May 2, 2011

The Food and Drug Administration (FDA) has issued draft guidance on labeling of reusable medical devices used in health care facilities. The new guidance is meant to reflect more complex reusable device designs, and affects the agency’s review processes for 510(k) clearances, premarket approval and humanitarian device exemption applications, as well as investigational device exemption applications specifically regarding labeling instructions for reprocessing reusable medical devices.

Three areas pertaining to reuse instructions and reprocessing validations are targeted by the new guidance: sterile reusable devices originally supplied to end users and then disinfected or sterilized between initial and subsequent patient use; reusable devices that were non-sterile when supplied to end users and required disinfection or sterilization prior to initial use and then reprocessed before subsequent use; and non-sterile single-use devices that end users sterilized prior to use.

The guidance explicitly excludes processes not specifically targeting reusable medical devices: manufacturing of single-use devices sold sterile, single-use device reprocessors as well as single-use sterile devices that do not have reprocessing instructions from manufacturers.

The FDA lists seven criteria for reprocessing labeling manufacturers of reusable devices should supply to end users:

  • Labeling should correspond to a device’s intended use
  • Reprocessing instructions should advise thorough cleaning of a device
  • Instructions should indicate the device’s appropriate microbicidal process
  • Reprocessing instructions should be technically feasible
  • Only legally marketed devices and accessories should be included in processing instructions
  • Reprocessing instructions should be comprehensive
  • Reprocessing instructions should be clear and understandable to end users

The new draft guidance reflects the growing sophistication of reusable medical device designs requiring more complex reprocessing methods, according to the FDA.

Interested parties may submit comments on the new guidelines within 90 days. Upon finalization, the draft guidance will replace “Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance” published in April 1996.


  • Stewart Eisenhart