How Safe are Medical Devices?

How safe are medical devices? You know you’re taking a risk if you’re skydiving or bull riding. But did you know there are serious risks associated with many medical devices? Maybe your diabetes leads to the use of an insulin pump. Or perhaps years of constant hip pain led you to a surgeon’s office to discuss a hip replacement. Or maybe your doctor recommends a spinal-cord stimulator to minimize your debilitating back pain.

Device manufacturers, and doctors, make bold claims on the benefits of medical devices. But it turns out that many devices involve serious health risks. How do medical device companies influence do doctors? And what is the government doing to keep patients safe?

How safe are medical devices?

Less safe than you probably think.

Patients report suffering life-altering injuries and disabilities from defective device implants.

How often do medical devices fail?

An investigation by the International Consortium of Investigative Journalists (ICIJ) found that in a recent 10 year period there were more than 1.7 million injuries from medical devices of all types. Additionally, there were almost 83,000 deaths.

What are high risk medical devices? 

Although any device can cause harm, some devices are riskier than others. The ICIJ investigation found that between 2008 – 2017, these 6 devices caused thousands of injuries:

Does the FDA keep patients safe from medical devices?

You’re not alone if you’re wondering how dangerous devices remain on the market. Why isn’t the US Food and Drug Administration (FDA) making sure medical devices are safe?

For starters, the FDA might not know about all device failures. According to a Kaiser Health News August 2021 report, patients and whistleblowers have repeatedly accused device companies of failing to report injury-causing defects to federal regulators as required, a charge device companies deny.

That being said, the FDA must do a better job approving and overseeing medical devices. The ICIJ investigation found that many of the FDA’s practices put patients at risk.

Importantly, and shockingly, the FDA often pushes devices through an abbreviated approval process, regularly approving most medical devices with little clinical testing.

Additionally, until very recently, the FDA kept records of device failures from the public. How and why? Read on…

A little bit of history regarding FDA device approval.

In response to tens of thousands of women developing life-threatening infections from an intrauterine device, Congress passed the Medical Device Amendments in 1976 to make sure medical devices were safe and effective.

The FDA, charged with carrying out this new law, created three classes of medical devices. (For information on the 3 classes, visit this FDA webpage.) In theory, products in the high-risk category must undergo the most rigorous clinical testing standards.

However, that usually doesn’t happen. Instead, the vast majority of devices go through a less stringent review process (called the 510(k) pathway) that provides an easy approval for devices deemed “substantially equivalent” to products already approved for use.

Unfortunately, this process for quick approval of equivalent devices should have been phased out as Congress originally intended. But, instead, it’s a standard way for thousands of devices to quickly and easily enter the marketplace.

The problem with this quick approval is that it assumes the original device was approved based on high-quality evidence proving that its clinical benefits outweighed its potential risks, and that new features in the next generation of the device don’t create new problems. Sadly, that is not always the case.

A few examples of device issues.

A hip replacement device was recalled because metal shavings from the devices made patients sick. But surgeons implanted tens of thousands of these particular devices before the FDA recalled the device.

And a device designed to break down and remove blood clots in stroke patients was quickly approved because it was similar to other approved devices. But dangerous problems with the new device led to more than 200 adverse event reports, including 14 deaths, within its first year of use. The device threatened patient safety by hindering clot removal and creating the risk of rupturing an artery. These reports led the manufacturer to recall thousands of the devices.

Seemingly lax oversight of artificial intelligence devices

Although artificial intelligence (AI) is the fastest-growing frontier in medicine, it seems to be growing without appropriate oversight. The FDA approved over 160 medical AI devices/products in recent years “based on widely divergent amounts of clinical data”.

Furthermore, the FDA did not require manufacturers to publicly document their testing on patients of different genders, races, and geographies, leaving doctors unsure about the effectiveness and quality of AI devices.

How else is the FDA failing the public?

In addition to problematic quick approvals, the ICIJ investigation also found the FDA doesn’t respond adequately when dangerous products are identified. For instance, the FDA responds slowly when they should be forcing companies to correct dangerous, sometimes life-threatening, products.

Furthermore, the FDA rarely pulls devices from the market, even when major problems emerge.

According to ProPublica, the FDA and its Center for Devices and Radiological Health are responsible for ensuring that high-risk medical devices are safe and effective. However, they mostly rely on manufacturers to identify and correct problems.

Although the FDA states it can seize products, order injunctions against companies or issue fines, it rarely does so. Instead, the FDA prefers to let companies make fixes voluntarily.

An example of an FDA failure to protect the public.

According to ProPublica, in 2014 FDA inspectors repeatedly found manufacturing and device quality problems with a heart pump device called the HeartWare Ventricular Assist Device (HVAD).

