On September 20th, Food and Drug Administration (FDA) published the draft guidance of new Global Unique Device Identification Database (GUDID) which is a major milestone in tracking medical devices and equipment. Medical devices are an important part of healthcare and are used in diagnosis as well as treatment. Some are used in hospitals and some are used in home/work environment and some are even implanted in the body
Now manufacturers will need to provide a unique identifier to FDA for each device that will uniquely identify that equipment.
Monitoring of the distribution and use of medical devices is major concern. It serves mainly two purposes, one is to make sure that its a genuine equipment and secondly it enables companies to recall the product easily if the need arises. Moreover if any adverse effects are reported on the equipment, they can be accurately traced back to the assembly/supplier level. The proposed regulation applies to all devices from a syringe to a pacemaker.
The proposed guidelines will allow manufacturers to supply the data using various mechanisms including HL7. You can find full draft of the proposed guidelines here.
This will require changes to B2B interfaces on Manufacturer side and every manufacturer will now need to submit that information to FDA. on the supply side, additional changes may be needed by manufacturers to upgrade their processes to be able to track parts differently.
In a nutshell, if you are a medical device manufacturer you should read the proposed draft and start working today so that you are able to meet FDA's deadline.