Healthcare Chronicles: The FDA's Take on Unique Device Identification
March 09, 2010
Healthcare Chronicles
by Jay Crowley
This report originally appeared in the February 2010 issue of DOTmed Business News
The FDA has for a few years now been developing proposed regulations for a Unique Device Identification (UDI) system, as mandated by Congress in 2007. In general, the system is intended to identify medical devices in an unambiguous and standardized way.
Once implemented, it could dramatically change the way medical devices and associated data are tracked and used to improve patient safety and medical practice.
Equivalents can be found in the retail space. For example, if you go to a grocery store and pick up a 12-ounce jar of Skippy Creamy Peanut Butter, there is a UPC code on it, and if you were to look it up in a database, it would unambiguously identify that jar of peanut butter and provide a tracking mechanism for those who are handling the product, from the FDA to the manufacturer, on down to the consumer. We want to create an analogous, standardized identification system for all medical devices, or at least most medical devices, and promote the use of data that can help organizations manage those products.
Here is where all sorts of benefits can accrue, but there are three in particular within the FDA's view of the world. One of these is recall management. We are concerned with finding recalled devices and doing everything we need to do up to removing them from use. We've done quite a bit of research and it's hard to know where these products are. We believe UDI, once implemented, can provide a means of effectively and efficiently managing these products.
Another related benefit is in post-market surveillance and adverse event reporting. We need to know specifically which device is associated with an adverse event in order to conduct the kind of analysis necessary to identify problems and take steps to resolve them.
Another driver is specifically around electronic health records. Medical devices that are implanted or used on a patient could be documented in a patient's electronic health record and drawn upon in epidemiological and comparative effectiveness research. In the overall industry, folks involved in supply chain management are very interested in UDI to improve ordering and distribution of products. We are hoping to publish the proposed UDI system regulations sometime in 2010, and a period of public comment would follow before we could determine a final ruling. We know we can't just spring this on device manufacturers. We would like to stagger implementation based on the device's premarket risk classification - class III being the riskiest. We think that UDI implementation for these could be required one year following the publishing of the final rule. Then, we envision Class II devices three years after publication of the final rule and class I devices would be rolled out within about five years. We are aware of the thin line we must walk in order to prevent any onerous cost-hikes for wholesale manufacturers of inexpensive devices. This is an important point that we are taking into consideration. UDI could also have a significant impact on the refurbishing and remanufacturing sector of the industry and how that is going to play out is yet to be understood. It could help the industry if we do this intelligently.
In general, the model is that the UDI numbers would remain for the life of that device, and remanufacturers significantly altering devices would probably have to apply their own UDI number in order to provide some transparency about how product X became product Y.
Another major impact on the industry would be in terms of emergency preparedness. The UDI system could potentially revolutionize the way we find and move products around in emergency situations. There is currently a lot of chaos that prevents us from being as efficient as we could be. These issues may not be particularly sexy, but if we can implement this system we would ultimately be serving the patient, wherever they may be.
Jay Crowley is senior advisor for patient safety for the Food and Drug Administration's Center for Devices and Radiological Health. He has been employed with the FDA for more than 20 years in a variety of positions, mostly in post-market and human factors research. Crowley has a bachelor's degree in engineering from Villanova University and a master's in engineering from the University of Maryland.
This report originally appeared in the February 2010 issue of DOTmed Business News
The FDA has for a few years now been developing proposed regulations for a Unique Device Identification (UDI) system, as mandated by Congress in 2007. In general, the system is intended to identify medical devices in an unambiguous and standardized way.
Once implemented, it could dramatically change the way medical devices and associated data are tracked and used to improve patient safety and medical practice.
Equivalents can be found in the retail space. For example, if you go to a grocery store and pick up a 12-ounce jar of Skippy Creamy Peanut Butter, there is a UPC code on it, and if you were to look it up in a database, it would unambiguously identify that jar of peanut butter and provide a tracking mechanism for those who are handling the product, from the FDA to the manufacturer, on down to the consumer. We want to create an analogous, standardized identification system for all medical devices, or at least most medical devices, and promote the use of data that can help organizations manage those products.
Here is where all sorts of benefits can accrue, but there are three in particular within the FDA's view of the world. One of these is recall management. We are concerned with finding recalled devices and doing everything we need to do up to removing them from use. We've done quite a bit of research and it's hard to know where these products are. We believe UDI, once implemented, can provide a means of effectively and efficiently managing these products.
Another related benefit is in post-market surveillance and adverse event reporting. We need to know specifically which device is associated with an adverse event in order to conduct the kind of analysis necessary to identify problems and take steps to resolve them.
Another driver is specifically around electronic health records. Medical devices that are implanted or used on a patient could be documented in a patient's electronic health record and drawn upon in epidemiological and comparative effectiveness research. In the overall industry, folks involved in supply chain management are very interested in UDI to improve ordering and distribution of products. We are hoping to publish the proposed UDI system regulations sometime in 2010, and a period of public comment would follow before we could determine a final ruling. We know we can't just spring this on device manufacturers. We would like to stagger implementation based on the device's premarket risk classification - class III being the riskiest. We think that UDI implementation for these could be required one year following the publishing of the final rule. Then, we envision Class II devices three years after publication of the final rule and class I devices would be rolled out within about five years. We are aware of the thin line we must walk in order to prevent any onerous cost-hikes for wholesale manufacturers of inexpensive devices. This is an important point that we are taking into consideration. UDI could also have a significant impact on the refurbishing and remanufacturing sector of the industry and how that is going to play out is yet to be understood. It could help the industry if we do this intelligently.
In general, the model is that the UDI numbers would remain for the life of that device, and remanufacturers significantly altering devices would probably have to apply their own UDI number in order to provide some transparency about how product X became product Y.
Another major impact on the industry would be in terms of emergency preparedness. The UDI system could potentially revolutionize the way we find and move products around in emergency situations. There is currently a lot of chaos that prevents us from being as efficient as we could be. These issues may not be particularly sexy, but if we can implement this system we would ultimately be serving the patient, wherever they may be.
Jay Crowley is senior advisor for patient safety for the Food and Drug Administration's Center for Devices and Radiological Health. He has been employed with the FDA for more than 20 years in a variety of positions, mostly in post-market and human factors research. Crowley has a bachelor's degree in engineering from Villanova University and a master's in engineering from the University of Maryland.
