How would you feel if you received an infectious disease or permanent injury caused by the reuse of an FDA "regulated" medical device AFTER the CDC and the FDA knew about an unsafe risk and did nothing?
Many Microkeratome components used for LASIK are licensed, "regulated" and approved by the FDA solely as single-use, disposable medical devices, but the FDA states the FDA has No jurisdiction to enforce Federal laws regarding these FDA approved medical devices.
Hundreds of LASIK Doctors have admitted reusing these single use blades, but none have lost their medical licenses and only a few have even been placed on temporary probation (to my knowledge).
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.
Why isn't any practitioner or user of these FDA "regulated" (Class I) medical devices (whether or Not he/she happens to be a Doctor) who uses them in an unnecessarily risky way or who does Not provide informed patient consent under the FDA’s regulatory authority and jurisdiction?
The House of representatives has investigated the FDA regarding allowing these harmful practices (as reported in the Washington Post). "If there is the remotest possibility that a catheter might be used twice, that you could potentially harm a patient, you should not use it," he said. "It's common sense."
"The Washington Post examined thousands of pages of documents, including FDA records, court filings and internal company reports, and was able to document dozens of cases of patient injuries and device malfunctions after single-use devices were reused over the past decade"
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.
The FDA hasn't even responded to a request for humanitarian aid or compassionate use of a medical device. They don't do anything about Doctors Not providing the Patient Handbooks, violating the labeling (including false advertisements), or Not informing patients they are getting an "off-label" treatment, but when the FDA was asked to simply put in writing that the manufacturer and a Doctor can do a treatment zone .5mm wider than the current 6.5mm maximum approved by the FDA (to come closer to matching an actual pupil size), the FDA would Not put it in writing. Is that humanitarian or compassionate?
"IF Doctors who do "second opinions" after LASIK (this is a big business due to all the people with problems) are used to seeing good results from LASIK, then why aren't the Damages from reusing microkeratome blades obvious to them? As odd as it sounds, many patients have told me their Doctors acted as if they did Not believe what they were telling them about their eyes and vision. My own statements about my vision and eye pain, etc. do Not appear in many of my medical records, and some Doctors have one diagnosis but Not others (in some cases I initially found out Only by getting copies of my medical records because some of the Doctors did Not tell me they had put these diagnoses in my records). One Doctor who was on the FDA's Ophthalmic devices panel said the objective evidence (without reviewing my artemis or confocal exams) was Not consistent with what I said about my vision. I was shocked when he said "I know many patients who would be happy with your vision". I'm sure that blind people would be happy with my vision, but how does that help with my terrible vision and eye problems that bother me all the time?"
"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."
"I must protest - there could never be legitimate 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 instruments. 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 appropriate 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."
"I thought surely the eye Doctors' Academy (that provides the Doctors with the board certification they put in their bios) would have a policy designed to protect patients' safety. Think again."
"At this time, the Academy [The American Academy of Ophthalmology] does not have a formal policy on the issue [reusing Microkeratome blades on multiple patients without sterilization]."