Medical devices, such as IVC filters for catching blood clots or artificial joint systems, undergo rigorous testing for safety and effectiveness before being approved by the U.S. Food and Drug Administration (FDA). When changes are made to these devices, they are supposed to be rigorously tested once again. A recent study from the University of California San Francisco and the Yale School of Medicine found that the testing of changes to high-risk devices does not stand up to scrutiny.
Modifying High-Risk Medical Devices
Manufacturers of medical devices often make updates and modifications to improve their functioning or safety. Any change could alter how a device performs, and therefore could impact patient safety. This means that changed devices are also supposed to go through the rigorous testing used for new devices. This is especially important for what are considered to be high-risk devices, those that either help sustain life, prevent health impairments, or have the potential to cause serious side effects or injuries.
Pressure to Speed Process and Low-Quality Studies
The recent study, which was published in August in the Journal of the American Medical Association, was a review of clinical trials that were used by the FDA to approve changes to high-risk medical devices. The review found that most of the trials that were used to approve these modifications lacked certain factors that are needed to ensure high-quality data: randomization, controls, and blinding. The review also found that many studies failed to report data or complete data from all participants and that many were shorter than six months.
One reason for the lack of quality in the clinical trials may be the pressure on the FDA to speed the approval process. The agency is under a lot of pressure to fast track innovative devise or modifications that could prove life-changing for patients. With that pressure, the FDA may be willing to overlook shortcomings of studies and trials. The researchers who wrote the review stated that physicians need to be aware that there is actually very little data about these modified devices, and that this could cause harm to patients.
If a Device Does Harm a Patient, Legal Options are Limited
In addition to the risks that these devices pose to patients, because of the limitations of testing, patients who are harmed have few legal options because the devices were FDA-approved. A Supreme Court decision from 2008 ruled that companies are legally protected by FDA approval. This ruling is most likely to hold up in cases in which the approval studies were found to be flawed or limited, which means that patients who suffer as a result have no way of recovering damages.
The FDA’s response to flawed studies has been to try to implement better post-approval procedures, such as making it easier for doctors to report issues or failures of devices. No real changes have been made yet by the FDA. The researchers suggest that real change will only come if the public speaks out and Congress gets involved in making assurance of effectiveness and safety of devices routine, standard, and guaranteed.