Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment

Event Information
Product Format
Prerecorded Event
Conference Date
Wed, Nov 23, 2016
90 minutes
Product Description

Understand FDA Regulatory Requirements in Developing Cleaning Validations for Reusable Medical Devices

In recent years, there have been many reported incidents of patient infection as a result of reusable medical devices that have been inadequately cleaned and reprocessed. Firms are subject to quality system regulation even if some cleaning validations of reprocessing reusable medical devices may be exempt from 510(k) premarket notification requirements.

In this session, expert speaker John E. Lincoln will discuss FDA expectations regarding reusable medical device design considerations, cleaning validation methods and labeling instructions for reprocessing reusable medical devices in compliance with FDA’s current policy. In particular, he will discuss what firms should consider when developing cleaning validations including cleaning instructions for reprocessing reusable medical devices.

Additionally, John will guide you through FDA’s current policy and regulatory requirements on cleaning validation for reprocessing reusable medical devices including labeling instructions contained in 510(k) or PMA. This session will help you be in alignment with the FDA’s current policy and will provide great opportunities to learn about regulatory requirements for mobile medical applications.

Session Highlights

  • Laws and Regulations
  • Definitions
  • Important Design Considerations for Reusable Medical Devices
  • Developing Reprocessing Instruction and Considerations for Reusable Medical Devices
  • Human Factors to Consider
  • Criteria for Consideration When Developing Cleaning and Reprocessing Instructions
  • FDA Cleared Cleaning Instruments
  • Documentation Requirements for 510(k)s or PMA
  • Summary of Recent Incidents Including Death
  • Common Pitfalls and How to Avoid
  • Enforcement Actions: Case Studies
  • PASS-IT Recommendations: Best Practices

Areas Covered in the Webinar:

  • Cleaning validation design - automated cleaning.
  • Cleaning validation design - manual cleaning.
  • IFU information to be supported.
  • Choosing test soils.
  • Choosing markers.
  • Expectations for controls.
  • Acceptance criteria selection.
  • Report preparation.

Who should attend?

  • R&D Scientists, Engineers, Managers, and Directors
  • Regulatory Affairs
  • Quality Professionals
  • Product Development Professionals
  • CROs
  • Consultants
  • Senior Management
  • Contractors and Subcontractors
  • Anyone interested in the subject

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

John E. Lincoln

John E. Lincoln is the Principal of J. E. Lincoln and Associates LLC, a consulting company; with over 35 years of experience in U.S. FDA-regulated industries, 21 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation...   More Info
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