Health watch article: Re-use of blades for LASIK
Bill Trattler, MD
Bay Area patients told doctors reused blades
BY JULIE SEVRENS
Mercury News
A Bay Area eye center has notified 2,700 patients that they
could have been
exposed to infectious diseases because the blades used in laser
surgery may
have been routinely reused on other patients before being
discarded.
Letters have been sent to patients of the LaserVue Eye Center
alerting them
that disposable microkeratome blades were routinely reused on
patients
undergoing laser eye surgery at the company's San Francisco and
Santa Rosa
locations.
For more than two years, doctors at both sites reportedly rinsed
the
equipment -- which is used to cut flaps in a patient's corneas --
in a
water solution before using them again, even though medical
protocol calls
for blades to be thrown away after use.
Furthermore, the blade holders were sterilized only after every
fourth
patient, a violation of medical guidelines, according to a state
health
department investigation.
The department requested that the firm send letters to its
patients
informing them of the practice of reusing the blades. The
doctors have
since stopped the practice, and the state medical board is
reviewing the
case.
It is possible, though the chances are very slight, that
infectious
diseases such as hepatitis B and C as well as the AIDS virus
could have
been transmitted in this manner.
``A fourth-grader would understand you need to follow at least
these basic
sterilization procedures,'' said Geoff Gordon-Creed, a San
Francisco
attorney who has filed a class-action lawsuit against the center
and two of
its physicians.
Drs. Sanjay Bansal and Swati Singh told health department
investigators
they reused blades in an attempt to give patients the best eye
care
possible. The physicians contended that they only reused those
blades that
served them well in prior surgeries, and that they threw away
any that had
visible blood on them.
``That was the reason why the blades were being (reused) -- for
precision
purposes -- not to compromise the procedure in any way or put
anyone at a
health risk,'' said Patrice Smith, a spokeswoman for LaserVue.
``Much of
the procedure is in the blade itself. The ability of the blade
to cut
well.''
Other eye surgeons said they were appalled by the practice of
reusing
surgical blades and believe the LaserVue case is rare among eye
clinics.
``There's no excuse for it,'' said Dr. Gary Kawesch of the Laser
Eye Center
of Silicon Valley, which has offices in San Jose and Pleasanton.
``The
concept of not sterilizing is something that is a very basic
principle of
surgery. The potential for disease transmission is huge.''
Most clinics discard the microkeratome blades after performing
laser
surgery on a single patient, Kawesch said. Very few surgeons
he's aware of
reuse blades, but when they do they sterilize them between
patients. Most
eye surgeons use ethylene oxide gas or steam to sterilize blades.
The blades, he says, cost $40 to $65 apiece, and one is used to
complete
the laser surgery on both eyes of a patient.
``I feel that for the fees patients are paying they deserve a
fresh
blade,'' Kawesch said. The surgery costs about $5,000 for both
eyes.
Manufacturers recommend in their literature that blades be used
only once,
then thrown out, according to Dr. Hamid Sajjadi, who performs
laser eye
surgeries at the Ellis Eye Center and Silicon Valley Eye Laser
Center.
Although diseases are more commonly transmitted through blood,
there is
evidence they can spread through contact with tears and other
conjunctival
tissue, said Dr. Jon Rosenberg, medical epidemiologist with the
state
health department.
The first patients began receiving their letters earlier this
month, and
many remain in a state of disbelief.
``I thought it was a joke,'' said Debbie Shubin, a Sebastopol
mortgage
broker who paid $4,400 to have her eyes operated on last year.
``I could
not believe that Dr. Bansal, with all of these diseases that are
out there,
would reuse an unsanitary blade on more than one patient.''
``I would never have had the surgery had I known he was going to
be reusing
blades,'' she said. ``I don't know anybody who would put
themselves through
that.'
-----------------------------------------------------------
Got questions? Get answers over the phone at Keen.com.
Up to 100 minutes free!
http://www.keen.com
Glenn Hagele - Council for Refractive Surgery Quality Assurance
about this at
http://www.surgicaleyes.org/ubboard/Forum23/HTML/000618.html.
