Current Regulatory Thinking in Reprocessing

Steven J. Elliott

Principal Medical Research Manager

NAMSA

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Overview Standards and Guidance FDA Draft Guidance Insights into the development and validation process Managing new validation studies

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Standards and Guidance

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AAMI TIR 12:2010 Designing, testing and labeling reusable medical

devices for reprocessing in healthcare facilities: A guide for medical device manufacturers

AAMI TIR 30:2011 A compendium of processes, materials, test methods,

and acceptance criteria for cleaning medical devices

These two guidances are critical with reusable medical devices. They offer great direction and insight to the available processes and procedures you could use.

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ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012

Comprehensive guide to steam sterilization and sterility assurance in health care facilities

Offers insight on what you should anticipate when it comes to the use of your medical device(s) in the actual health care facility.

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ANSI/AAMI ST81:2004/(R)2010 Sterilization of medical devices – Information to be

provided by the manufacturer for the processing of resterilizable medical devices, 1ed

U.S. version of ISO 17664

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Draft Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods

and Labeling When finalized, this document will supersede “Labeling Reusable

Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance”

Guides how FDA reviewers and inspectors/investigators are looking at reprocessing and reusable devices

Understanding and following this guidance will be critical to your success with FDA submissions and reviews on processed/reprocessed medical devices

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FDA Draft Guidance

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Validation Process

– One important thing to recognize and understand about each processing/reprocessing step when it comes to the draft guidance

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Cleaning It is important to recognize that the most

comprehensive instructions in the draft guidance for validation of a process is for cleaning efficacy

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Disinfection It is important to understand the Spaulding Classification

of your device when worst-case use or foreseeable misuse is considered

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Sterilization It is important to know the FDA-cleared cycles,

including the specified dry times

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All validations of processing/reprocessing instructions provided to the end-user by the manufacturer should be conducted under the direction of a comprehensive validation protocol

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All validations, in their own way, must address “worst-case” conditions when determining the challenge that will be presented to the processing/reprocessing procedures and the parameters of the study that will be conducted to validate those procedures

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To view the full series about Current Regulatory Thinking in Reprocessing Visit NAMSA Seminars

For information about the regulatory services NAMSA offers or our processing/reprocessing services Check out our service page on

Regulatory and Consulting View our Post-Market Support page Download our brochure on

Processing/Reprocessing Validations for Medical Devices If you have any questions or would like to request a quote

Contact us at clientcare@namsa.com.