Petition to STOP Reusing Blades for LASIK Surgery. Everyone has the right to LASIK Liberty (see www.LasikLiberty.com).

To: 

To Whom It May Concern:



Reusing a blade for LASIK surgery is Not like reusing one for cutting your hair. The cornea and blood produced from LASIK surgery is highly infectious tissue. For every LASIK surgery, every patient MUST have new microkeratome components (e.g., blades and cannulas) because prior patients are Not screened for highly infectious diseases. 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. See www.LasikLiberty.com for more information on medical Doctors who are knowingly committing these harmful and dangerous practices that have injured numerous US citizens for life.



The FDA’s policy is that they regulate the safety of medical devices “for their intended use” (http://0-www.fda.gov.lilac.une.edu/cdrh/LASIK/faq.htm), but

“a doctor may decide to use that device for other indications if the doctor feels it is in the best interest of a patient. The use of an approved device for other than its FDA-approved indication is called "off-label use." The FDA does not regulate off-label use or the practice of medicine.”



However, I have letters and emails from four LASIK surgeons (and I am seeking more) who agree that "There is NO patient benefit for reuse and there is a very high risk of harm to the patient" (see Dr. Glass’ signed letter at www.LasikLiberty.com).



The FDA and/or the CDC or another agency should immediately state that reusing the blades is not safe and unnecessarily puts the public health at risk (they can word it however they want) and STOP this unnecessarily risky practice immediately. Certainly making a public statement is within their jurisdiction. The FDA has done several recalls of devices used for LASIK in the past (http://www.lasikinfocenter.net/Webpages/LadarVision\%20Recall\%20Webpage.htm ) and recently did two public health notices for issues regarding similar risks as the reuse of blades.



1. “Both the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) continue to investigate reports of fungal keratitis in an effort to determine all contributing factors and/or products that place contact lens wearers at increased risk for Fusarium keratitis.”

http://www.fda.gov/cdrh/safety/041006-keratitis.html



FDA Not Ready To Order Recall Of Bausch & Lomb ReNu

http://www.consumeraffairs.com/news04/2006/05/fda_bausch.html



2. “The U.S. Food and Drug Administration says that it and the federal Centers for Disease Control and Prevention believe the risk for infection is low. Even so, the FDA recommends that hospitals and physicians who engrafted the suspect material contact patients around the country and advise them of the need to be tested. The FDA has also ordered the recall of bone, tendon, skin, heart valves and other tissues — known as "allografts" — distributed by the company at the heart of the alleged multimillion-dollar scheme, Biomedical Tissue Services of Fort Lee, N.J.”

http://www.ajc.com/metro/content/metro/stories/0423meshbodyparts.html?imw=Y



However, the Federal Government should do whatever is possible to protect the public health regarding LASIK surgeons who are reusing blades for LASIK unnecesarily and with no possible patient benefit.



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.



Over 21\% of US based LASIK surgeons admitted in a 2004 survey that they reuse microkeratome blades (see J Cataract Refract Surg. 2005 Jan;31(1):221-33; http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=15721716&query_hl=1 )



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.)



The first page of one of the microkeratome manufacturer's operators manual (see www.LasikLiberty.com) stipulates that Doctors are ONLY licensed to use the device as a single-use, disposable blade. Further the manual states that only physicians are granted a license under Federal law (the FDA stipulated this referred to Title 21, see http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=200121).



In general, the FDA defines safe as a "reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use."

http://a257.g.akamaitech.net/7/257/2422/01jan20051800/edocket.access.gpo.gov/2005/05-23745.htm



The FDA knows that reusing the blades has a "reasonable certainty" of being harmful (not safe) under the intended conditions of use, but they claim they have no jurisdiction to protect the public health from this obviously unsafe, not prudent, and harmful practice that the FDA knows violates the labeling and the Operators Manual for some of these devices.



My hope is that the medical boards, appropriate government agencies (e.g., the Federal Food and Drug Administration, FDA, and Centers for Disease Control, CDC), and any other appropriate regulatory authorities investigate and enforce laws that would stop harmful patient practices as soon as possible. As many as eight million patients have had LASIK so far.



Sincerely,

The Undersigned

Sincerely,

The Undersigned

The Petition to STOP Reusing Blades for LASIK Surgery. Everyone has the right to LASIK Liberty (see www.LasikLiberty.com). Petition to was created by National Vision Institute and written by Michael Patterson (npatter9@hotmail.com).  This petition is hosted here at www.PetitionOnline.com as a public service. There is no endorsement of this petition, express or implied, by Artifice, Inc. or our sponsors. For technical support please use our simple Petition Help form.

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