Senate hearing slams NRC medical regulation

May 19, 1993

The regulation of medical radiation came under fire this monthat a Congressional hearing held to follow up on reports of treatmenterrors in radiation therapy and nuclear medicine. The hearingcould be the first step in an overhaul of the way in which

The regulation of medical radiation came under fire this monthat a Congressional hearing held to follow up on reports of treatmenterrors in radiation therapy and nuclear medicine. The hearingcould be the first step in an overhaul of the way in which medicalradiation is regulated.

The hearing took place in Sen. John Glenn's (D-OH) GovernmentalAffairs Committee and was the result of newspaper reports, includingan investigative series by the Cleveland Plain Dealer, that describedradiation treatment errors (SCAN 1/27/93).

The Plain Dealer series claimed that patient safety has beenjeopardized by the patchwork of federal and state agencies withauthority over medical radiation. The series also faulted theNuclear Regulatory Commission for failing to enforce regulationsand for keeping inadequate records of radiation misadministrations.

The newspaper series, however, confused nuclear medicine withradiation therapy, leading readers to believe that the radiationtherapy errors described in the articles were the result of nuclearmedicine procedures. Nuclear medicine advocates have been tryingto clear up the confusion by differentiating their specialty fromradiation therapy. The latter could experience a serious regulatoryhit because of the scrutiny.

Nuclear medicine's cause was aided by opening comments fromNRC chairman Ivan Selin. Selin clearly defined the differencebetween radiation therapy and nuclear medicine and said that radiationtherapy should be the main topic of the hearing.

"Most, although not all, of the focus of our current concernis on therapeutic misadministrations," Selin said. "Ourtestimony will focus on radiotherapy since this is the area wherethe consequences of potential errors are generally the greatest."

Also testifying at the hearing were Dr. Bruce Burlington, directorof the Center for Devices and Radiological Health at the Foodand Drug Administration, and Aubrey Godwin, chairman of the Conferenceof Radiation Control Program Directors.

Much of the testimony concentrated on the consistency of medicalradiation regulation, which is divided between the FDA, the NRCand state agencies. One major problem is that the various agenciesinvolved often don't know what the others are doing, accordingto a committee aide.

"Regulation in this area is very scattered, fragmentedand inconsistent," the aide said. "We found instanceswhere people who were convicted of felony violations for coveringup radiation overexposures at hospitals went to other states andgot jobs as radiation safety officers. There are obviously somebig holes in the regulations here."

Senators also found fault with the NRC's knowledge of the numberof radiation misadministrations that occur each year.

"It appears that we don't really know how many peopleare being put at risk," the aide said. "The NRC doesn'tknow with any degree of confidence what the rate of misadministrationis. We don't know how many people have been injured or killed."

The committee ordered the NRC and the FDA to develop proposalsto improve oversight of medical radiation. The agencies were toldto report back to the committee by Aug. 6.

PROPOSALS COULD RANGE from methods to improve communication betweenagencies to a major overhaul of medical radiation regulation thatwould consolidate oversight of radiation-producing devices underone federal agency.

The FDA regulates the design and manufacture of x-ray-producingdevices and investigates instances of device failure but not humanerror. The NRC has more stringent regulations regarding the practiceof medical radiation, but its jurisdiction is confined to areasin which reactor-produced isotopes are used.

"You have two agencies with fundamentally different approachesto regulation," the committee aide said. "One has aquantitative risk-based approach to end use and the other basicallyonly regulates the design and manufacture of devices."

Glenn is likely to introduce some kind of legislation on theissue, the content of which will be shaped by the proposals madeby the NRC and FDA, the aide said.

While nuclear medicine escaped the hearing largely unscathed,it could be affected by any new regulation even if such effortsare targeted at radiation therapy.

The specialty's public image also suffered another hit aftertwo news reports on the hearing repeated the Plain Dealer errorby confusing radiation therapy and nuclear medicine.

An Associated Press story published in the Washington Postwas headlined "Nuclear Medicine's Risks Unreported,"despite the fact that much of the testimony in the hearing concernedradiation therapy. An ABC news story on the hearing containeda similar error, according to Kristen D.W. Morris, director ofgovernment relations for the American College of Nuclear Physiciansand the Society of Nuclear Medicine.

"The fallout from the hearing has been horrible,"Morris said. "Every time a new story comes out it just reinforcesthe confusion, and it really hurts the credibility of physicianswhen they have to explain that the newspapers made a mistake."