You may also need to upgrade your Flash Player.
You can upgrade your flash player by Clicking Here »
The U.S. Department of Health and Human Services (HHS) is seeking comments from public or private entities with an interest in biovigilance on how to identify risks and strategies for ensuring the safety of the U.S. supply of blood and blood components, tissues, cells and organs.
The sought-out comments are in response to a 2009 report titled “Biovigilance: Efforts to Bridge a Critical Gap in Patient Safety and Donor Health,” which recommended that HHS develop an action plan to support a national biovigilance program, including integration of systems within government and private sectors and steps to enhance mechanisms for surveillance.
The report defined the current state of U.S. biovigilance as “a comprehensive and integrated national patient safety program to collect, analyze and report on the outcomes of collection and transfusion and/or transplantation of blood components and derivatives, tissues, cells and organs.” However, this definition excludes vaccines, allergenic products and most recombinant human proteins. And, because biovigilance is an area of growing importance, its role should be expanded to:
Those interested in submitting comments should email them by June 9, 2011, at 4 p.m. EDT to email@example.com (attention Dr. Jerry Holmberg). Comments should be limited to no more than 10 pages. Holmberg is senior advisor for blood safety in the Office of the Assistant Secretary for Health in HHS Secretary Kathleen Sebelius’ office.