The following are answers to the most frequently asked questions (faq) regarding heparin contamination
- What adverse reactions could contaminated heparin cause in patients?
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, based on experiences with injectable drug products. Laboratories and clinicians should continue to follow usual quality control practices to assure that tests generated are reliable.
- What types of heparin-related side effects or adverse reactions have been reported?
The Food & Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has received 97 reports for adverse events occurring between Jan. 1 2008 and May 14, 2008 associated with heparin-containing devices. These reports include 11 deaths and 86 non-fatal events. Sixty-nine of the 97 reports noted the presence of at least one allergic, gastrointestinal and/or hypotensive symptom.
- What type of medical product or device may be affected by contaminated heparin?
Select medical devices either contain or are coated with heparin, while others are manufactured using heparin. Products or devices that are currently identified by the CDRH and manufacturers as affected by the recent heparin contamination include the following:
- Heparin lock flush solutions in vials and solutions in pre-filled syringes
- Devices used during cardiopulmonary bypass procedures (may include oxygenators, filters, reservoirs and cannulae)
- Catheters including vascular access catheters, drainage, retransfusion and thermodilution catheters and oximetry probes
- Vascular stents and grafts
- Assisted reproduction media devices
- In-Vitro Diagnostic (IVD) media and related devices
- Visit the FDA web site for a complete list of other medical devices that may contain or be coated with heparin
- Which IVDs may be affected by contaminated heparin?
Specialized devices including tests that measure heparin’s effect in the body, as well as more widely used devices for general purposes, including tubes containing heparin that are used to collect blood for testing, IVDs that are used to monitor heparin administered to patients, IVDs that use heparin as part of the device itself, and IVDs that rely on heparin in the manufacturing process.
- Is there a complete list of recalled products?
Yes. The FDA has a complete list of products affected by the heparin recall on its web site.
- What is the FDA / CDRH doing to ensure that medical devices using heparin are safe?
The FDA (CDRH) has alerted companies that manufacture medical devices and IVDs that contain heparin that their products may potentially be affected by contaminated heparin. Firms are advised to take the following steps to ensure their products are safe:
- Determine if any specific products manufactured or distributed may contain heparin and identify those products.
- Manufacturers or distributors of any products that do contain heparin or are manufactured with heparin should follow FDA recommended screening methods to ensure the safety of their products before releasing.
- Companies should immediately report any adverse reactions related to the use of heparin that have or may have caused or contributed to a death, serious injury or malfunctions that would be likely to cause or contribute to such.
- Put in place appropriate purchasing controls and acceptance procedures to enhance safety and effectiveness of devices prior to marketing.
- What can health care professionals do to help ensure patient safety?
Awareness of the potential for heparin contamination is key. Physicians should be alert to unexpected anaphylactic reactions in patients with devices or treatments using heparin and be prepared to treat these reactions appropriately; be alert for unexplained diagnostic results such as false positives or negatives; promptly report symptoms or problems believed to be associated with heparin; and contact the device manufacturer or the distributor for instructions about how to dispose of or replace devices that may contain contaminated heparin. Report possible heparin problems to the FDA’s MedWatch Adverse Event Reporting Program online or by phone at 1-800-FDA-1088. A reporting form also is available for download.
- What can consumers do if they believe they have an affected product?
Consumers – patients or caregivers – should make sure they have disposed of any recalled product, including heparin lock-flush solution. Your health care provider should be able to provide a replacement solution.Check the FDA list of recalled products. Also, contact your health care provider if you have any questions or concerns about whether or not your product or device may be affected by contaminated heparin.
Additional general information about the heparin problem can be found at the FDA heparin information site online.