510(k) Retooling-Part 1: Solution In Search of Problem

On August 3, the FDA released a 120-page report which included CDRH Director Jeff Shuren’s long-promised recommendations for overhauling the agency’s 510(k) device clearance program.

Will requiring more up front data from industry result in safer and more effective medical devices entering the market? Has the clearance program failed to protect public health?

The Hall Report

Ralph Hall, a Distinguished Professor and Practitioner at the University of Minnesota Law School tried to find out.

Ralph Hall/reilly.nd.eduProfessor Hall and research assistants reviewed 510(k) data over a five-year period (2005 to 2009) to determine if the FDA review system was permitting products onto the market without a reasonable assurance of safety and effectiveness.

Given the pressure on the FDA from agency whistleblowing scientists, consumer advocates, high-profile media cases like ReGen Biologics and aggressive Congressional leaders, the answer may surprise you.

99.78% Success Rate

Of the 19, 873 510(k) submissions made to the FDA over this five-year period, only .22% resulted in a Class 1 recall for premarket issues. Of those recalls, only two were for orthopedic implants.

In other words, the 510(k) clearance process works 99.78% of the time.

Here is what Professor Hall’s study showed:

39, 747

Average Submissions in 5 year time period

19, 873

Total 510(k) Recalls for 2005-2009

89

Total 510(k) Recalls for Pre-Market Issues for 2005-2009

43

Source:  Ralph Hall

Solution in Search of Problem

Are the 70 recommendations to overhaul the 510(k) program put out by the FDA a solution in search of a problem?

We’ll try to answer that question over the next few issues of OTW.

This is the first installment in a three-part series that looks at the effectiveness of the clearance program. The second installment will consider the recommendations offered by the FDA and their likely impact on the orthopedic industry and surgeons. Finally, in part three, we’ll focus on one of the recommendations already implemented by the agency: the establishment of the Center Science Council to be run by Bill Maisel, M.D., the newly appointed Deputy Director of the FDA’s Center for Devices and Radiological Health. 

This week we’re digging into Professor Hall’s research.

Research Methodology

Hall and his researchers classified an FDA clearance decision as “wrong” if the device was subsequently pulled off the market with a Class I recall. The researchers used Class I recalls instead of other measures (such as Adverse Events reports), because such recalls require mandatory reporting, are overseen by the FDA and permit researchers to separate review issues from non-review issues. Other measures may be inaccurate, unconnected to the reported event or anecdotal in nature.

Recalls occur because of one of three broad root causes:

• 
  

  Premarket Issues

The 510(k) clearance process is only relevant to premarket issues which deal with design problems and clinical data gaps before the product hits the market.

During the five-year period studied by Professor Hall, 116 Class I recalls were instituted.

There are 13 categories for a primary reason for a recall. Four are relevant to premarket concerns. Hall’s research revealed the following results within these four areas:

• 
  

  32 recalls for design issues

No Recalls Due to Clinical Risks

The evidence showed that NO RECALLS were identified as being related to newly discovered clinical risks. “This is a major difference compared to pharmaceutical recalls where human clinical trials are frequently used to identify clinical risk, ” said Hall.

As design/software issues are the major cause for recalls, Professor Hall says the best way to deal with those issues are through design controls. “The role of QSR (Quality System Regulations) is critical and could have substantial positive effects.”

Some physicians such as Rita Redberg, M.D., a cardiologist specializing in heart disease in women, testified in front of the Institute of Medicine (IOM) that human clinical studies should be required for any device implanted in humans. Hall debated Redberg in front of the IOM and believes she has a sympathetic audience on the panel.

This is important because the IOM will offer its own recommendations for a 510(k) overhaul next summer. Hall says the FDA may institute less controversial recommendations immediately from its own report and let the IOM tackle the more contentious issues. 

Would requiring additional human clinical studies have a significant impact on Class I safety recalls for cleared devices? “Our data indicates that it would have very little impact, ” says Hall.

“Industry and the FDA have done a great job of assuring safety. Given the need to balance safety and access and the inability to be all-knowing, can one expect more?” asked Hall.

It is clear that any recommendations to change the 510(k) process to provide greater assurance that unsafe implants are not going to go into people’s bodies is, in our opinion, a solution in search of a .22% problem.

Device Safety in Perspective

To put this .22% problem into perspective, Hall points out that 2.3% of Medicare hospitalizations result in a patient safety event; 2% to 4% of patients risk getting a hospital-acquired infection and 15% of patients over 65 receive unsafe prescriptions.

“If I were going into a hospital, I’d be worried about a lot of other things before I’d worry about the device that will be implanted in me, ” added Hall.

The professor should feel particularly safe if the device is an orthopedic device. Of the .22% of recalled cleared devices over the five-year study period, only 2.5% of those were for orthopedic devices. Infusion pumps and AED’s (automated external device) were the highest percentage recalls of the device group, garnering 17.8% and 10.2% of the total recalls. 

Given that some of the FDA recommendations include calls for more up front data and the creation of a new IIb device class, “PMA Light” as Hall agreed to call it, Hall says it would be hard to define a logical fourth class based on safety needs.

Physician Support

Professor Hall isn’t the only one who thinks the clearance review process works.

In a March 22, 2010, letter to FDA Commissioner Margaret Hamburg, M.D., the American Academy of Orthopaedic Surgeons (AAOS) and 12 other medical societies (including the North American Spine Society) wrote:

With very few exceptions, the 510(k) process provides a reliable pathway for safe and effective devices to enter the market and aid in the treatment of patients in need in a relatively short time. We believe this program unites a least burdensome approach to the regulation of medical devices, a transparent process for the review and clearance of medical devices, and the use of the most expeditious pathway for bringing new products to market. 

The AAOS exhorts the FDA to employ guidance documents and existing standards to further strengthen the 510(k) review process and transform it into a program that will continue to optimally serve the Agency, patients, physicians and the public into the future.

Untold Reasons for Overhaul

If the data clearly and irrefutably shows that the safety issues are a .22% concern, what is really driving the FDA’s push for revamping the 510(k) process?

Hall says that he sees deeper levels at work here. How is the FDA working internally? How is the overall risk/benefit equation of new products and devices being evaluated and what does it mean for the physician and his or her ability to offer their patients new and innovative products?

Next week we’ll dig into those questions. We’ll talk to Bill Mihalko, M.D., one of the AAOS representatives working with the FDA and Institute of Medicine to assure that orthopedic surgeons are heard and heeded.

Will the FDA recommendations result in patients getting faster access to life sustaining devices? Will it result in speeding innovation and keeping product development in the U.S.?

Click here to read the recommendations yourself. You’ve got until October 4, 2010 to let the agency know what you think.