| Comment Record|
Mrs. Deb Schue ||
2001-09-11 11:45:14 |
Altru Health System |
Health Professional |
| Comments for FDA General |
1. General Comments
DOCKET No. 97D-0318
1. Is it acceptable to implement directly to phase two by May 31, 2002? We are a small center and being able to do this would streamline the processes of SOP revision, Donor Record revision, and staff training.
2. We would also like to stream line the questions. We have a hard copy donor card that has maximized the space available. We would propose the following manner of questioning:
a. Have you visited or lived in the UK and/or Europe since 1980? (Establish when, where, how long, accept/defer *
according to SOP)
b. IF Yes to UK Travel: Did you receive any transfusion of blood, platelets, or plasma while there?
*Defer if 3 or more months cumulative in UK (1980-1996).
*Defer if any blood, platelet, or plasma transfusions received while in the UK.
*Defer if 6 or more months cumulative stationed in Belgium, Netherlands, or Germany (1980-1990).
*Defer if 6 or more months cumulative stationed in Spain, Portugal, Italy, Turkey or Greece (1980-1996).
*Defer if 5 or more years in BSE Risk Country(1980-Present).
Questions for clarification:
1. If the person was not associated with a military station in North/South Europe as described in the document, but they were in one of these countries for a cummulative total of 6 months...but less than 5 years....are they deferred or eligible?
2. Retrieval and Quarantine of previous units: Appears this is for in-date components only. That consignees should be
notified to retrieve and destroy these components.....Would these units also be reported to CBER through the Blood Product Deviation reporting process?
3. Recipient Tracing and Notification:
Is this section advising consignees of prior components (no longer in-dated) be notified...which units...as far back as records allow....?
In our case, we are a hospital based collection center and transfusion service. Since in many cases, we are both the distributor and the consignee. Who is responsible to determine if recipeint notification should occur? Is it the call of our Medical Director (aka responsible head) to determine if the recipient's physician should be notified.....or is it being recommended to notify the recipient's physician as the consignee and it is then his/her call as to notifying their patient?
Thank you in advance for clarification of these items.