FDA medical device regs, safety checks questioned by AMA ethics journal

MEDTECHDIVE – September 29, 2021 – Nick Paul Taylor

The AMA Journal of Ethics has taken a deep dive into U.S. regulation of medical devices, raising questions about whether FDA is striking the right balance between supporting innovation and protecting patients.

In setting up the issue, Ariel Wampler, a plastic and reconstructive surgery physician at Lahey Hospital and Medical Center in Massachusetts, shared data on the regulation, use of and impact of medical devices. Most of the statistics date back years but still provide a snapshot of the case against the current approach. Wampler notes that less than 1% of medical devices went through two large clinical trials, as is standard for pharmaceuticals, from 2003 to 2007.

As it’s typically easier and safer to discontinue use of a drug than an implant, Wampler suggests it “might be reasonable” to expect some devices be held to higher safety standards than pharmaceuticals.

Reported serious safety problems are exceedingly rare — less than 1% of devices cleared or approved between 2004 and 2009 have been subject to a Class I recall, though the recall system itself has also been criticized as being piecemeal and not comprehensive. Clinical trials of implants can be more complex, expensive and ethically problematic than studies of drugs.

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Is the FDA Failing Women?

AMA Journal of Ethics – Viewpoint – September 2021 – Madris Kinard, MBA and Rita F. Redberg, MD, MSc


Many devices in current use were marketed before the US Food and Drug Administration (FDA) began regulating devices in 1976. Thus, manufacturers of these devices were not required to demonstrate safety and effectiveness, which presents both clinical and ethical problem for patients, especially for women, as some of the most dangerous devices—such as implanted contraceptive devices— are used only in women. This article investigates whether and to what extent devices for women receive less rigorous scrutiny than devices for men. This article also suggests how the FDA Center for Devices and Radiological Health could more effectively ensure safety and effectiveness of devices that were marketed prior to 1976.

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Thousands of Patients Were Implanted With Heart Pumps That the FDA Knew Could Be Dangerous

ProPublica – Health Care – by Neil Bedi – August 5, 2021 

Inspectors repeatedly found manufacturing and device quality problems with the HeartWare heart pump. But the FDA did not penalize the company, and patients had the device implanted on their hearts without knowing the facts.

John Winkler II was dying of heart failure when doctors came to his hospital bedside, offering a chance to prolong his life. The HeartWare Ventricular Assist Device, or HVAD, could be implanted in Winkler’s chest until a transplant was possible. The heart pump came with disclaimers of risk, but Winkler wanted to fight for time. He was only 46 and had a loving wife and four children, and his second grandchild was on the way.

So, in August 2014, Winkler had surgery to implant the device. A golf-ball-sized rotor was attached to his left ventricle to pump blood through a tube and into his aorta. A cable threading out of a small incision in his waist connected to a battery-powered controller strapped to his body. If something went wrong, an alarm as loud as a fire drill would sound.

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Patient deaths called ‘injury,’ ‘other’ in FDA medical device database: study

MEDTECHDIVE – by Ricky Zipp – July 30, 2021

A researcher noted mislabeled patient death reports can go missed by the agency, potentially leading to unsafe devices remaining on the market.

A new analysis of the FDA’s Manufacturer and User Facility Device Experience database finds patient deaths associated with the use of medical devices are being mislabeled in the system and potentially being missed by the agency.

This type of negligence can bring about a lawsuit to those who are doing this and putting people’s lives at risk. This may require such law firms as LawTX.com as well as others who are in the vicinity of where these mislabeled reports are, to take action and start legal proceedings for families and individuals who have been affected by this outcome.

In a manual review of 1,000 adverse event medical device reports identified by a natural language processing algorithm, used to identify mislabeled patient death reports in the MAUDE system, 23% of reports were labeled as injury, malfunction, missing or other, rather than death, according to the study published Monday in JAMA Internal Medicine.

The report raises more questions about the FDA’s complex and often opaque public reporting process and database for medical device adverse event reports.

Madris Kinard, CEO of Device Events, which developed the software used to identify reports in the FDA’s database for the study, said identifying the correct number of deaths or serious injuries in mislabeled reports is crucial as it could potentially change the safety status of some devices.

“You can’t just say across the board that this is going to fix the FDA’s problems. There is no one number, typically, that they say, ‘Okay, well, when it reaches this number, we pull [a device.]’ It really depends on other market factors,” Kinard, one of the JAMA report’s authors and a former FDA official, said.

