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.

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