Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

Duration: 60 Minutes
The purpose of this webinar is to explain in detail the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.
Instructor: John Chapman
Product ID: 501104
Objectives of the Presentation
  • Reasoning behind labeling requirements
  • Intended use and design
  • Regulatory requirements
  • Validating cleaning and sterilization
  • Standards/guidance
Why Should you Attend
Much attention has been paid to the regulatory requirements of reprocessing single use devices. However, there is increasing attention being directed towards reprocessing reusable medical devices and regulatory requirements.

If a firm reprocesses another manufacturer's medical device, it becomes the legal manufacturer with all the responsibilities for compliance, especially sterility. Failure to prove sterility is almost certainly a cause for either voluntary recall or FDA mandated recall. The same is true if you are reprocessing your own medical device. Cleaning and sterilization instructions must be precise and validated if intended to be re-sterilized by the user facility.

Who can Benefit
  • QA Managers
  • Design Engineers
  • Regulatory Affairs Managers
  • Manufacturing Engineers
  • Quality Engineers
  • Hospital Operating Room Nurse Supervisors
$375
Recorded Session for one participant
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
John Chapman, BS, MBA, RAC has over 30 years medical device regulatory experience and over 10 years experience with the European Union’s medical device directive, 93/42/EEC. John has led two device companies to ISO quality system certification and CE marking. He has performed regulatory due diligence on over a dozen acquisitions in the past 12 years, exposing him to numerous quality systems, including consent decrees as well as many notified bodies. He earned his regulatory affairs certification (RAC) in 1998 and was a contributing author to 2004Fundamentals of EU Regulatory Affairs, RAPS, 2004. He co-founded a local RAPS chapter and has been a speaker at these meetings and the annual RAPS conference.

John has had specialized training and experience in FDA QSR, ISO 13485, European Medical Device Directives, ISO 9001, Canadian Medical Device Regulations, Auditing, Root Cause Analysis, Design Control, Bloodborne Pathogens, Hazardous Waste Handling, and FDA regulations. He has also presented live on-line seminars on various regulatory subjects.
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