Reusable Medical Devices – Getting Market Clearance in the United States

Reusable medical devices are devices that health care providers can reprocess and reuse on multiple patients. These reusable devices represent a large percentage of today’s new product development and submissions to the US FDA. Understanding and mastering the FDA’s Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling is the first step in getting new, reusable devices into the US marketplace. This FDA guidance document outlines general considerations of the design and safety of all reusable medical devices as well as what’s important to include in the development and validation of reprocessing instructions for users to follow.

In this presentation, an expert will review and discuss the key points of this document, provide useful tips for managing new validation studies and offer insight into the development and validation process to help accelerate the time to market approval. Avoiding costly FDA deficiencies is challenging; this course will help manufacturers get it right the first time.

Key Topics will Include:

• Useful tips for developing validation studies that are accepted on the first submission
• How to properly classify your device for reprocessing
• Understanding FDA’s six criteria for reprocessing instructions
• Understanding cleaning, disinfection, and sterilization – the differences between them and how they should be applied to products based on classification
• Useful tips on developing Instructions for Use to minimize human error or confusion

Per the FDA’s website, “Reducing the risk of exposure to improperly reprocessed medical devices is a shared responsibility among various stakeholders. This includes the FDA; manufacturers responsible for providing adequate reprocessing instructions that are user-friendly and proven to work; health care facilities responsible for cleaning, sterilizing or disinfecting the devices; and other organizations.”

As a device manufacturer, this webinar will help you understand your responsibility for the safety of all patients exposed to your device and ultimately help your product receive market clearance.

Speaker

Steven Elliott, Director, Quality Control and Sterility Assurance, NAMSA

Steven J. Elliott is Director of Quality Control and Sterility Assurance at NAMSA and the Site Director for the NAMSA Irvine facility. Steven has a B.S. in Microbiology from Auburn University and brings with him over 20 years of experience in the contract laboratory business, splitting time between NAMSA and WuXi AppTec. Just prior to coming on board at NAMSA, he held the position of Director of Microbial Assays at WuXi AppTec where he was responsible for sterilization and cleaning efficacy validations for reusable devices, antimicrobial efficacy testing, and for all custom Microbiology projects. Most recently Steven held the position of Principal Medical Research Manager for NAMSA’s Clinical and Consulting Division, where he oversaw the development and execution of reprocessing validation studies and custom Microbiology studies before taking on the role of Director of Quality Control and Sterility Assurance where he oversees all US Microbiology testing for NAMSA and Site Director for the Irvine facility where he oversees all the work done at the NAMSA Irvine facility. He has also worked in a variety of microbiology-related fields including food microbiology at Kraft-General Foods and virology research at Emory University. Steven has been a member of several working groups associated with the Association for the Advancement of Medical Instrumentation (AAMI), was the former co-chair of working group (WG) 13 for Washer-Disinfectors and has represented the United States as a delegate at the technical committee meetings of the International Organization for Standardization (ISO).

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