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Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death

JAMA Internal Medicine | Original Investigation | HEALTH CARE POLICY AND LAW – July 26, 2021
Authors: Christina Lalani, MD; Elysha M. Kunwar, BA; Madris Kinard, MBA; Sanket S. Dhruva, MD, MHS; Rita F. Redberg, MD, MSc

IMPORTANCE In the US, most postmarket medical device safety data are obtained through adverse event reports that are submitted to the US Food and Drug Administration (FDA)’s Manufacturer and User Facility Device Experience (MAUDE) database. Adverse event reports are classified by the reporter as injury, malfunction, death, or other. If the device may have caused or contributed to a death, or if the cause of death is unknown, the FDA requires that the adverse event be reported as a death.

OBJECTIVE To determine the percentage of medical device adverse event reports submitted to the MAUDE database that were not classified as death even though the patient died.

DESIGN, SETTING, AND PARTICIPANTS In this study, a natural language processing algorithm was applied to the MAUDE database, followed by manual text review, to identify reports in the injury, malfunction, other or missing categories that included at least 1 term that suggested a patient death, such as patient died or patient expired, from December 31, 1991, to April 30, 2020, for any medical device.

EXPOSURES Manual review of a random sample of 1000 adverse event reports not classified as death and of selected reports for 62 terms that are associated with deaths but were not classified as death.

MAIN OUTCOMES AND MEASURES Percentage of adverse event reports in which the patient was said to have died in the narrative section of the report but the reporter classified the report in a category other than death.

RESULTS The terms in the natural language processing algorithm identified 290 141 reports in which a serious injury or death was reported. Of these, 151 145 (52.1%) were classified by the reporter as death and 47.9% were classified as malfunction, injury, other, or missing. For the overall sample, the percentage of reports with deaths that were not classified as deaths was 23% (95% CI, 20%-25%), suggesting that approximately 31 552 reports in our sample had deaths that were classified in other categories. The overall percentage of missed deaths, defined as the percentage of deaths that were classified in other categories, was 17% (95% CI, 16%-19%).

CONCLUSIONS AND RELEVANCE Many of the findings of this study suggest that many medical device adverse event reports in the FDA’s MAUDE database that involved a patient death are classified in categories other than death. As the FDA only routinely reviews all adverse events that are reported as patient deaths, improving the accuracy of adverse event reporting may enhance patient safety.

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Beleaguered FDA in talks for drug-company funding

MarketWatch – July 13, 2021 – Eleanor Laise

Fees paid by drug and device makers influence agency operations at the expense of patient safety, critics say

Amid a firestorm over its approval of a new Alzheimer’s treatment, the Food and Drug Administration is holding closed-door meetings with companies it regulates — talks that critics say allow drug and device makers to exert outsize influence over the agency’s operations, threatening to erode public trust in the agency at a critical moment.

The talks focus on “user fees” that pharmaceutical and medical-device companies pay to the FDA annually and when applying for approval of new products. The FDA in recent years has become increasingly reliant on such payments, which funded nearly half of the agency’s total spending in fiscal year 2020. In exchange for the fees, the FDA agrees to certain deadlines for reviewing new-product applications, the type and frequency of meetings with companies submitting applications, and other commitments. The medical-product user-fee agreements are generally renegotiated every five years — a process that’s happening now, in advance of the current agreements’ expiration next year — and submitted to Congress for authorization.

“We simply can’t get a view into this process, and the lack of transparency is deliberate,” says Madris Kinard, a former public health analyst at the FDA and CEO of Device Events, which tracks medical-device adverse-event reports.

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The Brockovich Report – The Data Doesn’t Lie

The Brockovich Report – June 10, 2021 – By Erin Brockovich

I want to introduce you to someone who has become a friend and colleague, helping transform the way we track medical device information. I’m so grateful for her work!

Madris Kinard is the pioneer and creative force behind Device Events, an innovative medical device surveillance and metric reporting system. Since the company’s founding in 2015, she has been transforming the way patterns of adverse events in medical device usage are identified and tracked—a process that significantly helps healthcare professionals mitigate risk and make safer, more informed healthcare decisions for their patients.

The information in her database can help healthcare organizations, medical device manufacturers, insurance companies, and others identify problem medical devices and understand the history, quantity, and severity of related adverse events to assess and mitigate associated risk.

Her work has been featured on CNBC’s Power Lunch and CNN, and in The New York TimesJAMA Internal MedicineWashington Post Magazine, and others. She presents to numerous FDA public workshops and industry conferences, educating healthcare audiences nationwide about the importance of medical device surveillance.

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