- DEVICE NAMES: MESH, SURGICAL, POLYMERIC; MESH, SURGICAL
- PRODUCT CODES: FTL, FTM
ADVERSE EVENTS RECEIVED BY THE FDA
- Total Reports: 51,844
- Injury Reports: 48,974
- Malfunction Reports: 2,209
- Death Reports: 388
- Other: 273
- RECALLS: 27
ADVERSE EVENTS RECEIVED BY THE FDA
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.
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.”
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.
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.
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.
JAMA Network – December 16, 2020 -Madris Kinard, MBA; Lisa McGiffert, BA
Tracking Medical Devices With the US Food and Drug Administration’s Unique Device Identification System
In 2007, Congress mandated that medical device manufacturers create a unique identifying number for each of their products that was similar to a vehicle identification number on automobiles.1 Work to implement the law did not begin until in 2012, when Congress added a deadline. In 2013, the US Food and Drug Administration (FDA) adopted the final rule.2
Currently, device manufacturers must include a unique device identifier (UDI) on the label of all implantable and life-supporting/life-sustaining medical devices. By September 2022, the UDI will also be required for lower-risk, nonimplantable devices. The UDI is meant to be readable by people and also scannable; it contains up to 62 data elements, such as the company name, device name, and model number.3 This information is stored in the Access Global Unique Device Identification Database (AccessGUDID), a free, publicly available database maintained by the FDA.
Consumer Reports – December 8, 2020 – By Rachel Rabkin Peachman
Malfunctions or design flaws with continuous blood glucose monitors, insulin pumps, and other equipment can be devastating
Pamela, a 64-year-old from Arkansas, began using an insulin pump to manage her type 2 diabetes in 2013. She and her husband, Gary, were trained to use the pump, made by Medtronic, and according to a lawsuit later filed against the company, Gary often helped set up his wife’s device. (CR isn’t using their last name to protect their privacy.)
So it wasn’t unusual when one night in January 2016, Gary filled the pump’s reservoir with insulin and changed its infusion set, which connects the reservoir to the body via a thin plastic tube.
But Pamela and Gary didn’t know that the infusion set had a flaw that could cause the pump to deliver too much insulin—something that the lawsuit alleged happened to Pamela that night. While Gary was sleeping, Pamela’s blood sugar levels plummeted, and the next day he found her in a coma. Attempts to revive her failed; she died in a hospital a week later.
JAMA Internal Medicine – Sept 28, 2020 – By Madris Tomes, Device Events Founder & CEO
Reporting of adverse events to the US Food and Drug Administration (FDA) has long been the primary mechanism of identifying safety issues with medical devices—ranging from nasal swabs to cardiac defibrillators to in vitro diagnostic test kits. Each day, approximately 3500 adverse event reports are collected in the agency’s Manufacturer and User Facility Device Experience (MAUDE) database. As anyone who has tried to use it will attest, the database provides a difficult-to-use interface to search these reports.
Read Full Article: JAMA 9-28-2020 Identification and Market Removal of RIsky Devices
MASS DEVICE – Sept 21, 2020 – By Nancy Crotti
In a long-promised move, the FDA today announced that it has added several updates to its database of injuries and deaths reportedly related to medical devices.
The agency said it now includes new adverse-event summaries, the number of events and exemption number fields in its eMDR, eSubmitter and Manufacturer and User Facility Device Experience Database (MAUDE).
The FDA also recently added a data field called “patient problem code,” an outcome code assigned to an adverse event. This has been available in drug reports but the device division redacted them from public view in the past, according to patient safety advocate Madris Tomes (CEO of Device Events and former FDA public health analyst).