Emily Mitzel, Laboratory Manager, Nelson Laboratories, Inc.

1. 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

2. Reusable Devices
Copyright Nelson Laboratories 2014

3. Human tissue found inside an arthroscopic cannula during infection outbreak
investigation. Infection Control and Hospital Epidemiology, University of
Chicago Press.
3

4. Bristle from a cleaning brush inside a ―clean‖ arthroscopic shaver. Infection
Control and Hospital Epidemiology, University of Chicago Press.
4

5. Human tissue and other debris retained in surgical suction tubes. University
of Michigan Health System.
5

6. Surgical suction device cut in half was found to
be packed with debris. University of Michigan Health
System
6

7. 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
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8. 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
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9. 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Draft Guidance for Industry and FDA Staff –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
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10. 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
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11. 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
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Copyright Nelson Laboratories 2014

12. "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
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13. Cleanability?
Device
Design
Human Factors
Cleaning
Device
Compatibility
Instructions for
Use
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14. "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
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15. "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
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16. 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
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17. 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
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18. 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
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19. 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
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20. 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
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21. 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
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Copyright Nelson Laboratories 2014

22. 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
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23. 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
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24. 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
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25. 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
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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

26. 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
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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
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27. 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
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28. 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
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29. Cleaning Validation
Considerations
Worst case testing
Appropriate test soil
Appropriate residual
testing
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30. 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.
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31. 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
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32. 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
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33. Cleaning Markers
Cleaning
Bioburden
Protein
Hemoglobin
Carbohydrates
Total Organic Carbon
Detergent Residuals
Endotoxin
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34. 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
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35. 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
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36. Methods of Sterilization
STERRAD
®
Liquid
Chemical
Steam
Sterilization
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Ethylene
Oxide
Dry Heat
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37. Sterilization Validation Steps
SAL validation
with half cycle
paramters
Dry time
validation with
full cycle
paramters
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Temperature
profiling
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38. 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
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39. 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%
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40. 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
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41. 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
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42. 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)
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43. 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
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44. 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
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45. 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
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46. 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

47. Thank You!
Emily Mitzel, B.S., M.S.
Laboratory Manager
Nelson Laboratories, Inc.
801-290-7899
emitzel@nelsonlabs.com
Copyright Nelson Laboratories 2013
General Information:
sales@nelsonlabs.com
Seminar Information:
seminars@nelsonlabs.com47