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Whitepaper

WHITEPAPER

Considerations for Third-Party Reprocessing of Single-Use Medical Devices

Reusing single-use devices that have been safely reprocessed by a third-party reprocessor can enable health care providers to maintain high-quality patient care while saving on costs and reducing medical waste. Validated functionality testing must be paired with validated cleaning, disinfection, and sterilization processes to ensure safety and compliance of regulatory requirements.

This whitepaper is appropriate for design teams, quality assurance and regulatory personnel, and anybody interested in learning more about single-use device reprocessing. The knowledge gained from this presentation will aid in the safe and effective reprocessing of single-use devices.

  1. What does single-use reprocessing entail
  2. Regulatory requirements
  3. Cleaning validation approaches
  4. Selection of disinfection or sterilization processes
Emily Mitzel

Emily Mitzel

MS
Reusable Medical Devices Expert

Emily Mitzel is an Expert Advisor and Senior Scientist at Nelson Labs. Her expertise includes reusable device reprocessing validations, newly manufactured device validations, sterilization, and microbiology testing. Emily presents at Nelson Labs’ seminars, tradeshows, ISO, FDA, AAMI, and client facilities across the U.S. and internationally. Emily is an active committee member of many working groups...

Paul Littley

Paul Littley

BSE
Ethylene Oxide and Water Systems Expert

Paul Littley is an expert advisor at Nelson Labs. He is a Biomedical Engineer with over 15 years of medical device industry experience working in sterility assurance, quality assurance, manufacturing, and research and development. His expertise includes ethylene oxide sterilization validation, high-purity water system design validation and process controls, device reprocessing, cleaning validations, microbiology testing,...

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