In April 2017, we provided comments to the FDA including additional important information intended to reinforce positions stated in our May 2016 comments. This information was intended to identify specific critical concerns important to both blood collection establishments and transfusion services and to alert FDA to adverse, unintended consequences expected to impact the blood supply and, ultimately, patient care. At the July 2018 Blood Products Advisory Committee (BPAC) meeting the agency discussed the scientific evidence and operational considerations of all available strategies to control the risk of bacterial contamination of platelets with 5-day and 7-day dating, including testing strategies using culture-based devices, nonculture-based rapid bacterial detection devices, and the implementation of pathogen reduction technology (PRT). We presented a statement at the meeting, to assist FDA in evaluating the multiplicity of effective approaches that are available to enhance the safety of the blood supply. The allowance for multiple approaches balances the need to improve safety with economic and logistical considerations that may influence decision-making in different institutions.
