Posted: May 18, 2005
Addenda: May 20, 2005
Links Updated: July 13, 2011
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Addenda: May 20, 2005
Links Updated: July 13, 2011
A transfusion medicine physician in New England reports that his hospital is migrating from a "home-grown" blood bank information system to a commercial system for which the FDA has issued a 'Substantially Equivalent 510(k) Device Information' notification. He adds that their home-grown system used a format for their blood product unit numbers that cannot be used with their new information system. Thus, in order to "import" historical unit information into their new system, they need to convert old unit numbers into new unit numbers. The inquiring New Englander is concerned about compliance implications of reassigning unit numbers to historical units, and he would like to know how other institutions that have changed information systems have dealt with this issue. He reports that he reviewed the information in Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application but could not find a clear answer to his question in this document.
ADDENDA May 20, 2005
The following comments have been received.
1. A transfusion medicine physician at a hospital in one of the five boroughs of New York reports that in their experience there are two issues that need to be considered when embarking on a conversion of unit information for the purpose of switching from a home-grown to commercial computer system:
For archiving transfusion recipient transfusion histories, the information needed would include the kind of components that a patient received, a converted unique identifier for each component that the patient received, and the date and (perhaps) time each component was issued. For the aforementioned purpose a converted unit number should not be problematic, provided the converted unit number can be traced back to the original unit number.
For the purpose of tracing specific units to specific recipients based on an ID code provided by the supplier (as in recalls, lookback, etc), a change from an original to a converted identifier could present a challenge. One possible solution might be to create a freestanding database (using MS Access or some other program) of all transfusion info