This March, the California Department of Health Services ordered LaserVue to notify all its LASIK patients treated between March 1996 and May 1999 that they may have been exposed to infectious diseases. "The procedures used at LaserVue Eye Centers were clearly not in compliance with established infection control recommendations for the disinfection and sterilization of patient-care items," said Jon Rosenberg, MD, a state epidemiologist. "The seriousness of the breaches in infection control practices were sufficient to warrant the notification of patients who had undergone these procedures and might have been exposed by contaminated equipment." Alford pointed out that the Department decided that the patients need not be tested for any infectious disease.

In a May 4 letter to patients, LaserVue admited reusing blades and microkeratomes after rinsing them with water. "The practice was to reuse a blade on a second patient if that blade proved satisfactory on the first patient. ... This reduced the risk that an unproven new blade might have an imperfection that could cause a corneal flap disorder," said the letter from LaserVue. "It was also the procedure to reuse the microkeratome assembly on up to four patients without heat sterilizing it."

EyeWorld has learned that the Medical Board of California is investigating Bansal, Kay, and Singh in connection with the lawsuit's allegations.

Still, there are varying opinions regarding just what the standard of care is in the United States when it comes to microkeratomes and blades.

Bausch & Lomb's Hansatome user's manual, which is being updated as a matter of regular policy, recommends for the disposal of microkeratome blades after each use. The maker of the world's mostly widely used microkeratome recommends a three-step process for cleaning and sterilizing heads between each LASIK procedure. After each use of a Hansatome microkeratome, the manufacturer's specifications call for the head to be soaked for 2 minutes in sterile distilled water containing a Food and Drug Administration-approved medical cleanser; scrubbed on all six sides with a soft-bristle toothbrush, thoroughly cleaning all open cavities (blade holder, flap slot); rinsed in a second bowl for 1 minute; and then soaked for 5 minutes in sterile distilled water; and rinsed for 1 minute in third bowl of sterile distilled water. Once the rinsing and cleaning are completed, Bausch & Lomb recommends autoclaving for between 3 and 30 minutes, depending upon the type of autoclave being used.

In a declaration on behalf of the defense, Ralph G. Berkeley, MD, clinical assistant professor, University of Texas, Houston, who helped train Bansal, said, "The rationale for reuse of blades has nothing to do with saving time or money."

Berkeley said that because the quality of the incision is so critical in LASIK, blade quality is of paramount concern. "Ophthalmologists who learned LASIK in the early years of the procedure were taught to reuse blades on multiple patients as a way of reducing flap complications," he said.

Because of concerns about blade quality, Berkeley said, many surgeons learned to reuse blades as a precaution. "It is my opinion that the procedures used by Dr. Bansal ... were not below the standard of care and were consistent with what many other reputable and experienced surgeons were doing," he said.

Another refractive surgeon, Alan B. Aker, MD, said in a declaration for the court, "I do believe that using a new blade and sterilizing the assembly for each patient is certainly a good change, but it is not currently in practice throughout the United States or Canada or the rest of the world."

Other physicians argue that the standard of care in the United States is to use a fresh blade on each patient and to autoclave the microkeratome head after each use. Gary M. Kawesch, MD, a refractive surgeon who also practices in the Bay area, said LaserVue's microkeratome sterilization process and reuse of blades are not in keeping with the accepted standard of care in the United States. "The standard of care is a new blade and a fresh, sterilized keratome for each patient," he said. "Blades get dull with use, and every doctor knows there is 'invisible' blood, tissue, and fluid that can contaminate a blade or microkeratome."