As the number of US ophthalmologists using "homemade" excimer lasers to perform refractive surgery continues to grow, the US Food and Drug Administration (FDA) is taking action against the laser engineer thought responsible for making most of these "custom" instruments.
Ed Sullivan, doing business as ExSull, Drexel Hill, Pa, has been put on notice by the FDA that the agency regards him "clearly as a manufacturer with multiple manufacturing sites" subject to FDA rules and regulations and, if he makes another one of these excimer lasers "which are unapproved devices," he will be in violation of the federal Food, Drug and Cosmetics Act and subject to legal penalties, according to top-ranking FDA officials within the national Division of Enforcement.
Sullivan was informed in mid-May in a teleconference with top officials from both the FDA Division of Enforcement national headquarters and the Philadelphia District Compliance Office that it is the FDA's position that Sullivan's excimer lasers are not "custom devices" and not exempt from regulation as a physician's practice-of-medicine issue, as has been claimed by some of the ophthalmologists using his devices.(1) The agency also advised Sullivan "that any further [excimer laser] construction would be in violation of the act," and could lead to seizure, injunctions, and, eventually, civil penalties.
"He is making more than one, and even though they may be different in that they are serialized, they are all PTK and PRK lasers, are elsewhere available and not custom," said the FDA official. "It is pretty clear that what they are doing is different than a physician doing it within the auspices of his practice. This is classic manufacturing and he should not be doing this."
During the FDA telephone conversation, "it appeared that [Sullivan et al] were surprised by our position," the official said, "but they did not have the arguments to refute it at that point in time."
Patient consultants, working for ophthalmologists using Sullivan-built lasers in practices under investigation by the FDA, say Sullivan's plans were to build at least 10 excimer lasers for ophthalmologists in the US. The FDA is not certain it knows the exact number that have been built to date.
At least four homemade or custom-made excimer lasers are already being used by five refractive surgeons in the US, who had together treated more than 800 PRK (photorefractive keratectomy) and LASIK (excimer laser in-situ keratomileusis) patients by early summer, according to those surgeons or their employees.
This spring, Ronald W. Barnet, MD, and David D. Dulaney, MD, doing business as the Barnet Dulaney Laser and Refractive Institute in Phoenix, Ariz, and Kenneth K. York, MD, of Glendora, Calif, joined Frederic B. Kremer, MD, of Philadelphia and D. Stephen Hollis, MD, of Columbus, Ga, in using a "custom" excimer laser on refractive surgery patients in the US.
Kremer, who an FDA official says worked with Sullivan during the development of his laser more than 2 years ago, was one of the first in the homemade laser field. Kremer employees tell patients the doctor designed and built the laser himself. Hollis admits his laser is a clear Sullivan creation, which Hollis has used to perform more than 300 LASIK procedures.
York imported a used ExciMed (Summit Technology, Waltham, Mass) excimer laser from Canada through Hi-Line Medical, Inc, of Laguna Hills, Calif, and customized its optics and delivery system. He says he designed the instrument, which was then built to his specifications by engineers and machinists from the medical and aerospace industries. Sullivan was not one of those engineers, according to York.
When questioned specifically about the origin and FDA status of the Barnet Dulaney laser, a patient counselor said, "we had a laser engineer build our own state-of-the-art laser, one of only four in the country. It was built to our own specifications. The FDA cannot tell a surgeon what procedure they can or cannot do. The reason the FDA is looking at the laser equipment is for sales and marketing, and since we are not going to sell or market the laser, we don't need FDA approval." The FDA clearly disagrees.
In the first 3 months in which they had the homemade laser, Barnet and Dulaney performed more than 100 LASIK procedures, according to the counselor. She said more than 90% of those patients are seeing 20/40 or better one day postoperatively, and by the end of the first postoperative week, 96% were 20/40 or better. The center charges patients $1695 per eye, with financing available "with little or no down payment necessary."
Barnet Dulaney tells patients its laser is "a third-generation laser which is so much more sophisticated" than what the FDA is reviewing for the major US market. "It is comparable to the lasers in Europe and Canada," the patient counselor said. "There are only four in this country, the reason being they are just so extremely expensive to have built."
Other refractive surgeons argue that few of these excimer lasers are being built because they are in violation of FDA regulations and may leave the physicians using them open to serious legal liability. The validity of the "third-generation" designation is also challenged by at least one internationally renowned refractive surgeon who says "specific excimer laser generations have yet to be defined" and such labeling is "a marketing ploy" with "suggested superiority which has not been proven."
Neither Barnet nor Dulaney responded to repeated requests for an interview.
Kremer and Hollis clearly state on their promotional brochures that their lasers have not been approved by the FDA. Barnet Dulaney does not. In the glossy, full-color promotional materials sent to a patient by Barnet Dulaney in response to inquiries about laser refractive surgery, nowhere is FDA approval mentioned. Instead, the promotional section on PRK and LASIK tells patients, "The doctors and staff at Barnet Dulaney Laser and Refractive Institute are among the most experienced in the United States at performing corneal shaping. Over 15,000 refractive surgery procedures have been performed since 1984." It does not state that at the time the material was received, Barnet and Dulaney had only performed about 100 procedures using the homemade excimer laser--and they perform only LASIK, not PRK, according to staff members.
The closest the material comes to advising patients of the investigational nature of the device is a heading that reads: "EXCIMER LASER: A Promising Instrument Still Being Tested for Many Procedures" written next to a photo of a doctor dressed in surgical garb and wearing a surgical mask and cap, apparently in the process of using the laser on a patient.
The future of these excimer lasers, and the people who make them, is in question. An FDA regional compliance official involved in the Sullivan investigation says any ophthalmologist who now contacts Sullivan to have him build an excimer laser "could make a substantial investment--and if the agency feels that these things should be off the market, they could lose the whole device.
"The current political climate is to give the companies a chance to come into compliance," he said. "But if the agency decides to seize these devices, it would not look very good if US Marshalls burst into the doctor's office and decided to seize the product in front of all his patients. I am not saying that is what we are going to do, but that is one option the agency has."
So far the FDA has not seen fit to shut down any of the excimer laser centers or confiscate any of the homemade devices, in part because the agency has received no reports of any patient injuries. However, within portions of the ophthalmic community, increasing questions are being raised about quality control, proper technique, development of appropriate algorithms, and other technical, legal, and ethical issues. However, none of the physicians, employees, or others familiar with the lasers' operations have apparently been willing to go on record with the FDA with any specific charges.
"We told [Sullivan] unequivocally that if we hear of any injuries" caused by the use of his lasers, said the FDA official, "that would put us in a different mode and we would be out there immediately to seize them. Right now we do not have that information and it does not appear it exists."
Lisa A. Kearns investigates and reports industry news for The Journal of Refractive Surgery.
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