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How Safe is the FDA Medical Device Approval Process?

FDA medical approvalIn November 2018, hundreds of journalists from 36 countries revealed the results of a year-long investigation into medical device safety. They didn’t paint a pretty picture. One of the eye-opening revelations was the almost 83,000 people died in the U.S. between 2008 and 2017 due to medical device issues. These devices were also linked to more than 1.7 million injuries.

FDA Medical Device Approval

To recognize the potential weaknesses in the approval process, you need to have a general understanding of how it works. First, the FDA defines medical devices as instruments, implements, apparatuses, machines, implants, in vitro reagents, contrivances, or other related or similar items. This includes the device’s parts, components, and accessories. The FDA identifies these products as medical devices in one of the following ways.

  1. It’s listed in the official National Formulary, called the U.S. Pharmacopoeia, or in one of its supplements.
  2. The device was designed to perform either of the following functions:
  3. Diagnose a medical condition, illness, or disease.
  4. Ease, treat, cure or prevent a human or animal disease.
  5. The item is designed to affect the structure or function of human or animal bodies. Plus, chemical action on or in the body doesn’t play a part in how the device functions, nor does being metabolized. This metabolizing and chemical action wording sets medical devices apart from pharmaceutical drugs.

FDA Medical Device Classes

The FDA classifies medical devices by their levels of risk. They created three classes, plus two additional categories for specific cases and devices.

Class I

This is the lowest risk level, which means these items are subjected to the smallest amount of regulatory control. Think of items like bedpans, oxygen masks, and tongue depressors. More than a third (35%)* of all medical devices fall under Class I.

Class II

These devices are meant to be of medium level risk. 510(k), Premarket Notification is used to approve most Class II devices. Through this process, manufacturers claim there is another device on the market that is substantially equivalent (SE) to their “new” product.

This is one of the weaknesses in the approval process. Post-market surveillance, FDA-recognized performance standards, and patient registries are set up as control measures. However, no new testing is required on these 510(k) devices.

More than half (53%)* of today’s medical devices are Class II implements. Condoms, powered wheelchairs, sutures, urinary catheters, and acupuncture needles are Class II medical devices. But you may be surprised to learn that so too are prosthetic hips. And transvaginal mesh was originally a Class II medical device. It was reclassified at the higher risk level III in 2016.

Class III

Brand new inventions are classified at the 3rd level designation. They are categorized as life-sustaining, life-supporting, or essential in preventing health impairment. The Premarket Approval (PMA) Application process governs FDA approval of these products. This is a far more thorough application than 510(k).

Proposed design elements, testing protocols, and the results of the clinical trials must be submitted. Still, in some cases, these trials only include animal testing. This may even be the case for devices that will be implanted in humans. Moreover, it’s challenging to accurately predict how some devices will perform in real-world, mass applications.

The FDA is responsible for identifying risks and weighing them against the proposed benefits to determine whether approval should be granted. This warrants the strictest regulatory control for Class III devices. Only 9%* of U.S. medical devices are classified at this level. Some examples include implantable defibrillators, cardiovascular stents, urinary continence implantable devices, and intra-aortic balloons.

De Novo

Items that don’t have an SE counterpart already on the market, but the technology and safety profiles are well known may qualify as De Novo. The manufacturer offers it via a De Novo request to have it classified lower than a Class III. Additionally, if a manufacturer submits a device for 510(k) premarket approval, but the device is determined NSE, the manufacturer can resubmit it via a De Novo request in an effort to have the item classified in the I or II class.

Humanitarian Device Exemption (HDE)

An HDE applies when the device is designed to help with treatment or diagnosis of rare conditions that impact less than 8,000 U.S. patients annually. This was established with the 1984 Orphan Drug Act (ODA) – an orphan disease affects no more than 200,000 U.S. patients.

