Per Dan Mullen's request I am attaching my bio which describes my long involvement in the area of bar coding in healthcare. This on-going experience started during my tenure at the American Hospital Association when the first bar code standard was developed for the healthcare industry in 1983.

My presentation would emphasize the importance of understanding the business and operational issues surrounding bar code labeling first. The presentation would then discuss the existing approved health industry bar code standards and symbology options. The emphasis would be on how bar code symbology can be used as a tool in the management of products from manufacturing to actual use by patients. It would also point out that the existing bar code standards for healthcare describe a data structure for encoding information as well as provide several options for symbologies that can be used to encode this information. This approach allows a product labeler to select a bar code symbology that works in their particular manufacturing environment while being assured that it can be used through out the entire healthcare supply chain. It also means that as technology such as RFID evolves, a pharmaceutical manufacturer can use a different machine readable technology but encode the information using the same data structure. The consideration should be information/data first and then the appropriate (e.g. industry approved) way of encoding the information in a machine readable manner (e.g. bar code symbology, RFID tag, Smart Button, etc.)

Chair AIM Healthcare Committee

Karen Longe & Associates, Inc.

Lake Bluff, IL 60044

Dan Mullen will be submitting additional comments later today.

-----Original Message-----
From: Dan Mullen [mailto:dan@aimglobal.org]
Sent: Friday, July 12, 2002 12:18 AM
To: grossm@cder.fda.gov
Cc: Karen Longe (E-mail)
Subject: Speaker Request for July 26th Meeting

I would respectfully request some time on the podium for AIM's representative, Karen Longe, to present a brief presentation on:

1. Explanation of AIM - Technical/Standards Experience

2. General comments on the ability of bar code technology and other AIDC technologies

3. Symbology selection considerations

Karen is an experienced advisor and author for the healthcare community with regard to the evaluation and adoption of automatic identification and data capture technology. By copy of this email, I will ask her to forward her biographical information for your perusal.

Daniel P. Mullen

Interim CEO

AIM Inc. - The Association for Automatic Identification and Data Capture Technologies.

Email: dan@aimglobal.org <mailto:dan@aimglobal.org>

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