Malfunctioning Medical Devices

Sometimes medical malpractice cases are not about the doctors. In the three-year span between 2012 and 2015, over 250 patients were infected with “superbug” diseases that were the result of one type of malfunctioning medical device.

Duodenoscopes are endoscopic devices that are used in minimally invasive surgeries as a flexible scope that is used in diagnosing and treating digestive tract conditions, cancers, and gallstones. Currently, duodenoscopes are used in over 500,000 medical procedures each year.

In the case of duodenoscopes, manufacturers Olympus Corp., Pentax, and Fujifilm withheld vital information from doctors and hospitals about outbreaks caused by failing cleaning techniques. Investigations found that a rubber ring that was created to keep bacteria out of the scope wore down too quickly and allowed blood and tissue to become trapped inside. The recommended cleaning process would not catch this.

Though medical professionals followed the manufacture orders for proper disinfecting the devices. Contaminated devices spread carbapenem-resistant enterobacteriaceae in 25 separate outbreaks. Olympus Corp., which sells 85% of all duodenoscopes used in US hospitals, reportedly waited almost two years to issue warnings to regulators and hospitals about potential problems with the devices. The company sent warnings to European hospitals before alerting US hospitals.

The Senate Health, Labor, Educations, and Pensions committee that reviewed the outbreaks recommended that all medical insurance claims include the unique codes the Food and Drug Administration attaches to devices to log and track them. Attaching these codes to insurance claims would help both the FDA and medical device manufacturers better track the functionality of devices.

The Senate committee also found fault with the FDA’s process of evaluation, claiming that it was too slow and complicated and allowed time for more patients to become infected.

Unfortunately, there are not many steps patients can take to protect themselves from outbreaks due to tainted medical devices. Patients can look up procedures and medical devices on the FDA website to see if any warnings have been issued. When manufacturers withhold information from the FDA, these outbreaks become impossible to track.

One suggestion the committee offered was to give additional incentives to hospitals who report outbreaks. The committee suggested withholding Medicare reimbursement from hospitals who failed to report outbreaks in a timely manner.

Under current regulations, it is not always easy for hospitals to track the source of outbreaks. The duodenoscpes infects patients with a variety of illnesses, so Olympus Corp. blamed some of the subsequent infections on weakened immune systems and other factors attributable to the patients’ conditions. Infections from contaminated medical devices will affect each patient in a different way. Some patients may not notice any symptoms for a while. If you experience additional complications and illness during your recovery process or otherwise believe that a contaminated medical device is responsible for injury, talk to your healthcare professional.

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