ML20056C201
| ML20056C201 | |
| Person / Time | |
|---|---|
| Issue date: | 03/18/1993 |
| From: | Siegel B NRC ADVISORY COMMITTEE ON MEDICAL USES OF ISOTOPES (ACMUI) |
| To: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20056C200 | List: |
| References | |
| NACMUI, NUDOCS 9304270292 | |
| Download: ML20056C201 (4) | |
Text
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UNITED STATES
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B NUCLEAR REGULATORY COMMISSION E'.
If WASHINGTON, D.C. 20666-0001
\\...../
MEMORANDUM FOR:
Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety, NMSS FROM:
Barry A. Siegel, M.D., Chairman Advisory Committee-on the Medical Uses of Isotopes
SUBJECT:
SUMMARY
REPORT - MEETING OF THE ADVISORY COMMITTEE ON THE MEDICAL.USES OF IS0 TOPES, February 21, 1993 The Advisory Committee on the Medical Uses of Isotopes (ACMI) met on February 21, 1993 at 2:00 p.m. in the fiuclear Regulatory Commission's One White Flint-North Building in rooms 1-F-7 and 9.
Committee members present at the meeting were:
Barry Siegel, M.D., Chairman Peter Almond, Ph.D.
Judith Brown Steve Collins Daniel Flynn, M.D.
Melvin Griem, M.D.
Donald Hamilton A. Eric Jones, M.D.
Also present: John E. Glenn, Ph.D, (NRC),. (Designated Federal Official for'-
1 the panel), and Larry W. Camper, Section Leader, Medical and Academic Section, NRC.
The ACMUI met to prepare for their meeting with the Commission, scheduled for February 22, 1993. The following topics.were discussed:
1.
NRC's resnonse to the Plain Dealer articles
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Dr. Siegel) stated that although the Plain Dealer articles contained a large amount of factual information, it was presented in a sensationalistic manner.
The following] observations were made regarding the series:
In reviewing the number of therapy misadministrations, the denominator (of administrations) is only mentioned in passing.
Relative risks could have been emphasized since byproduct material ~is not uniquely hazardous.
(d s o 4 r 1 0 2 9 L XA
Statements in the series, relative to NRC's awareness (or apparent lack of awareness) of patient's " pain and suffering", were troubling.
The articles ~ referred to NRC's limits of statutory responsibility as though NRC itself limits its regulatory purview to byproduct material.
Judith Brown stated that the Cleveland Plain Dealer had performed a public service in printing the series.
She believes the articles focused attention on the need for public awareness of safety problems in radiation oncology and nuclear medicine.
Dr. Flynn believes the NRC response to the Plain Dealer articles and the incident in Indiana, Pennsylvania should focus chiefly on those licensees that need help, rather than on those with well-developed programs that rarely make errors.
It was pointed out that the NRC's tendency to group all medical uses of byproduct material under the term " Nuclear Medicine" was incorrect. Nuclear Medicine is aqt Radiation Oncology. Radiation Oncology is more dangerous from the point of view of the quantity of radioactive material used and patient radiation safety. A potential generic term proposed by the ACMUI is
" Radiation Medicine."
The ACMUI agreed that the committee stands ready to assist NRC in any way possible with any review of the medical use program.
2.
Patient Notification and Follow-uo Evaluation:
The following points were made during the ensuing discussion:
The professional " standard of care" is to tell the patient the truth about medical errors or other incidents. The responsibility for patient notification in cases of medical incident lies with both the physician and the institution.
Not informing in cases where incidents have occurred may represent fraudulent concealment, but there is not necessarily a legal duty to inform if there is no injury.
NRC requirements for patient notification exceed that which is required by the current standard.
FDA has authority to require patient notification if a device constitutes some danger to patients. No other Federal regulations require notification of the patient in the event of a medical incident.
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If the decision that the patient not be told is made by the referring physician, NRC has no legal authority to compel the referring physician to comply with NRC regulations.
i The committee agreed that NRC should seek the help of medical consultants to evaluate reports of =misadministrations. Patient notification should include a description of the misadministration, a description of all j
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actual or reasonably probable effects of the misadministration, and a plan for continued care or follow-up. Ms. Brown felt the patient also should be given an estimate of the financial consequences of such follow-up or continued care.
The committee agreed that when the aatient is not notified, a consultant should be asked to assess whether tie justifications for this decision are medically appropriate. Judith Brown indicated that lack of notification should not be justifiable simply because the referring physician claimed it was in his or her "best medical judgement" not to inform.
The committee felt that determining the reporting threshold for stochastic effects is a complicated policy issue, that would warrant much further discussion.
Concerning the need for a registry for patient follow-up or other data gathering mechanism, the committee agreed that it was necessary to keep track of patient misadministrations, as well as, other incidents with generic implications. However, patient follow-up to assess long-term affects was not felt to be a prudent use of NRC resources, since little useful new scientific information about radiation effects could derive from study of such a small number of patients.
The committee agreed that it is not NRC's role to act as " plaintiff's attorney."
Under-reportina of Events:
The ACHUI has no better data on under reporting of misadministrations than does the NRC. The procedures established by the Quality Managemant rule appear to provide the best opportunity to gather that data.
NRC Reaulatory Purview:
DR. Siegel reiterated the statement that byproduct material is not uniquely hazardous. The Atomic Energy Act limits NRC's authority to the regulation of byproduct material.
According to data provided by the American College of Radiology, of all of the radiological procedures performed in the United States, approximately 6% would be subject to NRC regulation if NRC had authority for medical.uses in all 50 States. Since NRC has only about one-third of licensees, it thus has direct authority for about 2% of ionizing radiation use in medicine. The ACHUI recommends that more uniform standards (or regulations) would have greater credibility, but is not certain whether NRC or another Federal agency with more direct overall responsibility for healthcare policy, financing, and regulation should have such global authority.
Brachytheraov Reaulation:
The ACHUI reviewed aspects of the misadministration that occurred in Indiana, Pennsylvania and agreed upon the following recommendations:
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Regulations.need to be developed that specifically address high-dose-rate afterloaders (HDR), since 10 CFR Part 35 is currently silent on these devices and procedures.
In HDR treatments, both the physician and medical physicist must be physically present at the console at the time of the treatment, and be prepared to respond in the event of a device failure or other emergency.
A recommendation was made that NRC review the training and experience requirements for RS0s, physicists, and technologists who practice HDR brachytherapy.
It was agreed by the ACMUI that, at the February 22, 1993, Commission briefing, DR. Siegel would give all of the committee's presentation except for the brachytherapy portion, which would be presented by Dr. Flynn.
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6 AW, $t.h, Barry A. Siegel, M.D., Chairman 3-l&-93 Date 4