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OB/GYN Editorial April 2002
FDA Device Approval: Does It Need to be Expanded?
Thomas E. Nolan, MD, MBA
Many federal jobs filled with political appointees are held up
in various committees in Washington, DC, either because of partisanship
or the paralyzing effect of the terrorists' strike of September
11. The naming of a new director for the US Food and Drug Administration
(FDA) has been held hostage in this prolonged vetting process. As
of the writing of this editorial March 18, 2002, there is currently
no FDA chief and the approval of new drugs and devices has been
excessively delayed.
Recently in "Smart Money" (a magazine published by the
Wall Street Journal) there was an article on the safety of trocars
and laparoscopic surgery. Over the past 10 years, advances have
been made in laparoscopic surgery including improved optics and
attempts to make the surgery "safer." Many of us involved
in gynecologic surgery have seen devices come and go, especially
those that did not perform as we expected. Another area that has
introduced new and advertised improved devices is for endometrial
ablation. One recurring theme is introduction of disposable instruments.
In our residency program, we have gone through various evaluations
of trocars of our smaller and less muscular female residents. One
of our previous attending female physicians always used a Hassan
for her laparoscopic procedures. She had found over the years that
she was not strong enough to be able to place a typical 10- to 12-mm
trocar and decided to use the Hassan. We are currently reevaluating
our insertion techniques and are making serious considerations to
use "open" insertion for all laparoscopic surgeries.
Various instruments and devices have been introduced at varying
cost. Better anesthesia and analgesia have converted surgical approaches
to laparoscopic surgery, resulting in easier ambulation and discharge.
The cost of laparoscopic surgery is extremely expensive and the
question of cost of hospitalization vs use of these devices is becoming
more germane. However, the bar has been raised and if you don't
do laparoscopic surgery, many feel you have fallen short of your
duties as a gynecologic surgeon. Additionally, it has been my experience
as a medical/legal expert that the number of lawsuits related to
trocar injuries has gone up exponentially over the past 3 years.
Whether the plaintiff's bar has discovered these cases or there
are more problems is a matter of conjecture; however, it has been
my experience that it is probably the increasing use of these devices.
Regardless, the number of lawsuits has increased dramatically secondary
to trocar injuries.
The Joint Committee on Accreditation of Healthcare Organizations
has been on a "quality improvement" mantra for the past
5 years. Databases have been developed to evaluate individual practitioners'
surgical skills for time to perform procedures, blood lost, and
complications. Friends of mine who are health care lawyers have
seen a remarkable increase in their business concerning credentialing
and decredentialing of physicians. As hospitals are increasingly
being sued, risk managers are becoming more reliant on "quality"
data. Currently, a favorite plaintiff ploy used is to sue the hospital
and nurses for not intervening when a physician is not "practicing
at the standard of care." Don't be surprised if you see the
nursing director demanding that you perform a cesarean section for
mild variable accelerations in the near future! Whether this is
for the good of patient care or to the detriment of physicians remains
to be seen. In light of these pressures, there are serious ongoing
discussions concerning credentialing of physicians in laparoscopic
procedures. How this is going to be done and monitored remains an
open question.
With the terrorist attacks in September 2001, the role of government
of being is reevaluated by many of our citizens. Deregulation of
energy sources resulted in many problems in California last summer.
The assertion that deregulation in the marketplace may allow the
consumer to get the best deal is coming under closer scrutiny. This
question of overall government intervention as well as scrutiny
may evolve into arguments of the government's role in providing
safe care to patients, and may very well spill over to surgical
devices. The number of devices introduced in the United States continues
to increase; however, the oversight of the safety of these devices
is being questioned. As with most pharmaceuticals that are introduced
into the open populations, various complications and side effects
that had not been previously described become more prevalent. In
my own experience, many of the devices that have been introduced
over the past decade have not always been as great as the manufacturers
had suggested. Once they leave the showroom and are used in the
operating room, some either failed or resulted in complications.
I have personally found poorly made instruments when companies change
manufacturers.
The obvious question is if there should be more regulation and
what administrative or legislative bodies should be used to achieve
this goal? My usual position is to champion physicians as being
proactive in these potentially adversarial relationships. However,
I am wondering how objective many of the pharmaceutical and instrument
makers want us to be. The problem I have seen over the years is
that no one individual or group is without bias and without a certain
amount of political influence. However, until the FDA announces
a leader as well as addressing these various issues the point is
moot. The question overall, however, is going to come down to: how
much regulation should the government have, how much regulation
should hospitals have, and what ethical duties do physicians have
to monitor the behaviors of their colleagues? As the practice of
surgery becomes more technical, will those individuals trained several
decades ago be able to keep up with newer techniques without endangering
patients? These are issues that are unresolved. Any comments from
our readership is actively solicited and published, if substantive.
Thomas E. Nolan, MD, MBA
Editor-in-Chief
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