FDA Updates Animal Tissues Guidance With Specific Recommendations on BSE

Devicemakers using material from animals that could carry transmissible spongiform encephalopathies should document the absence of TSE disease and standard vaccinations, such as live modified viruses, that the animal received, an updated FDA guidance says.

The draft guidance, released Jan. 23, is intended to replace a 1998 guidance on the avoidance of infectious diseases when animal tissue is used in medical devices. The updated version pays special attention to bovine spongiform encephalopathy, or “mad cow” disease, which is particularly problematic due to its long incubation time and the lack of a screening test that can be used on live animals.

Besides needing to document the absence of TSE, devicemakers using any material from cattle, sheep, goats and cervids such as deer and elk should record:

• The frequency and type of veterinarian inspections;
• Animal feed composition;
• Animal age at sacrifice;
• Animal sacrifice methods that reduce the risk of cross-contaminating non-TSE tissues with material from tissues that could contain TSE;
• Specifics of the pre- and/or postmortem inspections; and
• Tests performed for permitting tissue to be further processed and/or combined with other tissues and device components.

Devicemakers must also document whether any potentially TSE-infected material may have been processed in their facilities and the steps taken to prevent cross-contamination. The lifespan of TSE on surfaces is unknown and there are knowledge gaps in understanding how to remove it, the FDA says.

To assist in lowering the risk of BSE and other diseases, manufacturers should improve their knowledge of animal husbandry, the draft guidance adds. The current guidance primarily addresses geographic factors.

For materials sourced from all types of animals, devicemakers should document the species and the animal’s age, the tissues used, the animal’s country of origin and residence, methods for monitoring the health of the herd and the health of the individual animal and methods for transporting the animal tissue.

Regulatory submissions should also describe:

• Test methods and release criteria;
• Quarantine procedures for tissues until they have met or failed the release criteria;
• Test methods and acceptance criteria for in-process and final product bioburden or sterility;
• Methods for facility decontamination/sterilization; and
• Procedures for maintaining records of these activities.

Devicemakers should demonstrate and validate their procedures for equipment cleaning, decontamination and sterilization and document the results, the guidance says. And they should determine if their processing and sterilization techniques can inactivate and remove viruses.

“Viral inactivation data are often obtained by determining the amount of virus in the unprocessed source material before and after exposure to production and sterilization processes,” the guidance says. “You may determine the extent to which viruses are inactivated using scaled down versions of the specific production and sterilization methods . . . using appropriate model viruses.”

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