For several years, the medical device industry in the USA has tracked its myriad products without any unified system. The lack of a unified system didn’t allow identification of device names, years of manufacturing, model, and other product information. The American Hospital Association (AHA) realized the immediate need for a unique device identification for all medical devices.
A wide range of benefits
With the FDA Amendment Act of 2007, Unique Device Identification or UDI system was introduced. The implementation of the UDI system offers a range of benefits to medical device manufacturers, healthcare providers, individual consumers, and the healthcare system as a whole. Its popularity has increased in its widespread use, and the benefits it renders.
Identifying faulty medical devices easily
The US Food and Drug Administration (FDA) reports thousands of defective medical devices every year. The FDA has to sort out the validity of the reports, which is a challenging task. The hospitals and other medical facilities submitting the reports don’t have specific information about the medical device like manufacturer, supplier, batch number, expiration date, and so on. This makes it difficult for the FDA to identify between single occurrences, and concerning patterns of the reported faulty devices.
This is where UDI comes to the rescue. with the presence of the UDI label, one can acquire vital details like batch numbers, expiration numbers, manufacturers and suppliers, and other product information. Today, when FDA receives reports on faulty medical devices, they can cross-refer unique identification numbers and reduce the time to detect the first faulty device and the action required.
Lesser medical device errors
When particular information is provided concerning the medical device, the unique device identification or barcode offers an easy way to healthcare individuals to precisely recognize the medical devices. This eliminates the confusion regarding the myriad medical device models and also saves time.
The proper USI labeling enables an extra verification before the medical device is used in a patient. There are also cases where UDI assures that the expiration date is displayed properly on the individual devices instead of on the medical device boxes used for shipping. The additional authentication aids in preventing any chances of devices getting mixed up and allowing unnecessary consequences.
Faster recalls on flawed devices
When a faulty medical device is identified, faster recalling is necessary. The longer the time is required by the FDA to identify the date and origin of the faulty devices, announce and take action, there is greater the chance of harming patients.
Without UDI, recalls would be a tedious and time-consuming matter starting from identifying the origin of the faulty device to locating the inventory shipping them. UDI quickly helps to determine whether there is a need to recall and discontinue the use of flawed devices.
The presence of a unique device identification is offering significant data for medical devices in real-time. This helps medical professionals and doctors to examine the information on device implantation and in some cases the surgeon who was involved in the surgery. UDI is proving to be of great use for the entire healthcare and medical industry.