Although the FDA issued a warning letter, one of its most serious citations, the FDA did not penalize the manufacturer.  Instead, even as the HeartWare pump failed multiple inspections over many years, and reports of device-related deaths grew, the FDA relied on the device makers to fix the problems voluntarily rather than forcing them to do so.

Importantly, the processes used to inform patients about the potential dangers of HVAD failed, leading to patients agreeing to HVAD implants without understanding the risks.

Sadly, over 19,000 patients received an HVAD implant, most of them after the FDA’s 2014 discovery that the device didn’t meet federal standards. By the end of 2020, the FDA had received over 3,000 reports of deaths that the HVAD may have caused or contributed to.

FDA record-sharing failures.

Ever year the FDA receives hundreds of thousands of reports regarding medical devices associated with suspected device-associated deaths, serious injuries, and malfunctions. But, this information wasn’t always available to the public.

In fact, more than 20 years of data relating to medical device issues was not released. Consequently, some device manufacturers kept safety issues a secret.

Fortunately, the FDA just released information on approximately 6 million adverse event reports (injuries and/or malfunctions) dating back to 1999. These incidents are now included in the federal database Manufacturer and User Facility Device Experience, or MAUDE.

What’s MAUDE? It’s a database of medical device reports submitted to the FDA by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients and consumers). Another bit of good news? The FDA has plans to upgrade the MAUDE database to make the information more user-friendly. Some bad news? The MAUDE data is not as accurate as it should be.

MAUDE data is flawed.

Importantly, a study published in 2021, reviewed MAUDE entries and found that a significant number of medical device adverse events that caused patient deaths were not categorized as such in the MAUDE database.

Using an algorithm to search for terms related to death, such as “patient died,” “patient expired,” “could not be resuscitated,” and “time of death”. The analysis showed that 23% of reports with a death were not placed in the death category.

Moreover, the lead author of the study states that the research only focused on reports that contained at least one term associated with death, as opposed to searching all the reports from the MAUDE database. Because of this, they surmise the actual number of deaths improperly categorized is likely higher than they noted in their findings.

Certainly, this makes it impossible to properly determine the safety record of a particular device.

What’s the FDA say about allegations of shortcomings?

According to an AP article, the FDA “acknowledges its data has limitations, including mistakes, omissions and under-reporting that can make it difficult to determine whether a device directly caused an injury or death. But it rejects any suggestion of failed oversight.”

The government can and does impose fines.

In some cases, the government imposes fines on device companies for bribing doctors, illegally promoting products for unapproved uses and paying for studies that proclaim the safety and effectiveness of their products.

For instance, in 2016, Olympus Corp. of the Americas (the largest US distributor of endoscopes and related medical equipment) agreed to pay $623.2 million “to resolve criminal charges and civil claims relating to a scheme to pay kickbacks to doctors and hospitals”. And, Olympus also “agreed to make various improvements to its compliance program.”

Medical device companies spend millions to influence doctors.

Unsurprisingly, medical device companies invest countless resources to develop safe, effective products. But, at the same time, device companies also spend millions and millions to influence regulators, hospitals and doctors.

How much money are we talking about? 

In 2017 alone, the 10 largest medical device companies paid almost $600 million to US doctors and hospitals for consulting fees, research, travel and entertainment fees.

And manufacturers of hardware for spinal implants, artificial knees, and hip joints paid more than $3.1 billion to orthopedic surgeons between August 2013 and the end of December 2019.

Why should this concern you? Because your doctor should recommend a device for you because it will improve your health and well-being, not because it will improve your doctor’s bank balance.

In fact, industry whistleblowers and government investigators say all these payments “can corrupt medical judgment and tempt surgeons to perform unnecessary and wasteful operations”.

Furthermore, these companies spend millions to influence the US government. For instance, lobbying records show that since 2017 the top 4 spinal-cord stimulator manufacturers spent over $22 million to try to influence legislation that would benefit their businesses (which also includes other devices).

Fortunately, in the US, drug and device manufacturers must report their payments to doctors and hospitals. You can look up your doctor and/or hospital on the ProPublica Dollar for Docs site.

Medical device companies may hide the truth from doctors and patients.

Although device companies work hard to foster relationships with doctors and hospitals, they are not always honest about device safety and performance.

For example, a Kaiser Health News investigation examined malpractice and product liability lawsuits. Alarmingly, they found that device marketers are being accused of concealing or downplaying hardware defects in thousands of cases, leaving patients and doctors unaware of possible risks.

Interestingly, in many of these cases, company records, or actions taken by state or federal regulators, support these claims.

A few examples of dangerous devices.

