Duodenoscopy Remains a Risk for Infection with Little Alternative in Sight

Washington, DCDuodenoscope infection: It’s a perfect storm and a Catch 22 of sorts for any patient in need of endoscopic retrograde cholangiopancreatography procedures (ERCP). The use of a duodenosope, a lighted and flexible tube used to drain fluids from blocked pancreatic and biliary ducts, can be life-saving for the patient.

And yet duodenosopes can also be life-hampering, or worse - thanks to the potential for transmission of infections from previous patients when the reusable device has not been properly cleaned and disinfected. Such infections can include a variety of maladies that are resistant to antibiotics.

It constitutes the building blocks of a perfect storm, especially since the US Food and Drug Administration (FDA) has determined that the value of keeping duodenoscopes on the market and in active use outweighs any risks, so the threat remains.

The issue, according to the FDA’s own release about the matter, hinges on the complexity of the duodenoscope, and the degree of difficulty involved in cleaning and disinfecting the device - and thus, removing all potential for the transference of infection from a previous patient having been treated with the same device. To that end, the FDA’s own analysis has found that cleaning, or “reprocessing,” the device is sometimes lacking due to technicians failing to follow the manufacturer’s instructions for reprocessing to the letter.

The FDA has determined that such instructions are complex, labor intensive and prone to human error. So the FDA - while leaving the duodenoscopes on the market - has formed a response primarily targeting the reprocessing instructions associated with devices made by three primary manufacturers. The federal drug and medical device regulator has ordered postmarket surveillance studies “to better understand how the devices are reprocessed in real-world settings,” the official FDA release states.

“This is a significant step in the effort to combat infections spread through duodenoscopes. The FDA has undertaken an in-depth investigation into the factors that may play a role in infection transmission associated with duodenoscopes, and is now requiring manufacturers to study the devices in the clinical setting where they are being used,” said William Maisel, MD, MPH, deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “These studies will provide critical information about the effectiveness of current reprocessing instructions and practices that may provide additional information to inform the FDA’s actions to protect the public health and help reduce the risk of infections.”

Manufacturers - identified as Olympus America, Inc., Fujifilm Medical Systems, USA, Inc., and Hoya Corp. (Pentax Life Care Division) - have been given a month to submit a postmarket surveillance plan to the FDA detailing how the manufacturer intends to “evaluate, among other things, how well health care personnel are following instructions to clean and disinfect duodenoscopes between patients and to better understand the rate of contamination of clinically used duodenoscopes.”

It remains unclear as to the length of time a postmarket study will take, nor is it known when the data will be in the FDA’s hands and when the regulator intends to release the data and/or recommend changes to ensure the possibility of cross contamination between patients is minimized or mitigated altogether.

One thing is clear: the risk continues. By its own numbers, the FDA estimates there are some 500,000 procedures using a duodenoscope in the United States each year. There are also no alternative devices on the market. So it’s the duodenoscope or nothing - and given the lack of an alternative, the FDA has deemed it prudent to keep duodenoscopes on the market and active while the postmarket studies are conducted. That means upwards of 500,000 patients are at risk for serious infection, transferred to them from someone else.

Plaintiffs contemplating a duodenoscope lawsuit will want to know if any concern was expressed at the point at which the device was approved as to the complexity of reprocessing the duodenoscope - the instructions involved, and the real-world capacity for an overtaxed health system to take the time and care to properly reprocess the duodenoscope beyond any doubt for risk of infection.

What did the manufacturers know? Plaintiffs will want to know that too…