Medical devices containing animal tissue or material derived from such tissue are subject to compliance to the requirements of ISO 22442, especially the 1st and 2nd part.
ISO 22442‐1 provides requirements and guidance on risk management related to the hazards of these types of devices; it also outlines residual risk acceptability as defined in ISO 14971 and expected medical benefit compared to alternatives. These hazards may come from contamination by bacteria, viruses, agents that cause TSE, or anything else that may cause an undesirable pyrogenic, immunologic or toxicologic reaction.
Specifically, ISO 22442-2 deals with the controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin (other than IVDs). It applies where required by the risk management process as described in ISO 22442‐1.
For both Parts 1 and 2, the 2020 update was just released. In addition to updates to bibliography and various weblinks, the changes are as follows:
For ISO 22442-1:
- Controls on sourcing, collection and handling is difficult for animals that were not raised on a farm or that are wild caught. If compliance with ISO 22442-2 and ISO 22442-3 is not possible, exceptions should be documented and justified. If sourcing information is not possible to obtain, such as in the case of wild animals, the medical device manufacturer must demonstrate the level of inactivation of transmissible agents through a validated manufacturing process to achieve an acceptable level of risk.
- Clarification that source countries with ‘’minimal exposure’’ to BSE should be interpreted as countries with negligible exposure, on the Animal and Plant Health Inspection Service (APHIS) permitted list, and those with ‘’limited exposure to BSE’’ are interpreted the same way as countries with controlled BSE risk. Weblinks are provided for geographical BSE risk, the APHIS permitted list, and the members recognized as having negligible BSE risk.
- National legislation defines the process for removal of vertebrae, from the raw material of cattle of all ages, from countries with limited exposure to BSE.
- A new section defines the requirements for peptones – protein derivatives formed by the partial hydrolysis of proteins that are soluble in water. The risk is managed primarily by sourcing animals 30 months or younger, unless sourced from countries with controlled BSE risk. Animals must be deemed fit for human consumption by a veterinarian.
For ISO 22442-2:
- Cervids (Deer family) are now included in the list of animals from which sourcing of the animal material cannot be inspected by a veterinarian. The justification for this shall be documented and a relevant sampling plan provided. Manufacturers should apply relevant sections of the standard to such materials but may need to rely on other procedures which have been shown to be effective for risk reduction (see ISO 22442‐1).
- The enhanced expectation of using a validated biochemical IVD test (i.e. ELISA) for the presence of TSE in the source animal for direct use in medical devices that are not subject to a validated process (as outlined in ISO 22442-3) to reduce TSE risk.
- Clarification on atypical BSE types, especially in combination with intracranial applications;
- —When addressing the medical devices safety, sporadic atypical BSE should be addressed in the risk assessment.
- —To address the risk for transmission of the extremely rare, atypical BSE the age of the source cattle should considered as the important parameter. The extremely rare disease is restricted to animals typically older than 8 years. This shall be considered during risk analysis.
In summary, the largest impact of these changes is on medical devices that include bovine or TSE-susceptible species derived materials. It is important to note that the additions highlight the fact that if a manufacturer uses any bovine-derived animal material or derivative and wishes to streamline testing, sourcing and handling requirements with full risk management, it is encouraged to have such material be derived from young cattle, deemed fit for human consumption and preferably sourced from countries with acceptable levels of BSE risk as outlined by the guidance.
For devices containing bovine-derived animal materials that have intracranial applications, additional work will be required regarding atypical BSE types (H-type and L-type). Risk analysis for these atypical BSE types should be included in the animal tissue dossier.
If the medical device contains animal-derived materials from wild-caught or freely sourced (non-farmed) animals, as sourcing is not controlled, the level of inactivation of transmissible agents will need to be demonstrated through a validated manufacturing process to achieve an acceptable level of risk. This will create additional testing burdens on the device manufacturer.
At Qserve, we are prepared to assist with any changes or updates to your animal tissue documentation that may arise due to these new standard updates.