The U.S. Food and Drug Administration announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. A key change is that when manufacturers submit instructions for disinfecting the devices between uses, the Food and Drug Administration will not take the company’s word that the instructions work, but will demand proof. In the past, the agency essentially took manufacturers at their word when they claimed a procedure worked; now they will have to submit data proving so “with a high degree of assurance,” the agency said. 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.
The FDA issued a draft guidance discussing the reprocessing of reusable medical devices in 2011, and considered almost 500 comments before issuing the final guidance.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 FDA needs to evaluate substantial equivalence for a 510(k) premarket submission. 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.
FDA’s final 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.
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.
The FDA action followed reports last month that hundreds of patients may have been exposed to pathogens, including antibiotic-resistant “superbugs,” after flexible tubes called duodenoscopes were not properly disinfected between patients. Two patients at the University of California-Los Angeles died. The new recommendations apply, however, not only to duodenoscopes but to most medical devices intended for repeated use, including bronchoscopes and endoscopes.
To deal with the thousands of devices already in use, whose disinfection protocols were not subjected to rigorous validation, the U.S. Centers for Disease Control and Prevention released instructions for reducing the risk of transmitting infections. The protocol calls for swabbing the device after it has supposedly been disinfected and seeing if any microbes grow into detectable colonies, much as doctors take throat swabs to determine if a patient has a strep infection, before the device is used again. The duodenoscopes at the center of the recent superbug outbreaks are made by Olympus Corp, Fujifilm Holdings Corp, and Pentax.
As far back as 2009, the FDA believed that transmission of infection by duodenoscopes occurred when hospitals did not properly follow manufacturers’ instructions for “reprocessing,” or disinfecting, the devices between use. Only recently, the agency said, did it conclude that such transmission can occur even when the instructions are followed to the letter, an indication of how difficult it is to clean the complex equipment.
The FDA does not, however, “have the authority to require manufacturers to change their (device’s) design” even if it prevents disinfection, Dr. William Maisel, FDA’s deputy center director for science, told reporters.