Crowdsource-derived Data for Post-Market Surveillance of Drugs and Medical Devices

Recently,Oregon’s Senator Jeff Merkley, with Senators Chuck Grassley (R-IA), Michael Bennet (D-CO) and Herb Kohl (D-WI), introduced the bipartisan Ensuring Safe Medical Devices for Patients Act. It requires the FDA to issue a Unique Device Identifier rule by the end of 2012. There was a UDI program established a number of years ago, however it was not implemented. UDIs are important to track drugs and devices after they ar eon the market in case of problems requiring surveillance or recall. The identifier should be able to be followed at any point in the product’s life.
Adverse events from medications and devices are supposed to be reported to the FDA. Most are dreadfully underreported. Crowdsourcing is a potentially very useful tool in post-market surveillance of drugs and devices. What if the FDA established its own social community utilizing multiple ongoing participant-driven registries? Members (free to all) could query any drug or type of device, and report a problem. Health care providers may be members as well, observing trends and studies.
Having been a practicing cardiac electrophysiologist during many device and component recalls, I can attest to the inaccuracies and inconsistencies between device company registries and my own EHR (which was more correct than company records). These inconsistencies arise from: misspelling of patient names, wrong date of birth, or incorrect ID number. Patients may have one device system component from one company and another from a different one. This information may not be entered correctly in the last implant report or transferred from previous implants. Companies do not automatically share databases to insure complete information about a patient’s device system is either complete or updated. Timely data uploaded from a patient or caregiver in a crowdsource-derived universal database might be more accurate than a UDI which might not find its way to the FDA. One cannot have too many sources of tracking this type of information. A UDI is an improvement over the Wild West system we have now. But one should not underestimate the power of crowdsource-derived data.
The threshold for reporting an adverse reaction or device problem often times lies in the frequency of the issue at hand. Crowdsourced-derived data of such problems will dramatically accelerate the oversight process and potentially decrease morbidity and mortality. It will also globalize the oversight process, making it independent of where the drug or device is manufactured.

About davidleescher

David Lee Scher, MD is Founder and Director at DLS HEALTHCARE CONSULTING, LLC, which specializes in advising digital health technology companies, their partners, investors, and clients. As a cardiac electrophysiologist and pioneer adopter of remote patient monitoring, he understood early on the challenges that the culture and landscape of healthcare present to the development and adoption of digital technologies. He is a well-respected thought leader in mobile and other digital health technologies. Scher lectures worldwide on relevant industry topics including the role of tech in Pharma, patient advocacy, standards for development and adoption, and impact on patients and healthcare systems from clinical, risk management, operational and marketing standpoints. He is a Clinical Associate Professor of Medicine at Penn State College of Medicine.
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1 Response to Crowdsource-derived Data for Post-Market Surveillance of Drugs and Medical Devices

  1. Pingback: The Medical App is a Patient Advocacy Tool | The Digital Health Corner

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