The international standard that covers the use of ADMs in medical devices is ISO 22442-1 – Medical devices utilizing animal tissues and their derivatives. The standard focuses on minimizing transmission risk and provides guidelines to manufacturers. It describes procedures like animal inspections, long-term health monitoring, and transportation conditions for animal tissue. Countries like Canada and the United States use ISO 22442-1 as guidance to establish their regulatory requirements. They both require manufacturers to report data that ensures they’re conducting appropriate risk management.
In Canada, manufacturers can perform specific treatments on animal-derived materials, granting them reduced reporting obligations. These treatments effectively eliminate or inactivate pathogens, lowering the disease transmission risk. For instance, gelatin derived from bones can undergo alkaline or acid treatments, proven to eliminate pathogens and significantly minimize the associated risk.
The European Union has similar regulations on the use of animal-derived materials in medical devices, outlined in section 13 of EU (2017/745). It details how, among other requirements, animals must receive appropriate veterinary care based on the intended use of their tissues. Additionally, treatment of animal tissues to eliminate pathogens is typically required, except in cases where it would compromise the performance of the medical device.
When discussing the use of ADMs in electronics, it can be challenging to separate fact from fiction. Many unverified claims surround this topic, and many manufacturers choose not to disclose the use of ADMs in documents such as material declarations. However, whether for ethical reasons or to prevent the transmission of animal-borne diseases, manufacturers must be able to confidently assess their parts for animal-derived materials if the need arises.