Businesses that deal in any way with the manufacture, distribution, sale, or end-use of implantable medical devices will want to keep close track of new legislation just introduced into the United States Senate. The bill, introduced by three Democrats and one Republican, has been titled the Ensuring Save Medical Devices for Patients Act. It would require that such devices carry identifiers that are individually unique so that the devices could be tracked and managed more effectively.
According to the bill, the FDA will have to issue final rules by the end of 2012 that would allow implantable medical devices to be "tracked through the distribution chain and once they are being used with patients" by means of their unique identifiers. The intent of the legislation is to make it more feasible to find out which patients need to be informed of a recall. This can happen when devices are determined to be defective or harmful in some way. According to the senators who introduced the legislation, almost 5,000 people in the United States died in 2009 because of medical devices that turned out to be defective or harmful.
The FDA has previously indicated that "A unique device identification system will help reduce medical errors; will allow the FDA, the healthcare community, and the industry to more rapidly review and organize adverse event reports; identify problems relating to a particular device…. and thereby allow for more rapid, effective corrective actions."
The IT infrastructure needed to track medical devices by their identifiers in any phase of the supply chain may not be in place already at all businesses that will need it. As the legislation moves through Congress, such businesses should consider working with an IT consulting firm that can offer them timely advice about the issues involved.