Making medical implants with animal material. Get ready, changes are on the horizon.

Posted on February 3, 2014 · Posted in FDA Regulatory Updates

When the word medical device is spoken, most people think of modern gadgets and body parts made with high end plastics and metals. The thought of sheep, bovine (cow), porcine (pig) or cervids (deer) materials don’t typically enter the mind.

Believe it or not, these animal materials are treating a wide variety of human conditions and extending the lives of many. Examples of devices containing animal materials include dental implants, tear duct plugs, heart valves, and even sutures. Although the use of such materials may be changing the way humans are treated, the use of these materials does not come without cost.

Animal materials do run the risk of containing such disease as transitional spongiform encephalopathy (TSEs). Examples include; mad cow disease (BSE) from bovine material and scrapie found in sheep materials.

To help mitigate the risks of materials containing such diseases, the FDA has issued new draft guidance for material and device manufacturers (other than IVD manufacturers) for proper processing, manufacturing and testing of these materials before they reach production facilities and the public. The guidance is also developed to help companies know about information that should be included with FDA submissions (510ks and PMAs).

FDA recommends that companies using any material derived from an animal with the possibility of carrying TSE infection to document and identify the following details (list is not exhaustive).

1. All materials & tissues used with the exact animal species identified.

2. The animal material country of origin.
Some countries are either known for holding animals that contain TSEs or are at higher risk for holding animals with TSEs.
Countries where BSE exists: Great Brittan, Switzerland & France.
High Risk Countries: Austria, Croatia, Denmark, Finland, Germany, Italy.

3. Maintain traceability records: monitoring the health of a herd and the health of specific animals from which tissues are collected.

4. Information concerning the long-term health of the herd (e.g., documented breeding history, animal traceability, absence of TSE disease, and standard vaccinations).

5. The frequency and type of veterinarian inspections.

6. Animal feed composition (ie: records of co-mingling of feeds, and labeling of animal feed composition).

7. Animal age at sacrifice.

8. Animal sacrifice methods that reduce the risk of cross contaminating non-TSE tissues with material from tissues that could contain TSE (along with USDA status of the slaughter house).

9. Tests performed (and release criteria) for permitting tissue to be further processed and/or combined with other tissues and device components (e.g., a Certificate of Analysis)

The FDA draft guidance can be read here.

Image courtesy of Health Innovations in Context; (September 21, 2011 by: mhivon
Category: Animals and Health)