As a manufacturer of medical devices, Medtronic is required to demonstrate the safety and efficacy of its products to global regulatory authorities before our products and technologies can be used in humans. Demonstrating device safety and efficacy often can only be achieved using animal models that are specifically prescribed by regulatory authorities. The responsible use of animals to ensure the safe and effective use of Medtronic’s products helps minimize risk to patients.
For more than 30 years, Medtronic has been a leader in pioneering innovative approaches to reduce the use of animals. It is our commitment and policy to treat laboratory animals humanely and with respect.
When the use of animals is necessary, Medtronic supports a replacement, reduction, and refinement strategy as outlined by Russell & Burch’s seminal 3R’s Principle.1,2
The Medtronic Global Animal Use Policy requires that the use of animals in research activities will ultimately contribute significantly to patient welfare. Research and development activities using animals are conducted only after the requisite approval from the Institutional Animal Care and Use Committee (IACUC). Medtronic requires all in vivo research to be conducted in accordance with the United States Animal Welfare Act (CFR Title 9, Chapter 1, Subchapter A). We adhere to the National Academy of Sciences Guide for the Care and Use of Laboratory Animals.2
Medtronic will not use non-human primates unless specifically required by a regulatory authority or where no other adequate in vivo model exists to sufficiently ensure patient safety or efficacy.
Our Mission to alleviate pain, restore health, and extend life requires the highest level of care for patients, which in turn demands comprehensive training for healthcare professionals to drive positive patient outcomes. When possible, inanimate methods are used for training, including developing novel simulation systems, using tissue models, and employing extensive didactic instruction.
Medtronic evaluates alternatives to the use of animals in physician training; however, there are instances where alternatives are not available or are not adequate. In these instances, Medtronic follows the same rigorous ethical and quality standards it follows for animals used in research and development. We comply with international guidelines stipulating the need for animal studies before any human exposure, as outlined in the World Medical Association's Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects.
Medtronic’s global animal use policy strictly prohibits the use of animals for sales personnel training.
Russell, W M. S, and Rex L. Burch. The Principles of Humane Experimental Technique. London: Methuen, 1959. Print.
National Research Council. 2011. Guide for the Care and Use of Laboratory Animals: Eighth Edition. Washington, DC: The National Academies Press.