In an era of sophisticated information technology and rapid communication, the medical device community lags far behind other fields in its ability to alert patients about safety concerns.
For example, auto manufacturers and government regulators are able to quickly identify potential safety concerns by linking reports of crashes, malfunctions and defects with individual vehicle identification numbers (VINs).
They can then communicate recalls to affected customers by using their VIN. Manufacturers will issue notifications via mail or e-mail, or offer customers the ability to search the manufacturer’s website using their VIN.
In health care, drugs are tracked using a system established in the 1970s called National Drug Codes (NDCs). The 10-digit NDCs are assigned to all manufactured medications. The code tracks the vendor, product, and package code, which can then be captured in electronic health records and the FDA’s national database.
Unfortunately, we do not yet have a similar national system that can identify and communicate potential concerns for the tens of millions of patients with implantable devices such as pacemakers, glucose meters, artificial joints, and defibrillators.
Patients are bombarded by news stories about device recalls, but unless they have access to information about the exact make and model of their device, they have no way of knowing if they should be concerned. Since most medical device procedures take place in a hospital, a patient’s health care providers may also lack this critical, sometimes life-saving information.
The patient is then burdened with the task of tracking down their specialist or surgeon, in hopes that they documented the specific device information.
Clearly, the current health care information infrastructure does not yet support a robust surveillance system.
