars@nelsonlabs.com
  • 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. Questions? Paul Heney Design World pheney@wtwhmedia.com Phone: 440.234.4531 Twitter: @DW_Editor Emily Mitzel Nelson Laboratories emitzel@nelsonlabs.com Phone: 801.290.7802 Steve Twork Bal Seal Engineering stwork@balseal.com Phone: 949.460.2160
  • 49. Thank You  This webinar will be available at designworldonline.com & email  Tweet with hashtag #DWwebinar  Connect with Design World  Discuss this on EngineeringExchange.com