My experience with medical devices goes all the way back to the pre solid-state days of vacuum tubes and hand wired circuits. Back then, the typical equipment warranty was for one year. Today, despite quantum improvements in design, manufacturing techniques, and quality assurance methodologies that have all contributed to high levels of reliability, the typical warranty for medical device manufacturers is still one year. This is outrageous!
If automobile manufacturers can guarantee their new cars for three to five years, medical device manufacturers should at least be able to do the same. Just think about it, a typical automobile has more than 5,000 moving parts all working under constantly changing stresses and temperatures. When we contrast the environment for automobiles with that of bedside monitors, we find that we may drive autos in icy sub-zero weather or in intense desert heat. We drive them on high-speed super highways, or stop and go city traffic. We encounter potholes, rain, snow, ice, and sleet – the worst possible conditions. Medical devices, on the other hand, have very few moving parts. We always operate them in comfortably heated rooms with relatively low humidity. They are seldom moved, and are never subjected to rain, sleet, snow and potholes. Given the lack of moving parts and the ideal environmental conditions, medical devices should have a warranty period at least as long, if not much longer, than automobiles.
Why then do medical devices have such a short warranty period? Is it simply because manufacturers can get away with it? Is it because we do not challenge them? Is it because if they offered four or five year warranties they could not sell us lucrative maintenance agreements? Modern manufacturers have managed to achieve significant improvements in equipment reliability. There is no reasonable justification for them to offer the same one-year warranties that they offered sixty years ago in the days of vacuum tubes and hand wired circuits.
I know of a few hospitals where the Biomedical Engineering Department has taken the initiative and worked with their Purchasing Departments to negotiate much longer warranty periods when they buy new equipment. I have also seen situations where some manufacturers have agreed to provide free lifetime replacement parts for devices, and I am aware of one major infusion pump manufacturer who extended coverage to all labor and materials for the lifetime of their pumps. If the Biomedical Engineering Departments in these few hospitals were able to work with their purchasing departments to negotiate extended warranties, all Biomedical Engineering Departments should be able to do this.
The key to getting started is to make a carefully planned presentation to the persons responsible for your capital equipment purchasing. In your presentation, discuss the changes in equipment design and manufacturing processes over the years that have led to improvements in reliability. Talk about the differences between automobile and medical device warranty periods and be certain to emphasize the vast differences in conditions of use between the two. Also, make certain that your purchasing staff understands that they are not simply purchasing an extended warranty, but you are asking to have the warranty period extended at no extra charge. Most importantly, do not discuss the possibility of an extended warranty period with any salespeople until after you have negotiated the price. Otherwise, the salesperson will attempt include the costs of the added warranty period to the sales price.
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