Spinal cord stimulators.

These stimulators, implanted in patients’ backs, use electrical current to block pain signals. The use of these devices has increased dramatically over the years as the device manufacturers, and doctors, praise the ability of these devices to safely treat a wide range of painful conditions.

In fact, spinal cord stimulators are one of the fastest-growing products in the medical device industry, with roughly 60,000 units implanted each year.

However, these devices are more dangerous than many patients know, according to an AP investigation. These stimulators account for the 3rd highest number of medical device injuries reported to the FDA, with 80,000+ incidents reported since 2008.

What types of injuries?

The FDA data shows reports of shocks, burns, and spinal-cord nerve damage ranging from muscle weakness to paralysis. Furthermore, the FDA data includes over 500 reports of death for patients with spinal cord stimulators. However, scant details make it impossible to determine if the stimulator itself or the surgery to implant the device caused the deaths.

Dangerous breathing machines.

Philips makes breathing machines to pump air to those who struggle to breathe, including ventilators for the very sick and CPAP machines for people with sleep apnea. In an effort to reduce annoying rattling noises, they added industrial foam to their breathing machines. However, they soon started receiving reports of “black particles” or “dirt and dust” inside machines and other reports of contamination.

Yet, instead of notifying the FDA, they withheld more than 3,700 complaints received over an 11 year period, according to a ProPublica and Post-Gazette analysis of tens of thousands of reports. And they waited until 2019 to launch a formal investigation of the problem – 9 years after they started receiving complaints and 3 years after their first known tests found degrading foam.

Company records obtained show officials knew about the dangers but continued to sell machines that the FDA has since said are capable of causing severe illness or death. Alarmingly, they aggressively marketed new machines fitted with the hazardous foam through the beginning of COVID-19.

The public was not warned until June 2021, more than 10 years after the first reports. Philips finally recalled millions of machines, acknowledging that the foam could crumble in heat and humidity and send potentially “toxic and carcinogenic” material into the noses, mouths, throats and lungs of users.

What types of harm did users suffer?

People using Philips machines suffered from unexplainable illnesses, including vomiting, dizziness and headaches. Moreover, users were newly diagnosed cancers of the lungs, throat, sinuses and esophagus.

For more details, read the ProPublica article here.

A few other examples of unsafe medical devices.

In October, 2021, the FDA announced expanded recalls for Medtronic Insulin Pumps and for a Medtronic Remote Controller. The FDA designated both devices as Class I – the most serious type of recall – due to a risk of death or serious injury.

Additionally, Kaiser Health News conducted their own investigation regarding medical device safety and found interesting, albeit frightening, information on blood glucose meters, dental implants, surgical staplers, breast implants and more.

How safe are the medical devices your doctors recommend?

Importantly, don’t agree to a device without serious consideration, unless it’s a life-or-death situation. Because there is potential for serious harm, talk to your doctor, get a second opinion, and do your own research.

Ask your doctors the following questions:

• Are there any steps you can take to avoid the device? Will a change in diet or exercise lead to ample improvements? Will physical therapy help? Other medical procedures?
• Is it possible to remove the device if a problem develops?
• How long has the recommended device been on the market? Importantly, don’t assume that new means better. “New” means less time in use, which can lead to less robust outcome results as compared to older devices. And don’t assume that all devices in a particular category are equally safe and/or effective.
• Have there been clinical trials for this specific device? What do the results show?
• How many surgeries have you performed using this specific device? What were the outcomes for these patients?

Additionally, do some independent research:

• Search the FDA’s Manufacturer and User Facility Device Experience (MAUDE) to determine if there have been incidents of harm caused by any device you are considering. Although realize this report may not offer a full picture of death rates.
• Additionally, research online:
  • Look for any history of complications experienced by other patients. Search for the type, brand, and model of the recommended device, along with “complications” or “problems”.
  • Learn about clinical trial studies involving devices. Because doctors can’t keep track of the large numbers of studies, it’s a good idea to do your own research. Of course, you can/should ask your doctor as well.
• Use the ProPublica Dollar for Docs site to determine if your doctor and/or hospital receives payments from the device company. If so, ask your doctor about the payments and any potential influence the money has on his/her recommendation.
• Search for and join a Facebook group for patients who have experience with the device you are considering. You can receive helpful information from these peer-to-peer networks, proven to be a beneficial source of information. For more information on this topic, read my blog post: Can You Trust Advice from Other Patients?

Lastly, if you use a medical device or have an implanted device, it’s important to understand that it may take months before you or your doctor learn of a recall on a faulty device. For more information, read What You Need to Know About Medical Device Recalls.

NOTE: I updated this post on 11-8-23.