The regulator sent the letters to the Olympus, Fujifilm, and Pentax as part of an effort to fight against a wave of deadly bacterial infections attributed to the insufficient cleaning and sterilization of the devices. Duodenoscopes are reusable flexible tubes that go down the throat in order to treat gastrointestinal tract ailments.
A week after issuing new guidance for cleaning the complicated medical device, the duodenoscope, the Food and Drug Administration (FDA) has issued warning letters to three of the device’s largest producers for multiple violations. The regulator sent the letters to the Olympus, Fujifilm, and Pentax as part of an effort to fight against a wave of deadly bacterial infections attributed to the insufficient cleaning and sterilization of the devices. Duodenoscopes are reusable flexible tubes that go down the throat in order to treat gastrointestinal tract ailments. Roughly 500,000 procedures involving the device take place annually. Last week, the FDA encouraged hospitals that can afford it to take cleaning measures beyond those recommended by manufacturers, including the use of ethylene oxide gas, as an alternative to thermal treatment for the heat-sensitive devices.
The increased awareness comes after several outbreaks of dangerous drug-resistant bacteria, including last year at UCLA’s Ronald Reagan Medical Center due to contaminated scopes that killed at least two people, with 179 people possibly being exposed in total. A Connecticut hospital reported up to 300 people may have been exposed to a form of E. coli bacteria from duodenoscope procedures, and four people were infected by a superbug at Los Angeles’s Cedars-Sinai Hospital. This follows a massive outbreak at Seattle’s Virginia Mason Medical Center in Seattle, in which at least 31 people were infected and at least 11 people died between 2012 and 2014. Beyond E. coli, other bacterial outbreaks attributed to the devices include the heavily drug-resistant CRE, along with an outbreak of pseudomonas aeruginos.
In the letters, the FDA accused Olympus and Pentax of failing to notify the agency within 30 days if their devices “caused or contributed to a death or serious injury,” an FDA mandate. Regulators also faulted Olympus for not establishing standard procedures for hospitals needing to report serious problems with the scopes. The FDA wrote that Pentax’s and Fujifilm’s cleaning instructions for the devices were not up to the regulator’s standards, as well as for design flaws that made the devices difficult to sterilize. Fujifilm was cited for not scientifically proving that its cleaning procedures for duodenoscopes are 100 percent effective. The FDA also found an application error for Fujifilm, writing that the ED-450XT5 and the ED-530XT devices contained “substantial differences” and needed separate 501(k) applications.
The companies have 15 days to respond to the warnings with potential solutions to the violations. Olympus spokesman Mark Miller told Bloomberg that the agency is reviewing the letter “so that we can provide the required response in a timely manner.” A Fujifilm spokesperson emailed Fierce Medical Devices, saying the company “takes this issue very seriously and is working closely with FDA. Actions have been and will continue to be taken to ensure that our products and processes meet FDA requirements, and pose no risks to the health and safety of the public.” Despite the risks of infection, the FDA has decided against removing duodenoscopes from the market, saying that the “benefits outweigh the risks.” Agency spokesperson Jennifer Dooren said in an interview last month that the risk of infection from a properly cleaned device is “relatively low.” Still, the FDA has reported 142 cases of infection caused by the device since 2010.
Fierce Medical Devices – Emily Wasserman
Reuters – Toni Clarke
Washington Post – Brady Dennis