Review of NRC licensing also targets x-ray rules

Congressional hearings called to investigate problems in the NuclearRegulatory Commission's medical licensing program will also discussthe regulation of x-ray devices. One focus of the hearings willbe whether more uniform federal standards are needed for the regulationof radiation-producing devices, according to a congressional aide.

The hearings are the result of a series of newspaper articlesin the Cleveland Plain Dealer that investigated treatment errorsin radiation therapy and nuclear medicine (SCAN 1/27/93). Theseries described a number of deaths caused by radiation overdosesduring medical treatment and excoriated the NRC for its failureto keep more accurate records of radiation misadministrations.

The series prompted Sen. John Glenn (D-OH) and Rep. MichaelSynar (D-OK) to call for congressional hearings on the NRC's medicallicensing program. The NRC regulates medical products createdby nuclear reactors, such as radioisotopes used in nuclear medicineimaging and cobalt-based radiation therapy. X-ray imaging devicesand x-ray linear accelerators for radiation therapy are not regulatedby the NRC.

A hearing in Glenn's Governmental Affairs Committee has beenscheduled for April 22; a hearing date in Synar's Government Operationssubcommittee on environment, energy and natural resources hasnot yet been set.

The Glenn hearing will deal with more than NRC regulation ofradiation therapy and nuclear medicine. The scope of the hearinghas broadened to include x-ray-producing devices regulated bythe Food and Drug Administration, according to an aide.

"We're looking into accelerators, CT scanners, x-ray machinesand fluoroscopy devices," the aide told SCAN. "The regulationof medical radiation is really fragmented, and the approachesbeing taken are different (among) the different regulating parties.The NRC has a much different approach than the FDA. The stateshave different approaches from each other."

For example, technical manufacturing criteria for CT scannersdo not require inclusion of a device to measure radiation doseduring use, he said. This makes it impossible for a state regulatorto know how a scanner is actually performing.

The Glenn hearing will also cover operator training, radiationmisadministration reporting requirements, FDA inspections of devicemanufacturers and the division of regulation between states andthe FDA.

"We are bumping into the larger issue of the quality ofhealth care that Americans receive as it is impacted by the regulationor the absence of regulation in this particular area of medicine,"the aide said. "There needs to be some clear federal guidancefor policies concerning the wide-scale use of (radiation-producing)devices."

Representatives from the FDA and the NRC will probably testifyat the hearing, according to the aide. Several medical professionalsocieties and equipment manufacturer associations may appear aswell.