Reporting requirements currently in section 35.33 would not be entirely abandoned. On August 26, 1993, the NRC and the FDA created a memorandum of understanding to coordinate existing NRC and FDA regulatory programs for medical devices, drugs, and biological products that use byproduct, source, or special nuclear material. The committee urges the NRC to continue to cooperate with the FDA as provided in their memorandum of understanding to obtain data on devices, drugs, and biological products that relate to device malfunction, serious injury, and death. This coordinated effort between the two agencies will capture important data on technology and human (user) error related to device use but will exclude information relative to medical or technical judgment. This also reinforces the notion that the NRC, like the FDA, should not intervene in the practice of medicine.

B2. The committee recommends that the NRC initiate formal steps under the Administrative Procedure Act to revoke Part 35 in its entirety, if Congress fails to act within two years in response to the two recommendations to Congress stated above.

In addition to overly stringent enforcement, the regulations themselves are excessive and duplicative: 10 CFR Part 35 covers areas that either are already regulated at the institutional level or are best left to the states, to professional societies, and to patients in consultation with their doctors. States regulate the medical uses of other forms of ionizing radiation and, as discussed below, could easily fold byproduct material into their regulatory programs. The CRCPD could add byproduct material to its suggested state regulations. These additions could incorporate relevant concepts currently in Part 35 (see discussion below under Recommendation C1 to the CRCPD and states). The FDA collects data on adverse effects of radiopharmaceuticals and incidents of failure of radiation-emitting medical devices, and it could assume the monitoring responsibilities of the NRC.

Quality improvement programs are put in place by institutions and health plans, with the support of the Joint Commission on Accreditation of Healthcare Organizations and other private accreditation organizations. Doctors have ethical obligations, codified in professional standards, for informing patients of medical errors. The committee believes that the relatively low misadministration rate could be maintained by less stringent programs that are administered at the state level by professional societies, and by existing liability law.

The committee strongly endorses the formal route of notice and comment, subject to the Administrative Procedure Act, to accomplish the rescission of all of Part 35. The committee recognizes that this process will take some time.

B3. The committee recommends that the NRC separate the costs of formulating regulations from the costs of administering those regulations.



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