According to the Medicare Payment Advisory Commission,1 the medical device industry has developed and sold an enormous number of products they feel play a crucial role improving the ability to diagnose and treat illness. However, there are a relatively small number of large diversified companies supplying these devices specific for therapeutic use.
In a report to Congress, the Medicare Payment Advisory Commission stated:2 “The industry is distinctive both for its tendencies to make frequent, incremental changes to its products and its extensive ties with physicians.”
While medical devices are regulated by the Food and Drug Administration (FDA), the regulatory framework is less stringent than that used for pharmaceutical drugs. Many devices considered to be low risk may be marketed without prior approval and those considered medium risk are only required to demonstrate they are substantially equivalent to an existing device before being marketed.
Due to a rapidly expanding scientific and engineering knowledge base, there’s been an acceleration in the development of new devices. The FDA3 maintains information for manufacturers to determine if their product is a medical device, how to classify it, label it and report it. The FDA Medical Device Reporting (MDR) regulation mandates reporting device-related adverse events.4
On the surface it appears as if the FDA and other federal agencies are seeking to protect consumers from malfunctioning or poorly designed devices. However, an investigative report by Kaiser Health News (KHN)5 revealed a hidden program.
The Voluntary Malfunction Summary Reporting has allowed manufacturers to submit MDRs in summary form. The KHN6 investigation found these collections included 1.1 million reports since 2016.
MAUDE tracks public reports
Publicly, the Manufacturer and User Facility Device Experience Database (MAUDE)7 is where adverse events are reported for medical devices. The FDA also maintains MedWatch,8 an adverse event reporting program for the public where individuals may subscribe to safety alerts and learn of new reports made on human medical products or may report serious problems themselves.
Within the MAUDE system is an online search that allows the public to look through the database for information on medical devices that may have malfunctioned or caused a death or serious injury. According to the FDA, the database remains current through the end of the past month, and the they seek to include all reports.9
Before KHN revealed the existence of a hidden database kept by the FDA, The Associated Press reported spinal stimulators used to treat pain and other conditions caused more than 80,000 deaths from 2008 to 2018. While marketed as a panacea for a wide range of pain disorders, the stimulators accounted for the third highest number of medical device injury reports to the FDA.10
These devices became one of the fastest growing medical products as doctors and companies aggressively marketed them as a safe antidote to the opioid crisis. However, patient reports indicate they are responsible for shocks, burns or spinal cord nerve damage resulting in muscle weakness and paraplegia.
Of the 4,000 different types of medical devices tracked by the FDA, metal hip replacements and insulin pumps are the only two logging more injuries. Medical device manufacturers have insisted spinal cord stimulators are safe and 60,000 are implanted annually.
An investigative collaboration between the AP, NBC, the International Consortium of Investigative Journalists and 50 other media partners around the world, discovered more than 1.7 million injuries and nearly 83,000 deaths related to spinal cord stimulators.
In response to the investigative piece by the AP, the FDA released a statement saying it would take new action to create11 “a more robust medical device safety net for patients through better data. Unfortunately, the FDA cannot always know the full extent of the benefits and risks of a device before it reaches the market.”
This statement was made just months before information was released by KHN showing FDA has supported a program that hides reports on faulty medical devices, injuries and malfunctions, leaving doctors and medical forensics professionals unable to make informed decisions about treatment.
Hidden reports place patients at risk
The program was initiated 20 years ago. The FDA justified it saying the program was designed to allow for more efficient internal review of well-known risks.12 This special exemption allowed manufacturers to file reports of malfunctions into a database that remained hidden from doctors and the public view.
The repository of device-related injuries has expanded since its inception. At least 1.1 million incident reports have found their way into the internal alternative summary reporting archive instead of the widely scrutinized public database.
An FDA official who spoke with KHN13 said this program “is for issues that are well-known and well-documented with the FDA” and that it “has allowed the FDA to more efficiently review adverse events … without sacrificing quality” of the review or information received.
The simple goal two decades ago was to cut down on redundant paperwork. A former FDA official told KHN14 the program took shape after under-reporting triggered changes allowing criminal penalties against device companies. Once this happened, thousands of injury and malfunction reports came into the agency every month.
Some of these were so similar that Larry Kessler, a past FDA official, reported they were “mind-numbing” to review. As a solution, they proposed device makers could seek a “special exemption” to avoid reporting certain complications into a public database and would instead send a spreadsheet each quarter, six months or year, listing the injuries or malfunctions of their devices.
In this way, reviewers would look for problems or spikes in known issues while the public and physicians remained unaware of the vast number of injuries and malfunctions being reported every month.15
Buried data in FDA special exemption reports
KHN read over reams of records looking for references of reporting exemptions. In addition, the FDA also opened other pathways for manufacturers to report thousands of injuries and deaths listed in lawsuits. These exemptions were applied to products considered risky, such as pelvic mesh and devices implanted in the heart.16
A spokeswoman for the FDA confirmed these exemptions were created without public notification. Records from the FDA provided to KHN showed more than 480,000 injuries or malfunction reported in this program in 2017 alone. These alternative summary reports are not well-known, even within the industry.
For instance, Matthew Baretich, a biomedical engineer from Denver, Colorado, helps several area health systems analyze patient injuries and make equipment purchasing decisions. In order to do his job, he regularly scans public injury reports and when asked about these alternative summary reports he said,17 “I’ve got to tell you, that’s a new term to me.”
