Clinimetrics DeviceTracking™ System
The Clinimetrics DeviceTracking™ service offers effective
tracking of devices from the manufacturing facility, through the
distributor network and, ultimately, to the patient.
Federal Regulations* require that medical device manufacturers
obtain and maintain user information regarding life-sustaining
and life-supporting devices. The regulations specify tracking
requirements for devices used outside a user facility, that are
intended for use by a single patient over the life of the device,
and for devices implanted in a patient for more than one year.
The Clinimetrics DeviceTracking™ system was designed to
capture all of the required information, and to provide a system
that can track additional documentation over and above federal
requirements. Programming options are available if desired, to
collect additional information relating to device design, user
assessments, quality of life documentation, and device economic
parameters
DeviceTracking™ Elements:
- Manufacturer Registration
- Manufacturer registers device with Clinimetrics when
distributed through distributor network (device user facilities
and physician)
- Clinimetrics tracks expiration and reports status of device
- Distributor Network Registration of Device Distribution
or Implant
- Clinimetrics tracks the status of each device registered
by manufacturer
- Implant notification
- Updates are distributor network driven
- Six month updates are obtained by Clinimetrics from
the Distributor
- Optional direct patient update available
- Standard Reports
- Manufacturer registrations
- Distribution Network registration (practitioner implant)
- Device expirations not implanted
- Physician non-reports to include dates/results of follow-activity
- Six month or annual updates to Physician and if elected
Patient
- Explants
- Deaths
The Clinimetrics DeviceTracking™ service will ensure
that in the event of a recall or safety alert a tracked device
can be traced from the device manufacturing facility directly
to the patient.
* 21 CFR 821 and the Guidance for Industry and FDA Staff; Medical
Device Tracking
© COPYRIGHT CLINIMETRICS 2003. ALL RIGHTS RESERVED.
|
