2006N-0292 Unique Device Identification
FDA Comment Number : EC11
Submitter : Mr. Brian Vargo Date & Time: 08/22/2006 09:08:05
Organization : Mr. Brian Vargo
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
The availability of a standard system of identifying medical devices would be greatly beneficial to us in the Clinical Engineering/ Healthcare Technology Management field. We track each device with a unique tag, which is linked to a generic description, model number, manuf., ECRI codes, etc. The ECRI codes are the only reliable means of tracking types of equipment, say physiological monitors. Querying by other parameters we use could accidentally exclude certain units. The issue with ECRI codes is that these are often too encompassing. This can make it difficult to ensure preventative maintenances or plan strategic purchases and upgrades. Additionally, it is part of our long term plans to track equipment automatically, such as with RFID. A universal, standard identification system would be very beneficial in that regard.