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Important Safety Information on Contaminated Heparin Coated Medical Devices - Notice to Hospitals

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Contact: Marketed Health Products Directorate (MHPD) Enquiries

NOTICE TO HOSPITALS
Health Canada Issued Important Safety Information on Contaminated Heparin Coated Medical Devices

June 11, 2008

Please distribute to the relevant Departments of Surgery, and other involved professional staff and post this NOTICE in your institution.

Health Canada was made aware of medical devices coated with contaminated heparin and wishes to inform healthcare professionals of relevant safety information.

Certain medical devices are coated with heparin, these 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 recommends the following:

The presence of a contaminant, oversulphated chondroitin sulphate (OSCS), in the active pharmaceutical ingredient of certain lots of heparin was communicated by Health Canada to Canadians on March 27, 2008. In the United States, the use of injectable heparin products contaminated with OSCS has been associated with an increase in reported serious allergic and anaphylactic reactions and possible lack of pharmaceutical effect. In Canada, there has been one report of allergic reaction related to the use of injectable heparin.

Health Canada is currently evaluating the situation in conjunction with all manufacturers of heparin coated medical devices. Health Canada has requested that manufacturers provide specific information with respect to the safety and quality of the heparin used to coat their devices. To date, there has been no evidence that the low levels of OSCS from heparin coated medical devices have caused adverse effects in exposed patients.

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.

Health Canada in conjunction with the medical device manufacturers will continue their investigation, and provide additional updates if needed when new safety information is available.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious or unexpected adverse incidents in patients treated with heparin coated medical devices should be reported to the marketing authorization holder or to Health Canada at the following address: