Healthcare News & Insights

Report: What hospitals did wrong in scope outbreak crisis

If your hospital uses duodenoscopes or similar devices on patients, you’ll want to pay close attention to a new federal report about the recent infection outbreaks tied to tainted scopes. Reason: The problem is more far reaching than originally thought – and there may be a few changes regarding medical devices as a result. 

ThinkstockPhotos-510351863According to the report, which was conducted by a Senate committee, 250 patients in four countries ended up contracting the same type of carbapenem-resistant Enterobacteriaceae (CRE) infection from duodenoscopes. Over 200 infections occurred in the U.S.

In many cases, hospitals followed what they thought were correct cleaning procedures for the reusable scopes, but they weren’t thorough enough for disinfection, so the bacteria remained inside them, sickening patients.

The CRE outbreaks were spread across several hospitals in multiple states, including California, Illinois, Pennsylvania, North Carolina, Massachusetts and Florida.

Two hospitals had over 30 patients fall ill due to the tainted scopes: Advocate Lutheran General Hospital in Illinois and Virginia Mason Hospital and Medical Center in Seattle.

Most of the affected facilities were larger hospitals with specific protocol in place for identifying, tracking and addressing the cause of infections. Because of this, the committee expressed concerns that more patients may have been affected since smaller hospitals may not have the resources available to pinpoint whether tainted scopes caused infections.

Late, neglected reporting

Although hospitals that experienced outbreaks tended to address them in a reasonable time frame, the committee’s report took them to task for not reporting the issue to all the proper authorities immediately.

In particular, the feds took issue with the fact that none of the facilities followed the mandatory guidelines to report the CRE infections to the scope manufacturers (which included submitting an adverse event form). So important details about the nature of the infections were omitted, which made investigating the problem more difficult.

Even worse: Some hospitals didn’t even report the infections to the manufacturers at all.

Hospitals also didn’t fulfill their obligation to report any deaths they suspected were caused by tainted scopes to the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

In fact, many facilities didn’t even realize they were obligated to report these events to the FDA. The ones that did submitted late reports with missing information. And only one hospital, Advocate Lutheran, submitted a report to the CDC.

Future changes

Per the report, “hospitals’ slow approach left FDA with an inaccurate picture of the frequency and severity of these events.” The CDC had an even less complete picture of the outbreaks caused by tainted duodenoscopes. This all made it much more difficult to determine the full magnitude of the problem.

As a result, the committee recommended that the feds should toughen the rules regulating how hospitals should report infections and other issues caused by medical devices.

Specifically, they want the Centers for Medicare & Medicaid Services (CMS) to make reporting a requirement for participation in Medicare. Hospitals that don’t submit these reports in a timely fashion could be dropped from Medicare.

The committee also recommended other changes that could affect hospitals – specifically that the unique device identifier numbers included on medical devices such as duodenoscopes be reported on insurance claims and stored in patients’ electronic health records. That would better help the FDA and CDC find out exactly which devices are causing problems – and potentially identify any threats faster since they wouldn’t have to wait for manual reports.

More recommendations – and even a potential recall of the affected duodenoscopes – may be coming down the pipeline shortly. We’ll keep you posted.

In the meantime, you may want to be extra careful with cleaning and disinfecting procedures if your hospital is using similar scopes to perform procedures on patients, or even consider another option for the procedures altogether.

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