High-Risk Device Identification

High-risk device identification is an important step in ensuring that medical devices can be rapidly and accurately identified throughout their distribution and use. Medical error is often caused by confusion with similar devices, especially when they are used in different procedures and settings. Direct marking with UDIs, and submitting UDI data to the Global Unique Device Identification Database (GUDID) will help reduce such errors by making it much easier for health care providers to identify a device and obtain important descriptive information.

High-Risk Device Identification: The Secret to Protecting Your Website from Fraud

In addition, UDIs will make it possible for FDA to more quickly and precisely identify devices that are linked to adverse events, or otherwise of interest, leading to faster development of solutions. Using UDIs to identify devices will also allow the FDA to more rapidly and effectively focus any safety alerts or other communications, reducing the risk of confusion with similar devices and allowing patients to receive appropriate and timely responses to any concerns.

In a typical example, a cardiac guide catheter is used to assist with the delivery of other devices during a procedure. The guide catheter is for transient use and has a risk classification of IIa according to the Medicines (Database of Medical Devices) Regulations 2003. However, a patient may be given the same type of cardiac guide catheter for multiple procedures, potentially increasing the duration of its use and thereby increasing its risk classification to III. To avoid this potential increase in risk, the manufacturer of the guide catheter could change its design to make it more robust and thereby decrease its risk classification.