Medical Devices Today

Medical Device Reports To FDA Rose 77% In 2006

From the August 2007 issue of "The Silver Sheet"

The number of adverse events reported to FDA under the Medical Device Reporting (MDR) program rose last year to an all-time high, and agency staffers predict the trend will continue through 2007.

According to CDRH's Office of Surveillance and Biometrics (OSB), there were 325,742 reports of device-associated injuries, deaths and malfunctions in calendar year 2006 - a 77% increase over 2005, when 184,222 reports were filed.

"Just wait until 2007 is here. At this point we are anticipating a higher number [of MDRs] than last year," said Mary Brady, a deputy division director in OSB. "It all depends on how manufacturers are choosing to report, what they are reporting, and what they consider a reportable event."

Device Firms Struggle To Find Qualified Quality Assurance Professionals

CDRH Director Ulatowski Recommends Manufacturers Look For Certain Skills

From the July 2007 issue of "The Silver Sheet"

Finding well-trained, highly skilled professionals to fill a variety of quality assurance (QA) positions is proving increasingly difficult for a large number of medical device manufacturers, leading some to encourage people interested in the quality profession to make more use of specialized education and certification programs.

“It just seems like there aren’t enough people to fill the funnel. There’s a big gap,” says Don Middlebrook, VP of regulatory affairs and quality assurance at Pleasanton, Calif.-based Thoratec.

“If you look at the people who have the big [QA] jobs at the moment, they’re all baby boomers, and as they retire and the shifts occur and people are moving around and filling those jobs, it’s creating a vacuum at the lower level,” he says.

FDA Urges Device Manufacturers To Double-Check Their CAPA Systems

From the June 2007 issue of "The Silver Sheet"

Corrective and preventive action (CAPA) violations were cited in 87% of device warning letters last year, leading FDA to remind firms to fully investigate complaints, find the root cause of nonconforming products and document their CAPA activities.

According to statistics compiled by FDA, 69 out of 79 quality system warning letters sent to firms in calendar year 2006 included at least one CAPA observation.

"I can tell you that from reviewing inspection reports and writing up warning letters, pretty much everything that comes across my desk [includes] some sort of CAPA observation, " Melissa Torres, a biomedical engineer in CDRH's Office of Compliance, said at a recent Association for the Advancement of Medical Instrumentation (AAMI) seminar in Arlington, Va.

A Day In The Life Of CDRH Compliance Officer Cap Uldriks

From the June 2007 issue of "The Silver Sheet"

If Cap Uldriks could tell device firms two things about FDA, this would probably be first: Despite the bum rap it sometimes receives, the agency isn't a secretive organization that plots to make manufacturers' lives miserable by conducting unnecessary enforcement actions and issuing confusing documents.

"A lot of people think the agency is a monolithic, kind of dark thing that you can't penetrate, and we have all this thinking that goes on in soundproof rooms, and we're strategizing like they do at the Pentagon. No," says Uldriks, a consumer safety officer in CDRH's Office of Compliance.

"Once you figure out how we think and how we work, we're really very transparent," he said during a May 16 interview in his office in Rockville, Md.

Poor Supplier Control Causing Recalls, FDA Says; Contract Is Key To Success

From the May 2007 issue of "The Silver Sheet"

FDA is stressing the importance of complying with supplier controls in an effort to stem the rising number of recalls associated with vendor-provided products.

“We as an industry have to start focusing in on this,” Kim Trautman, FDA GMP/quality systems expert, told “The Silver Sheet.” As industry has “become more globalized,” she says, “it has started to outsource a lot more things. In doing so, it has now started to stretch its controls of those suppliers thinner and thinner.”

Trautman and other FDA officials are speaking at industry conferences and workshops to highlight vendor issues and remind companies of their responsibility to abide by the purchasing controls section of the Quality System Regulation.

New Usability Standard Aims To Help Firms Institute Human Factors Programs

From the April 2007 issue of "The Silver Sheet"

After decades of being relegated to an afterthought for some manufacturers, the concept of incorporating human factors into medical device development has finally gained some traction, several FDA officials say.

Usability is becoming such a widely accepted industry concern that it will soon be the subject of a brand new international standard that will give firms advice on how to build and maintain their own human factors programs.

Warning Letters Drop 24% In 2006; FDA Weighs Additional 'Corporate' Letters

From the March 2007 issue of "The Silver Sheet"

The volume of FDA quality system warning letters fell 24 percent in 2006, but not necessarily because the device industry has become more cognizant of Quality System Regulation requirements, FDA acknowledges. Rather, limited agency resources and a high investigator turnover rate could be to blame, officials say.

Device Recalls Reach New High In 2006 As FDA Works On Postmarket Issues

From the February 2007 issue of "The Silver Sheet"

Despite a 27 percent drop in class I device recalls in 2006, overall recalls logged by industry rose 5 percent to 616 – the highest number recorded since FDA issued its 1997 correction and removals regulation.

Draft Revision Of Risk Management Standard Gives Firms More Guidance

From the January 2007 issue of "The Silver Sheet"

Managers and employees responsible for risk management will soon gain updated guidance, thanks to a revision of ISO 14971, the voluntary international standard that explains how to manage medical device risk.