In this fifth and final installment of our series on defective medical device issues, we are discussing the lack of a national device registry in the United States. Despite calls from various advocacy groups and some preliminary efforts at the federal level, the U.S. still lacks a central repository for information about medical devices that are currently (or have previously been) on the market. This is a glaring deficiency, and it is one that presents various challenges for patients and health care providers who are seeking complete information about the safety and performance of a medical device. National device registries are utilized in countries such as the United Kingdom and Australia and have been instrumental in identifying safety issues with several hip implant products that have been recalled over the last decade. National device registries also greatly simplify the ability to monitor patients long-term following implantation of a medical device, which is important to identify potential safety issues as well as evaluating medical device performance.
Without a National Device Registry, Patients and Health Care Providers Do Not Have Access to the Information They Need
There are a number of challenges to implementing a national device registry in the United States. First of all, not all health information regarding patients is maintained by a single source, as is often the case in countries with socialized medicine. Also, manufacturers do not generally maintain a master log of patient names and contact information when devices are implanted, and that information is often buried in written medical and billing records and is not necessarily even known by the surgeon and certainly not the patient. This historic failure to maintain records relating to patients has led to patients not being timely notified of product recalls.
Manufacturers also contend that a national device registry would be very costly, although those arguments carry less weight as more medical records are maintained in electronic databases. Progress, albeit slow, has been made in establishing a nationwide medical device registry for the Veteran’s Administration medical system (in partnership with the FDA and the Centers for Medicare and Medicaid) which should allow for timely notification of safety recalls, tracking of medical device performance and other metrics, and improving the healthcare provided to veterans and their families.
Device registry data are often utilized to show long-term performance of a device against competing products. Manufacturers are critical of this data, however, as they contend (at least when the data is unfavorable) that medical devices fail for a number of reasons (other than the existence of a product defect) and that it is unfair to assess the performance of devices without greater controls of variables, such as can best be determined in a clinical study. Unfortunately, once a medical device is approved through the Premarket Approval process or cleared for marketing through the FDA 510k clearance, there is little incentive for a manufacturer to conduct any studies that might shed light on performance or safety issues with a product. Also, most of the information that is provided to the surgeons choosing these devices for their patients come from sales representatives and marketing departments that are far more focused on sales than spotlighting safety or device performance issues.
A National Device Registry Would Help Health Care Providers Make Informed Decisions and Protect Patients from Avoidable Risks
To be clear, there is some information available. The FDA maintains several medical device databases, and it also publishes information about medical device recalls. However, none of these resources are entirely comprehensive, and medical providers and patients looking for information need to know specifically where to look in order to find the relevant device information. Even then, differing standards mean that the details they are trying to find will often be missing.
In summary, there are several issues that create avoidable risks when it comes to implantable medical devices. Manufacturers can and should do more, and the federal regulatory structure has significant room for improvement as well. Unfortunately, patients who are injured by defective devices and their families bear the brunt of these shortcomings. Those who are injured and suffering deserve better, and taking legal action is an important step toward achieving better results.
Contact Searcy Denney | A Florida Product Liability and Mass Tort Law Firm
Our firm represents individuals and families in Florida and nationwide in product liability and mass tort litigation involving defective implantable medical devices. If you would like to speak with an attorney about filing a claim, please call 800-220-7006 or submit your case online to schedule a free initial consultation.
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