Anyway, of the 2,700 patients, none have contracted anything due to
the reuse of the blades (yet). Four have rallied around one attorney
to sue. Not because the reuse technique harmed them directly, but
because of the potential for harm and the "stress" caused by being
exposed to this technique.
The California state medical board is investigating, but has come to
no conclusions (yet).
Before you jump on this doctor (yet), it is important to note that his
reuse technique was TAUGHT to him by one of those "top LASIK surgeons
in the U.S., who has been one of the chief laser investigators, has
helped pioneer many improvements, and is annually is an instructor at
the American Academy of Ophthalmology refractive surgery meeting."
Not anyone mentioned on this newsgroup recently, but someone that
organized ophthalmology looks up to. Believe it or not, there were
(legitimate?) reasons for this reuse technique.
This will be a long and windy road.
Glenn Hagele
Executive Director
Council for Refractive Surgery Quality Assurance
http://www.usaeyes.org
glenn....@usaeyes.org
GEM
How can this action be excused at all. Why did the surgeons think these
blades were "disposable". Would they give injections to thousands of people
with the same needle, and just wash them every few patients.
To excuse it because this is what they were taught is arrant nonsense. These
are doctors, who are supposed to have intelligent independent minds, not
mindless automatons.
There are lots of things that we are taught and have to rethink with
experience and in the light of new developments. That is why we are
independent professionals that the public should be able to trust.
I know drivers who routinely take immense risks, and non have killed
themselves or others (yet). Does that make it right. Hepatitis, AIDS and
vCJD have been shown to be transmissible by corneal surgery- is it any
wonder that the patients are stressed?
GEM
Glenn Hagele - Council for Refractive Surgery Quality Assurance
<glenn....@usaeyes.org> wrote in message
news:395ac07f....@news.concentric.net...
Glenn Hagele - Council for Refractive Surgery Quality Assurance
wrote:
>What an indictment on the Council for Refractive Surgery Quality Assurance.
>How can this action be excused at all. Why did the surgeons think these
>blades were "disposable". Would they give injections to thousands of people
>with the same needle, and just wash them every few patients.
>To excuse it because this is what they were taught is arrant nonsense. These
>are doctors, who are supposed to have intelligent independent minds, not
>mindless automatons.
>There are lots of things that we are taught and have to rethink with
>experience and in the light of new developments. That is why we are
>independent professionals that the public should be able to trust.
>
>I know drivers who routinely take immense risks, and non have killed
>themselves or others (yet). Does that make it right. Hepatitis, AIDS and
>vCJD have been shown to be transmissible by corneal surgery- is it any
>wonder that the patients are stressed?
>
>GEM
Nothing in my statemtent is, or is meant to be, an excuse for an
unsafe medical practice.
Our organization is watching this situation very closely. I have
contacted the doctor directly and spoken with other surgeons about the
case. The practice of blade reuse has been abandonded by this doctor
so no additional patients are being exposed to a potentially unsafe
practice. Judgement of the appropriateness (or lack thereof) of blade
reuse will be made by the appropriate governing body in the state of
California. I believe it is reasonable to allow this surgeon to
opportunity to make his case to his peers and those on the California
medical board and be judged by an appropriate body, not by a consumer
organization or an anonomous Internet newsgroup poster.
Steve Friedman MD
save money and increase profit by re-using blades and save labor costs
if they are not at least sterilized between different patients.
That profit maximizing motivation is not limited to Laservue.
I assume Council for Refractive Surgery Quality Assurance will add
the "sterility requirement" to their list of aspiring Lasik experts
seeking to affiliate with yet an additional organization.
Looks like Taco Bell is now performing eye surgery (so to speak)
To quote a recent Bill Gates TV commercial
"The best is yet to come"
Just food for thought.
Steve Friedman, MD Lasik recipient 94' (pre Lasik gold rush)
On Thu, 29 Jun 2000 11:53:00 +0100, "GEM" <gor...@gemcc.u-net.com>
wrote:
>What an indictment on the Council for Refractive Surgery Quality Assurance.
>How can this action be excused at all. Why did the surgeons think these
>blades were "disposable". Would they give injections to thousands of people
>with the same needle, and just wash them every few patients.
