The FDA announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection such as endoscopes.
Medical devices intended for repeated use are commonplace in health care settings. They are typically made of durable substances that can withstand reprocessing, a multi-step process designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. While the majority of reusable devices are successfully reprocessed in health care settings, the complex design of some devices makes it harder to remove contaminants.
“Despite the recent concerns about multi-drug resistant bacteria infections associated with duodenoscopes, patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective and clear to the healthcare community that uses them. Doing so should provide greater assurance to patients that the devices used on them are safe and effective.”
The FDA’s guidance document, titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” includes recommendations medical device manufacturers should follow pre-market and post-market for the safe and effective use of reprocessed devices.
A device manufacturer’s reprocessing instructions are critical to protect patients against the spread of infections. As part of its regulatory review for reusable medical devices, the FDA reviews the manufacturer’s reprocessing instructions to determine whether they are appropriate and able to be understood and followed by end users. The guidance lists six criteria that should be addressed in the instructions for use with every reusable device to ensure users understand and correctly follow the reprocessing instructions.
The six criteria for clear reprocessing instructions are:
- Labeling should reflect the intended use of the device.
- Reprocessing instructions for reusable devices should advise users to thoroughly clean the device.
- Reprocessing instructions should indicate the appropriate microbicidal process for the device.
- Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.
- Reprocessing instructions should be comprehensive.
- Reprocessing instructions should be understandable.
The guidance also recommends that manufacturers consider reprocessing challenges early in device design. Manufacturers will be expected to conduct validation testing to show with a high degree of assurance that their cleaning and disinfection or sterilization instructions will consistently reduce microbial contamination.
The FDA recommends the use of worst-case simulated use protocols throughout the validation of the cleaning, disinfecting and sterilizing processes. Where applicable, clinicians should be consulted to determine the extent and nature of real-world, worst-case device contamination. Also, practicality and human factors issues should be considered when establishing the reprocessing protocols. The cleaning validation protocols should use the shortest times, lowest temperatures, weakest dilutions, etc., for each step of the cleaning instructions. The device company should perform a detailed, side-by-side comparison of the text of the cleaning instructions and the text of the validation protocols to identify and account for all worst-case processing conditions.
The FDA issued a draft guidance discussing the reprocessing of reusable medical devices in 2011, and considered almost 500 comments before issuing the final guidance. The final guidance provides more clarity about testing protocols and what data should be submitted to the agency for a premarket submission, such as the data the FDA needs to evaluate substantial equivalence for a 510(k) premarket submission. The FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities.
Manufacturers seeking to bring to market certain reusable devices, such as duodenoscopes, bronchoscopes, and endoscopes, should submit to the FDA for review their data validating the effectiveness of their reprocessing methods and instructions.
Separately, the FDA also announced in the Federal Register that the agency’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will hold a public meeting on May 14 and 15, 2015, to discuss recent reports and epidemiologic investigations of transmission of infections associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography (ERCP) procedures in hospitals in the United States.
See the FDA Announcement
See the FDA’s guidance document, titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling”
See also Medical Law Perspectives, January 2012 Report: Hospital-Acquired Infections: Who Is Liable and Why?
See also Medical Law Perspectives, April 2012 Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory
See the March 11, 2015 blog Uncleanable ERCP Duodenoscopes: Manufacturer, Hospital, and Physician Liability?