I agreed, Michael.
Ming Wang, M.D.,Ph.D.
Clinical Associate Professor of Ophthalmology of University of Tennessee
Attending Surgeon, Saint Thomas Hospital
Director, Wang Vision Institute
>I noticed you're using the Intralase laser now so I was hoping you would help stop the reuse of blades from the microkeratomes.
thanks,
Michael Patterson
----- Original Message -----
From: Michael Patterson
To: Ming Wang
. . .
I have attached a letter I just got from a local LASIK surgeon Dr. Paul Glass which I have sent to the FDA and the CDC. I would like to get other Doctors to sign similar letter which I would pass on to these regulatory authorities as well as other Doctors and medical boards, even the media if it's ok with you.
What do you think of what he wrote?
see attached for the signed copy.
xxxx
To Whom It May Concern:For every LASIK surgery, every patient MUST have new microkeratome components (e.g., blades and cannulas). Reusing microkeratome components that come into contact with blood or the cornea on multiple patients is not within the practice of medicine for patients in the United States let alone within the standard of care for any Medical Doctor (for any medical procedure including LASIK). There is NO patient benefit for reuse and there is a very high risk of harm to the patient. Based on my review of the risks associated with reusing microkeratome blades or cannulas on multiple patients (especially without proper sterilization), this practice can spread infectious diseases (e.g., DLK, HIV, hepatitis, CJD, etc.) as well as corneal infections (a complication that does lead to loss of eye and blindness). Proper sterilization of the microkeratome blades with regard to CJD prions is not practical and the blades do come into contact with the eye and blood (which are considered highly infectious tissue). The microkeratome then inserts the tissue into the eye of any other patients it comes into contact with. In addition, microkeratome blades get duller every time they are reused which causes irregular flaps made in the cornea, less smooth flaps, epithelial ingrowth, keratitis, and other serious problems. In general, the reuse or reprocessing of single use devices on multiple patients is a serious concern (see http://reform.house.gov/UploadedFiles/121605%20FDA%20Medical%20Device%20Letters.pdf). Reuse also appears to be an off-label use or even violation of the FDA approval. Worse yet, the patients are exposed to the contaminated blades without resterilization. I think patients should be properly educated and informed prior to having LASIK surgery. In light of present day Medical ethics, patients should be given true informed consent by a licensed medical professional (e.g., the M.D. Ophthalmologist surgeon explaining the true risks to physical and mental health). Unlicensed sales people who may be dressed to look as if they are medical professionals (e.g., wearing white lab coats) should not be allowed to explain things as their information may be incorrect and they may mislead patients. Reusing a microkeratome blade used on another patient is not prudent and far too risky for patients. No patient should be subjected to a reused medical device that is labeled single use, and disposable even if the patient has informed consent. Reusing blades without patient informed consent violates many medical ethical principles including HHS IRB guidelines (see http://www.hhs.gov/ohrp/irb/irb_appendices.htm), The Declaration of Helsinki "It is the mission of the physician to safeguard the health of the people" (see http://www.hhs.gov/ohrp/irb/irb_appendices.htm#j6 ), the Belmont Report "Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms. " (see http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm ) and the THE NUREMBERG CODE "The voluntary consent of the human subject is absolutely essential." "The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury." (see http://www.hhs.gov/ohrp/irb/irb_appendices.htm#j5). Apparently, two Doctors in CA admitted to reusing a single blade on multiple patients and were placed on probation by the medical board, and I believe the penalty should be higher than this decision. "LaserVue reused microkeratome blades among patients rather than sterilizing or replacing them. Former patients may have been exposed to infectious diseases such as HIV or Hepatitis. " "Class Action o/b/o 2,700 former LaserVue patients. In a settlement to an investigation brought by Medical Board of California (MBC), defendants admitted that their protocol was to rinse and reuse a blade on up to 4 eyes. MBC concluded that defendants departed from standard of care and placed them on probation."(see http://www.lasikinfocenter.net/Webpages/Ongoing%20Litigation%20Against%20RS%20Webpage.htm.)My hope is that the medical boards, appropriate government agencies (e.g., the FDA and CDC), and any other appropriate regulatory authorities investigate and stop harmful patient practices as soon as possible. As many as eight million patients have had LASIK so far.
Sincerely,
Dr. Paul J. Glass, M.D.May 1st, 2006
xxxx
Michael Patterson, Ph.D., BSEE
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