NRC Proposes $5,500 Fine for Washington, D.C., Hospital for Temporary Loss of Nuclear-Powered Pacemaker

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NRC NEWS U. S. NUCLEAR REGULATORY COMMISSION OFFICE OF PUBLIC AFFAIRS, REGION I 475 Allendale Road, King of Prussia, Pa. 19406

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I-99-23
April 1, 1999

CONTACT:

Diane Screnci (610)337-5330/ e-mail: dps@nrc.gov Neil A. Sheehan (610)337-5331/e-mail: nas@nrc.gov

 

NRC PROPOSES $5,500 FINE FOR WASHINGTON, D.C., HOSPITAL
FOR TEMPORARY LOSS OF NUCLEAR-POWERED PACEMAKER

The Nuclear Regulatory Commission has proposed a $5,500 fine against a Washington, D.C., medical facility for a violation of agency requirements involving the handling of radioactive material. Specifically, the violation stems from the temporary loss of a nuclear-powered pacemaker.

Washington Hospital Center, 110 Irving Street, N.W., reported to the NRC last Nov. 30 that a nuclear pacemaker was missing. During a follow-up review on Dec. 2 and 3, NRC inspectors learned the device, which contained 2.8 curies of plutonium-238, had been removed from a deceased patient at a funeral home last August and returned to the medical facility for disposal. Washington Hospital Center, in turn, shipped the pacemaker on Sept. 15 to St. Jude Medical in Sylmar, Calif., via the U.S. Postal Service, believing St. Jude was the proper recipient of the device. (Once removed, nuclear pacemakers are supposed to be returned to the company that sold them for proper disposal.)

However, when Washington Hospital Center contacted St. Jude Medical on or about Oct. 22 to confirm receipt of the pacemaker, it was informed the device had not arrived. Further, the hospital learned St. Jude was only supposed to receive non-nuclear pacemakers; nuclear pacemakers were to be shipped to a company in Colorado which has a storage facility for the devices in Florida.

Despite searches for the pacemaker at Washington Hospital Center, St. Jude Medical and postal facilities, the device was not located until March 26, when Washington Hospital Center reported to the NRC it had been found at a company in St. Paul, Minn. While the nuclear material is housed in an extremely sturdy metal container, if someone had ruptured the device they could have received a dose from radioactive material in excess of NRC allowable limits.

On Feb. 8, NRC staff held a predecisional enforcement conference with officials of the medical facility to discuss several apparent violations relating to the incident, along with their causes and corrective actions. Based on the information gathered at the meeting and by NRC inspectors, the agency has determined the loss of control of the pacemaker between Sept. 15, when it was being prepared for shipment, and March 26 constitutes a violation. A fine of $5,500 is being proposed for that violation because of the particularly poor performance of the medical facility. In addition, the NRC cited, but did not fine, Washington Hospital Center for another violation: the failure to make a timely report to the agency after the pacemaker was found to be lost or missing.

In a letter to the Washington Hospital Center notifying it of the violations, NRC Region I Administrator Hubert J. Miller noted three predecisional enforcement conferences have been held in the past two years to discuss violations at the facility. "The violations discussed at the prior two conferences resulted in the NRC issuance of $5,000 and $2,750 civil penalties on April 10, 1997, and April 28, 1998, respectively," Mr. Miller wrote. "In each of those cases, the failure to provide adequate training and instruction to staff was a contributing factor, as it was in a prior civil penalty issued to you on April 28, 1994, for other violations at your facility. In this case, the failure to train hazardous materials personnel in the applicable Department of Transportation requirements may have been a root cause of the loss of control of the pacemaker."

Eight additional apparent violations involving Department of Transportation requirements will be referred to the U.S. Postal Service for its review and action, as appropriate.

Washington Hospital Center is required to respond to the Notice of Violation within 30 days, addressing among other things how it will ensure future off-site shipments of radioactive material meet requirements.