Statement on Intermountain Health Care, Inc
The Food and Drug Administration (FDA) has suspended the product and establishment licenses for Intermountain Health Care, Inc. (IHC) blood bank and collection facilities in Salt Lake City, and elsewhere in Utah, because of numerous serious violations of federal regulations designed to protect the safety of the nation's blood supply. This action prohibits IHC from collecting and manufacturing blood and blood products in interstate commerce. In addition, IHC agreed to suspend all of its operations related to the collection and manufacture of blood and blood components within the State of Utah.
Although FDA has no information at this time that these violations resulted in the use of infectious blood products, recent FDA inspections of several IHC facilities suggest the potential for unnecessary risks.
IHC's main facility is located in Salt Lake City, and the company operates four auxiliary locations in Utah. It supplies 80 percent of the blood for the state. To ensure an adequate supply of blood and blood products, the firm is cooperating with FDA to identify alternate sources of blood from other suppliers. In addition, FDA and IHC are recommending that elective surgery be postponed to conserve needed blood supplies for emergencies.
The U.S. blood supply is protected by a system of overlapping safeguards designed to prevent the release of unsuitable products The failure of an individual safeguard does not automatically translate into the release of unsafe products, but it may increase the potential risk.
April 26, 1997
Contact:
Lawrence Bachorik
(301) 827-0601