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    ASTM Medical Device Cleaning:, ,: Design

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    Rakesh
    This document summarizes ASTM activities related to medical device cleaning. It discusses considerations for designing devices to facilitate cleaning, validating cleaning processes, and verifying cleanliness. It provides examples of ASTM standards developed for extracting and quantifying residues and establishing test soils and limits for acceptable residue levels. The overall goal of these ASTM efforts is to provide guidance on cleaning medical devices to help ensure they are sufficiently clean prior to patient use or reprocessing.

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    ASTM Medical Device Cleaning:, ,: Design

    Uploaded by

    Rakesh
    112 views27 pages
    This document summarizes ASTM activities related to medical device cleaning. It discusses considerations for designing devices to facilitate cleaning, validating cleaning processes, and verifying cleanliness. It provides examples of ASTM standards developed for extracting and quantifying residues and establishing test soils and limits for acceptable residue levels. The overall goal of these ASTM efforts is to provide guidance on cleaning medical devices to help ensure they are sufficiently clean prior to patient use or reprocessing.

    Original Title

    Cleaning Workshop UCM268707

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    This document summarizes ASTM activities related to medical device cleaning. It discusses considerations for designing devices to facilitate cleaning, validating cleaning processes, and verifying cleanliness. It provides examples of ASTM standards developed for extracting and quantifying residues and establishing test soils and limits for acceptable residue levels. The overall goal of these ASTM efforts is to provide guidance on cleaning medical devices to help ensure they are sufficiently clean prior to patient use or reprocessing.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    112 views27 pages

    ASTM Medical Device Cleaning:, ,: Design

    Uploaded by

    Rakesh
    This document summarizes ASTM activities related to medical device cleaning. It discusses considerations for designing devices to facilitate cleaning, validating cleaning processes, and verifying cleanliness. It provides examples of ASTM standards developed for extracting and quantifying residues and establishing test soils and limits for acceptable residue levels. The overall goal of these ASTM efforts is to provide guidance on cleaning medical devices to help ensure they are sufficiently clean prior to patient use or reprocessing.

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    ASTM Medical Device Cleaning:

    Design, Clean, Verify

    Stephen Spiegelberg

    Cambridge
    Polymer Group, INC.
    Consultation, Testing, and Instrumentation for Polymeric Materials
    7-17 Presentation (10/1/2010)
    History: ASTM Activities
    American Society for Testing and Materials

    • Sulzer Interop Recall in 2000

    ~2000 revisions due to lack of osseointegration


    $1B class action settlement

    7-17 Presentation (10/1/2010)


    ASTM Activities on Cleanliness

    • Workshop on Device Cleanliness


    (May, 2003)
    • Start of F04.15.17 (Device
    Cleanliness)

    • Symposium on Device Cleanliness


    (May, 2005)

    • Workshop on “How Clean is Clean


    Enough?” (November 2010)
    • Start of 4 new cleaning standards

    7-17 Presentation (10/1/2010)


    ASTM Activities on Cleanliness
    • Verify
    – How to quantify residues on implants
    • Clean
    – How to validate clean lines and provide guidance
    • Design
    – How to design implants with cleaning in mind

    7-17 Presentation (10/1/2010)


    Design - Considerations

    • Single use or re-usable?


    • What materials are used in device?
    • What manufacturing materials will be used that
    could leave residues?
    • What cleaning systems are available for use?

    Cleaning should be part of the design input process

    7-17 Presentation (10/1/2010)


    Design – Single Use or Re-usable?
    • Cleaned by manufacturer
    • Components only exposed to a single cleaning cycle
    • Known manufacturing residues to be removed during
    cleaning
    – Polishing compounds, lubricants, coolants,
    buffers

    7-17 Presentation (10/1/2010)


    Design – Single Use or Re-usable?
    • Cleaned by reprocessor or hospital
    • Exposure of components to tissue and fluids
    • Cleaning and disinfection require access to surfaces
    – Design for disassembly and cleaning

    • Adequate instructions for reprocessing


    – Potential damage to component during cleaning
    – How many times can it be reprocessed?

    7-17 Presentation (10/1/2010)


    Design to Minimize Cleaning
    • Design components for simple, effective cleaning
    – Blind spots
    – Mixed materials (what cleaning agents can be used on them)
    – Sharp corners, fine features, threading
    – Disassembly of re-usable parts for cleaning
    • Design components for simple manufacturing
    – Fewest manufacturing steps
    – Fewest number of processing compounds (grit blast, polish, masking)
    • Design simplest cleaning operation
    – Omnidirectional cleaning vs. directional
    – Avoiding redepositing removed soil on clean parts
    – Cleaning your clean-line
    – Cross-contamination of different components cleaned in the same clean-line

    • Design with cleaning validation in mind


    – How to assess how clean your parts are?

