Contaminated Heparin Coated Medical Devices Warning Issued in Canada
June 12th, 2008 amy
Health Canada yesterday issued a warning letter to hospital and medical staffers on safety information regarding medical devices coated with contaminated heparin.
Heparin coated medical devices include but are not limited to certain cardiovascular catheters, oxygenators, pumps, filters, blood reservoirs and blood collections tubes. In order to minimize the risk and complications associated with the use of heparin coated medical devices, Health Canada has recommended careful monitoring of patients during and immediately following the use of heparin coated medical devices for signs of allergy or anaphylactic reaction, gastrointestinal symptoms (nausea, vomiting, abdominal pain, and diarrhea), and/or unexplained hypotension.
Unfortunately, it is not possible to entirely rule out the fact that the presence of OSCS could affect the safety and effectiveness of the medical devices. It is therefore recommended that health care providers monitor their patients closely. Heparin-related adverse events may include, but are not limited to: allergic/anaphylactic reactions, unexplained hypotension, gastrointestinal symptoms, unexplained thrombocytopenia, inadequate or excessive anticoagulation/hemorrhage, unexplained or premature catheter/device thrombosis or acute dyspnea. In-vitro diagnostic tests could also give inaccurate results if heparin is used either as part of the assay or as part of the specimen collection, since the anticoagulation properties of heparin could be affected by the presence of the contaminant.
In the U.S., contaminated heparin has been linked to more than 80 deaths and hundreds of adverse reactions.
