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The Gray Sheet Article: "Former CDRH Director Put Problem Solving Before Data Monitoring"

Courtesy of FDC Reports

[Editor’s Note: To mark the FDA centennial and the 30-year anniversary of the Medical Device Amendments to the Food, Drug & Cosmetic Act, “The Gray Sheet” is conducting a series of interviews looking back at the history of device regulation. Recently we sat down with John Villforth, who served as CDRH Director from 1982-1990.]

When John Villforth visits the headquarters of the center he led for eight years, it almost seems as if he never left.

As he strolls through the building in Rockville, Md., chatting with employees old and new, it’s hard for an observer to believe he retired from FDA over 15 years ago.

In contrast to the agency’s current focus on post-market data collection, Villforth told “The Gray Sheet” that he tried to focus on identifying and fixing problems with device design during his tenure.

Villforth became director of the Bureau of Radiological Health in 1969 after years of experience in the military studying the effects of nuclear fallout. When the bureau - which became part of FDA in 1971 - merged with the agency’s medical device center in 1982, he took on the role as chief of the Center for Devices & Radiological Health. After retirement, Villforth served as president of the Food & Drug Law Institute and later founded the FDA Alumni Association.

Ironically, this longtime public health officer says he initially didn’t want to come to FDA. In 1970, some radiological health responsibilities were transferred to the just-established Environmental Protection Agency. Meanwhile, Villforth retained control of a bureau - with a mission to protect the public from unnecessary exposure to radiation from electronic products - that was up for grabs within HHS.

A big piece of the bureau’s mission involved educating the public and industry about radiation issues; Villforth was concerned that this agenda was not a good fit with FDA’s primary role as a regulator - “cops, if you will.” But he was not given a choice, and he soon began to appreciate how the two approaches could support each other. “I totally underestimated FDA folks,” Villforth says today. “There was a total willingness to appreciate what we were trying to do.”

Villforth says he was particularly focused on interacting with stakeholders to find practical solutions to issues. He is skeptical, in many cases, of heavy-handed enforcement and of over-analysis of data.

These traits are particularly relevant to his approach to postmarket oversight of medical devices - an endeavor increasingly in the limelight during recent years (1”The Gray Sheet” Jan. 23, 2006, p. 3).

A Practical Approach To Problem Solving

When he took the helm of the newly formed CDRH in 1982, device adverse event reporting was completely voluntary. It was not until 1984, with the publication of the Medical Device Reporting (MDR) regulation, that manufacturers were required to report to FDA any event in which a device might have caused death or serious injury. It was another six years until similar requirements were extended to user facilities.

Villforth and his staff received anecdotal information on adverse events from state inspectors, consumer complaints and professional societies. In many cases, CDRH scientists would see the need to correct a class of devices just by looking at design issues with a single device.

"I felt in my conscience that we were able to get the information that we needed,” Villforth says. Accordingto the former director, who has Masters degrees in sanitary engineering and physics, the mechanical nature of medical devices calls for a different regulatory approach than do pharmaceuticals.

“I think unlike the drug arena where you want to have a lot more of a statistical basis, many of the events in the medical device area could be identified and fixed without necessarily saying ‘well we haven’t collected all the data that’s necessary,’ he explains.

Because the safety and effectiveness of a medical device is typically dependent on how a patient or practitioner uses the product, simply talking to nurses or doctors about an issue will often provide an engineering solution to a broader device problem, he says.

Villforth places particular importance on “human factors” engineering, which deals with developing effective user interfaces.

Early in Villforth’s tenure at CDRH, his staff learned from speaking to some nurse professional organizations about a few instances of elderly patients being crushed to death by hospital beds. It turned out the problems were due to patients accidentally pushing readily accessible “up and down” buttons. The needed design change was clear and the center worked with bed manufacturers to implement the change. In the meantime, they put together a patient warning system for old bed designs and widely disseminated literature to hospitals.

To highlight the need for focusing on engineering solutions rather than taking a more forceful legal/regulatory approach, Villforth likes to cite the controversy surrounding anesthesia equipment that erupted in the mid-’80s.

In 1984 Congress held hearings to investigate the deaths of four patients who received fatal doses of anesthesia as a result of faulty O-rings in machines manufactured by Puritan Bennett (now a subsidiary of Tyco International).

