As a medical device manufacturer, you make devices designed to improve quality-of-life and longevity. However, even with the best intentions and dedication to quality, complications can arise. These might be a malfunctioning part, design flaw, or simply a required device software update. Regardless of the issue, it is incumbent on you, the manufacturer, to address the problem.
You will potentially be required to communicate field notices, recalls, or warnings to mitigate potential harm. This is not only the right thing to do, but, in certain cases, is required by federal regulation and law. The tracking provisions of section 519(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 360i(e), were added in 1990 by the Safe Medical Devices Act (SMDA) and amended in 1997 by the Food and Drug Administration Modernization Act (FDAMA).
When a recall or field notice becomes necessary, there could be a significant negative impact to your brand as well as costly legal ramifications if not handled properly. The primary factors to the success of a recall are the speed of notification and accuracy of data pertaining to everyone associated to those devices.
Patients as well as purchasers of the device must be notified immediately to avoid potential adverse events—this would not be a good time to find that you lack all the pertinent information needed for reaching these parties.
Incomplete records of purchasers, providers, and patients make contacting these parties nearly impossible. Moreover, even if you do have contact information, it may be out-of-date. As a result, you face a serious risk of failing to notify many interested parties when initiating a recall.
Post-manufacture device tracking and the subsequent alerting is necessary throughout the device’s entire useful life, which can exceed 10 or 15 years. Rather than maintaining a costly, ineffective administrative process in-house, you can turn to Patient Alerting Logistics. We track all your devices, from manufacture through the useful life of the device.
When communication is necessary, our comprehensive services will handle the logistics. We maintain contact with your patients and keep their ever-changing information updated. We sustain device relationships to patients so you can immediately send out thousands or even millions of alerts within seconds, while also receiving acknowledgement of delivery. We provide a fully automated communication ecosystem for healthcare that solves this problem once and for all.