Senate Report: Ineffective Medical Device Monitoring Puts Patients at Risk

Dec 30, 2016 - Personal Injury by Cross & Smith

Doctors use duodenoscopes to perform valuable diagnostics that can be vital to patients. However, these devices are known to have significant risks of infection, even after they have undergone recommended cleaning procedures. Earlier in 2016, the U.S. Senate issued a Minority Staff Report that expressed significant concerns about known links between duodenoscopes and increasing cases of Carbapenem-Resistant Enterobacteriacea (CRE).

Since CRE is also known as a superbug that does not respond well to most antibiotic treatments, patients need to understand the risks. In this case, an ounce of prevention is definitely worth a pound of cure.

Much of the Failure Points to Lapses in Communication

The direct cause of the CRE infections is linked to difficulty in fully cleaning duodenoscopes. Even though manufacturers issued detailed cleaning instructions that were followed by medical providers, it appeared that those instructions did not fully remove the CRE-causing bacteria.

Still, the direct cause of infection was far from the only problem. Even as medical providers, device manufacturers and even the federal government became aware of potential issues, a series of communication errors like the following seems to have prevented a timely effected response:

• At least 16 hospitals that had traced the infections to duodenoscopes did not notify federal regulators or send the required notification to the device manufacturers.
• Hospitals that did report events to manufacturers did not issue reports quickly, and they issued informal phone or email reports that did not include the information needed by the manufacturers to submit accurate reports for the Food and Drug Administration (FDA).
• Once the FDA began investigating how recommended cleaning procedures did not prevent the spread of infection, they did not notify hospitals, doctors and the public about their concerns for 17 months. At least 68 more patients suffered infections during this time.
• An outmoded device database, combined with reporting issues, prevented the FDA from understanding the urgency and scope of the infection issues.
• The FDA was also unaware of previous findings in Europe that the cleaning methods were insufficient, and the agency had no system in place to collect independent information about adverse events. They wasted time collecting data and analyzing information that was already available.

Frank Patient-Doctor Discussions Can Help Avoid Serious Illness

Looking beyond the obvious connection between inadequate device cleaning and CRE infections, the Minority Staff Report makes it clear that insufficient communication between medical providers, manufacturers and government agencies have led to a serious problem. This means that, when patients sustain duodenoscope-related CRE infections, any number of parties may be liable of medical malpractice.

Patients cannot typically fully prevent infection in cases like these. However, they can reduce their risk by making it clear that they understand the issues and engaging their doctors in detailed discussions about prevention methods observed by all medical providers connected with an anticipated procedure.

Each Tuscaloosa injury attorney at our firm encourages all patients to take a proactive approach before undergoing any medical procedure, and promptly seek a free legal consultation whenever adverse events happen.

Additional Resources:

ERCP Procedures and Duodenoscopes: Infection Risks and Considerations, Association for Professionals in Infection Control and Epidemiology

Other Blog topics

Hospital Infections and Alabama Medical Malpractice Claims, Tuscaloosa Medical Malpractice blog