During the hearings, Villforth says a leading clinician testified that anesthesia caused up to 10,000 deaths per year. But after hearing this startling figure lawmakers brought the questioning back to the four deaths associated with the Puritan Bennett device, rather than addressing the broader issue. “It blew my mind at the time,” he says.

When Villforth and his colleagues did look into the broader issue, they found that problems with anesthesia equipment were most often due to inconsistencies in design. The dials to control anesthesia and oxygen varied widely, he explained. “So from a human engineering standpoint the people in the heat of surgery may be tweaking the wrong dials and overdosing patients.”

Villforth says his staff then addressed the problem by issuing recommendations to physicians and manufacturers and launching educational initiatives.

Statistics Can Obscure Big Picture

When manufacturer adverse event reporting became mandatory in 1984, things changed; but by Villforth’s telling, not necessarily for the better.

He fully acknowledges that for certain types of devices, such as in vitro diagnostics, a broad base of statistical information is helpful to assess post-approval problems. But he is dubious about information gathering getting overly embroiled in “bureaucracy.”

"I must confess to a certain amount of distrust of bureaucrats, having been one,” Villforth says. “And the distrust comes from when you get a good idea, how do you draw the boundaries around that good idea?”

Immediately after the MDR regulation was enacted, the device center was inundated with reports, Villforth says. Companies, trying to avoid regulatory scrutiny, started to over-report events. This issue remains a problem today.

"I felt that while I was there until 1990 that we were never getting the mileage out of [the MDR program] because we never got the people to mine that data in some sort of intelligent prioritization that would help drive appropriateness. I never felt comfortable with it.”

Part of the problem with the system, Villforth says, was the fact that many device events do not easily fit into the three basic MDR adverse event categories: death, serious injuries and serious malfunctions.

Villforth is skeptical about a proposal by current CDRH Director Dan Schultz to develop a universal unique identifier system for devices to help in postmarket surveillance (2”The Gray Sheet” Feb. 6, 2006, p. 3). He worries that the further government intervention could add complications.

"It would always be good, in some cases, to have some of that data,” he says. “Would I trust that the people who would implement it wouldn’t over-prescribe it to the point that it would have a detriment? I don’t know.”

User Fees Foretold

During his tenure, Villforth did not experience one of the central issues in today’s premarket arena - user fees; however, user fees became inevitable as he approached retirement.

Although Villforth left FDA more than a decade before the Medical Device User Fee & Modernization Act was enacted, the fees were already a major topic of discussion during his years at the agency.

"There was an anxiety that if you had it, it would redirect your program,” Villforth says. "You’d be dancing to the beat of a different drummer with this and it could change your priorities.”

At the same time, CDRH, by the standards of some staff, did not receive the funds it needed to complete its mission. Furthermore, as the 1980s came to completion, the rate of premarket application reviews was slowing significantly.

In addition to funding issues, Villforth attributes the slower review times to an excessive level of congressional scrutiny during that period. In the late 1980s, Rep. John Dingell (D-Mich.) brought to light one of the biggest scandals in FDA history: several reviewers had repeatedly accepted bribes from generic drug makers in return for speedier approvals. Ultimately, five FDA officials were convicted of felonies.

After congressional investigators found corruption in the drug center, they began looking for wrongdoing in the agency as a whole. This came on the heels of a major recall of the Bjork-Shiley heart valve initiated by then-Pfizer subsidiary Shiley in 1986.

Congressional staffer Claudia Beville was assigned by the House Energy & Commerce/Oversight subcommittee to investigate the device center around this time (3”The Gray Sheet” June 13, 1994, p. 22). According to Villforth, she would actually walk up and down the halls of the center’s offices “basically reminding people what they found in the drugs area.” She would also make the point that the problem with the heart valve should have been identified before the product was approved for marketing.

Because of this heightened scrutiny, Villforth says, some reviewers worried that if they cleared a product too soon they might be suspected of corruption. This sentiment contributed to the slowdown in approvals that eventually led to an environment in which user fees were enacted.

More Than A Regulator

In the end, Villforth came to recognize the necessity for a regulator or “cop” approach in some situations. He paraphrases a former FDA official to make the point: “FDA is an educational organization...But we put slow learners in jail.”

However, he remains proud of his and the original radiological health bureau’s focus on bringing parties together to work out solutions. He believes they brought a new, lasting approach to CDRH that went beyond basic enforcement.

And it’s that conviction, he says, that makes him glad he went to FDA over 35 years ago.

- Matthew Perrone

Updated August 3, 2006