Reducing Risk: Validated Methods for Cleaning Reusable Medical Devices

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
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