Why the FDA can’t protect the public
BMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c4753 (Published 03 November 2010) Cite this as: BMJ 2010;341:c4753All rapid responses
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Lenzer and Brownlee (1) have highlighted the potential value for post
marketing surveillance. We would agree that this is a much neglected tool,
especially in the evaluation of medical devices (2). We would like to add
that such surveillance does not only apply to "complex" or novel devices,
such as those discussed; any new intervention is a potential candidate for
this type of surveillance.
The decision of the UK government in 2001 to replace all reusable
tonsillectomy instruments with single-use devices, in response to advice
from SEAC regarding the potential risk from vCJD, is a lesson in point.
Whilst these were not inherently complex devices, their introduction led
to wide spread adverse events, which were both device related and clinical
in nature. They were subsequently withdrawn and most surgeons in England
returned to reusable instruments. At the time, the root cause of the
failure was not understood and no mechanism existed to explore the reasons
for the failure. In Wales, we did not return to reusable instruments, but
instead tonsillectomy temporarily ceased prior to the introduction of
specified single use instruments, which were then surveyed in use (3).
A two-stage implementation process was used. First we established a
detailed, quality and safety driven instrument and supplier assessment
programme as part of a procurement and contracting process, and second we
created a national independent surgical instrument surveillance system for
all such single-use instruments. Both instrument performance and
complications rates were followed.
The product evaluation stage revealed instruments from some companies
that were unfit for purpose, despite being CE marked, and our supplier
audits revealed significant issues which included the misclassification of
devices. This had the (perhaps unintended) effect of removing them from
the scrutiny of Notified Bodies. It also appears that similar quality
problems are widespread with CE marked reusable surgical instruments (4).
These shortcomings suggest to us that there may be room for a reassessment
and modernisation of the regulatory and device accreditation process, with
perhaps a closer alignment of the regulatory process for medicines and
devices.
The surveillance system was key in the early stages in identifying
and correcting problems with some of the single-use instruments and has
subsequently enabled us to demonstrate that the product, when procured in
this way, was clinically safe (5).
Lenzer and Brownlee (1) raise the issue of poor denominator data, and
the need in this situation to rely on "signals" arising from those adverse
events that are appropriately reported. In our situation participation in
the surveillance system has been well over 90%, thus providing the
necessary denominator data, but of equal importance to us were the outcome
measures being surveyed. It is tempting to believe that a focus on adverse
clinical events alone is sufficient; this unfortunately makes for a very
blunt and potentially insensitive surveillance tool. The inclusion of
individual device behavior provides for a much more forensic approach. In
this situation the data may not only provide the explanation for a
failure, but also the route to a corrective solution and an improved or
safer device. It may also enable defective product to be identified and
removed before they are used on patients and can offer system wide,
focused early warning of potential problems. Furthermore, it may provide
the necessary evidence for large-scale intervention such as wholesale
product withdrawal.
To establish such comprehensive surveillance is not trivial. In our
case The Welsh Assembly Government provided essential strategic direction
and the initial funding, but the key to our success was the coordinated
inclusion of the main stake holders including the clinicians using the
product, device manufacturers, procurement and contracting expertise,
independent medical device experts, and epidemiological input from the
National Public Health Service in Wales.
The additional contribution from regulatory bodies in any future
similar work would provide the final assurance and authority required to
endorse and validate these efforts in the eyes of the public, clinicians,
the wider medical device community and healthcare policy makers. It would
also send appropriate signals to those members of the global medical
device industry who, in the current economic climate, may be under the
mistaken impression that the Health Service is only interested in saving
money at the expense of quality and patient safety.
1. Lenzer J, Brownlee S. Why the FDA can't protect the public. BMJ
2010;341:c4753.
2. Avorn J. Regulation of devices. BMJ 2010;341:c5730.
3. Tomkinson A, Phillips P, Scott JB, Harrison W, De Martin S,
Backhouse SS, et al. A laboratory and clinical evaluation of single-use
instruments for tonsil and adenoid surgery. Clin. Otolaryngol.
2005;30(2):135-42.
4. Brophy T, Srodon PD, Briggs C, Barry P, Steatham J, Birch MJ.
Quality of surgical instruments. Ann. R. Coll. Surg. Engl. 2006;88(4):390-
3.
