Trimedyne Gets FDA Warning on Lasers
Regulators have warned Trimedyne Inc. to correct alleged deficiencies in the manufacture of its surgical lasers.
On April 7, the federal U.S. Food and Drug Administration issued the Irvine company a warning letter alleging that it had failed to report information involving injuries to individuals treated with its laser systems and that it hadn’t established procedures to make sure its products conform to specifications.
The letter, reporting results of an agency investigation of the company’s Irvine factory, also indicated the company’s plans to remedy the situation are “adequate.” The agency indicated that changes involving certain technical issues are still being evaluated.
James Kelly, Trimedyne’s chief financial officer, noted, “We want to be both in technical compliance and, in spirit, in conformity with the rules.”
In the letter, the agency contended the company failed to make sure that all complaints involving the quality, safety or performance of its products are appropriately reviewed. It said the company hadn’t evaluated about 25 reports of damaged mirrors inside machines, noting that damage to a mirror could change the laser beam that’s emitted during surgery.
One expert, while unfamiliar with Trimedyne’s situation, said laser injuries normally involve burning or charring of tissue.
Kelly wouldn’t specify how many cases of injury the agency concluded it should have reported to regulators. He said, however, that a couple of injuries resulted when a physician was using the laser in an experimental way.
The “holmium” lasers in question--Trimedyne’s major product line--are approved for urological and gynecological surgeries and other applications. A single product lists for $125,000, weighs hundreds of pounds, and is about the size of a floor-model copy machine.
In 1995, the FDA issued 1,557 such warning letters to companies making medical devices, drugs, foods and cosmetics, with the device makers receiving 657 of the total. An agency spokeswoman said such warnings generally are sufficient to motivate companies to comply with regulations, so the agency doesn’t resort to more serious measures.
