Today, it's easier for public health officials to track down tainted spinach or contaminated dog food than it is to find a faulty medical device implanted in someone's body, helping to keep them alive.
That's because more than 40 years ago, the retail and grocery industries put bar codes and a consistent tracking system that links to a uniform numbering system in place for all products sold in stores. It's why we have price scanners, self-check-out lines, reliable information on inventory and a process for recalling products from the shelves. In fact, numbered bar codes have become so ubiquitous, most of us couldn't imagine buying something in a store without them.
But there is no such system in place for medical devices, including those implanted in patients. For all the bragging about having the most sophisticated medical technology in the world, it's a national embarrassment that we've yet to develop any standard way to track and monitor these devices once they enter the marketplace.
But solutions are out there.
More than five years ago, Congress recognized how backward the healthcare industry was and passed a law requiring a standard numbering and tracking system for medical devices, called Unique Device Identification. However, since the law was passed, the industry has dragged its feet and the Food and Drug Administration has only recently issued regulations that would tell companies how to implement UDI. Adding insult to injury, the UDI regulations are slow moving, and won't require the system to be fully operational for years.
The consequences of this glacial pace of action are dangerous and potentially deadly. Lack of a consistent tracking system prevents effective adverse event reporting, a safety gap that is so severe that an Institute of Medicine 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."
Just one recent example illustrates the point. Some readers may have recently read about a faulty pacemaker lead, which led to more than 20 deaths. What's gone unreported is that in a world without UDI, it's nothing short of a miracle that the problem was discovered at all. The only reason we know about this device is because one enterprising physician noticed abnormalities in his patients, and decided to pour through event reports on the off chance of finding a trend. His research was manual, slow and the records he had at his disposal were incomplete. Even now, it's impossible to quantify the overall failure rate of this pacemaker because the only available records are voluntarily reported and not definitively linked to the product.
But the problem is more pervasive than that. Even in the event that a safety problem becomes clear, a non-existent tracking system means that most device recalls are ineffective. In fact, of the 700 annual recalls, the Government Accountability Office estimates that over half the time (53 percent) companies are unable to remove all the faulty devices from the market, largely because there is no way to track medical devices in the supply chain.
In the case of this pacemaker lead, there are 79,000 other Americans out there with faulty defibrillators implanted in their hearts. So even though we know the pacemaker is faulty, we can't be sure that we’ve found and removed all these leads from the market.
UDI is the missing link. A consistent numbering and tracking system would enable providers to link specific devices to specific outcomes, thereby enhancing adverse event reporting and streamlining the process of analyzing data sets to identify safety concerns. Moreover, enabling healthcare providers to track medical devices electronically will improve the speed and accuracy of product recalls.
And if the patient safety benefits weren't enough persuasion, there's also compelling evidence to show that automating the now manual process of tracking of medical devices would save the healthcare industry approximately $16 billion each year from greatly improved efficiencies.
Although UDI will save lives and money, it will be years before the identifiers are widely in use because FDA has proposed an excessively long, multi-year timeline for implementation. So, instead of moving this essential technological enhancement forward, we continue to wait.
We can't afford more years of foot dragging before healthcare joins the 21st century with standard systems that are in place in almost every other aspect of daily life. The fact that we have a UDI rule represents progress. But given the strong chorus of voices requesting UDI, including repeated calls for action from hospitals, doctors, consumer groups and patient advocates, it's imperative that we move on this regulation quickly — not years from now. The costs of additional delays are just too high.
Mike Alkire is COO for the Premier healthcare alliance.
That's because more than 40 years ago, the retail and grocery industries put bar codes and a consistent tracking system that links to a uniform numbering system in place for all products sold in stores. It's why we have price scanners, self-check-out lines, reliable information on inventory and a process for recalling products from the shelves. In fact, numbered bar codes have become so ubiquitous, most of us couldn't imagine buying something in a store without them.
But there is no such system in place for medical devices, including those implanted in patients. For all the bragging about having the most sophisticated medical technology in the world, it's a national embarrassment that we've yet to develop any standard way to track and monitor these devices once they enter the marketplace.
But solutions are out there.
More than five years ago, Congress recognized how backward the healthcare industry was and passed a law requiring a standard numbering and tracking system for medical devices, called Unique Device Identification. However, since the law was passed, the industry has dragged its feet and the Food and Drug Administration has only recently issued regulations that would tell companies how to implement UDI. Adding insult to injury, the UDI regulations are slow moving, and won't require the system to be fully operational for years.
The consequences of this glacial pace of action are dangerous and potentially deadly. Lack of a consistent tracking system prevents effective adverse event reporting, a safety gap that is so severe that an Institute of Medicine 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."
Just one recent example illustrates the point. Some readers may have recently read about a faulty pacemaker lead, which led to more than 20 deaths. What's gone unreported is that in a world without UDI, it's nothing short of a miracle that the problem was discovered at all. The only reason we know about this device is because one enterprising physician noticed abnormalities in his patients, and decided to pour through event reports on the off chance of finding a trend. His research was manual, slow and the records he had at his disposal were incomplete. Even now, it's impossible to quantify the overall failure rate of this pacemaker because the only available records are voluntarily reported and not definitively linked to the product.
But the problem is more pervasive than that. Even in the event that a safety problem becomes clear, a non-existent tracking system means that most device recalls are ineffective. In fact, of the 700 annual recalls, the Government Accountability Office estimates that over half the time (53 percent) companies are unable to remove all the faulty devices from the market, largely because there is no way to track medical devices in the supply chain.
In the case of this pacemaker lead, there are 79,000 other Americans out there with faulty defibrillators implanted in their hearts. So even though we know the pacemaker is faulty, we can't be sure that we’ve found and removed all these leads from the market.
UDI is the missing link. A consistent numbering and tracking system would enable providers to link specific devices to specific outcomes, thereby enhancing adverse event reporting and streamlining the process of analyzing data sets to identify safety concerns. Moreover, enabling healthcare providers to track medical devices electronically will improve the speed and accuracy of product recalls.
And if the patient safety benefits weren't enough persuasion, there's also compelling evidence to show that automating the now manual process of tracking of medical devices would save the healthcare industry approximately $16 billion each year from greatly improved efficiencies.
Although UDI will save lives and money, it will be years before the identifiers are widely in use because FDA has proposed an excessively long, multi-year timeline for implementation. So, instead of moving this essential technological enhancement forward, we continue to wait.
We can't afford more years of foot dragging before healthcare joins the 21st century with standard systems that are in place in almost every other aspect of daily life. The fact that we have a UDI rule represents progress. But given the strong chorus of voices requesting UDI, including repeated calls for action from hospitals, doctors, consumer groups and patient advocates, it's imperative that we move on this regulation quickly — not years from now. The costs of additional delays are just too high.
Mike Alkire is COO for the Premier healthcare alliance.