Reusable medical device can save lives… and spread infection
By Jessica Powell, Burg Simpson Shareholder
The FDA issued interim results of an ongoing, mandated post-market surveillance studies in order to “inform patients, hospitals and health care facilities of higher-than-expected contamination rates with duodenoscopes after processing.” But what does that mean?
Duodenoscopes are a very complex type endoscopic device, that is, it’s a type of device used to examine the inside of the body. Duodenoscopes are most commonly used in a procedure called retrograde cholangiopancreatography (ERCP), which allows the physician to examine the pancreatic and bile ducts. Among other things, an ERCP may be performed to diagnose conditions of the pancreas or bile ducts and to assist in gallbladder surgery.
Duodenoscopes are complex, expensive medical devices. For this reason, they are not disposable—they are used on more than one patient. Accordingly, duodenoscopes are put through a process of cleaning after every patient called “reprocessing.”
Since the duodenoscope is reusable, there is concern that the device can transfer fluid or tissue from one patient to another, which can lead to the spread of infection. Due to this concern, on October 15, 2014, the FDA ordered the three manufacturers of duodenoscopes (Fujifilm Medical Systems USA, Inc., Olympus Medical Systems Corp., and Pentax of America) to conduct post-market surveillance studies.
The FDA’s Interim Report
Interim results from the post-market surveillance studies indicated a higher than expected contamination rate in reprocessed duodenoscopes. In other words, after they were cleaned, there was tissue and/or fluid was still present on the duodenoscopes. In fact, the interim results showed up to 3% of properly collected samples tested positive for organisms more often associated with disease, such as E. coli and Pseudomonas aeruginosa.
Duodenoscopes can be life-saving. Accordingly, the FDA recommends “that you do not cancel or delay any planned procedure without first discussing with your health care professional”; however, “[b]efore having any medical procedure it’s a good idea to learn more about […] steps the health care facility takes to keep patients safe.” The final results of the studies are expected in 2019.
If you or a loved one has had an ERCP or other procedure using a duodenoscope and subsequently developed an infection, contact one of the experienced medical device attorneys at Burg Simpson’s Cincinnati office today. Our award-winning attorneys would be happy to discuss your potential claim. Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.