The Food and Drug Administration (FDA) on Thursday responded to calls for tighter regulation on scopes linked to a superbug outbreak by issuing stricter guidelines for manufacturers of reusable medical devices.
The new guidelines come in the wake of a deadly, multi-state outbreak of antibiotic-resistant bacteria known as Carbapenem-resistant Enterobacteriaceae (CRE) that is tied to the use of duodenoscopes in patients who undergo a diagnostic procedure used to check for diseases of the liver, bile ducts and pancreas.
The Centers for Disease Control and Prevention dubbed CRE a "nightmare bacteria" due to its resistance to last-resort antibiotics and reported that it kills half of all patients in whom it reaches the bloodstream, FierceHealthcare has reported.
An FDA warning issued shortly after news broke of two CRE-related patient deaths at UCLA's Ronald Reagan Medical Center cautioned healthcare providers that manufacturers' cleaning guidelines may still leave the devices vulnerable to CRE contamination. But some said the agency took too long to take action because it first received reports about duodenoscopes' CRE risk in 2012 and left providers at a loss for how to handle use and sterilization of the devices.
The FDA's new guidelines seek to fill this gap by requiring manufacturers to submit scientific data to show that clinicians can safely clean the devices before the scopes receive agency approval. Recently, the FDA both blamed manufacturers for what it deemed flawed tests of their cleaning protocols and acknowledged it was unaware duodenoscope manufacturer Olympus Corp. had been marketing an altered design of the device since 2010 without FDA approval.
Hospitals that have experienced outbreaks have taken matters into their own hands by switching to gas sterilization of duodenoscopes, isolating infected patients and decontaminating infected patients' rooms, among other measures, FierceHealthcare has reported. And even hospitals that have not experienced outbreaks aren't taking chances with the devices: Swedish Medical Center, Harborview Medical Center, the University of Washington Medical Center, Providence Everett and the Veterans Affairs Puget Sound Health Care System, all in Seattle, all have started to test their duodenoscopes for pathogens, the Associated Press reported.
In spite of the recent controversy, the "risk of acquiring an infection from a reprocessed medical device is low," William Maisel, M.D., deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in a statement Thursday. "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," he said.
But Chris Lavanchy, engineering director at the ECRI Institute, told the AP that the FDA's new guidelines will only go so far toward fixing the current contamination risk.
"Unfortunately, it's going to take manufacturers some time to design a different way to do this," he said. "And then it's going to take the FDA time to confirm that it's a safer approach."
The FDA also announced Thursday that it will hold a public meeting regarding the CRE outbreak May 14-15.
To learn more:
- here's the guidelines (.pdf)
- check out the FDA statement
- read the first AP article
- here's the second AP article