Information

September 2003

Tutoplast Dura mater

Health Canada is the national authority that regulates the safety, efficacy and quality of therapeutic products (such as medical devices) used in Canada. It derives its statutory authority over therapeutic products from the Food and Drugs Act and Regulations.

Tutoplast Dura mater is a medical device that was available in Canada between January 1982 and April 2002 for use in various surgical treatments, including neurosurgery.

The term "medical device" covers a wide range of products used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Some examples include pacemakers, artificial heart valves, hip implants, synthetic skin, medical laboratory diagnostic instruments, test kits for diagnosis and contraceptive devices.

The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) at Health Canada is the national authority that monitors and evaluates the safety, effectiveness and quality of diagnostic and therapeutic medical devices in Canada. The Medical Devices Bureau enforces the Medical Devices Regulations, which aim to address to the extent possible, the safety, effectiveness and quality of medical devices in Canada. This is done through a combination of pre-market review, post-approval surveillance and quality systems in the manufacturing process.

In Canada, certain medical devices must have a Medical Device Licence before they can be sold. To determine which ones need a Licence, all medical devices have been categorized based on the risk associated with their use. This approach means that all medical devices are grouped into four classes with Class I devices presenting the lowest potential risk (e.g. a thermometer) and Class IV devices presenting the greatest potential risk (e.g. pacemakers).

Prior to selling a medical device in Canada, manufacturers of Class II, III and IV devices must obtain a Medical Device Licence. Although Class I devices do not require a Licence, they are monitored through Establishment Licences.

What is Tutoplast dura mater?

Dura mater is a tissue that covers and protects the brain and spinal cord. Commercially processed dura mater, obtained from human donors, has been used in the surgical treatment of many conditions in Canada since the 1970s.

Tutoplast Dura manufactured before 1992 was processed with a less concentrated disinfectant solution than material manufactured after October 1992. The disinfectant used initially, which was in accordance with what was known regarding prion diseases at the time, was a ten times weaker solution of sodium hydroxide than was used starting in 1992.

Processed dura mater is regulated as a class IV medical device. Tutoplast Dura (manufactured by Tutogen Medical GmbH of Germany) was first sold in Canada in January, 1982.

The April 2001, edition of "Neurology" published details of the first case of classical Creutzfeldt-Jakob Disease (CJD) associated with the use of Tutoplast Dura.

Following the publication of this news, Health Canada took action to obtain further information on the current surgical need for the use of Tutoplast Dura in Canada. It wrote to orthopaedic, neurosurgical and otolaryngological professional associations seeking advice on the importance to their members of the continued availability of Tutoplast dura mater. The Canadian Neurosurgical Society (CNSS) responded by conducting a survey of their members. Of those who replied, 61% supported discontinuing the use of donor dura mater.

On April 10, 2002, Health Canada suspended the medical device licence for Tutoplast Dura. The suspension means that the importation and sale of this medical device is no longer permitted in Canada.

Physicians were advised at the time to place any existing Tutoplast product in a secure location and immediately inform the manufacturer or distributor.

This action was based on the following considerations:

• Advice received through Health Canada's consultation with the Canadian Neurosurgical Society
• The recommendations of a leading Canadian expert on prion illness (Dr. Neil Cashman).
• The availability of adequate alternative materials that can be used instead of commercially-processed dura mater obtained from human donors.

The Canadian distributor of Tutoplast Dura conducted the recall of the product as per Health Canada's request.

The day following the suspension of the licence (April 11, 2002), Health Canada initiated an Import Alert with Canadian Customs.

Health Canada informed international partners of the suspension and recall action through the National Competent Authority Report system. Health Canada forwarded copies of the medical device suspension letter and of the Safety Advisory to the German authorities for information pertaining to the manufacturer Tutogen Medical GmbH in their jurisdiction.

Health Canada sent a letter to health care professionals on April 11, 2002, advising them:

• Not to use Tutoplast Dura manufactured by Tutogen Medical GmbH in any surgical procedure, as it is no longer licensed for sale in Canada.
• To place any remaining stocks of Tutoplast Dura in a secure location so that it can no longer be used and immediately inform the manufacturer or distributor who sold the product.

Individuals who want more information on the recall may leave a message on the Medical Devices Hotline at 1-800-267-9675. A Health Canada official will return the call.