    7-17 Presentation (10/1/2010)


    Design: ASTM Activities

    7-17 Presentation (10/1/2010)


    Design: ASTM Work Item 31799

    • Serrated edges
    • Hinges
    • Acute angles
    Cleaning systems
    • Coils
    • Junctions between insulating sheaths
    • Long or narrow opaque lumens
    • Blind ends
    • Threaded areas

    7-17 Presentation (10/1/2010)


    Cleaning
    • Adequate removal of soils without introducing new residues
    – Cleaning agents
    – Migration of residues from one location to another
    – Elution/extraction
    • Damage to component or materials
    – Mechanical, thermal, chemical
    • Validation of cleaning process
    • Cost and process time
    • Cross-contamination
    – Multiple product lines

    7-17 Presentation (10/1/2010)


    Cleaning: Considerations
    cleaning materials cleaning systems
    • Water • Ultrasonics
    • Detergents • Water jets
    • Surfactants • Refluxing
    • Buffers • Baths
    • Chelators • Mechanical (brush)
    • Enzymes

    effectiveness in removing residues

    vs.

    damage to components

    7-17 Presentation (10/1/2010)


    Cleaning: Single Use
    • Validating cleaning lines
    • FDA: Validation of Cleaning Processes (7/93) – pharmaceutical
    primarily
    – Equipment design
    – Written procedures
    – Analytical verification New ASTM work item
    – Sampling
    – Establishment of limits

    7-17 Presentation (10/1/2010)


    Cleaning: Clean-line Validation
    • Worst case analysis
    – Residues (test soils)
    – Devices
    • Sample configuration
    – Device vs. coupon
    • Choosing analytical method to verify cleanliness
    – Test frequency
    – Validation of method
    – Sample size (statistics)
    • Monitoring cleaning system in real-time/batch
    • When/how should a clean-line be re-validated
    • Acceptance criteria

    7-17 Presentation (10/1/2010)


    Cleaning: Re-usable Devices

    Adequate instructions for disassembly and cleaning


    7-17 Presentation (10/1/2010)
    Verify: Is cleaning successful?

    • Test methods
    • Establishing acceptable limits

    Alumina oxide residue

    7-17 Presentation (10/1/2010)


    Verify: ASTM Activities

    • ASTM F2459 - Standard Test Method for Extracting Residue from


    Metallic Medical Components and Quantifying via Gravimetric
    Analysis
    • ASTM F2847 - Standard Practice for Reporting and Assessment of
    Residues on Single Use Implants
    • ASTM E2314 - Standard Test Method for Determination of
    Effectiveness of Cleaning Processes for Reusable Medical
    Instruments Using a Microbiologic Method (Simulated Use Test)
    • ASTM D7225 - Standard Guide for Blood Cleaning Efficiency of
    Detergents and Washer-Disinfectors

    7-17 Presentation (10/1/2010)


    Verify: ASTM F2459
    Standard Test Method for Extracting Residue from Metallic Medical
    Components and Quantifying via Gravimetric Analysis

    • Describes extraction protocol


    – Ultrasonic bath
    – Reflux
    – Extraction efficiency
    • Gravimetric assessment of soluble and
    insoluble residue

    7-17 Presentation (10/1/2010)


    Verify: ASTM F2847
    Standard Practice for
    Reporting and
    Assessment of Residues
    on Single Use Implants

    Decision tree for


    sample preparation
    and analysis

    7-17 Presentation (10/1/2010)


    Verify: ASTM F2847

    7-17 Presentation (10/1/2010)


    Verify: ASTM F2847

    7-17 Presentation (10/1/2010)


    Verify: Test Soils

    • New ASTM work item


    • Standardized test soils
    • Validate
    – Clean lines
    – Test methods (and establish detection limits)

    7-17 Presentation (10/1/2010)


    Verify: Test Soils

    7-17 Presentation (10/1/2010)


    Verify: ASTM WK 33439

    • Test Soils
    – Blood analog
    Formulas and shelf life
    – GI fluid analog

    • Use for cleaning testing


    – Apply the soil on a test device by a pipette tip, painting the soil
    onto the device using a brush, or by immersing the device in the
    test soil.

    – Dry for up to 24 hours

    – Fix with glutaraldehyde

    Increasing cleaning challenge


    7-17 Presentation (10/1/2010)
    How Clean is Clean Enough?

    7-17 Presentation (10/1/2010)


    Verify: Establishing Residue Limits
    • WK32535: Establishing Limit Values for Residues on
    Single use Implants
    – Biocompatibility
    • Baseline measurement of currently marketed implants
    • Field reports of success/issues
    – Clinical success = acceptable limits
    – Biocompatibility
    • Animal studies, cytoxocity studies
    – Achievable with clean-line
    • Statistics
    • Cost
    FDA does not intend to set acceptance specifications or methods for determining
    whether a cleaning process is validated. The firm's rationale for the residue limits
    established should be logical based on the manufacturer's knowledge of the materials
    involved and be practical, achievable, and verifiable. (Validation of Cleaning Processes (7/93))
    7-17 Presentation (10/1/2010)
    For More Information

    ASTM Task Group F04.15.17

    November 16th, 2011 (Tampa, FL)

    stephen.spiegelberg@campoly.com

    http://www.campoly.com

    7-17 Presentation (10/1/2010)

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