>To excuse it because this is what they were taught is arrant nonsense. These
>are doctors, who are supposed to have intelligent independent minds, not
>mindless automatons.
>There are lots of things that we are taught and have to rethink with
>experience and in the light of new developments. That is why we are
>independent professionals that the public should be able to trust.
>
>I know drivers who routinely take immense risks, and non have killed
>themselves or others (yet). Does that make it right. Hepatitis, AIDS and
>vCJD have been shown to be transmissible by corneal surgery- is it any
>wonder that the patients are stressed?
>
>GEM
>
>Glenn Hagele - Council for Refractive Surgery Quality Assurance
><glenn....@usaeyes.org> wrote in message
>news:395ac07f....@news.concentric.net...
>> There was a very interesting thread on the SurgicalEyes bulletin board
>> about this at
>> http://www.surgicaleyes.org/ubboard/Forum23/HTML/000618.html.
>>
>> Anyway, of the 2,700 patients, none have contracted anything due to
>> the reuse of the blades (yet). Four have rallied around one attorney
>> to sue. Not because the reuse technique harmed them directly, but
>> because of the potential for harm and the "stress" caused by being
>> exposed to this technique.
>>
>> The California state medical board is investigating, but has come to
>> no conclusions (yet).
>>
>> Before you jump on this doctor (yet), it is important to note that his
>> reuse technique was TAUGHT to him by one of those "top LASIK surgeons
>> in the U.S., who has been one of the chief laser investigators, has
>> helped pioneer many improvements, and is annually is an instructor at
>> the American Academy of Ophthalmology refractive surgery meeting."
>> Not anyone mentioned on this newsgroup recently, but someone that
>> organized ophthalmology looks up to. Believe it or not, there were
>> (legitimate?) reasons for this reuse technique.
>>
>> This will be a long and windy road.
>>
>>
Glenn Hagele - Council for Refractive Surgery Quality Assurance
>I assume Council for Refractive Surgery Quality Assurance will add
>the "sterility requirement" to their list of aspiring Lasik experts
>seeking to affiliate with yet an additional organization.
>
CRSQA is a consumer organization and really doesn't have any business
telling a doctor how to be a doctor. We DO look at outcomes and
ANYTHING a doctor does that causes poor outcomes would affect that
doctor's ability to become or continue to be certified.
Bill Trattler, MD
I must protest - there could nbever be ligitimate reasons for
placing patients at incredible risk of HIV, viral hepatitis, or
Mad Cow disease - all which can potentially be transmitted via
the use of unsterilized sharp instuments.
There is absolutely no excuse for this. It goes against
every medical standard and as well goes against the laser
centers licensing by OSHA (a governmental organization that
certifies that surgery centers are following the appopriate
blood borne pathogen.
And I have to say that your organization will lose complete
credibility if this type of action is excused. These surgeons
and the laser centers put their patients at severe risk. You
can't look back and say no one was injured, so their actions
were OK. Mad Cow Disease (Jacob-Creutzfeld) can be transmitted
via the cornea (there are documented cases of patients
transmitting this disease following corneal transplants) - and
this disease may take 20-40 years to show up. As well, HIV is
known to be present in tears - and blood is not an uncommon
sight with LASIK.
In your reply - could you please explain the purpose of
CRSQA. Is it to help consumers? Is it to protect consumers?
It shouldn't matter whether you are friends with these surgeons -
their violation of safe medical practices should land them out
of medicine - and your organization should be leading the charge
against these surgeons and any other LASIK surgeons who put
laser center profits ahead of providing patients with the safest
of surgeries.
Bill Trattler, MD
Miami, FL
http://www.AskLasikDocs.com
Bill Trattler, MD
I must protest - there could never be legitimate reasons for
placing patients at incredible risk of HIV, viral hepatitis, or
via the use of unsterilized sharp instuments.
There is absolutely no excuse for this. It goes against
every medical standard and as well goes against the laser
centers licensing by OSHA (a governmental organization that
certifies that surgery centers are following the appopriate
And I have to say that your organization will lose complete
credibility if this type of action is excused. These surgeons
and the laser centers put their patients at severe risk. You
can't look back and say no one was injured, so their actions
were OK. Mad Cow Disease (Jacob-Creutzfeld) can be transmitted
this disease decades following corneal transplants) - and this
Glenn Hagele - Council for Refractive Surgery Quality Assurance
better choice of surgeon. It would appear that the LaserVue doctor
may not have passed that test, however we will not know because the
application to become certified by our organization was withdrawn
before patient outcomes data was submitted for evaluation.
