FDA Toughens Reusable Device Testing Rules

The U.S. Food and Drug Administration (FDA) is toughening testing procedures for manufacturers of reusable medical devices. The agency issued the new requirements in the wake of news that two people in a Los Angeles, Calif., hospital had died from a deadly bacteria traced to medical scopes.

The changes will apply to new devices the FDA approves rather than ones currently on the market that have led to the infections. Officials acknowledged they could only recommend—not require—that products now being sold use the more rigorous testing.
Agency officials said the stricter guidelines potentially could apply to a broad array of reusable devices, including the type of endoscopes at issue in California. Manufacturers of the devices that are hardest to clean also will be required to submit data proving they can properly be disinfected.

The FDA has come under pressure to take stronger steps to prevent future outbreaks of bacteria-related illnesses caused by insufficiently sterilized medical devices. The FDA can order manufacturers to stop distributing and even recall devices they make, though agency officials say that action must be weighed against the risks to public health if the device is totally removed from circulation. The agency has not yet taken that step in this case. About 500,000 procedures are performed annually in the United States using endoscopes, according to the market data.

Officials said that manufacturers of the scopes implicated in the Los Angeles deaths were asked last year to submit data to show their procedures for cleaning them were adequate, but the information those companies provided was “insufficient.” Previously, companies had to collect data but were not required to give it to the FDA.

“We are taking an A-to-Z approach to this,” said Stephen Ostroff, M.D., chief scientist at the agency. It first issued a draft of the changes announced in early March in 2011. Ostroff said the agency had expedited the final version just released “in light of those recent episodes.”

The announcement came nearly a month after California hospital officials reported that five patients had fallen ill and two had died from contaminated endoscopes at Ronald Reagan UCLA Medical Center. Officials said the likely cause was a superbug that may have been transmitted during procedures using the devices, called duodenoscopes. The affected patients suffered from a drug-resistant superbug known as CRE, or carbapenem-resistant Enterobacteriaceae, during “complex endoscopic procedures” to diagnose and treat diseases in the pancreas between October and January at the hospital, UCLA’s Health System said in an emailed statement.

Attorneys for two patients of the “superbug” infection at a Los Angeles, Calif., hospital have filed lawsuits against the manufacturer of tainted duodenoscopes implicated in the outbreak.

At the time, the hospital said it had gone above and beyond the cleansing procedure that was recommended by the manufacturer.
The CRE superbug has been described as a form of “nightmare bacteria” by Tom Frieden, head of the Centers for Disease Control and Prevention (CDC). “Our strongest antibiotics don’t work and patients are left with potentially untreatable infections,” he said. CRE infections, most of which occur in hospital settings, can lead to infections in the bladder or lungs, causing coughing, fever or chills. And according to the CDC, the bacteria kills nearly half of patients who get infections in the bloodstream.

Other hospitals also have reported problems. In January, officials at Virginia Mason Hospital in Seattle, Wash., acknowledged that 32 patients had been infected with a dangerous bacteria via duodenoscopes from November 2012 to early 2014.

The duodenoscopes are inserted down the throat and through the stomach to the top of the small intestine, an area called the duodenum. They are used to diagnose and treat diseases of the liver, bile ducts and pancreas. The devices themselves pose little risk to patients, but their design, which includes microscopic crevices nearly impossible to reach with a brush, makes them difficult to disinfect.

In the future, manufacturers will be required to thoroughly soil their devices and then follow their own cleaning instructions to prove that the device can be adequately disinfected.

“We are asking to see a higher safety margin,” the agency told The New York Times.

The FDA began looking at the risks associated with duodenoscopes disinfection as early as 2009. At that time, problems were cropping up because of flaws in the cleaning process, officials said. By 2013, the users of the devices were following the process properly, but the problems did not go away.

The FDA has said it received 75 reports from January 2013 to December 2014 of bacterial infections across the country believed to be linked to duodenoscopes, though the tally could be an undercount, the Times reported. Ostroff said “even that number is far too high.”

Guidance Details
The new recommendations outlined in the guidance are aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection. 

Medical devices intended for repeated use are commonplace in healthcare settings. They typically are 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 healthcare settings, the complex design of some devices makes it harder to remove contaminants, according to the agency.

The FDA’s guidance document, titled, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling,” includes recommendations medical device manufacturers should follow premarket and postmarket 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,” according to regulators.

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 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 consistently will reduce microbial contamination.

“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., 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 issued a draft guidance discussing the reprocessing of reusable medical devices in 2011, and considered almost 500 comments before issuing the final guidance, agency officials noted. 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 information 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 officials wrote.