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Senate Report: Ineffective Medical Device Monitoring Puts Patients at Risk

Jun 1, 2016 Brown Moore Medical Malpractice

Last January, the U.S. Senate issued a Minority Staff Report that contained key findings of known links between duodenoscopes (essential diagnostic devices) and increasing cases of Carbapenem-Resistant Enterobacteriaceae (CRE).

However, our Charlotte medical malpractice lawyers point out that there may be plenty of blame to go around. If any number of related parties had spoken up in a timely manner, fewer patients might have fallen victim to this serious problem.

Faulty Devices Were Only The First Part of a Superbug Outbreak

Closed-channel duodenoscopes perform an important diagnostic function. They are used to detect and treat certain pancreas and bile duct conditions, but it is now known that their design makes them difficult to sterilize using the instructions that were initially provided by the manufacturer. In September 2013, certain medical centers traced a cluster of antibiotic-resistant patient infections to the devices. In fact, those issues sickened at least 250 patients worldwide.

Unfortunately, the issues related to these infections extended farther than the devices alone. Fewer infections might have occurred, except for issues such as the following:

  • The manufacturer might have revealed the sterility issues with more testing and issued more effective cleaning instructions.
  • After becoming aware of lab reports indicating that the devices could harbor and spread bacteria, the primary manufacturer failed to alert the Food and Drug Administration (FDA), nor did they alert hospitals, doctors, or patients until two years had passed.
  • Many hospitals knew about the duodenoscope-related infections, yet they failed to notify federal regulators.
  • Once the initial hospitals identified the source of the infections, it took 17 months for the manufacturers and the FDA to issue alerts to hospitals, doctors, and the public.
  • The FDA apparently was unable to respond efficiently due to an outmoded adverse event device database, while also being unaware that two independent European labs had already documented serious issues.

In other words, any number of communication errors occurred between all parties involved with the devices, and patients suffered from a set of avoidable circumstances.

An Immediate Recall May Help Alleviate Future Related Issues

Almost immediately after the publication of the Minority Staff Report, Medscape announced the recall of the device until appropriate modifications can be made. Unfortunately, this recall came more than three years after the discovery of a potentially deadly issue.

While the Report set forth a number of recommendations to help speed up responses to similar issues in the future, it seems clear that patients cannot fully rely on their safety, even when they need valuable diagnostic procedures to identify potentially-serious medical issues.

Without a doubt, diagnostic procedures are essential in helping to protect patient health. However, it is essential for patients to ask medical providers to answer pointed questions before undergoing any medical or diagnostic procedure. Just as important, they should not assume that their own post-procedure home care might have caused infections or other injuries. To help identify often-complex liability issues and take appropriate legal action, call us at 800-948-0577 or use our convenient online contact form.