Governmental Oversight of Potentially Dangerous Medical Devices

Public and scientific criticism is growing that governmental oversight of medical devices being implanted in Americans is insufficient, often allowing downright dangerous devices to harm patients. Medical-device safety is imperative because some like defibrillators, pacemakers and heart valve rings are literally life sustaining.

Even if a device does not directly prolong life, if it does not safely, reliably and effectively perform its intended function, a patient may be catastrophically injured, sometimes permanently. Recent controversial medical devices known to have caused harm to patients after reaching the market include:

  • Surgical mesh that can puncture organ walls
  • Artificial hips that shed metal particles into surrounding tissues
  • Heart-defibrillator wires that short out

The Food and Drug Administration is the federal agency responsible for seeing that medical products such as devices, medications and dietary supplements (among other things) marketed for use in patients are safe. Within the FDA, the Center for Devices and Radiological Health, known as the CDRH, specifically oversees medical devices.

Current FDA procedures have been criticized for allowing new devices to be sold before sufficient pre-market testing is done to determine whether devices are truly ready for safe use. Normally, most devices must conform to stringent pre-market testing and receive FDA approval before they are allowed to be sold.

However, if a manufacturer can show the agency that a device is "substantially equivalent" to one already on the market, the device can be released for sale without the same rigor. Allowing an equivalent product to market without the usual amount of testing and data is referred to as a "501(k) approval."

The 501(k) process is meant for less risky devices, but reportedly the question of what is a risky device can be problematic, allowing more serious devices to receive 501(K) status. For example, ProPublica recently reported in a major investigation that the heart valve ring industry asked the FDA to reclassify the rings to a lower risk level that would allow 501(K) equivalency approval without rigorous pre-market review, and the FDA did so.

After a medical device is on the market if it becomes apparent that the device violates federal consumer safety law by being either defective or a health risk, the responsible private party (like the distributor or manufacturer) usually voluntarily recalls the device. The FDA also has the power to force a responsible company to recall a dangerous device, although FDA-initiated recalls are reportedly not common.

A recall can mean several things. The device may have to be removed from the patient's body, but it could mean instead that the device needs to be checked, fixed or monitored.

In addition to the recall decision, when a product is released without sufficient pre-market evaluation and reports of injury surface later, the FDA may require manufacturers to do testing, or the agency itself may conduct studies and gather evidence, and determine whether warnings must be issued to consumers or medical professionals.

Medical facilities are supposed to report device problems to the FDA, and manufacturers are to inform the agency when they take affirmative actions to protect patient health in response to device concerns. The FDA also has the power to fine manufacturers for certain device safety violations.

A recent New England Journal of Medicine article called for the U.S. to require a national registry for each high-risk medical device in use, a common requirement in other countries. Each time the device is implanted by a medical provider the surgery and later postoperative outcomes are recorded in the registry. Some U.S. providers are voluntarily using such registries already.

While Americans wait for stricter federal laws and regulations to be implemented, citizens may be wary of medical-device reliability. Ask your doctor probing questions; get a second opinion; and do outside research.

If you or a loved one is injured by a defective medical device, you may have legal remedies like lawsuits for personal injury, product liability or medical malpractice. If a loved one has died from complications from a dangerous medical device, you may have grounds for a wrongful death suit. Talk to an experienced medical device attorney to learn about your options and rights.