FDA Needs Backbone in Device Approval, Experts Say
Posted: June 19, 2009
A panel of medical industry experts testified before a congressional hearing, telling Congress that FDA needs to add teeth to its approval process for medical devices to better protect patients. For example, Beth Israel Deaconess Medical Center cardiologist William Maisel, who also heads up the Medical Devices Safety Institute, said recalls for Medtronic pacemakers and leads raise questions about the FDA's ability to swiftly identify safety problems. "Additional consumer safeguards are needed. Only by demanding more-thorough, scientific device evaluations can FDA hope to reestablish consumer confidence in its ability to protect the public's health," Maisel told the panel, adding that the agency is too reliant on the device industry's ability to police itself. Marcia Crosse, health care director for GAO also spoke. She said that FDA seemed unable to thoroughly review medical devices before they are approved and continue to monitor them for problems once they are put into use. However, AdvaMed spoke up to defend the regulations that govern the agency. "FDA has comprehensive authority to regulate medical devices through a combination of premarket and postmarket controls," Stephen Ubl, president of AdvaMed, said in a release from the association. So, there are several questions being raised: 1. Is FDA doing its job? 2. Does the agency already have the regulatory weight to properly oversee medical device approvals? 3. If so, what are they lacking to properly do the job? 4. If not, what new legislation would solve the problem? What do you think?
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The commercial interests of

Submitted by Jason White (not verified) on June 23, 2009 - 5:58pm.

The commercial interests of industry and public safety are generally aligned more than some may believe. This is because commercial success generally requires a high degree of reliability and safety for the customers to buy the product.

With the current state of regulation, I have typically found that the actual margin of difference between the needs of the FDA to protect the public and the internal needs of my company to be relatively small.

Rather than being regulatory in nature, I have found that the common root causes in most of the recent cases to be some combination of the following:

1) Some deficiency in the laboratory test methods that were used to qualify the product.

It is extremely challenging, if not impossible, to fully replicate all the conditions of use within the human body across the full range of variables that exist.

One solution that has been proposed after the recent ICD lead failures is to mandate clinical studies to qualify new designs that are essentially equivalent to a previous design, in terms of medical use and interaction with the body.

I am opposed to this idea for 2 main reasons; 1) From an ethical perspective, I believe that human subject testing should be reserved to test questions that cannot be answered in any other way. This tends to mean that questions that are truly medical in nature should be the domain of clinical studies. 2) If the purpose of this testing is to prevent failures that occur at extremely low rates, it would require extremely large numbers of clinical implants to qualify a design improvement in this manner.

It should be possible to test a design better in a non-clinical setting. The initial failure to detect the problem was not due to it being impossible to do so, but some deficiency in the test method. I believe the appropriate course of action in this case is to: a) review the original testing to identify the deficiency that allowed the failure to be missed. b) Improve the test method to capture the failure mode. c) Repeat the testing with revised test method and an improved design d) submit the results for approval to market.

2) Another reason for failures in medical devices is some deficiency in capturing all the relevant manufacturing process variables during initial qualification of the product.

I believe that the appropriate solution is analagous to the one previously presented: a) refine the scope of the test plan to capture the variables that originally allowed the failure. b) improve the manufacturing controls to prevent the failure. c) demonstrate that the controls are effective. d) Submit the test results for approval to market.

I think the failures that are motivating this discussion are not linked to insufficient regulatory oversight. Rather, I believe it is the natural result of the process which minimizes risk, but does not (and cannot) totally eliminate it.

I believe that individuals on both sides typically have the public safety interests at heart, but lack all the information that is needed to create a perfect design with each new release of a product.

It would be ideal if controls to protect the public safety could be entirely proactive in nature and if all defects could be identified before any commercial use. However, I don't believe that this goal is realistic. Further, if this goal were to become the standard by revision of regulatory requirements, it would diminish the amount of benefits we as a society could hope to receive from new technology and innovation, because less products could make it to market.

I believe the regulatory system that we currently have is pretty well optimized to protect public safety. Most defects are currently identified proactively during the process of bringing a new product to market, and these defects do not get attention from the public, so they lack this perspective. Through the post-market surveillance system, low level defects are identified and the best corrective actions can be quickly implemented.

I think the focus should remain on the technical root causes of the problems, for which I think the usual suspects are presented above.

The FDA has neither the

Submitted by Alfred (not verified) on June 23, 2009 - 4:59pm.

The FDA has neither the manpower nor the expertise to properly test and screen the medical devices and drugs that it is asked to approve. Companies manipulate the data from clinical trials to put the best spin on it and many problems can only be spotted after a large number of tracked patients has been undergoing treatment with the new drug/device for years.
Either increase the FDA's funding by a factor of five (or more) or formalize the current largely self regulating nature of the industry.

FDA has the ability and the

Submitted by Dave Murray (not verified) on June 23, 2009 - 4:27pm.

FDA has the ability and the authority to safely regulate medical devices. The problem is polictical influence on the agency whether from lobbyists or government itself to make decisions that are politically popular but are not supported by science. If the agency could be protected from those influences much as the court system is they could better do their job.