When Are 'Safe' Medical Devices Dangerous?

No product can be 100% safe, but yet FDA's mission with respect to medical technology is to ensure that devices are both safe and effective. Defining what exactly "safe" means, however, is no simple task.

Brian Buntz

Most of the criticism from patient advocates and some politicians concerning medical device industry or the FDA's clearance of them is that neither does enough to ensure the safety of medical technology--especially for controversial products such as, say, metal-on-metal hip implants, power morcellators, or duodenoscopes.

"Fundamentally, the question of 'how safe is safe' seems like one of the simplest questions concerning medical devices but it is perhaps one of the most difficult," says Mike Drues, president of Vascular Sciences (Boston), who will be giving two presentations at MD&M West in Anaheim. "Where do you draw the line and who decides?" he says. "Airplanes are relatively safe, but every once in awhile, one will fall out of the sky. How is that different than thalidomide, hip implants, or any drug or device that has become controversial?"

Imagine that the hypodermic syringe was a new product now, Drues says. "Would it get onto the market? One could think of a heck of a lot of harm that could be caused by using them improperly." But syringes are one of the most commonly used and important medical products ever developed.

In the end, it is simply difficult to determine at what point regulatory requirements are either so high they they discourage innovation or so low that devices are too dangerous, Drues says. "We could increase the regulatory burden in order to show that a product is safe, but as we continue to increase the burden, how many companies are going give up their product development efforts because the burden is too high?"

"It is one thing to measure how many people are harmed or killed by a medical device. On the other hand, how do we measure the number of people without access to a promising medical device or drug that is not on the market because the manufacturer decided it was just not worth commercializing?"

A classic example of a product that illustrates this conundrum is mechanical heart valve with a reproducible failure mode after it was in the patient for 18 to 24 years. "After seeing that data, Congress or FDA could instantly increase the regulatory burden, requiring testing it for 25 years," Drues says. "But if we did that, how many heart valves would be available?"

In the end, the question of how safe is safe is also an economic one. "Look at cars," Drues says. "We could design them that are virtually impossible to get into accidents. But we haven't really done that yet by and large, although some of the high-end cars are starting to offer crash avoidance technology," he adds. "The technology isn't new. But if we developed cars with crash-avoidance features 20 years ago, they might have cost $300,000."

"The flip side to the safety question is how many people can we afford to save today? Most people don't like to think about the monetary value of a human life, but the insurance companies do it all of the time," Drues says. "Medicine is a business--no question about it."