Medical devices such as defibrillators and hip replacement systems can significantly improve a patient’s life. They may even save it. However, in recent years they have also become a source of concern as some are recalled because of failure. Others have actually caused harm. Thus, the Food and Drug Administration (FDA) which is charged with protecting the public’s health has implemented a new system for patient benefit.
In an effort to improve patient safety, the FDA)has launched a new labeling system: the unique device identification system (UDI). The goal is to identify problems with the devices sooner leading to faster recalls. This could prevent patients from suffering harm by a defective medical device.
How the UDI Works
The FDA will require these devices to have a code (similar to a barcode), either on the device itself, the packaging, or its label.
The unique code will include relevant information such as:
- expiration date;
- model;
- lot number; and
- version.
A database – the Global Unique Identification Database – will catalogue these identifiable medical devices. Consumers will have access to this information but no patient information is stored in the system. Class III medical devices are required to have a UDI within a year.
The first of the devices to be phased into this system are those considered high risk, Class III:
- artificial joints;
- implanted pacemakers;
- heart pumps;
- defibrillators; and
- heart valves.
Class II devices have three years in which to comply:
- joint prostheses;
- infusion pumps; and
- powered wheelchairs.
Devices considered low risk, where patient safety isn’t a concern, may be exempt from the rules. Class I devices not exempt from the rule have five years. If a medical device has caused serious illness or injury, contact an attorney. The law firm of Gacovino, Lake & Associates can help determine if there is a case. Call (800) 246-478 to set up your consultation.