5. Tomkinson A, Harrison W, Owens D, Harris S, McClure V, Temple M.
Risk Factors for Postoperative Hemorrhage Following Tonsillectomy.
Laryngoscope in press.
Competing interests: No competing interests
I read with great dismay the article "Why the FDA can't protect the
public" written by Shannon Brownlee and Jeanne Lenzer. While it is clear
to me that they already made up their minds about the FDA and the medical
device community before writing the article, it is unfortunate that they
didn't spend time acknowledging the cutting-edge advancements and
improvements to patient care medical devices provide every day.
Health care providers and medical device manufacturers strive to
ensure that patients have access to the safest, most efficacious products
that will increase their quality of life. Today, with cutting-edge
technologies and medical advancements, the average American can expect to
live to 78, a 65% increase over the past 100 years. The medical device
industry is perhaps one of the greatest unsung contributors to increased
life expectancy. Research has shown that since 1980, death rates have
declined 16 percent and Americans spend 56 percent fewer days in the
hospital, due in part to medical devices.
Brownlee and Lenzer seem quick to focus on select instances of
unfortunate results, while failing to acknowledge the overwhelming success
rate and positive experiences of millions of Americans each year. In
fact, a recent study of FDA approved medical devices from the past five
years showed that less than one percent of devices were recalled. And,
the overwhelming majority of those recalls were attributed to
manufacturing and design issues in a post-market setting. The fact is
that FDA is the gold-standard for reviewing and approving medical devices.
These numbers clearly contrast the "sky is falling" narrative that
Brownlee and Lenzer are communicating to your readers.
Perhaps worse, they rely on expert commentary in their research by
two individuals who have a long history of criticisms
towards both regulators and medical device manufacturers. Browlee and
Lenzer have already published their opinions in Reader's Digest this past
August. I'm not sure what their goals and methods are in re-writing
stories in multiple publications, but I do know that your readers expect
to hear both sides of every story, and it is unfortunate that the authors
didn't see to it.
Both the FDA and medical device industry share common goals to ensure
patient safety and promote innovation so that patients can lead healthier,
more productive lives. Perhaps the next time Brownlee and Lenzer decide
to look at one of America's most innovative and patient-driven industries,
they will acknowledge this part of the story.
Competing interests: No competing interests
When I saw the cover, I went straight to the important topic of
medical device safety. As an interventional radiologist, device safety is
of major interest and we have seen stent failures and problematic IVC
filters for example. However, I can tell you exactly "Why the FDA can't
protect the public", and that is because the public is British, and the
journal is the British Medical Journal. I spent last year in the United
States but the actions of the FDA and the role of MAUDE are not
particularly relevant to us here in the United Kingdom. You might say,
well we always carry international content but I would nevertheless found
commissioned articles and commissioned editorials about device safety in
the UK more relevant.
Competing interests: No competing interests
FDA's Extensive Postmarket Authorities
The article "Why the FDA can't protect the public" by Shannon
Brownlee and Jeanne Lenzer makes a number of unwarranted claims about the
robustness of FDA's post-approval oversight of medical devices. FDA has
in place extensive postmarket authorities to help it ensure the continued
safety and effectiveness of medical devices. FDA's rigorous premarket
reviews are complemented by various requirements that continue to
safeguard consumers after a medical technology is placed on the market.
* Comprehensive Quality System Requirements ensure that companies'
manufacturing processes consistently yield high-quality medical
technologies.
* FDA's medical device recall regulations plus manufacturers'
procedures ensure that, if and when a problem arises, it is addressed
quickly and effectively.
* Mandatory adverse event reporting requirements provide a mechanism
for FDA and manufacturers to detect and correct problems in a timely
manner.
* Postmarket tracking requirements for certain higher risk devices
help ensure that when rare, unanticipated problems are identified device
users are located and informed quickly and effectively.
* FDA has the authority to order companies to conduct postmarket
studies to validate postmarket safety signals.
* FDA has the authority to order a postmarket study as a condition of
approval for a device.
* FDA also has the authority to convene an independent advisory panel
to review postmarket data and recommend further action.
Competing interests: No competing interests