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GUIDANCE DOCUMENT

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion Draft Guidance for Industry December 2018

Draft

Not for implementation. Contains non-binding recommendations.

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion

Docket Number:
FDA-2014-D-1814
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

We, FDA, are issuing this guidance document to provide blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets through the performance of pathogen reduction technology (PRT), or bacterial testing of platelets intended for transfusion. PRT is performed shortly after platelet collection by blood collection establishments. Bacterial testing encompasses initial testing (primary testing) of platelets by blood collection establishments, and subsequent retesting (secondary testing) prior to transfusion principally by transfusion services, but also by blood collection establishments. With the introduction of PRT, the recommendations for pathogen reduction, and those for secondary testing of previously cultured but not pathogen-reduced platelets, as described in the guidance, would provide for adequate control of the risk of bacterial contamination in these products. We are also providing recommendations to allow the use of secondary testing of platelets as the basis to extend the dating period of platelets when appropriately labeled bacterial detection devices and storage containers are used.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-1814.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave WO71-3128
Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010