No LaserVue doctor is certified by our organization.
The California medical board has the authority to suspend or revoke a
surgeon's medical license immediately. Based upon the facts, they
have not determined that such an action is warranted. At least, not
yet. Until an appropriate agency has affirmed our suspicions that the
reuse of microkeratome blades across patients without autoclave
sterilization was medically inappropriate, I don't see how a consumer
organization should make this medical evaluation. We can raise the
issue as a concern and I have personally contacted the doctor and have
been assured (and there are court orders to back this up) that the
practice of reuse has been abandoned.
We are not in the business of crucifying doctors in the absence of an
appropriate agency response that what LaserVue did was, in fact, not
medically appropriate. I may think it was inappropriate, you may
think it was inappropriate, but the licensing body in the state where
this doctor practices - the people who are the ones who decide what is
appropriate - has not taken action against the doctors involved.
Does this raise concern? Absolutely. Was it medically inappropriate?
Consensus is that it was not the best way to care for patients, but
the people who decide what is and is not appropriate have not seen fit
to limit the doctor's license to practice medicine. I think it is
important to let the appropriate bodies investigating this make their
findings. They know a lot more about this than what we have learned
from a newspaper article and my conversations with the doctor
involved. Letting the process take its course is not making excuses.
For right now, the practice of reuse has been abandoned and none of
the 2,700 patients have contracted any reuse related problems. That
may be just luck and just luck is no way to run a medical practice,
but these facts should not be ignored.
The questionable nature of these events indicates the importance of
patient education and organizations like CRSQA. The type and degree
of care varies greatly from doctor to doctor. Whether you use our
Tough Questions For Your Doctor to screen a surgeon on your own or
simply choose a CRSQA Certified Refractive Surgeon, the idea is to
increase your odds of achieving the outcome you desire. We continue
to help patients find the better surgeons.
sma...@nospamsonic.net
Glenn,
I'm going to have to side with Dr. Trattler on this one. This reuse of
blades is absolutely inexcusable and should not have happened - period.
And I speak as a ptient of Dr. Bansal and LaserVue. Although my surgery was
done after they discontinued the practice of reusing the microblades, I
nonetheless feel betrayed by their lack of concern for their patients. I
would NEVER have chosen to have my surgery at LaserVue if I had been aware
of this issue.
I think you're going to have to decide whether your organization is
primarily beholden to the Laser Clinics or Patients. I don't think you can
have it both ways anymore.
Best regards,
Steve
--
_ _
/ \._ _|_ o|_) _ _.._ _| _ _ ._ _ smachol "at" optiboard "dot" com
\_/|_) |_ ||_)(_)(_|| (_|o(_(_)| | | http://optiboard.com
|
Bill Trattler, MD
I LASIK surgeon contacted me via a different forum who was
using the LaserVue surgery center to do cases - until he was
instructed by the staff that he had to reuse blades and reuse
other disposable equipment without sterilization. This included
using the "sterile" saline on multiple patients.
There is no State or national mandate that laser surgeons
perform a certain number of LASIK surgeries per year - yet your
organization has set an arbitrary number. There is also no
State or National organization that mandates that LASIK surgeons
have a certain percentage of patients reach 20/20 - yet your
organization has set this number up. The reasons one would
suppose is to try to identify surgeons that might be of high
quality. I just can't believe that you are waiting for a State
agency to punish LaserVue and that you would even say that what
they did was extraordinarily dangerous. How can you be more
concerned about incidental flap complications than the overall
safety of the person having the procedure. There is no question
that they broke very clear safety regulations - they admitted it
in the article and you obviously confirmed it in your
converstation with them.
