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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
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
Moderator Presenters
Paul HeneyDesign World
Emily MitzelNelson Laboratories
Steve TworkBal Seal
Engineering
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
todayo Baseline testing on Canted Coil Springs in various Bal Seal groove
configurations
• Keeping up with new standards and methodso Various reprocessing methods
Cleaning Samples• Single housing with
multiple groove typeso “Typical” spring configurationo Enclosed grooveo No flush ports
• 5mm bore• Stainless steel
Cleaning Methods
• Reusable Cleaning (Baseline test in accordance with AAMI TIR30: 2011)
o Manual cleaning methods• Scrubbing and rinsing• Pressure washing
Cleaning Results
Cleaning Results
Cleaning Results
Next Step
• Reusable cleaning(Baseline test in accordance with AAMI TIR30: 2011)
o System cleaning methods (proposed baseline test)
• Ultrasonic• Automated
washer/disinfector
Alternative Solutions
• OD or ID Flush Ports• Open grooves• Product alternatives
Healthcare Reprocessing of Medical Devices and Human Factors Debrief
Emily Mitzel, B.S., M.S.Laboratory ManagerNelson Laboratories, [email protected]
Reusable Devices
Human tissue found inside an arthroscopic cannula during infection outbreak investigation. Infection Control and Hospital Epidemiology, University of Chicago Press.
Bristle from a cleaning brush inside a “clean” arthroscopic shaver. Infection Control and Hospital Epidemiology, University of Chicago Press.
Human tissue and other debris retained in surgical suction tubes. University of Michigan Health System.
Surgical suction device cut in half was found to be packed with debris. University of Michigan Health System
Cleaning/disinfection/sterilization of reusable devices in a HCF.
http://www.today.com/health/today-investigates-dirty-surgical-instruments-problem-or-1C9382187http://video.today.msnbc.msn.com/today/46479070#46479070
NBC Special
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
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
• 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
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
• 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
Cleaning
Device Design
Device Compatibility
Instructions for Use
Human Factors
Cleanability?
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
• 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
• 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)
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
• 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
Specific instructions need to include:
• Detergent dosage• Temperature• Water quality • Time• Brush type and size• Specialized supplies - include and part numbers
IFU – Cleaning Information
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
• 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
In conjunction with designing deviceso 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
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
• Aluminum based metals• Pliable materials such as:
• Silicone• Rubber
May have a significant effect on thermal
conductance
Material Design Features that Make Cleaning
Difficult
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
= 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
Worst case testing
Appropriate test soil
Appropriate residual testing
Cleaning Validation Considerations
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
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
Performed per Manufacturers IFU• soaking• brushing• flushing
Manual: Most common method - Mandatory• ultrasonic cleaners
Mechanical:• washer/disinfector
Automated: Mandatory also if device appropriate
Methods of Cleaning
Cleaning
ProteinHemoglobin
Total Organic CarbonCarbohydrates
Detergent Residuals
Endotoxin Bioburden
Cleaning Markers
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
Cleaning Validation Information
NeededDescription 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
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
Thank You!
Emily Mitzel, B.S., M.S.Laboratory Manager
Nelson Laboratories, Inc.801.290.7899
General Information: [email protected] Information: [email protected]
Summary• Improved awareness on cleanability
o Better understanding of cleaning methods and expectationso Bal Seal Canted Coil Spring - one solution shown to meet AAMI
TIR30:2011 guidelineso Alternative hardware configurations (e.g., flush ports) may further
enhance cleanability in more challenging conditions
Questions?Paul HeneyDesign [email protected]: 440.234.4531Twitter: @DW_Editor
Emily MitzelNelson [email protected]: 801.290.7802
Steve TworkBal Seal [email protected] Phone: 949.460.2160
Thank You This webinar will be available at designworldonline.com & email
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