Bruce Barkalow, president of a biomedical engineering firm in Michigan, is who government officials and attorneys call when medical devices fail. In an interview with KHN18 he said he was not aware of the reports, and that the data would be meaningful to his forensic investigations. Former FDA commissioner Dr. Robert Califf, who held the post from 2015 to 2017, said he was unaware of the program.
Information blackout on 100 medical devices
All deaths are mandated to be reported in MAUDE, but hidden databases have included malfunction reports for nearly 100 medical devices, including those implanted in patients or used in surgeries. The FDA declined to give KHN a complete list of devices granted exemptions but confirmed exemptions have been used for intra-aortic balloon pumps, surgical staplers and mechanical ventilators.19
Recently, the FDA announced it will be terminating the alternative summary reporting program in an effort to increase transparency. It also revealed it would open past records to the public within weeks. Former FDA official Dr. S. Lori Brown called this:20
“… a victory for patients and consumers. The number one job of the FDA — it shouldn’t be “buyer beware” — is to have the information available to people so they can have information about the devices they’re going to put in their body.”
Federal records have also shown the agency allowed makers of breast implants to hide hundreds of thousands of injuries and malfunctions in alternative summary reports. Exemptions will end for implantable cardiac defibrillators, pacemakers and tooth implants.21 The FDA reportedly began to close the program as far back as mid-2017.
However, data provided to KHN22 shows that in the first nine months of 2018 the FDA accepted more than 190,000 injury reports and 45,000 malfunction reports in their hidden reporting program. In the upcoming release of data, the FDA will open summary reports filed before mid-2017. Going forward, device makers will be required to file individual reports for each patient harmed by medical devices.
However, the FDA also said it will not stop device makers from filing exemption reports withheld from the public when there is mass litigation over a device, nor has a plan been announced to open records that contain injury reports related to pelvic mesh and surgical robots.
As a comparison, KHN23 found 84 accounts of stapler related injury were filed with MAUDE in 2016 while 10,000 malfunction reports were sent to the in-house database.
The FDA had initiated a newer summary reporting program in which more than 5,500 types of devices are covered, allowing manufacturers to log device malfunctions. They announced these will be left in place, but manufacturers will not be allowed to report serious injuries in this program. However, the FDA has a spotty historical record of disclosing reports to advisers.24
Bad information devastates families
While it may be easier for those counting reports to forget, the millions of hidden accounts of medical device malfunctions and injuries have devastated families and destroyed countless lives.
• After living for years in pain after a crushing injury, Jim Taft consented to using a spinal cord stimulator from Boston Scientific to cloak the pain and get off pain medication.25 The stimulator failed soon after it was surgically implanted, delivering electric shocks so strong he couldn’t sleep and at one point fell down a flight of stairs.
It was implanted in April 2014 by a neurosurgeon who received $181,000 from the company over five years as consulting fees and payment for travel and entertainment. By the time Taft had the spinal cord stimulator removed four years later, the damage sustained left him unable to walk more than a few steps. He’s now virtually paralyzed.26
• A lawsuit brought by the family of Mark Levering, 62, alleges he nearly lost his life during surgery. Hospital staff performed CPR for 22 minutes while surgeons sutured a severed vein caused by a stapler malfunction. He was in a medically-induced coma and underwent several more surgeries to repair the damage.
After awakening from the coma, he was unable to walk and cannot consistently recognize his wife or son due to the lack of oxygen to his brain and the subsequent brain injury.27
• In 2013, April Strange had surgery to remove a benign liver growth. When the stapler malfunctioned, she bled to death, leaving behind a husband and two daughters, then ages 6 and 8. After surgery, the stapler was thrown out, leaving Strange’s husband unable to prove it had a defect. While stapler-maker Covidien denies allegations their product has a defect, they reached an agreement to settle with the family.28
FDA collaborates with manufacturers and CDC with states
Federal agencies charged with protecting public health interests appear to take actions leaning toward protecting big business instead. As the FDA begins revealing the number of under reported injuries and malfunctions in surgical equipment and medical devices, the Centers for Disease Control and Prevention (CDC) is hiding information about deadly infections in hospitals.
Although the CDC is vigilant in their surveillance of hospitals out of the country, The New York Times29 exposed a culture of secrecy within the U.S. that affects health care. One recent infection affecting hospitals has been Candida auris, which the CDC calls30 “an emerging fungus that presents a serious global health threat.”
The fungus is often multidrug-resistant, difficult to identify using standard lab methods and causes outbreaks in multiple health care settings. However, the CDC and states appear to be collaborating to hide outbreaks as a way to avoid frightening patients.
Knowledge of an outbreak is important when you’re making decisions about nonurgent matters, such as elective surgery. The New York Times31 reports hospitals hide the outbreaks even when disclosure could have saved lives.
Take steps to protect your health
The best way to avoid the potential for medical device malfunction or uncontrolled infection is to protect your health. While there are times when you may need to seek immediate medical attention for accidents and injuries, I believe your best course of action is to maintain optimal health using strategies I’ve discussed in past articles.
Begin by getting eight hours of quality sleep, maintaining a healthy gut microbiome, eating a nutritionally balanced diet and getting plenty of exercise and movement each day. For guidelines and tips to help you, see the following articles: