Followup
DATE: February 7, 2000
TO: Interested Parties
FROM: Stephen D. Nightingale, M. D., Executive Secretary
Advisory Committee on Blood Safety and Availability
SUBJECT: Recommendations of Advisory Committee on January 27, 2000 - Followup 8/3/00
1. The Committee directs its staff to create
on the Committee's web site a list of key recommendations that the Committee
has made, in a format that would permit the public to see what progress has
been made in implementing each of these recommendations.
Done.
2. The experience of aviation and other industries
supports the use in all blood establishments (i. e., both blood and plasma
collection centers and facilities that provide transfusion services) of a
confidential, non-punitive system for the management of errors and accidents
not subject to regulatory requirements.
FDA is reexamining its current guidances
to determine if additional recommendations are needed to address investigation
and reporting of errors and accidents associated with blood and plasma treatments,
as suggested in the Quality Interagency Coordination Task Force Report.
FDA will publish a Final Rule on this
matter in the near future.
4. Quality assurance programs in all blood establishments
should capture, analyze, and respond to data on all deviations from established
procedures, as well as errors and accidents, independent of whether affected
blood units were distributed or caused adverse medical events.
Such reporting is understood to be a component
of Good Manufacturing Practice. FDA is considering recommending the MERS-TM
system developed by Dr. Harold Kaplan and colleagues, with grant support from
the National Heart, Lung, and Blood Institute, for management of transfusion
medicine error and accident investigation and reports.
5. FDA should extend its current error and accident
reporting requirements to apply to all blood establishments, including hospital
transfusion services, rather than only to licensed blood establishments.
This will be a component of the Final
Rule described in 3. above.
6. In order to facilitate improved transfusion
safety, for errors and accidents not subject to regulatory requirements, there
should be established outside the regulatory framework an effective, confidential,
non-punitive system for the accumulation, analysis, and dissemination of data
from all blood establishments' quality assurance programs.
Referred back to the Advisory Committee
for further consideration.
7. Industry and government should be encouraged
to facilitate the evaluation and implementation of devices that promise to
prevent misidentification of blood products and/or patients.
FDA is evaluating its application review
procedures for product and recipient identification devices to ensure efficient
handling of these applications.
SDN August 3, 2000
|
Download Reader 