Because of the way these levels are set up, it usually benefits the manufacturer of a new device to bypass the far more rigorous Class III PMA application process. They’ll often try to get their device approved as a Class II device, instead, through the 510 (k) process or a De Novo request. Unfortunately, this practice can lead to the approval of dangerous, defective devices. And even the more rigorous Class III PMA process can fail consumers. You only need to look at the many faulty and dangerous medical devices and the harm they’ve caused over the years to realize that the FDA Approval Process is faulty.

*FDA statistics current as of 04/09/2019

Missing Diversity in Clinical Trials

Clinical trials are an essential part of the FDA approval process for new medical devices. But most of them are lacking in diversity. Typically, test groups are not representative of the nation’s population. This can lead to skewed data. And it means some groups are overlooked.

Some races, ages, genders, and ethnic groups are more predisposed to certain conditions and diseases than others. Devices that treat those conditions are likely to target those people. Therefore, clinical trial participants should reflect this.

Historical problems, trust issues, availability, and accessibility all impact how successful trial runners will be in recruiting diverse trial groups. But until they overcome these problems, this vital tool in the approval process will remain flawed.

Spotlighting Dangerous Medical Devices that Passed FDA Approval

You’re likely aware of some of the very notable medical devices that have harmed rather than helped patients. The news covers product recalls and lawsuits for most of the more widespread cases, like NuvaRing, DePuy Hip Implants, and the Da Vinci Robot Surgical System. The following medical devices are also among these alarming cases.

Spinal Cord Stimulators

The 2018 investigative report on medical devices shined a light on the dangers of spinal cord stimulators. The devices are used for chronic pain management. They work by blocking pain signals with electrical currents that are sent through wires placed along the spine. The data was too spotty to draw a direct causal link between the implants and more than 500 deaths. But the statistical link is worrisome.

Also alarming, are the numerous burn and shock injuries caused by the stimulators. Some victims have been paralyzed from nerve damage in the spinal cord. Others have experienced muscle weakness and other related issues. Physicians implant about 60,000 spinal cord stimulators every year. Data revealed 78,172 injury reports for these devices between 2008 and 2017.

Injury Statistics on Other Potentially Dangerous Medical Devices

  • Metal Hip Replacements led to 103,104 injuries during the 10-year time frame that was covered by the investigation.
  • Implanted insulation pump injuries numbered 60,561 injuries and damage from the insulin pump with sensor neared 95,000 over the same time period,
  • Transvaginal Mesh saw 60,795 reported injuries over the past decade.

Additional Avenues to Approval

It’s important to note that billion-dollar pharmaceutical companies and medical device manufacturers wield a lot of power in D.C. and with the medical profession. They spend billions of dollars in these sectors. They use their money and its power to influence regulators and laws through government lobbying. With consulting fees, all-expense-paid trips, research grants, and other expenditures, they seek to convince medical providers to use their products over other treatments and options.

Changes on the Way?

Public outcry ensued when the AP and other news organizations released their findings. The FDA quickly promised to overhaul its medical device approval process. It claims the proposed changes were already in the works, but the timing is suspect.

The FDA plan is to remove many of the devices that are older than 10 years from their database to help modernize the Class II 510(k) process. The idea is that manufacturers won’t be able to use decades-old technology to launch replacement devices on the market without sufficient testing. The FDA says they already cleared just over 3,000 old devices in 2017.

Most recently, the FDA ordered the halt of sales and distribution of transvaginal surgical repair mesh in the treatment of pelvic organ prolapse (POP). This action followed a February advisory committee meeting that reviewed the safety and effectiveness of the controversial medical device.

Seeking Help

It remains to be seen whether FDA changes will deliver much-needed improvements for the medical device approval process. In the meantime, many thousands of Americans continue to suffer harm and injury from various devices and implants. These victims deserve compensation for their damages and suffering. If you or a loved one has been harmed by a medical device, contact our skilled New Jersey Product Liability Lawyers to discuss your situation.