By Mike Alkire
Electronic tracking systems have been commonplace in just about every industry since the 1970s. Virtually every product sold in America has a barcode on it, linking it to a central database so that the product can be easily identified. That is how manufacturers can recall products, from contaminated peanut butter to toxic dog food from store shelves within hours, and trace E. coli-infected spinach to the field in which it was grown.
Yet we have no such system for medical devices, including those that are implanted in patients to help keep them alive. It’s hard to believe that our country can track the location of dog food better than we can a sophisticated medical device.
This blind spot in healthcare prevents effective adverse event reporting. It’s a safety gap that is so severe that an Institute of Medicine (IOM) panel concluded in 2011 that our nation's ability to spot problems is so inadequate that it's "impossible to confidently draw broad conclusions about the safety and effectiveness of products that are on the market."
Even safe medical devices can pose dangerous health threats to patients if used together with other incompatible devices or machinery. For instance, certain devices can negatively interact with the magnetic fields in magnetic resonance imaging (MRI) machines, putting patients undergoing routine imaging procedures in life-threatening situations. Without an industry-wide tracking system for medical devices, healthcare providers cannot always identify device incompatibilities in time to avoid these preventable patient safety errors.
But we’re not only risking patient health, we’re also wasting billions of dollars in healthcare spending. As we continue to debate ways to reduce our national debt, the lack of a uniform tracking system for devices is creating inefficiencies in healthcare, adding $16 billion a year in unnecessary costs to our healthcare tab.
The situation becomes increasingly frustrating when you take into account the fact that solutions exist to solve this serious problem. A law requiring Unique Device Identification (UDI) -- standard numbering and tracking system for medical devices -- was passed by Congress in 2007 with broad support from hospitals, doctors, consumer groups and patient advocates. Yet more than five years later, no system is in place. It was only in July 2012 that the Food and Drug Administration (FDA) issued proposed regulations that would tell companies how to implement UDI. Adding insult to injury, the implementation process proposed in the UDI regulation are slow moving, and won't require the system to be fully operational for seven years.
Not only will UDI enable an efficient means to recall medical devices and track and trace products, but it will also enhance supply chain security; combat counterfeiting and diversion of products; help prevent product shortages; reduce medical errors through bedside scanning of products; and represent an easily accessible source of device information for patients and clinicians.
Today, in the event that a safety problem becomes clear, a non-existent tracking system means that recalls are usually ineffective. Recall notices go out to hospitals and healthcare facilities, but finding all the affected devices is next to impossible. Hospital materials managers have to comb through shelves of products to find a defective device. This takes tons of time, and is a manual, mistake-laden process.
In fact, of the 700 device recalls initiated a year, the Government Accountability Office (GAO) estimates that half the time (53 percent) companies are unable to remove all the faulty devices from the market, largely because there is no uniform way to track medical devices electronically in the supply chain.
For devices that have already been implanted, the problem is worse. Late last year, a defect was identified in one implantable medical device. It led to an FDA recall. Since then, a study was published showing that the device caused patient injuries and deaths. The outrage, patient advocates, doctors and hospitals, say, is that there are 79,000 other Americans out there with this device implanted in them. And there is no automated, uniform method of identifying who they are.
The author of the study summed it up well in an interview with Bloomberg. To draw his conclusions, he had to manually “find the reports, read them, and extract the data.” He went on to suggest that “because the reports are in narrative form and don’t always directly tie a device to a death or other adverse event, the work was laborious.”
If we had UDI and a better data tracking system, researchers would be able to mine a large scale data set to discover anomalies quicker. And they’d be able to present a compelling set of evidence to FDA, the manufacturer and others to warrant a recall. In this case, issues with the device were only found because researchers slogged through secondary resources.
Enabling healthcare providers to track medical devices electronically in the supply chain will improve the speed and accuracy of product recalls, as well as adverse event reporting and much more. In addition to the important safety benefits, automating the now manual process of tracking of medical devices is projected to save the healthcare industry billions each year from greatly improved efficiencies. These efficiencies gained and savings realized as a result of UDI will benefit all stakeholders, including patients, healthcare providers, distributors and manufacturers. FDA should move rapidly to both consider the proposed regulations and shorten the timeline for implementing the rules.
Mike Alkire is chief operating officer of the Premier healthcare alliance.