Posted 13 January 2016
By Michael Mezher
A Senate report released Wednesday finds that the US Food and Drug Administration's (FDA) post-market surveillance system for tracking medical devices is ineffective.
The report found systemic issues related to device oversight and reporting, which contributed to at least 25 superbug outbreaks linked to closed-channel duodenoscopes that infected some 250 patients in the US and Europe between 2012 and 2015.
Duodenoscopes made headlines in early 2015 after Carbapenem-resistant enterobacteriaceae (CRE) outbreaks at Virginia Mason Medical Center in Seattle, WA and UCLA Ronald Reagan Medical Center in Los Angeles were traced to the devices. In the US, duodenoscopes are sold by three companies: Olympus, Fujifilm and Pentax, with Olympus controlling approximately 85% of the market.
The report, based on a yearlong investigation by Senator Patty Murray (D-WA), said FDA is "overly-reliant" on device makers and health care providers following medical device reporting (MDR) requirements. When hospitals and manufacturers fail to report safety issues, or do so in an untimely manner, FDA is left with little ability to detect device safety issues.
Despite outbreaks taking place at multiple hospitals in 2012 and 2013, FDA was not made aware of the issue until it was notified by the Centers for Disease Control and Prevention (CDC) in September 2013.
When FDA began investigating the scopes after being alerted by CDC, the agency took more than 17 months to issue a safety communication for the devices. Since then, the agency has taken several actions, including convening an advisory committee meeting to discuss the devices, warning duodenoscope manufacturers, issuing new reprocessing guidelines and recalling a device commonly used to clean duodenoscopes.
According to the report, all three manufacturers failed to properly notify FDA of safety issues related to their scopes, with Olympus submitting "incomplete and misleading" reports, and Fujifilm and Pentax submitting "late and incomplete" reports.
Hospitals also frequently failed to send required adverse event reports to regulators and manufacturers.
"It appears that not a single hospital that experienced infection outbreaks linked to the duodenoscopes sent the required adverse event form to the device manufacturers [and] generally failed to communicate directly with FDA and CDC," the report says.
In addition to asking FDA to evaluate closed-channel duodenoscopes to determine if a design change is necessary to prevent infection, the report makes a series of recommendations to improve FDA's ability to respond to public health issues related to medical devices.
The report calls on Congress to require unique device identifiers (UDIs) on insurance claims, electronic health records, and device registries to improve FDA's ability to monitor devices.
The report also requests FDA issue updated guidance for when manufacturers are required to submit a new 510(k) for device modifications, and says that FDA should have stronger authority to deny 510(k) submissions over insufficient reprocessing validation data. Both Olympus and Fujifilm failed to submit a 510(k) for design changes to their duodenoscopes when they moved from open- to closed-channel designs.
FDA should also act more quickly to alert the public to emerging device safety issues, the report says. In December 2015, FDA released a draft guidance for comment that would do so by communicating emerging safety signals based on early data that could impact a device's benefit-risk profile.
Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients