FDA’s Center for Devices and Radiological Health (CDRH) is concerned about the safety and effectiveness of medical devices that may be affected by heparin contaminated with oversulfated chondroitin sulfate (OSCS), and the possible effects the contaminant may have on the accuracy of in-vitro diagnostic (IVD) assays. In order to minimize the risks associated with use of this product, CDRH is providing recommendations to physicians and healthcare providers to avoid use whenever possible of products containing, coated with or affected by heparin found to be contaminated with OSCS.
1. What adverse reactions could contaminated heparin in medical devices cause in patients?
Based on experiences with injectable drug products, the contaminated heparin could be associated with various clinical events including severe allergic reactions, gastrointestinal symptoms (nausea, vomiting, abdominal pain, and diarrhea) and/or very low blood pressure. Although it is also possible that contaminated heparin may cause inaccurate results of in-vitro diagnostic tests (IVDs) that utilize heparin either as part of the assay or as part of the specimen collection, to date no testing problems have been reported. Because clinical care decisions might be based on inaccurate test results, laboratories and clinicians should continue to follow usual quality control practices to assure that tests generated are reliable.
2. Have heparin-related adverse events been reported from the use of any medical devices?
FDA’s Center for Devices and Radiological Health (CDRH) has been reviewing the reports in its post-market database for heparin-related adverse events with medical devices. CDRH has received 97 reports for adverse events associated with heparin-containing devices that occurred between January 1, 2008 and May 14, 2008. These include 11 deaths and 86 non-fatal events. The majority (82%) of reports were associated with use of heparin lock flush solutions although reports have also been received for other medical devices including heparin-coated oxygenators and circuits used during cardiopulmonary bypass procedures and heparin-coated vascular grafts. Sixty-nine (69) of the 97 reports noted the presence of at least one allergic, gastrointestinal, and/or hypotensive symptom following use of the device.
FDA has not determined conclusively that contaminated heparin in medical devices caused these events. The fact that someone reports an adverse event does not necessarily mean that the medical device, or the heparin it contains, caused the event. Likewise, symptoms reported in association with a death are not necessarily the cause of the death. Many patients have other serious conditions, or may be receiving other therapies that could have contributed to the reported event. In addition, it is uncertain at this time whether the devices cited in the reports contained contaminated heparin or not.
CDRH will continue to analyze the adverse event reports it receives for heparin-containing medical devices and will update this information periodically.
3. Which medical devices and products might be affected by the heparin problem?
Some medical devices contain and/or are coated with heparin, and some IVDs are manufactured using heparin. CDRH and manufacturers are aware that some devices have been affected by the recent contamination. Products coated with, containing or manufactured with heparin that may be affected include:
4. Which in-vitro diagnostic devices (IVDs) might be affected by the heparin problem?
IVDs that may be affected include specialized devices such as tests that measure heparin’s effect in the body, and more general and widely used devices such as tubes containing heparin that are used to collect unclotted blood for various kinds of testing. Other examples include the following:
A list of other diagnostic products that may contain or be coated with heparin can be found at: http://www.fda.gov/cdrh/safety/heparin-device-list.html
5. Where can I find a list of recalled products?
A list of recalled products is available here: http://www.fda.gov/cder/drug/infopage/heparin/#recalls
6. What is FDA (CDRH) doing to ensure that medical devices containing heparin are not affected?
FDA (CDRH) has contacted manufacturers of medical devices and IVDs that contain heparin, or use heparin during the manufacturing process, to alert them that their products may potentially be affected by contaminated heparin. CDRH has requested that manufacturers take the following immediate actions premarket and post market:
7. What actions is FDA (CDRH) recommending for health care professionals?
8. What should consumers do if they believe they have an affected product?
9. Where can I find more information about the heparin problem?
Updated June 3, 2008
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