By: Alan Bennett
Making it real. It’s a dilemma we all face at the FDA when trying to explain many of our regulatory decisions. I face it every year when I give the "Regulation of Drugs and Medical Devices" lecture to upper level engineering students at Oregon State University.
These are the innovators and builders of the future. Many may develop or work on FDA regulated products during their careers. For most, I am the first, and may be the only, person who works at the FDA that they will ever meet. In the short time I have with them I feel the pressure of making them see the real world consequences to the public health of FDA’s regulatory actions.
Frankly I’ve always felt at some level that I have fallen short, but not this year. FDA’s involvement led to the recall of a product sold by a local firm in Oregon. A deep kneading shiatsu massage device, the "Shoulderflex," lead to the strangulation of a young woman. The instructions tell purchasers to lie down and rest their neck and shoulders over the device’s moving "kneading fingers" which provide a shiatsu massage. For the woman in Florida, her leather necklace became tangled in the moving "fingers." The necklace became tighter and tighter and she was strangled.
I obtained one of the devices and took it to the class to provide something tangible to illustrate the importance of engineering safety into medical products. It worked. The product is labeled “helps relieve muscle pain” which led to a discussion of the intended use of the product and why intended use is important to FDA’s jurisdiction over the product and how it is regulated.
The students took a close look at the product. They wanted to determine just how the “fingers” had grabbed the necklace. Almost immediately they began to talk about how safety could have been engineered into the device. They came up with several engineering solutions that they felt the company had missed. In the end they concluded that the woman’s death could have and should have been avoided.
These kinds of very personal stories are really not that difficult to find. As a Public Affairs Specialist in Portland, Oregon, I spend most of my time trying to make clear to diverse audiences exactly how FDA protects the public health. I share those stories and try to add one fact that I recently learned from Commissioner Hamburg: while the FDA regulates products that account for almost 25 cents of every dollar spent by consumers, taxpayers only contribute on average about 8 dollars a year to fund the Agency’s operations.
No matter what our resource level, I will keep talking to those students and future innovators at Oregon State and the public about the critical difference FDA makes to their health and well-being.
Alan Bennett is the Public Affairs Specialist in FDA’s Office of Regulatory Affairs, Portland, Oregon Office.