Hello, Operator? FDA Probe Reveals Unreported Medical Device Injuries

Michael GrossmanDecember 08, 2016 6 minutes

The ancient Greek physician Hippocrates is often called "The Father of Western Medicine." Among his contributions to the medical world are several of its terms and information about how to diagnosed several pulmonary disorders. He is credited as the inspiration for the Hippocratic Corpus (hence its name), which is a series of over sixty lectures, textbooks, research notes, and philosophical treatises on various subjects in medicine. However, his most famous contribution to the world of medicine, at least in a broad cultural sense, is probably the Hippocratic Oath.

The Oath is a credo historically espoused by physicians, and is one of the most widely known and popularized Greek medical texts. It originally required a physician to swear, by a number of gods thought to be associated with healing, to uphold specific ethical standards. It is still considered a rite of passage for many medical practitioners, although various modernized versions are often used. The message delivered is still at its heart the same: "Do No Harm."

It's my earnest opinion that health care professionals operate with this principle in mind for the most part. Despite their efforts, though, sometimes things don't go right and patients get hurt--not to be flippant, but you can't win 'em all. Hippocrates saw to it that doctors swear never to intentionally inflict harm, but accidents do happen. While there are times that patient injuries can be attributed to human error, there's many an occasion where the devices used by these professionals cause unforeseen damages. When such incidents occur, hospitals are ethically and legally required to report those injuries as a measure to prevent others.

Unfortunately, those reports are not always made, and when that duty is neglected, harm is done.

Medical Device Injuries Go Unreported Across the Country.

In the event that patient injury occurs in the pursuit of their duties, doctors and their employing hospitals are obligated to document and report these issues as a matter of course. The Food and Drug Administration (FDA) regulates the use and distribution of medical devices in the United States. According to the regulations established by the federal agency, hospitals are required to report serious injuries potentially caused by medical equipment to the device's manufacturer within ten days. If the injury proves fatal, the hospital must also alert the FDA during that period. Regardless, manufacturers must file reports with the FDA within 30 days of learning about a device allegedly causing injury or death. For egregious issues that could require immediate action to prevent public health crises, companies have five days to report them to the agency.

A recent investigation of 17 U.S. hospitals, including several high-profile facilities, determined that each inspected hospital had failed in several instances to promptly report injuries or deaths related to medical equipment malfunction on their premises. In one such instance, FDA investigators found delays of 10 months and 18 months before two separate patient deaths related to devices were reported.

The industry probe was prompted by a number of widely-publicized injury cases, some fatal, related to malfunctions of power morcellators and bacteria-contaminated endoscopy equipment. The latter incidents often revolve around so-called "superbugs," which tend to be antibiotic-resistant. Without additional sterilization efforts, these bacteria can be transmitted on the endoscopes from one patient to the next, causing serious infections that are difficult to treat.

The FDA believes the discovered under-reporting phenomenon to be indicative of the medical industry at large; the agency's blog issued a short statement about their findings which included the following:

"We believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals... Hospital staff often were not aware of, nor trained to comply with, all of the FDA's medical device reporting requirements."

No disciplinary measures are expected to be taken against the hospitals beyond making their reporting transgressions public; instead, the FDA wants to work on new ways to maintain open channels of communication. The agency recently held a public workshop seeking input on improving hospital surveillance procedures and how hospitals can better evaluate device performance in clinical settings. Various reforms were suggested, including tracking insurance claims data to supplement the injury reports and automating event reports through electronic record-keeping methods.

Manufacturers Also Play a Role in Reporting.

In 2015, the FDA issued warnings to several duodenoscope (a type of endoscope) manufacturers, alleging that they cut corners on the manufacturing, testing, and reporting requirements needed before new medical devices can get approved for market use.

The FDA first warned of the scopes' potential to transmit antibiotic-resistant germs in 2009. Since then the devices have been implicated in superbug outbreaks at multiple U.S. hospitals. According to the agency, over 350 confirmed "superbug" infections in 41 medical centers around the world have been attributed to negligent behaviors on the part of the manufacturers, combined with hospitals' omitted incident reports. The FDA itself took a hit in a Senate report drafted about the superbug outbreaks, due to its inability to properly oversee and regulate the duodenoscopes' clinical usage.

The FDA's approach of "making nice" with the manufacturers and hospitals seems a trifle toothless, considering citizens were seriously injured and in a few cases killed by the defects in the products. However, it's not necessarily within the scope of the agency's power to offer more summary judgment with respect to the injuries caused. The civil justice system is a more effective recourse to those infected by the superbug--or in the more tragic cases, their surviving families.

How Does This Issue Relate to Personal Injury Law?

Given that the FDA's primary concern right now is trying to stay in the loop with places that are required to talk to them (but don't anyway), it's unlikely they'll be much use in pursuing damages for people injured by these devices. Medical device injuries can take a variety of forms, but lately seem to revolve around particular pieces of hospital technology:

  • Power morcellators, used in the removal of uterine fibroids, have been shown through testing to potentially spread cancerous cells through a patient's body during the surgical procedures,
  • Duodenoscopes, long flexible tubes fed through the mouth and down the throat to inspect the digestive tract that can attract and retain bacteria that resist conventional sterilization, and
  • Heater-cooler devices, used to regulate patient temperature during open-heart surgery that can transfer airborne bacteria into the open chest cavity and cause life-threatening infections.

That is far from a complete list, but I am not trying to inflate the problem or stir panic; hospitals are still the right place to go when a situation calls for urgent medical attention.

In creating and attempting to market these devices, each manufacturer is implicitly stating that it has eliminated the foreseeable risks of using the product. By "foreseeable risks," I'm typically referring to hazards associate with conventional use of the device, as well as predictable unconventional use. Medical devices, especially those listed, don't have many "off-label" applications, so the big things for their makers to predict involve the parameters for which they were designed. All of them needed safeguards against electric shock, given their proximity to (or use inside) the body. Any moving parts must be tested for efficient interaction, since the devices--particularly the morcellator--are used for delicate small-scale work, and can't afford to misfire.

If a company is unable to refine its product to eliminate the potential for predictable injury, it must instead warn the product's users of the risks. A consumer who then chooses to use the device can do so with all relevant information, which constitutes informed consent. A lack of communication is too often the case between manufacturers and end-users; in this case, the users (hospitals and doctors) would also need to convey those risks adequately to patients upon whom the devices would be employed. When contacting personal injury attorneys, many victims claim they were never informed of any potential risks.

Many patients have come forward after suffering damages from these devices, seeking redress from the companies that made them on the grounds that the manufacturers were not forthright about the risk of these injuries. Failure to warn is a valid form of negligence claim and may serve as an avenue through which people who suffered in the hospital receive compensation for their medical bills, pain and suffering, and lost wages.

Federal Oversight is Necessary if Self-Governance Can't Be Trusted.

Like many industries, the health care world is fairly tight-lipped about its flaws. I may be able to respect that intellectually as a business decision--admitting failure tarnishes a reputation and costs potential future business--but given the purpose of health care, both at an immediate patient-care level and in the world of medical manufacturing, I cannot fathom such disregard of consumer safety. Corporate solvency should never be set above human lives.

Thus, while I'm not crazy about federal oversight, it appears to be more than necessary to keep the industry in line. If they can't be trusted to do the right thing when someone is hurt in their care, the FDA will need to keep a more careful eye on goings-on.