Los Angeles Times Article - Speedy FDA Approvals and Recalls

pkost

Trusted Information Resource
Re: LosAngeles Times Article - speedy FDA approvals & recalls

I don't know the figures and I don't have much US experience, but I'm willing to bet that the results haven't been normalised - I'm pretty sure there are a hell of a lot more 510k than ones that have undergone trials and therefore you are more likely to have recalls!

It reads to me like typical journalistic hyperbole


edit: for those that like to see the source here is the initial peer reviewed article http://archinte.ama-assn.org/cgi/content/full/archinternmed.2011.30 I'm now off to read it!
 

pkost

Trusted Information Resource
Re: LosAngeles Times Article - speedy FDA approvals & recalls

Upon reading the original article, I continue to hold the opinion that it is of rather poor quality. Not only does the study ignore the larger number of 510k applications, it does not detail what the recalls were for. Additionally and perhaps worse is the heavy bias that is apparent throughout the article.

If I had peer reviewed it, it would not have been published in its current form
 

pkost

Trusted Information Resource
Re: LosAngeles Times Article - speedy FDA approvals & recalls

3rd post (it may be apparent that this article annoys me!)

From the FDA website in Jan - Dec2010 a total of 2766 510k applications were made (I can't tell if these were approved or just received)

Similarly from a period of Dec 09 - Nov 10 a grand total of 48 original PMA submissions were made an additional 805 were supplements.

I think that says it all really.
 
Last edited:

Steve Prevette

Deming Disciple
Leader
Super Moderator
Re: LosAngeles Times Article - speedy FDA approvals & recalls

The article states:

More than 70% of the 113 recalled devices were cleared for market under a shorter Food and Drug Administration review because they were deemed similar to products already on the market, the study found.

Interestingly, the article does not state what percent of devices going through the "full" process were recalled. Without that information, we can't tell if the shorter process is any better or worse in this regard. I would not be surprised to find out that "more than 70%" of all devices go through the shortened process.
 
M

MIREGMGR

Re: LosAngeles Times Article - speedy FDA approvals & recalls

The author of the article didn't understand the study's numbers and is ignorant of the relevant issues and the nature of the processes involved.

The study itself is problematic...Zuckerman's "the process should be more stringent. (...) It doesn't have to be slower" self-evidently comes from someone that doesn't have any idea how to devise a workable system that will accomplish what she advocates for the required workload within the available budget.

Probably it was a mistake to change to a 510(k) clearance process for defibs. It's generally recognized that that decision was politically influenced by Congress and AdvaMed, to the benefit of companies and investors who wanted to get high-return products onto the market. The proper fix for that would be to much better insulate the FDA from Congressional and AdvaMed pressure, and formally include both RPN and risk severity by itself in the decision calculus for device clearance path.

The study's suggestion of a "IIb"-similar clearance path, with mandated patient studies, would add cost and time to the clearance process without adding determinative power as to the quality of products' engineering, component qualification and manufacturing after they enter the broad market. The great majority of device recalls of course are related to failures due to these issues, not to whether they deliver a useful benefit when well made and well applied.

Perhaps the article writer's research consisted of a cocktail party conversation.
 
M

Martin IT

Re: LosAngeles Times Article - speedy FDA approvals & recalls

It reads to me like typical journalistic hyperbole

Thanks to share with us your point of view. I agree. Very often journalist dosen't understand what they are speaking about and use it to produce some 'exagerated' news!
 

pkost

Trusted Information Resource
Re: LosAngeles Times Article - speedy FDA approvals & recalls

Thanks to share with us your point of view. I agree. Very often journalist dosen't understand what they are speaking about and use it to produce some 'exagerated' news!

Alas, although it may be the case that journalists frequently take technical information and interpret it into some hyperbole, it appears that in this case the blame cannot be laid solely at their door as the original source material is equally floored.

Although a journalist should verify their source for accuracy and quality, you should be able to rely on the quality and integrity of a peer reviewed article such as the one used as source here.

In the scientific and academic community there is much discussion on the effectiveness of current peer review methods and this article highlights the case perfectly. I have absolutely no idea how the article in the archives of internal medicine managed to get through the review process.
 
S

SHall

Re: LosAngeles Times Article - speedy FDA approvals & recalls

Nice to see a place to grouse about this. It would be just silly and frustrating to expect to discuss this in comments at LATimes, so another reason to be very grateful for Elsmar.

Not only does the study not standardize the recalls to the number of approvals, it makes no attempt to compare by volume of use. The most significant factors I see in the Cardiovascular category are the maturity of the technology and the conditions of use.

The Cardiovascular category is dominated by AEDs. I wonder what portion of AEDs are NEVER used? I looked up just one of the Welch Allyn recalls, (April 2005) and this is from the Reason for Recall:

"The malfunction occurs when impact to the exterior of the AED20 causes an internal electrical short resulting in the AED20 failing to analyze the patient’s heart function. When this malfunction occurs during clinical use, the AED20 displays a “Defib Comm” error message on the device display." (http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm063873.htm)

In simple terms... it was broken before they tried to use it, due to impact that caused a short. The device's fitness for use should mean that it can stand by in the intended environment... public, uncontrolled, and populated by [FONT=&quot]monkeys [/FONT] untrained and enthusiastic bystanders. However, I don't think that a clinical study would have detected some of these issues. The AED device is not being held to the "without this, the patient would wait for the EMT or depend on CPR" standard, it is being held to the "a different AED might have worked" standard. The AED stands out because it is a complex device, still early in its product evolution, and deployed rapidly in the name of the public good.

If other recalls of AEDs have similar causes, I'd suggest that the devices were not subjected to sufficient "simulated use" conditions in the validation of the designs. Perhaps leaving each sample in a busy public place with a large and vibrantly colored "Don't touch" sticker might have resulted in the sort of impact and rude handling that was not encountered in transit simulation and thermal cycling.:D

Compare this to stunningly large numbers of diagnostic and therapeutic catheter and balloon products in this segment which are used by cardiologists, radiologists, and electrophysiologists. Virtually 100% of these devices will be used, for their intended use, and in an environment that is dependable about reporting any issues. Whether approved through the 510(k) or PMA route, these seem to have represented a small number of serious recalls. In part, these devices get a pass. A device that fails to work is promptly detected by the trained user and replaced.
 
M

MIREGMGR

There have been several AED recall actions lately...I think the FDA is on the warpath regarding them.

I agree with your analysis...human clinical trials are the wrong solution to the problem and wouldn't have caught the AED issues, which have to do with the FDA's ability to judge whether the engineering process has designed all of the needed properties into the product, and whether the component qualification and manufacturing will actually build the product that was cleared.

Part of the problem in that regard, of course, is that the FDA doesn't have a rule or guidance that specifically addresses either ruggedness in general, or reliability on long-term standby. The FDA should be able to develop such guidances, but historically their process has been so ponderous that they can't.

In fairness to Zuckerman, she's regularly attended meetings and hearings and has forcefully argued in professional-journal papers and articles for making the FDA's risk definition at time of device classification and clearance path determination, the same definition that is used in determining whether a recall situation needs to be Class I...which certainly makes sense.

She's also long advocated a new concept for the 510(k) process, which goes off the track mostly when technology has advanced too far past what existed in 1976, yet the first market entrant of the device type in question arguably won't bear the costs and timeline required for the PMA process that other companies then could piggyback on via 510(k).

Unfortunately, the recent paper's argument for a "IIb" classification is the one that's simple enough for the lay world to semi-understand, so that's the one that everyone's reading about.
 
Top Bottom