Senate mulls report on medical radiation rules

November 3, 1993

An initiative to reform the way medical radiation is regulatedis moving slowly through the federal bureaucracy--but moving nonetheless.The initiative, which was spawned by a series of investigativearticles in the Cleveland Plain Dealer, has already

An initiative to reform the way medical radiation is regulatedis moving slowly through the federal bureaucracy--but moving nonetheless.The initiative, which was spawned by a series of investigativearticles in the Cleveland Plain Dealer, has already resulted inan agreement between federal agencies to coordinate their medicalregulatory activities more closely.

The Plain Dealer series was published in December 1992 anddetailed radiation treatment errors in radiation therapy and nuclearmedicine (SCAN 1/27/93). The series claimed that patient safetyhas been jeopardized by a patchwork of federal and state agencieswith authority to regulate medical radiation. The series alsoclaimed that the NRC did not keep adequate track of radiationtreatment errors.

The series infuriated nuclear medicine physicians by confusingnuclear medicine with radiation therapy and by focusing on whatphysicians said were anomalies in an otherwise exemplary safetyrecord. The articles gained enough notoriety, however, to triggera congressional hearing May 6 in Sen. John Glenn's (D-OH) GovernmentalAffairs Committee.

At the hearing, the committee found that the two federal agencieswith authority over medical radiation, the Nuclear RegulatoryCommission and the Food and Drug Administration, often were inthe dark about each other's regulatory activities. The committeeordered the NRC and the FDA to develop proposals to improve cooperationbetween the two (SCAN 5/19/93).

The agencies responded in August by issuing a memorandum ofunderstanding (MOU) covering the regulation of medical devices,drugs and biological products using byproduct, source or specialnuclear material.

Under the MOU, the agencies agreed to notify each other whenthey receive reports of a device malfunction or treatment error.Each agency assigned a contact person to act as a liaison to speedexchange of information and to ensure appropriate follow-up toadverse event reports.

The agencies also agreed to share information submitted inproduct approval applications if the product in question couldbe related to the regulatory mission of the other agency.

In addition to the MOU, in September an NRC task force submittedto Glenn's committee a report on improving government regulationof medical uses of ionizing radiation. For the most part, thereport stated that there is not enough information about the adequacyof the current regulatory system to decide whether it should bechanged.

Instead, the task force recommended that the federal governmentset performance standards for medical uses of radiation, thenconduct surveys to determine if the standards are being met. Thetask force offered a range of options for reforming the systemif the standards are not met.

"We are unable to quantify the adequacy of today's frameworkor fully evaluate the effect of changing to any of the other regulatoryoptions," the report said. "We are only able to indicatethat if problems exist in a certain area, for example radiationtherapy, then a specific option may be best for addressing theseproblems."

The options recommended by the task force consisted of differentmethods for structuring the division of labor between federalagencies and the states for medical radiation regulation.

GLENN COULD USE THE REPORT'S recommendations as a springboardfor more stringent regulation of medical radiation, although insubmitting the report the task force stated that it believed thechanges should be made within the existing regulatory frameworkand that no new legislation is needed.

A Glenn staffer, however, was disappointed with the equivocaltone of the report and said legislation could be forthcoming.

"They say that sufficient data are not available,"the aide said. "That may be true, but they go on to say,`If it ain't broke, don't fix it.' You still have problems outthere that aren't going to go away."

Glenn's committee is examining the possibility of strengtheningregulatory requirements for devices that have a low probabilityof causing treatment errors but have serious consequences whenerrors do occur. Such devices include linear accelerators, othertypes of radiation therapy devices and fluoroscopy devices. Nuclearmedicine would probably not be included in such an initiative.

"The one thing we've concluded is that (the report) doesnot address the issue of a more formal and disciplined regulatoryapproach to devices with low probability and high consequences,"the aide said. "The idea is to establish quantitative safetyenvelopes for these devices. These things need to be looked atmore carefully."

Fluoroscopy devices with high-level control modes in particularneed more stringent government oversight and could be the targetof legislation, the aide said.

High-level control fluoroscopy is also the target of regulatorychanges proposed by the FDA. The proposal as published in theMay 3 edition of the Federal Register would set an exposure limitof 20 roentgens (R) per minute for high-level control fluoroscopy.A 1991 study by University of California at Los Angeles researchersfound that maximum exposure rates for high-level fluoroscopy rangedfrom 21 to 93 R/minute. Radiation therapy uses radiation beamsat levels over 40 to 50 R/minute.

If adopted, the new regulations would require manufacturersto install hardware on fluoroscopy devices to limit radiationoutput, although some manufacturers already make devices thatcomply with the proposed limit.

The proposed rules will be effective one year from the daythe final version is published in the Federal Register.