For example - how about the well known case where the dentist
transmitted HIV to numerous patients because of inproper sterile
technique during teeth cleaning. Do you want to wait until harm
is found - the answer is clearly no. There is no purpose for
the CRSQA unless you are going to take an active role in trying
to raise the safety of LASIK - both in doing no harm and
providing good results
Larry Bickford
sma...@NOSPAMsonic.net wrote:
> Glenn,
>
> I'm going to have to side with Dr. Trattler on this one. This reuse of
> blades is absolutely inexcusable and should not have happened - period.
[some text deleted]
> I think you're going to have to decide whether your organization is
> primarily beholden to the Laser Clinics or Patients. I don't think you can
> have it both ways anymore.
Bill Trattler, MD,wrote:
For example - how about the well known case where the dentist
transmitted HIV to numerous patients because of inproper sterile
technique during teeth cleaning. Do you want to wait until harm
is found - the answer is clearly no. There is no purpose for
the CRSQA unless you are going to take an active role in trying
to raise the safety of LASIK - both in doing no harm and
providing good results
Well, Glenn,
I think you have some major damage control to do, at this point. Steve and
Bill have said it straight, and a straight and appropriate response is due
from your organization.
--Larry
--
Larry Bickford, OD
Doctor of Optometry
Family Practice Eye Health and Vision Care
The EyeCare Connection--- http://www.EyeCareContacts.com
Note: To reply via email, use eye...@eyecarecontacts.comm (and remove last "m")
Glenn Hagele - Council for Refractive Surgery Quality Assurance
withdrawn before we were even able to look at his outcomes.
2) The doctor has abandoned the reuse of microkeratome blades across
patients.
3) I have personally talked with the surgeon to verify that the
practice has not continued and to find out why this occurred in the
first place.
4) The San Francisco Bay area doctors to whom we refer patients do not
reuse blades across patients without sterilization.
5) On every eyecare related bulletin board and newsgroup this issue
has been raised and awareness has been heightened.
6) We are monitoring the California medical board for any action they
may take.
7) Patients using our Tough Questions would probably have excluded
this surgeon or would have received a new blade for each eye.
8) I'm not a doctor, so I cannot condemn this practice as a peer. We
are not a licensing or regulatory agency so our response is limited.
9) The medical board that governs this doctor has not found a valid
reason to act.
As a consumer/patient organization I am afraid there is not much more
that we can do but wait until something new happens (like a California
medical board action or a civil court judgement) then offer these
events as clear evidence that this doctor was out of line. In the
meantime, we don't send patients there and we have expressed our
concern on the medias we have a presence.
CRSQA certification is voluntary and those who don't volunteer our out
of our loop. It is very difficult for us to pass judgement on a doctor
who is not certified by our organization or at least in application
for certification. If the surgeon had not withdrawn his application
we may have been able to act on our findings, but he did withdraw his
application and we have no findings.
It would be nice if we had a legal or regulatory leg to stand on, but
we don't. If the California medical board can't find justification to
act, it is unlikely that CRSQA could. Without the doctor's voluntary
participation, our hands are tied. The doctor has already withdrawn
that participation.
sma...@nospamsonic.net
> 7) Patients using our Tough Questions would probably have excluded
> this surgeon or would have received a new blade for each eye.
I was a patient of this Doctor and I DID use your questions. No problems
were apparent after the questioning. At the time of my surgery however,
they had stopped resuing the blades. Nonetheless, if I had known that they
did this in the recent past, I would have NEVER chosen to go to this clinic.
Steve
Bill Trattler, MD
comments - saying that
"Before you jump on this doctor (yet), it is important to note
that his reuse technique was TAUGHT to him by one of those "top
LASIK surgeons in the U.S. ..... Believe it or not, there
were (legitimate?) reasons for this reuse technique."
To me - this is very concerning. Perhaps your criteria for
certification are not helpful for patients - as they really do
not help patients find a doctor that will provide superior
safety and results.
I am especially concerned that you are glossing over a
situation where serious patient harm occurred. They admitted
violating rules and regulations regarding the reuse of
disposible items without sterilizing them. This is an
unquestionably serious offense and placed thousands of patients
at severe risk. You can't pull out statistics that as far as
you know no patient has yet been harmed. This is backwards
thinking.
