GUDID Tracking System

With the release of a new FDA regulation, implanted devices are to be tracked by device, lot code, patient, body location, and implant date, plus a date if explanted as well. Biopsy marking clips, self-absorbing markers, chips and seeds are all included. Many of the devices have a 60 digit alpha numeric coding system.

PenRad has prepared a Patient Device tracking module to collect implanted devices.

During a biopsy or localization procedure, the GUDID information is collected for each device implanted.
GUDID information that is entered is included in the narrative report, fulfilling another regulation component.

For facilities not using PenRad’s narrative reports, GUDID data is catalogued via the Devices Implanted button located on the Patient Maintenance screen. The user then selects the procedure type that populates the implant date, enters the location, and enters the device type and GUDID #. If a device is removed, for example; by lumpectomy, the explant date can be captured.

Click to enlarge

During narrative report generation, a location list is auto created where marker or seed is referenced (left image), then only GUDID # needed (bottom left image).

For compliance with new regulation, PenRad added administrative report FDA GUDID Device Implants (bottom right image).

 

 

Click to enlarge

Click to enlarge

 

 

 

 

 

 

 

 

 

This report facilitates custom searching capabilities for recalled devices or devices of concern, by manufactures, by lot numbers, and by serial numbers for patient identification.

When the FDA readies a national database for GUDID data, this data can be submitted via this report, allowing FDA to contact responsible parties for concerns and resolution.

Interested in one-on-one training or a refresher? This insures your facility is incorporating all the latest technology, thus maximizing efficiency and economics. Give us a call at 763-475-3388.

Recommendation for product development?
sales@penrad.com | 763.475.3388

© 2019 PenRad Technologies, Inc. 730-23-00411 AA

Start typing and press Enter to search