Rise Of The Rest Winner Monitors Heater-Cooler Issues First Identified In York

By David Weissman
The York Dispatch, Pa.

WWR Article Summary (tl;dr) Entrepreneur Madris Tomes has created a product which can allow the medical community to identify issues with devices months or even years before the FDA issues recalls or warnings about that device.

The York Dispatch, Pa.

Madris Tomes admits that her recent victory in AOL founder Steve Case’s Rise of the Rest competition gave her an extra sense of validation, but she’s understood the importance of her work for years.

The Spring Garden Township entrepreneur’s company, Device Events, compiles adverse event medical device reports submitted to the U.S. Food and Drug Administration (FDA) in an easily readable and searchable format.

That tool, marketed primarily to hospitals and insurers, can allow the medical community to identify issues with devices months or even years before the FDA issues recalls or warnings about that device, Tomes said.

Her presentation was enough to warrant a $100,000 investment from Case — Tomes said, once received, that will make him the company’s largest cash investor — and plenty of local news coverage.

It wasn’t the first time Tomes had spoken to The York Dispatch, though, as she had approached the newspaper in early 2016 to talk about how the company she had just started could add context to an emerging local medical story: infections found in York Hospital patients linked to heater-cooler devices.

Infections: WellSpan announced in late 2015 that, after a collaborative investigation with the state Department of Health and Centers for Disease Control and Prevention (CDC), it had identified a bacterial infection outbreak linked to a device it used during open-heart surgeries.

The exposure to nontuberculous mycobacteria, or NTM, has been linked to six deaths and eight infections among York Hospital patients, according to WellSpan’s latest update.

While WellSpan admitted that it failed to completely follow the device manufacturer’s recommended cleaning procedures, the FDA and CDC issued alerts, describing these infections as a newly discovered risk with regard to the device.

The heater-coolers were a previously unknown threat because they don’t come into direct contact with patients, but further investigation found there is potential for contaminated water to transmit airborne bacteria through its exhaust vent and into the patient.

Patient infections linked to the devices were similarly discovered at Penn State Hershey Medical Center and pair of hospitals in Iowa before the FDA issued a recall specifically for the heater-cooler manufactured by German-based Sorin Group (now LivaNova) that was used by those facilities.

FDA oversight: While local news reports covered the medical device issues from the perspective of WellSpan and the state Department of Health, Tomes said she was particularly interested in the federal oversight.

A former FDA employee, Tomes said she saw firsthand the limitations of the agency’s postmarket surveillance system, which stored all adverse device event reports submitted by manufacturers, hospitals and doctors.

Tomes said the unit responsible for monitoring those reports was understaffed, and the technology was flawed.
The reports often had misspellings or manufacturers checking wrong boxes — such as checking the malfunction box when a patient death occurred — that combined to prevent regulators from seeing the full extent of issues with any one device, Tomes said.

Tomes’ knowledge helped lead to a York Dispatch investigative report that detailed reports submitted from at least 16 hospitals to the FDA regarding issues with heater-cooler devices, despite just a handful of hospitals publicly acknowledging any infections.

Device Events: While Device Events is able to more easily decipher the number and types of heater-cooler adverse event reports than the FDA’s public-facing system, Tomes acknowledged that her system does have limitations because it pulls from that FDA data.

The biggest issue is large amounts of redactions, which often include locations of the incident.

Tomes said she understands why the FDA redacts hospital names from its reports (for patient privacy reasons), but she doesn’t understand why it continues to redact city and state identifications which, if available, would allow her to use geolocation technology to identify if clusters of reports are related to, say, a local water source.

The York Dispatch successfully submitted an open-records request for state names associated with heater-cooler reports, finding that reports came from at least 10 U.S. states since 2010.

During an interview on Tuesday, Oct. 17, Tomes showed The York Dispatch that the FDA has received more than 2,300 adverse heater-cooler event reports with an expected spike in 2016, after the FDA issued its warning.

While the heater-cooler’s issues are more widely known in the medical community now, Tomes said her system can still benefit users of the device, particularly those who don’t have the Sorin model recalled by the FDA.

While an FDA panel on the devices in early 2016 found that the construction of the device, regardless of manufacturer, made them difficult, if not impossible, to clean, the agency’s latest advisory states that its investigation showed the infection outbreak likely stemmed from contamination at Sorin’s manufacturing facility.

Tomes said that type of advisory might cause hospitals using other manufacturers’ heater-coolers — York Hospital, for example, switched to a different manufacturer — to believe there’s little or no risk with their device.

Device Events showed, however, that incident reports have been submitted to the FDA regarding heater-coolers from at least three other manufacturers.

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