What is Medical Device Tracking?
Medical device tracking is monitoring and tracing medical devices throughout their lifecycle. The primary goal of medical device tracking is to enhance patient safety by facilitating the identification and recall of devices that may pose a risk to patients or fail to meet regulatory standards.
FDA Regulations and Requirements for Medical Device Tracking
21 CFR 820.60, 65, 86; ISO 13485:2016 section 7.5.8, 7.5.9
Overview of medical device tracking regulations
Manufacturers of medical devices are required to register their establishments with the FDA and list their devices commercially distributed in the United States. The FDA uses this information to maintain a database of medical devices and their manufacturers, facilitating traceability and regulatory oversight.
Obligations of persons involved in the tracking process
ENGINEERING AND QUALITY ASSURANCE (QA) are responsible for ensuring that all parts, processes, and products requiring traceability are assigned unique part and process numbers.
MANUFACTURING is responsible for ensuring that all parts and products requiring traceability are assigned unique lot numbers.
QUALITY ASSURANCE will maintain all records to ensure timely retrieval of traceability documentation.
Premarket notification submissions for tracking purposes
Before PreMarket Notification:
- UDI established
- DHR records
- Risk Management
Importance of tracking medical devices for patient safety
It is important to track medical devices in case the device has a non comforting or default and causes harm. These devices that were made in the same lot or batch need to be recalled, with traceability these devices can be effectively recalled back to the manufacturer.
Implementation of Medical Device Tracking System
This is done through having an Unique Device Identifier by the manufacturer.
Audit procedures for ensuring compliance with tracking regulations
During an audit, an auditor will ensure compliance by making sure that there is a UDI barcode. They will also ensure that according to the risk level of the device how many parts of the device are tracked.
Components of a Medical Device Tracking System
Device identifier requirements
The requirements include- unique, FDA standard format, labeling, submission to GUDID.
Role of Distributors in Medical Device Tracking
Distributors are required to ensure that manufacturers have a UDI and are registered with the GUDID.