Marie Louise Corner - Comment

Document ID: FDA-2011-N-0090-0009
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: August 01 2012, at 12:00 AM Eastern Daylight Time
Date Posted: August 7 2012, at 12:00 AM Eastern Standard Time
Comment Start Date: July 10 2012, at 12:00 AM Eastern Standard Time
Comment Due Date: November 7 2012, at 11:59 PM Eastern Standard Time
Tracking Number: 810bc920
View Document:  View as format xml

This is comment on Proposed Rule

Unique Device Identification System

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The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to medical devices I feel form a healthcare point of view this will greatly enhance the ability of organisations to identify manage and control medical devices. Identification has always been a problem with regards to compiling a retrospective inventory in particular to contractors who would look to implement managed equipment services in healthcare. This service would allow for better equipment replacement programming and service development as well as supporting the resale market. The increased level of safety that would be delivered by this scheme would also present positive action to reduce pure risk and increase safety. I feel there may be resistance from some manufactures and some difficulties to overcome such as which devices will be required to be identified? Gloves are a medical device you would need millions of numbers to address the need for these this is why they are currently batched. Some reusable instruments such as surgical blade holders may have increased infection risks with the application of an identifier. All in all I feel this is a real ground breaking move forward

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