The federal government fields some 70,000 reports a month on problems with medical devices, with implications ranging from minor to deadly.
Patients, lawyers, doctors and others trying get a picture of possible problems with artificial knees, syringes and other devices don’t have the time to sift through all those reports.
Madris Tomes of York County is trying to make sure they won’t have to.
Tomes, a computer and medical-device expert who once worked for the U.S. Food and Drug Administration, which oversees the growing medical-device field, has developed software that she said will ease the search for information on medical devices.
Her web search tool, Device Events, launched at the start of January, months after she founded a business of the same name, Device Events LLC.
Tomes, who lives in Spring Garden Township, York County, said Device Events provides easy-to-use information on a medical device’s manufacturer, any side effects and any product recalls or complaints associated with it.
“My understanding is, there’s nothing else exactly like it, since the data has been housed in different places over the years, and I know how to find it,” Tomes said.
The price for Device Events ranges from $10,000 to $30,000, depending on factors like whether the purchaser is a nonprofit, Tomes said. The cost includes consulting time from Tomes, along with training and follow-up, she said.
The product arrives as patients are wanting to know more about what has been implanted in their bodies, Tomes said. “They want to know, ‘What kind of hip did I get? Am I going to need to get it replaced?’”
Tomes, who began selling the product in 2015 before its official launch on Jan. 3, has sold the product to a number of subscribers, ranging from a large U.S. hospital that she declined to identify to attorneys and patient-advocacy groups.
While she declines to disclose sales so far, she said they have been encouraging.
One advocacy group she has been working with represents those who claim to have been hurt by Essure, a birth-control device implanted in women.
The group sought out Tomes after hearing about Device Events through Erin Brockovich, the well-known activist who was played by Julia Roberts in a 2000 film. Brockovich traveled from the Washington D.C. area to meet with Tomes last year in York to talk about medical-device safety and how Tomes can help.
“She’s very determined, she’s very intelligent, and she’s doing it for the right reason. And that’s to inform people and to help them make better choices,” Brockovich said.
“Her work is highly significant,” Brockovich added. “She’s creating awareness so other people don’t have the same thing happen to them.”
Tomes said awareness is important because, she said, “If you have a recall, it’s not just as simple as taking the product off the shelf, because you might have a device that has been implanted in a patient.”
An inside track
Tomes, 44, graduated in 1990 from Dallastown Area High School, earned an undergraduate degree in marketing with a minor in insurance from Penn State University, and has an MBA in information technology from American University in Washington, D.C.
She spent 13 years in the D.C. area, working as a Medicare fraud analyst for one company and as a consultant for consulting firm Booz Allen Hamilton, which at the time was expanding its health care practice.
The company asked her to help the FDA with a project. The agency hired her two years later.
Over the next two years with the FDA, Tomes saw the reports the agency received on problems with drugs and devices, and the number, like the number of medical devices, has been “skyrocketing,” Tomes said.
Services like Device Events that quickly inform hospitals and other providers about problems with medical devices are becoming more and more important, said Dr. MaryEllen Pfeiffer, director of patient safety for WellSpan. She estimates there are some 25,000 medical devices used in the WellSpan system, which includes six hospitals and more than 130 patient-care sites.
The impact of devices on patient health “is something we’re very vigilant about and take very seriously, so any program that can support that is very useful,” Pfeiffer said.
WellSpan York Hospital recently was among facilities nationwide connected to problems linked to a medical device used during open heart surgery. In late October 2015, WellSpan revealed a potential infection stemming from the device used during surgeries at York Hospital between Oct. 1, 2011 and July 24, 2015.
Caused by a bacteria called non-tuberculous mycobacterium, the infection also has been found in patients at Penn State Milton S. Hershey Medical Center.
WellSpan has used software for many years that keeps it up to date on possible problems with medical devices. “This isn’t something that we could do by ourselves,” Pfeiffer said, noting that the organization moved to a new software vendor about a year ago.
WellSpan also has a staff person, an “alert-tracker specialist,” who reports to her and works closely with the patient-safety staff and other departments at WellSpan, Pfeiffer added.
Tomes believes the issue of medical-device problems will soon grow in the public consciousness, much like opioid abuse has gained traction in recent years.
She has gotten so busy with her research that she hasn’t had time to market the Device Events product, so she has hired two sales and marketing representatives so she can work on patient advocacy and product development, Tomes said.
“I’m not an attorney, I’m not a doctor,” she said. “I’m more of an investigator, most of the time just trying to find what the problems are, who’s hurting, and who needs help.”