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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Amid coronavirus pandemic, Maryland company’s single-use medical scopes in high demand

The Baltimore Sun –  April 30, 2021 – Hallie Miller

The coronavirus pandemic has altered social norms and daily routines, influenced consumer spending and upended the global economy. It also may be changing the way medical professionals examine and operate inside your body.

Reusable medical scopes have long been the standard in patient care settings, despite isolated reports of contamination, infection and even death emerging from hospitals alleged to have failed to fully sanitize the devices. The U.S. Food and Drug Administration says that the risk associated with reusable scopes is “relatively low,” provided that cleaning and reprocessing guidelines are strictly followed.

Hospitals currently are not required to track which patients receive which scopes, which could pose problems in controlling a potential contamination event, said Madris Kinard, a former FDA official and the CEO of Device Events, a company that tracks adverse events and equipment recalls in medical settings.

She said patients may not be aware of the life span of the instruments used to examine their insides.

“I look at it as a systemic issue, that these devices can’t be cleaned,” Kinard said. “If the FDA could identify a better way to clean them, they would’ve tried, and manufacturers are trying too.”

Kinard said there have been 2,600 contamination reports filed to the FDA in the last decade, a figure that may be vastly underreported. Contamination reports decreased in 2020, which Kinard said is likely due either to the introduction of scopes with disposable parts or the number of elective procedures decreasing during the pandemic.

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HHS shoots down ‘flawed’ plan to let some devices skip review

Medical Design & Outsourcing – April 15, 2021 – Nancy Crotti

The Biden administration has nixed what it described as a “flawed” Trump-era decision to exempt certain medical devices — including infusion pump controllers and fetal monitors — from regulatory review.

HHS published the original notice in the Federal Register on Jan. 15, shortly before President Joe Biden was set to take office, without speaking with the FDA before doing so, according to an FDA notice set to appear in the Federal Register tomorrow.

The Jan. 15 notice listed 83 Class II devices and one Class 1 device that HHS had exempted from regulatory review during the COVID-19 public health emergency and proposed making their exemption permanent. They included home ventilators, cardiopulmonary bypass pressure gauges, fetal cardiac monitors, long-term extracorporeal support systems, certain imaging software, ethylene oxide sterilizers and aerators, and certain masks (including N95 respirators), gloves and gowns.

FDA watchdog Madris Tomes, CEO of Device Events, told Medical Design & Outsourcing that she was pleased to learn about the withdrawal of the Jan. 15 decision.

“Although adverse event reports can be used to identify signals (patterns of problems with devices), the absence of these reports does not mean that a device is safe and effective,” Tomes said in an email. “Devices are often under-reported. Further review of the notice in January, that has now been withdrawn, acknowledged that assumption was flawed. It is very understandable that in the midst of the pandemic, that some devices would be authorized for use without the formal 510(k) process. However, assuming that an EUA could replace the typical review process for these devices indefinitely was not a good call by HHS, and I’m glad that Dr. Woodcock’s office has recognized and addressed these flawed exemptions.”

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In the Net [Hernia Mesh]

HARPER’S MAGAZINE – March 2021 Issue – By Trudy Lieberman

For years, Michael Ransford had known he would need surgery for his umbilical hernia. “People said if it ruptured, it could kill me,” the sixty-year-old farmer told me. The pain from a second hernia, on his right testicle, sent him “through the roof.” In 2016, shortly before Christmas, Ransford had an operation to repair both at Columbia Memorial Hospital, near his home in Ghent, New York.

In a postsurgical report, Ransford’s doctor, Gary Pearlstein, noted that he had repaired both hernias with polypropylene mesh, a type of synthetic netting that is commonly used in such surgeries. Pearlstein used an oval mesh patch on the testicular hernia and a circular mesh patch on the umbilical hernia. The hospital’s records identify the circular mesh as the Proceed Ventral Patch, a device consisting of multiple layers of material, produced by Ethicon, a subsidiary of Johnson and Johnson. The mesh provided “a nice solid repair,” Pearlstein wrote.

Meanwhile, complaints about hernia mesh are stacking up in the FDA’s MAUDE database, where device manufacturers are required to report malfunctions, serious injuries, and deaths. Doctors don’t have an obligation to report such incidents, but many of them, along with patients’ lawyers, are filing complaints, according to Madris Kinard, CEO of Device Events, a firm that reports on recalls and medical devices. Kinard told me that there had been a “drastic spike in hernia mesh cases reported since 2017.” That year, there were 3,149 complaints; in 2020, there were 13,942. Ten years ago, the agency’s Office of the Inspector General estimated that only 14 percent of adverse events caused by devices are ever reported to the FDA. Kinard said this suggests that the number of adverse events linked to hernia mesh is much higher than current statistics show.

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Signals Newsletter – January 2021 – Adverse Event Trends

The proliferation of medical devices and resulting adverse events have doubled over the past 5 years.  In 2016, the average monthly number of reported adverse events was 65,000.  In 2020, the average was 127,000 per month.  A 100% increase.  The reasons for this increase are the continued introduction of new devices and the improving transparency in reporting of adverse events driven by the FDA and patient advocacy groups.

This Signals Newsletter highlights the general trends in adverse events for all devices as reported to the FDA and captured in the FDA MAUDE database and provides insight into recent news worthy events.

View Signals Newsletter – January 2021 

HHS could make permanent pandemic-related exemptions for some devices

Medical Design & Outsourcing – January 19, 2021 – By Nancy Crotti

HHS has used the Trump administration’s waning days to propose permanently exempting certain medical devices — including infusion pump controllers and fetal monitors — from the FDA 510(k) clearance process.

In a notice published Jan. 15, 2021, in the Federal Register, the agency also listed seven types of patient examination gloves that it has decided to immediately stop reviewing for 510(k) clearance.

The agency also proposed permanently exempting 84 Class II devices from the clearance review process, including home ventilators, cardiopulmonary bypass pressure gauges, fetal cardiac monitors, long-term extracorporeal support systems, certain imaging software, ethylene oxide sterilizers and aerators, and certain masks (including N95 respirators), gloves and gowns.

The agency said it based its decisions on a review of adverse events reported to its MAUDE database about the types of devices between 2010 and 2020. The devices recommended for permanent exemption accounted for 46 deaths reported to MAUDE, including 16 related to facility-use apnea monitors.

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