Transparency over Heparin Coated Medical Devices
Hon David Cunliffe
Minister of Health
23 May 2008
Minister requires Transparency over Heparin Coated Medical Devices.
The Minister of Health David Cunliffe says he is satisfied that Medsafe is taking a consultative and transparent approach over health products coated with the contaminated blood thinner Heparin.
“The country’s clinical networks were all informed about a possible risk from injectable heparin in April and to the best of our knowledge there is none of the contaminated injectable Heparin in New Zealand. In addition, information about the possible use of contaminated heparin in the coatings of medical devices was distributed to DHBs last week,” said Mr Cunliffe.
“A Medsafe Action Team has identified that only 1 medical device that is in contact with patients contains contaminated heparin in its coating. This device is an oxygenator used in heart-lung surgery.” ”
“It is also important to remember that none of the contaminated blood thinner used in injections has been distributed in New Zealand and the concern here is over one Heparin coated product used in cardiothoracic surgery,” said Mr Cunliffe.
“Expert advice is that clinicians should use uncontaminated products where possible, Replacement supplies of this device are not expected for at least two months and DHBs are taking steps to obtain an alternative to the affected devices.”
“All the country’s DHBs and private surgical hospitals have been alerted to the contamination and the manufacturer of the affected device has already taken steps to inform DHBs to limit the use of the device.
www.fda.gov/cdrh/safety/heparin-device-list.html (FDA list of affected devices)
www.fda.gov/cdrh/safety/heparin-notice.html (FDA notice to medical device manufacturers and distributors)
Questions and Answers
What has the
heparin become contaminated with?
The heparin has become contaminated with oversulfated chondroitin sulfate.
What is oversulfated chondroitin sulfate?
Oversulfated chondroitin sulfate mimics heparin's qualities and is a modified form of chondroitin sulfate. Chondroitin sulfate is a naturally occurring substance made from animal cartilage and is often used in supplements to treat arthritic joints.
How does this affect its
safety and/or effectiveness of treatments?
Injectable heparin contaminated with this ingredient has caused severe adverse reactions (anaphylaxis and hypotension) and deaths internationally. Injectable heparin contaminated with oversulphated chondroitin sulfate has not been distributed for use in patients in New Zealand.
The risk to patients of the heparin coating on some medical devices is regarded as very low. There have been no reports in New Zealand or internationally of harm conclusively linked to use of a medical device containing the contaminated heparin.
In most cases the heparin found in medical devices is bound to the surface of the devices as a coating designed to stop blood clotting on the devices itself.
As only small amounts of heparin are used in these devices and the heparin coating is not designed to dissolve away, any contaminant that may be present would not be expected to be released into the patient’s bloodstream.
Are other heparin
products affected - for example heparin supplied in syringes
No, these are medicines and there no contaminated medicine has been supplied in New Zealand.
What is heparin used for in medical devices?
It is applied as a coating to prevent blood clotting. The coating designed to stick to the product and not to dissolve.
What alternatives, if any, are
There are other products from other manufacturers which may potentially be used, however it is not known whether the fittings on these devices are compatible with other devices needed to carry out surgery. Further research is being carried out to establish whether these products can be used.
How long until we get alternative supplies of contaminant-free heparin coated devices?
Indications from Medtronic, the manufacturers of the devices containing contaminated heparin are that it will be at least 2-3 months before stocks of medical devices containing uncontaminated heparin are available.
Who is Medsafe working with to ensure as
much as possible is known about the problem?
Medsafe is working with regulators around the world including the US Food and Drug Administration. A Technical Advisory Group is being convened to provide expert clinical advice on the issue.