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Medical Device Cleaning Validation Studies


On March 17, 2015, FDA published new guidance describing testing and labeling requirements for reusable medical devices.  The updated guidance is timely, since recent outbreaks of CRE from endoscopes exposed several missing validation studies from implicated manufacturers.

FDA’s historical guidance pertaining to cleaning and disinfection of reusable medical devices was contained in a document entitled “Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance.” FDA has now replaced the historical guidance document with a new, overhauled document, called “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff.”  The historical document and the new document may be viewed by clicking the links above.

Medical device makers should note the following, paraphrased from the new guidance:

FDA requires all reusable medical devices to have cleaning and disinfection validation studies conducted, with the scope of the studies being proportional to the device’s potential to serve as a vehicle for infectious disease.

For the following devices, FDA must review and approve cleaning and validation data (typically through the 510k process) prior to sale.

  • Bronchoscopes and accessories
  • Ear, nose and throat endoscopes and accessories
  • Gastroenterology and Urology endoscopes and accessories
  • Automated Endoscope Reprocessors
  • Colonoscopes
  • Neurological endoscopes
  • Arthroscopes and accessories
  • Laparoscopic instruments and accessories

Microchem Laboratory can conduct both the cleaning and disinfection validations necessary to satisfy FDA’s validation requirements.  If your company is in need of validation studies, please contact the lab today.