Conclusion

Human factors related to healthcare reprocessing of medical devices is a valuable component of product development for all medical devices. If reprocessing steps are performed incorrectly, or not at all, it could result in serious harm to the next patient. In-use, or human factors testing, is a powerful method to ensure that users can appropriately follow and perform all of the reprocessing steps. This is an integral part of preparing the device for regulatory submission. Proper reprocessing of medical devices will decrease hospital acquired infections and increase patient safety.

References

  1. Food and Drug Administration. 2015. Guidance for Industry and FDA Staff – Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. U.S. Department of Health and Human Services, Washington, DC.
  2. Food and Drug Administration. 2002. Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff. FDA. Infection Control Devices Branch. Division of Dental, Infection Control and General Hospital Devices. Office of Device Evaluation. Center for Devices and Radiological Health.
  3. Food and Drug Administration. 2016. Draft Guidance for Industry and FDA Staff – List of Highest Priority Devices for Human Factors Review. U.S. Department of Health and Human Services, Washington, DC.

This article was written by Emily Mitzel, M.S., consulting manager/senior scientist at Nelson Laboratories, Salt Lake City, UT. For more information, Click Here.