July 15, 2000

SAN FRANCISCO ¯ The California Department of Health told the LaserVue Eye Centers in March to notify 2,700 laser in situ keratomileusis (<< LASIK>> ) patients that their surgeons rinsed and reused microkeratome blades and handpieces instead of sterilizing them.

The department’s Division of Communicable Disease Control investigated the LaserVue Eye Centers of San Francisco and Santa Rosa and found a low risk of transmission of viral diseases between patients. Nevertheless, the health department told the surgeon that, “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 to contaminated equipment.”

Jay Bansal, MD, director of the LaserVue Eye Centers, said that he and other surgeons reportedly began to rinse and reuse blades on a second patient to make more predictable flaps. He said he started this practice based on reports presented at meetings and from doctors in other countries who do so.

He started the practice at LaserVue’s Santa Rosa center starting March 1, 1996 and in San Francisco in July 1997. He stopped the practice at both centers on May 27, 1999.

Health department epidemiologist Jon Rosenberg, MD, wrote in a memo for the case record that, “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 to contaminated equipment. We believe that the risk of infection transmitted by this procedure is low and, therefore, the California Department of Health Services is not recommending that all patients be tested for infection.”

However, the department added that patients have a “right to know” that they could have been exposed. Dr. Bansal sent a letter May 4 to inform each patient of the practice and has since received mixed reactions.
“Low” risk
Dr. Rosenberg’s investigation concluded that microkeratome blades were rinsed with sterile water and reused bilaterally on a second patient provided that the blade worked properly for the first patient, the first patient had no visible bleeding and less than 30 minutes elapsed between procedures.

His investigation also revealed that the microkeratome assembly was rinsed and reused for up to four consecutive patients as long as no patient had visible bleeding and less than 30 minutes elapsed between each procedure.

The health department consulted with the Centers for Disease Control and Prevention and then reached a consensus opinion that there was a low risk of spreading blood borne viruses. The infection prevalence in the population was low, virus concentrations in the cornea were low, surgeons did not reuse blades if they saw blood, and rinsing with sterile water likely removed a good deal of the virus load, according to a health department memo.

Dr. Bansal, who had cooperated with the investigation, added that he had stopped reusing blades before the courts and health department intervened.
Lawsuit filed
Former employees brought suits last year against Dr. Bansal and his wife, Swati Singh, MD, regarding the practice of rinsing and reusing blades. The suit charges battery, negligence and fraud and deceit.

The suit seeks to return the << LASIK>> fees, and to award patients for emotional distress and punitive damages. The suit also asks the court to create and monitor a fund to test and follow the patients for diseases.

To date there is no evidence of physical injury resulting from the protocol, counsel for Dr. Bansal pointed out.

The lawsuit alleges that the doctors reused blades and microkeratomes to maximize profits by reducing costs and increasing the number of patients they can treat each hour. Cleaning microkeratomes and suction rings every fourth patient allowed surgeons to treat between 33% and 50% more patients every day, according to the lawsuit. Dr. Bansal denies these allegations.

A California judge issued an order in July 1999 that Dr. Bansal stop reusing microkeratome blades, but according to Dr. Bansal he had already stopped the practice because their quality improved and flap complications were not as much of a problem.
Real concerns
According to corneal specialist Kenneth R. Kenyon, MD, “The quality of microkeratome incisions diminishes with each use of the blade. At our center, we only use a blade for a single procedure, and despite its cost, we toss it. It’s been proven that the quality of the cut diminishes and the incidence of epithelial ingrowth and other mechanical problems that are caused by irregular cuts increases.”

And while the risk of viral transmission is low, according to Dr. Kenyon, the real concerns involve bacterial infections such as Staphylococcus, Streptococcus and Pseudomonas.

“The risks of microbial contamination are rare, but cases have been reported,” he said. “When you are dealing with a zero-defect tolerance situation, one has to be careful to the full extent of our capabilities, just as you would for an intraocular surgical case.”

Hepatitis viruses and even rabies have been shown to be transmitted by means of corneal transplants. The potential for these viruses to gain entrance systemically through ocular inoculation is definitely a finite risk, albeit very small, he said.

Dr. Bansal said that among the thousands of cases he has done, only three bacterial infections easily treated with Ciloxan (ciprofloxacin HCl, Alcon) occurred.
Suit challenged
The lawsuit has since been challenged in appellate court, which will decide whether to allow the case to move forward as a class action suit.

Challenges include the plaintiff’s refusal to name in the suit a third surgeon who allegedly followed these practices, even though the surgeon’s patients are included. This would deny the plaintiffs access to full recovery of damages, according to the brief filed in the appeal.

Also, the court cannot determine who underwent << LASIK>> with sterile blades and who underwent the procedure with rinsed and reused blades.

And it would be inappropriate to file as a class action the claims of emotional distress, which are highly personal and individual to each patient, according to the court briefs.

According to Dr. Bansal’s attorney, Fletcher C. Alford, “The appellate court is considering whether the plaintiffs and their counsel are bringing this case not in the best interests of the patients, but rather as some sort of a vendetta against Dr. Bansal.” The plaintiff’s attorney Geoffrey Gordon-Creed called this “a preposterous statement.”

The appellate court put on hold the lower court’s decision to move forward as a class action suit and required the plaintiffs to file a response by June 22. At that time, the court will likely dismiss the suit, Mr. Alford said.

According to Mr. Gordon-Creed, “It is unlikely that the appellate court will decertify the case as a class action.” Even if it does, he said that his firm will proceed with multiple individual lawsuits against Dr. Bansal and LaserVue.

Mr. Alford added that, “This is a unique type of surgery. The standard of care is evolving and he made a reasonable medical judgement that what he did is in the best interest of his patients. And no one was harmed by it. The law does not provide a remedy for people who feel that they’ve been wronged in some way but have no injury.”