Medical devices are essential for the treatment of many conditions, improving length of life as well as quality of life. However, post-market surveillance of these medical devices is significantly more difficult than tracking the performance of pharmaceuticals due to the wide variation in devices. For example, medical devices can be either permanently implanted or temporarily attached to patients and may include different drugs or emit radiation. The U.S. Food Drug Administration (FDA) is establishing a unique device identification (UDI) system to adequately identify medical devices through their distribution and use. This system was created to make it easier to locate devices wherever they may be in the supply chain and requires manufacturers and distributors to label either the medical device or its packaging with a unique number that can be understood by humans and a machine (for example, a barcode). By inputting the unique number or scanning the barcode, health care providers will be able to retrieve basic data about the medical device such as its serial number, its lot number, and its manufacture and expiration dates.
UDIs allow the FDA to access device data and also streamlines device monitoring. Because they allow for more accurate reporting, it is much easier to identify and correct problems more quickly. This improves safety tracking and ensures that recalls are dealt with more efficiently. UDIs also have potential to help identify dangerous devices more quickly before they cause harm to patients through post market surveillance. Device performance is evaluated over time and can also be leveraged to back up the approval of new devices or new uses of devices that are currently on the market. UDIs can also improve cost saving strategies. According to the Health and Human Services' inspector general, the Centers for Medicare & Medicaid Services (CMS) can't track how much recalled and defective medical devices cost Medicare because of a lack of medical device information on health insurance claims forms. UDIs could reduce Medicare costs by helping to identify failed devices more quickly and reducing medical errors.
However, the benefits of UDIs can only be fully recognized if manufacturers, distributors, payers, providers, healthcare systems, and other stakeholders that play key roles in the lifecycle of a medical device adopt them. Strides will need to be made to incorporate UDIs into health information. Currently, most hospitals do not have the technology or the infrastructure to support the use of UDIs and are unable to upgrade their out of date systems because these changes are often too costly. While most manufacturers are compliant with the new code requirements, the majority of hospitals lack the capacity to record these IDs in patient records. Hospitals use thousands of medical devices so keeping close track of these devices requires sophisticated inventory management software that simply isn't available to all healthcare facilities. Without clinical implementation, UDIs are very limited in utility to improve patient care.
UDIs have the potential to create better care and better knowledge of how medical devices work from a population health perspective. While the FDA is working on laying the foundations of the system, implementation and integration are critical. The pressing issue at hand now is whether or not healthcare facilities will have the means to adopt the system once it has been built. While potential solutions to slow adoption include FDA funding of the development of Electronic Health Records that are capable of recording UDIs, it is more important that the FDA create demand and convince providers that having this information technology readily available will dramatically improve their patient care.