Feasibility assessment of eliminating the use of animals for training purposes

Medtronic designs, develops, manufactures, sells and services highly sophisticated medical devices to fulfill our mission of alleviating pain, restoring health and extending the lives of those patients who receive our products and therapies. Our primary responsibility to our customers and the patients they serve is to ensure that our products are safe and effective, and that our products are used correctly by the physicians and medical personnel who prescribe and install them. Given Medtronic’s reputation for quality and the consequences of incorrect usage of our products, our responsibility for ensuring proper training and correct usage of products is as much a part of our products as the devices themselves.

A vast array of training methods and materials have been developed and employed by Medtronic to provide a comprehensive understanding of the products and surgical techniques required for proper installation and usage. These methods and materials include instructive training sessions, computer simulations, cadavers, animate and artificial tissues, haptic feedback systems, visualization systems, and, in very limited and specific instances, live animals.

Over the years, Medtronic has made a significant investment in creating and developing the training tools and methods described above to substantially reduce the use of live animals for training purposes. Through these efforts, our use of animals for training purposes is but a small fraction of what it was just five years ago, and we remain committed to seeking additional alternatives to the use of animals.

Although Medtronic believes that continuing its proven efforts for reducing the use of animals for training purposes is both admirable and appropriate, Medtronic assessed the feasibility of complete elimination of the use of live animals for training purposes, while maintaining the appropriate levels of training for physicians, allied healthcare professionals and Medtronic personnel necessary for safe and effective installation and use of Medtronic products. Medtronic does not pursue the use of animals for the sole purpose of training sales staff.

To provide a comprehensive assessment of the feasibility of eliminating the use of animals for training purposes, both existing as well as potential future Medtronic products and therapies were considered. A multi-discipline, cross-functional assessment of the training programs of the small number of existing products requiring animals was undertaken. Similarly, an envisioning exercise was performed for potential future products and therapies. In these exercises, the animal training elements of current and future product training programs were evaluated on the following criteria:

1. Current status of potential alternative training methods and materials;
2. Feasibility of creating comparable alternative training methods;
3. Clinical requirements of the training (by target trainee type, for example, physicians, sales/field consultants, etc.);
4. Adequacy and effectiveness of training techniques; and
5. Implications and consequences of insufficient training.

Based on the criteria identified, the assessment team reached the following conclusions:

1. For current products which require the use of animals for training, there are currently no alternative means of training that are capable of addressing requirements identified for physicians and healthcare professionals. For training of sales/field personnel, the training requirements for several products may be able to be reduced.
2. Given the rapid expansion of innovation and technology in the medical device industry and attempting to envision the future products and therapies which the company may develop, it is possible that these products and therapies may require the use of animals for proper training. While the need for the use of animals will be evaluated at that time, complete elimination of this training option is currently neither feasible nor appropriate.
3. Medtronic’s current development of, and search for, alternative training methods is active. The results of these efforts are measurable and significant.

The assessment team recommends the following actions:

1. Continue the current practices and culture of seeking and developing alternative training methods, and further reducing the use of animals for training purposes.
2. Implement company-wide training for compliance with our animal use policy.

Medtronic has pioneered a number of advancements in eliminating animal use in medical device training. Medtronic believes that the goal of eliminating animal use is laudable, and continues to strive to reach this goal. However, because safe and effective use of medical technologies by healthcare professionals cannot always be adequately addressed through alternatives, it is not currently feasible to completely eliminate the use of animals for training.