If you want your organization to be a consumer advocate, then
you need to jump on any and all situations where patients are
placed at risk, regardless of whether they are CRSQA certified
or not. In fact - since reusing blades has been shown to place
patients at risk for buttonhole flaps, I would hope that you
make the reuse of blades even with sterilization as a reason to
not be eligible for certification.
Again - as a patient advocacy organization - you need to be
a patient advocate. Your organization should help explain to
patients on forums such as these the severe danger of actions
such as LaserVue.
These are just my thoughts on this very serious subject
Bill Trattler,MD
Glenn Hagele - Council for Refractive Surgery Quality Assurance
You are an ophthalmologist and as a peer if you want to crucify Dr.
Bansal you may. We are a consumer organization without a regulatory
or legal leg to stand on. I have already listed what we have been
able to do about this situation.
It is a fact that Bansal was taught the reuse of blades across
patients by a respected surgeon. Stating a fact is not an excuse nor
a defense of a procedure.
We are between a rock and a hard place on this one. We have our
published guidelines for doctors who volunteer to be certified by our
organization. Bansal's request to become certified was withdrawn. We
are not a regulatory agency, so we can't say he was in violation of a
regulation. We are not a licensing organization, so we cannot pull
his license. Our organization structure specifically states that we
are not to dictate how a surgeon practices medicine.
CRSQA's function is to identify the better surgeons and to provide
tools for individuals to do the same. It is not our function to hunt
down or condemn surgeons whose techniques are questionable.
We can attempt to influence, and my call to Bansal was a part of that
influence. We can cite scientific studies or position statements from
medical organizations, but the American Academy of Ophthalmology, the
American Society of Cataract and Refractive Surgeons, the American
Medical Society, the International Society for Refractive Surgery, the
California Medical Society, and even the California Medical Board have
not made a single official pronouncement that what Bansal did was
wrong.
If these MEDICAL organizations are not able/willing to denounce
Bansal's actions, why do you think a consumer/patient organization has
the authority to do so or should?
I have not been able to find a single reference that is specific to
reuse of microkeratome blades across patients without autoclave. If
you have one, let me know. I would be then be able to use that study
as evidence that Bansal's actions were wrong. Until then, this is a
matter of opinion and we are not a medical organization with the right
to make medical opinions. Every comment I make on this newsgroup or
other bulletin boards can be backed up with information from trade
journals and published papers. This situation has no backup.
Common sense indicates that the reuse of microkeratome blades across
patients without autoclave is unwise or even dangerous. Common sense
would also indicate that a surgeon touching the patient's eye without
gloves when making sure the microkeratome suction is sufficient would
be unwise or even dangerous, but this is done too. There are a lot of
things going on that I may think are wrong, but there are limits to
what can and should be done.
The only reason we are involved in this debate at all is because
Bansal had applied for certification with our organization. That
certification was never issued.
It may be enjoyable for people critical of our organization to poke at
us hanging in the wind, but it does not change the limits of this
situation.
joh...@my-deja.com
remains same -- Glenn is defending them. The only reason I could think
of is that Glenn tries to make it controversial and brand his
organization and he succeeds (at least to me). Other than that he is a
crazy man.
- John
Sent via Deja.com http://www.deja.com/
Before you buy.
Glenn Hagele - Council for Refractive Surgery Quality Assurance
>After reading all the messages regarding this issue, my conclusion
>remains same -- Glenn is defending them. The only reason I could think
>of is that Glenn tries to make it controversial and brand his
>organization and he succeeds (at least to me). Other than that he is a
>crazy man.
>
>- John
>
>
It appears that stating the facts of this case sounds like a defense.
It is not. I do not offer an opinion on Dr. Bansal's actions and have
offered the opinion of several other surgeons who have all said the
reuse of microkeratome blades without sterilization is inappropriate.
Dr. Trattler offered this same opinion. As surgeons they are fully
qualified to offer this opinion. As a researcher, I can find nothing
specific to Bansal's actions.
If I am defending anything, I am defending the due process that should
be afforded anyone accused of such a deed. I'm not thrilled with
guilty by accusation. The regulating agency made a milk-toast
response and the licensing agency appears unwilling to do anything,
however the issue is here for all to see and the doctor is not
certified by our organization.
The reports of my lunacy are greatly exaggerated.