Into the Vault: An FDA Historian’s Perspective

Originally Published MDDI August 2004

Device History



Heather Thompson

The history of medical devices began long before MD&DI's first issue in 1979. Actually, the history of medical devices is much longer—and perhaps more sinister—than a 25th anniversary issue could begin to cover. It is full of brilliant ideas, not-so-hot ideas, and ideas that never got off the ground. 

As part of her responsibilities as an FDA historian, Suzanne Junod, PhD, rummages around the agency's basement, so to speak, to unearth medical relics of years past. The information that Junod collects is from FDA's formative years, before current standards were in place and before modern technology played a role. 

Medical devices present unique challenges compared with prescription drugs and other healthcare products. What FDA really looks at when evaluating medical devices is the manufacturing of the product. Junod says the device industry is radically different from many other categories that fall under FDA jurisdiction. “A lot of devices are really engineered products,” she explains. “So advances often come in engineering, not in safety and efficacy.” In other words, while safety and efficacy are the agency's primary concerns, they may be a direct expression of the quality of engineering.

“FDA has not so much changed as matured” in its relationship with medical devices, says Junod, who is amassing historic medical devices in anticipation of FDA's 100th anniversary, in 2006. While FDA's mission has changed incrementally, the medical device industry has changed drastically. 

In the high-tech halcyon days following World War II, Junod explains, the medical device industry began producing complex, but ultimately useless, devices. “At the end of the war, there were all sorts of electronic components that the military had not used,” says Junod. Contraptions with minor medical value flooded the marketplace. “They used all these little components so they looked official. They looked like they should do something, but, of course, they didn't do anything. They were totally fraudulent.” Gadgets with sophisticated-sounding names, such as the bioelectrometer, were little more than transistors with dials and gauges. The devices were mainly used to impress patients. For example, a microdynameter was marketed for “up-to-the-minute scientific body analysis” and makers claimed it could find chemical changes in tissue that preceded symptoms of illness by measuring electrical currents generated by the body. Sometimes, Junod says, a patient wouldn't even know what a device was for or how it was treating the problem. 

Still, FDA oversaw these types of devices without engaging much controversy. Devices were regulated primarily by an amendment to the Food, Drug, and Cosmetic Act passed in 1938. The amendment was designed to control the sale of illegitimate products invented by quack doctors. That legislation enabled FDA to take care of simple problems and remove blatantly fraudulent devices. However, the agency did not have the resources to keep up with rapid technological changes.

Along Comes Regulation

As technological advancements came to the medical device industry, Junod explains, FDA had to learn how to meet new challenges. The advent of implantables, such as heart valves and pacemakers, represented real progress in the use of modern technology for medical devices, but they also carried greater risks. “They were legitimate,” says Junod, “but they were not always meeting quality standards from an 
engineering standpoint.” FDA needed a way to gauge engineering standards to ensure the devices worked consistently and properly. 

Another impetus for regulation and reform came from controversy and public outcry. The Dalkon Shield was a birth-control device that gained 
popularity in the early 1970s but had several design flaws that presented a danger to its users. The device was marketed for prescription use and resulted in several lawsuits. The Dalkon Shield controversy created lasting reservations about the use of certain medical devices that are still part of the public consciousness. Fortunately, it also demonstrated to FDA the dangers of under-reporting problem cases and inaccurate claims made by manufacturers. 

In response to engineering flaws and controversial devices, Congress passed the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act. The amendments required companies to demonstrate the safety of certain medical devices before they could be put on the market. Good manufacturing practices were also published and put into practice by 1978. 

Even after the 1976 amendments, safety problems remained. Some devices, such as silicone implants, were “grandfathered in under the law,” Junod says, “and it took a while to look backwards and see what had caused a problem.”

Junod emphasizes that developing regulations to govern the medical device industry was an impromptu process. “When [FDA started implementing the 1976 amendments], we didn't have a bunch of specialists in the device area. We had the radiological health people from NIH, and then we had some early engineers that had some experience, but [the experts] basically created themselves.” 

Gadgets and Gizmos

Many of the devices in the FDA vault are whimsical or laughable compared with today's sophisticated standards. It's important, however, not to dismiss these items as foolishness. The treasures found by Junod are reflections of a culture dedicated to the invention of gadgets and gizmos that bordered on magical. Those early days were essential building blocks to the technology that has proved to be truly extraordinary, changing the way we view technology, the way we think of health, and the way we live. Both FDA and MD&DI thrive on the urge to look at the history of medicine and take a lesson from the past. 

Copyright ©2004 Medical Device & Diagnostic Industry