At a half-day breakout session on the AAMI Medical Device Software Standard, the HIMA Conformance Assessment Tool, UL 1998, the FDA Off-the-shelf software guidance, and other software standards and policy initiatives for the medical device industry was presented as part of the annual AAMI International Standards Conference. FDA and several industry speakers participated. John Murray,...Read More

St. Joseph’s Hospital and Medical Center Blood Bank 3/16/00″…6. Inadequate computer security in that employees have access to functions they are not qualified to perform. For example, Technical Assistants (TA) have access to the Blood Order Processing function, Blood Label Check function and Blood Product Testing function, although they are not qualified to perform the...Read More