LaserVue's practice, he said, "goes against everything doctors know about fundamental, basic elements of sterilization techniques." He called Bansal's defense for reusing blades to avoid defective ones "ludicrous."

Kawesch estimated that maybe one in 1,000 blades is defective and that those defects can be seen during routine preoperative inspection. Moreover, he said, microkeratome assemblies should be autoclaved for 5 minutes after each use. In his practice, Kawesh rotates three microkeratomes in and out of service to reduce operating room downtime.

By reusing blades, Kawesch said, LaserVue may simply have been trying to save money. Assuming a patient flow of 300 patients a month and a blade cost of $50 each, total blade costs should have been about $15,000 a month. By reusing the same blade on two patients, the center would have saved $7,500 a month. Moreover, by not investing in additional microkeratome units or heads, the center would have realized additional savings. However, Bansal's counsel has indicated in court documents that LaserVue always had at least two microkeratomes available on surgery day, so that there would have been no money-saving motivation for his practices.

Stephen D. McLeod, MD, a refractive surgeon and assistant clinical professor at the University of California, San Francisco, agreed that LaserVue's practice is not consistent with the standard of care. "I personally advocate changing the blade between each patient," McLeod said. "My own practice is to change the blade between eyes of each patient; I demand a pristine cut each time, and there is evidence that the blade dulls after even one use."

While different manufacturers have varying recommendations for microkeratome sterilization, McLeod said that it is critical to sterilize the microkeratome head into which the blade fits. "As a general rule, all nondisposable microkeratome heads can be autoclaved and should be between all patients," he said. "We have three nondisposable microkeratome bodies and five heads, so I use a freshly autoclaved head for each eye of each patient."

In his supporting declaration filed on behalf of the plaintiffs, August L. Reader III, MD, associate clinical professor, University of Southern California, San Francisco, said, "In LASIK procedures, it is beneath the standard of care to fail to change the blades in the microkeratomes between patients. It is also beneath the standard of care to not sterilize the microkeratome between patients. The standard of care requires that the microkeratome be sterilized in an autoclave between each patient. ... The failure to properly sterilize the equipment between patients can result in the transfer of diseases between patients."

In another filing on behalf of the plaintiffs, Joseph B. Marzouk, MD, chief of the infectious disease service at Summit Medical Center in Oakland, Calif., said, "Because of the lack of sterilization of surgical instruments, there has potentially been the transmission of bodily fluids, which includes blood, from one LaserVue patient to another."

"Of particular concern," McLeod said, "is virus in tear film, including hepatitis. Also, bleeding might occur in patients with pannus - not uncommon in longtime contact lens wearers - and so direct blood-to-blood transmission can theoretically occur. Based on corneal transplant data, corneas have transmitted rabies, Creutzfeldt-Jakob disease, hepatitis B, cytomegalovirus, herpes simplex virus, bacteria, and fungi. While this may well be due to the higher risk posed by cell-to-cell transmission made possible by whole-tissue transplantation, cellular fragments adherent to the blade or tear film contamination pose an unknown risk."

Certification of the class-action status of the lawsuit against LaserVue was pending when EyeWorld went to press. Among the grounds for challenging certification of the class identified by the lawsuit is the fact that Barry S. Kay, MD, a former partner at LaserVue, is not named as a defendant in the action - although he treated more than 1,000 of the potential plaintiffs. Approximately five former LaserVue patients currently are part of the case out of an estimated 2,700 patients who were treated during the time LaserVue was reusing its blades and microkeratome assemblies. According to informed sources, the parties involved in the case, including Bansal's malpractice insurance company, are involved in settlement discussions.