'Bermuda cards' allow off-label use of Visx laser

by Keith J. Croes
Executive Editor

An off-shore modification of Visx keycards

allows U.S. surgeons to employ excimer

laser treatments widely used elsewhere

around the world.

 

A number of refractive surgeons in the United States are using Visx keycards that have been reprogrammed in Bermuda to override a software change ordered by the Food and Drug Administration a year ago, according to sources in private practice and industry.

At a rate of $40 per card, the Hamilton, Bermuda-based company, Technological Health Care Products (THCP) Ltd., "enhances" prepurchased Visx keycards meant for U.S.-sited lasers, a THCP official said. The card's original "international" program, used extensively outside the United States, is thus restored and available for use on the U.S. machine.

Legal issues

An FDA official charges that the cards are "illegal," which is probably technically correct, according to Wayne Matelski, an attorney who specializes in FDA regulations. "A component of a regulated device is a device itself, and the card is unapproved," he said. The FDA would argue that [the cards] are illegal and would probably seize them if given the chance."

The approved cards, which cost $260 each when purchased from Visx Inc., of Santa Clara, Calif., are hand-carried to Bermuda, or even sent by express mail, by laser center or practice representatives, not necessarily the surgeons themselves. Surgeons who use the reprogrammed cards point out their practice-of-medicine privilege to use an approved device for off-label applications.

"There is definitely a practice-of-medicine issue here," Matelski said. "It would be up to the court to decide. A pro-government court might be expected to favor the FDA over the surgeon. However, a well-respected surgeon in a regional court might prevail."

The reprogrammed cards allow the treatment of higher degrees of myopia and astigmatism than permitted by the approved labeling of the Visx laser. THCP believes that the company's service violates no U.S. or Bermuda laws. "We do not market directly in the U.S., and word-of-mouth is the only way we market. U.S. doctors personally contact our office here for keycards," said a THCP official, who declined to reveal his name. The FDA has not contacted the company, he said.

Numbers unavailable

The THCP official declined to reveal the number of cards the company has reprogrammed and the number of customers served. "The volumes have not been as large as we originally expected," he said.

A U.S. laser center executive, whose operation includes three Visx lasers, acknowledged sending one shipment of about 800 cards to THCP for reprogramming. "We think this is the high road compared to custom lasers and gray-market lasers. These are approved lasers with proven software," said the executive, who requested anonymity.

In a number of public statements, Morris D. Waxler, PhD, acting branch chief for the Diagnostic and Surgical Devices Branch of the FDA's Center for Devices and Radiological Health, has called the cards "illegal." Waxler pointed out that the agency recently outlined a regulatory pathway for surgeons who wish to apply for an investigational device exemption (IDE) for treating these patients.

"We are very sympathetic to the forces at work here, which is why we've developed a process so that surgeons who want to do these procedures can get an IDE or get into an established study," Waxler said. "The surgeons who are using the cards are not contributing to the data collection and interpretation going on in order for us to understand what we're doing to these patients."

CRS-USA reaction

CRS-USA Inc. is pursuing one such IDE with a study coordinated by Guy Kezirian, MD, of SurgiVision Consultants, Inc., Scottsdale, Ariz. "The Bermuda cards raise concerns for patients and surgeons alike," Kezirian said.

"Undergoing surgery with unvalidated technology that is obtained from an off-shore source leaves them with little recourse should a problem occur. The problem for surgeons is that they are left holding the entire bag for liability. Will their malpractice insurance cover them for activities the FDA says are illegal?"

With the recent approval of the Visx laser for low to moderate astigmatism, the demand for Bermuda cards will likely shrink, at least temporarily, industry sources predict. The pressure on the FDA to approve treatments for high myopia, however, is likely to grow.

Although Visx has heard reports of reprogrammed keycards, the company is not involved with the activity in any way, according to a Visx spokesperson. The THCP official also noted that THCP has no association with Visx.

(From www.eyeworld.org)