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October 24, 2016

FDA Plan An Empty Promise

On October 24, 2016 the FDA announced

that they are working with hospitals to modernize data collection about medical devices.

In an email to Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health,
former FDA employee, Madris Tomes, told him why his plan will fail.

From: Madris Tomes <madris@deviceeve​>

To: "" <>; "" <>

Sent: Monday, October 24, 2016 1:49 PM

Subject: RE: FDA is working with hospitals to modernize data collection about medical devices

Hello Dr. Shuren,

As the former UDI External Program Manager at the FDA and the former project manager for the MAUDE replacement, I feel that I need to speak up. While I applaud the efforts of MDEpiNet and CDRH to push to integrating UDI in EHRs and Claims, this cannot be the only solution. There are no plans available that I have seen (publicly) to capture UDI in EHRs or claims payment systems for re-processed devices...only for implanted devices. Neither the power morcellator nor the endoscopes, cited in your letter below, are these types of devices. The layperson will not know this and it is an empty promise that is a temporary diversion.

Hospitals and other user facilities need to submit reports directly to the FDA, as should physicians. 99% of physician adverse event reports go directly to manufacturers. Do those manufacturers then report to FDA? Are those reports honest?

CDRH needs to improve adverse event regulations and enforce those regulations consistently with monetary penalties that will be punitive enough to induce manufacturer and hospital compliance.

UDI in EHRs and Claims is only a piece of the solution. That will not allow the collection of malfunctions that are caught prior to patient involvement that can allow for safety signals to be identified. Adverse event reporting is still vital and the only public mechanism available. As a consumer, I will not have access to claims data or EHR data, and certainly not to ASRs ad RSRs. Adverse events (via MDR) are the only “transparent” mechanism currently available. Sentinel is 8 months behind on fulfilling requests and FOIA is a close second (my current request MAY be fulfilled by December and was placed in June).

UDI does not help the women of Essure. They know what device is in them yet the FDA fails to reverse its decisions on the device’s safety. Morcellator use has been curbed primarily due to health insurer pressures on physicians, not by an FDA recall. The DaVinci robotic surgery device has over 20,000 adverse events and no recall. Death reports pour in every month. VNS therapies have caused 108+ deaths, yet new indications for the device have still been approved. One model of the Olympus duodenovideoscope was recalled, although there are CRE and NTM superbug infections in peritoneal dialysis machines, LVAD, bronchoscopes, 3 brands of heater coolers (not only the one recalled) as well as superbug bacterial colonizations in all 3 other major scope manufacturer’s devices.

Further, the redaction of data in the name of HIPAA or as a “trade secret” makes the Freedom of Information Act almost useless. Often the number of injuries caused by a device or the location of a superbug outbreak and even the type of bacteria/contamination is hidden from the public. How are physicians supposed to make informed choices about the devices they use on their patients and how is the public to trust the FDA when the names of the contaminants and location of the outbreak is redacted? This protects only the hospitals…not the patients and physicians. Our healthcare costs are going up due to the FDA’s negligence and failure to communicate with the public who trusts them, yet is deceived by the FDA at almost every turn.

You have the ability to change this right now. There is no need to wait for a panel meeting in December. Your center controls this data. Your center controls the transparency of the data, and your center fails to disseminate this data.

Your decisions are costing patients their lives every single day.


Madris Tomes, MBA

York, PA

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