(1998; 18 pages)
Human dura mater (freeze-dried) - restrictive measures
Germany. In order to minimize the risk of transmission of pathogens of spongiform encephalopathies (e.g. Creutzfeldt-Jakob disease), the Federal Institute for Drugs and Medical Devices has restricted the indications for medicinal products containing freeze-dried human dura mater "soft" as follows:
- in neurosurgery if autologous tissue is not available in sufficient quantities or not sufficiently stable, and when synthetic materials are not indicated.
- in paediatric surgery for omphalocele/gastroschisis or in tracheal stenosis when autologous tissue is not available in sufficient quantities, and when synthetic materials are not indicated.
The following individuals are excluded as donors for extraction of starting materials for the production of these medicines if the following criteria have not already been ascertained at the time of the production process:
• persons who developed a spongiform encephalopathy or symptoms of this type of disease.
• persons who died in a neurologic/psychiatric clinic.
• persons who are older than 50 years.
• recipients of a human organ/tissue transplant or extract except if no infective potential could be found for the respective organs/tissues according to the prevailing scientific knowledge.
• persons who had invasive central nervous system surgery.
• persons who had in their family a genetic form of spongiform encephalopathy (including familial Creutzfeldt-Jakob disease; Gerstmann-Sträussler-Scheinker syndrome, fatal familial insomnia), or if this possibility cannot be excluded; and
• those in whom a potential spongiform encephalopathy could not be excluded on the basis of neurohistological or other neuropathological tests, as well as tests for the detection of prion protein in the brain tissue, or other tests according to the prevailing scientific knowledge.
[See also Pharmaceuticals Newsletters Nos. 7&8, July&August 1997, No. 1, January 1996, and No. 3, March 1994]
Reference: Communication from the Federal Institute for Drugs and Medical Devices, Berlin, dated 30 December 1997.