ATL refutes UM 7 overheat warning

A Food and Drug Administration warning to Advanced TechnologyLaboratories (ATL) regarding its Ultramark 7 ultrasound systemappears to have been successfully refuted by the company.

ATL, headquartered in Bothell, WA, manufactures and distributesfour ultrasound systems in the Ultramark series. The Ultramark7 was introduced in 1990 as a compact, mobile unit aimed at private-officeand hospital-based cardiology users.

The FDA warning, issued in October, stemmed from concerns aboutpotential overheating of the Ultramark 7 transducer. During in-housetests, ATL researchers discovered that circuit failures couldcause the transducer to become warm to the touch, said Terry Sweeney,director of regulatory affairs for ATL. The problem was firstidentified in late 1991. The company subsequently informed theFDA and then took steps to correct it.

The increased transducer temperature could potentially causeproblems only if used in ob/gyn applications, however, and theUltramark 7 is designed and marketed as a cardiac scanner. Nevertheless,possible harm to fetal bone was the primary concern of FDA investigators,according to the agency's letter. The agency issued standingorders in October that any new product applications by ATL wouldbe placed on hold until the problem was corrected.

Further regulatory action is unlikely, however, because ofa detailed response sent by ATL that clarifies the scanner's appropriateapplications.

In its November response, ATL detailed its discovery and reportageof the defect in 1991 and emphasized that the scanner is intendedfor cardiac applications only.

"So far, the FDA has not responded, but in unofficialconversations we've been given to understand that it agrees thesystem is not intended for fetal scanning," Sweeney said."At no time has the agency initiated a product recall ofthe Ultramark 7."

The company also refuted claims made by the FDA that ATL violatedgood manufacturing practices and medical device reporting requirements.The FDA claimed ATL was two weeks late in filing its defect report,although the company claims the document was filed within thelegal 15-day reporting limit.

The case has not been finalized by the FDA, but the ATL responseappears to have assuaged agency concerns, according to Wally Tellerite,an FDA staffer in the agency's office of compliance.

"It appears that the warning letter may have resultedfrom inadequate information," he said. "We've receivedATL's letter, in which it states the unit is only intended forcardiac use, not fetal scanning. With this additional information,the problem should be resolved without further regulatory action."

Other details about the FDA investigation are confidentialuntil the case is closed, Tellerite said.

According to conversations between ATL and the FDA, however,the agency's ban on pending approvals will be lifted followingan on-site audit, which will probably occur within six months,Sweeney said. The time lag will not adversely affect ATL products,he said.

"We don't have any works-in-progress that will be affectedduring that time period," he said. "We don't have anythingpending that is that close to approval."

That includes ATL's ultrasound image management system, whichwas discussed on the floor at the Radiological Society of NorthAmerica meeting. ATL has yet to file a new product applicationfor the system.