Petition to the Food and Drug Administration to enforce the single-use requirement for all Microkeratomes and their components used for LASIK (in accordance with existing regulations) Or to place a moratorium on their use (a partial or full withdrawal of approval). 

1.3 Legal Basis for this Petition

The Petitioner makes a public demand that the Food and Drug Administration (the leading U.S. public health regulatory agency) assert its authority and supremacy in protecting the Public Health.

 

The Petitioner acknowledges that the FDA does NOT regulate the practice of medicine. The Petitioner further acknowledges that an "off-label" use of any device where benefits clearly outweigh risks may constitute the practice of medicine. However, practice of medicine does not allow anyone, including medical doctors, to break Federal or State laws. Furthermore, any user of these Class I devices (whether licensed physician or not) who violates the labeling of these devices unnecessarily exposing patients to a non-Prudent degree of risk, does not provide informed consent, and therefore, is not practicing medicine by definition.  Thus, these practices are within the regulatory authority of the FDA.

 

The Petitioner asserts that when used in LASIK surgery, every patient MUST receive new microkeratome components (e.g., blades and cannulas), regardless of whether the device is operated by a physician, or a technician working under the supervision of a physician. Microkeratome components necessarily come into contact with blood and infectious corneal tissues. As such, their reuse is not practice of medicine, or even within the Standard of Care for any licensed physician, for any medical procedure, including LASIK. Moreover, if sterilization of Microkeratome blades and components is not performed at all, or is conducted by third parties whose motives are mainly economic (not necessarily medical) then this also falls under the authority of the FDA. Finally, sterilization techniques commonly used (when they are used) are not effective with regard to HIV/Aids and other infectious diseases (let alone Creutzfeldt-Jakob Disease prions), historically an overriding public health concern which requires these components be used once and only once, then disposed of as hazardous medical waste. Accordingly, the Petitioner concludes that there is NO patient benefit for reuse of these device components, but instead, a very high potential for harm.

 

There are multiple additional legal bases for this petition because the Microkeratomes are regulated by the FDA as Class I medical devices for use in refractive eye surgery (commonly referred to as LASIK).

 

1.3.2  The FDA does Not regulate the practice of medicine, but the FDA does regulate all users and practitioners of these devices.  Not everything that a medical Doctor does is considered the practice of medicine.  Being a licensed medical Doctor does Not allow a person to break Federal or State laws.  An off-label use of a device explicitly for the potential benefit of a patient (where the benefit clearly outweighs the risk) would be considered a legitimate practice of medicine.  However, when there is no patient benefit and/or the risk outweighs any benefit, then Not following the FDA labeling does Not constitute the practice of medicine By definition.  Part of the definition of the practice of medicine is to put the patients’ best interests ahead of those of the Doctor.  Any practitioner or user of these Class I devices (whether or Not he/she happens to be Doctor) who uses them in an unnecessarily risky way (including committing an assault) or who does Not provide informed patient consent would be under the FDA’s regulatory authority.

 

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.)

 

 

Read more: Full FDA Petition