RIS 2007-27, Improving Public Understanding of the Risks Associated with Medical Events
| ML071360295 | |
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| Issue date: | 12/05/2007 |
| From: | Schlueter J NRC/FSME/DMSSA |
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| References | |
| RIS-07-027 | |
| Preceding documents: |
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| Download: ML071360295 (11) | |
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF FEDERAL AND STATE MATERIALS
AND ENVIRONMENTAL MANAGEMENT PROGRAMS
WASHINGTON, D.C. 20555 December 5, 2007 NRC REGULATORY ISSUE SUMMARY 2007-27 IMPROVING PUBLIC UNDERSTANDING OF THE RISKS ASSOCIATED
WITH MEDICAL EVENTS
ADDRESSEES
All U.S. Nuclear Regulatory Commission (NRC) medical use licensees. All Radiation Control Program Directors, and State Liaison Officers.
INTENT
NRC is issuing this Regulatory Issue Summary (RIS) to help improve public understanding of the risks associated with medical events (MEs), as described in 10 CFR 35.3045. No specific action or written response is required. NRC is providing this RIS to Agreement States for their information and for distribution to their medical licensees, as appropriate.
BACKGROUND
On April 24, 2002, the Commission published a final rule in the Federal Register amending 10 CFR Part 35, Medical Use of Byproduct Material, in its entirety (67 FR 20250). The revision includes a section, 10 CFR 35.3045, Report and Notification of a Medical Event, that provides criteria for reporting and notifying individuals about an ME. The requirements in this section of the final rule are based on those in the previous 10 CFR 35.33, Notifications, Reports, and Records of Misadministrations. An ME is defined in 10 CFR 35.2, Definitions, as an event that meets the criteria in 10 CFR 35.3045(a) or (b). The final rule can be viewed on the NRC
public web site, at http://www.nrc.gov/reading-rm/doc-collections/cfr/part035/.
In Staff Requirements Memorandum (SRM)-M040302B dated March 16, 2004, the Commission directed the staff to, among other tasks, provide recommendations on how to effectively communicate to the public the risks, if any, associated with MEs. The Commission also directed the staff to involve the Advisory Committee on the Medical Uses of Isotopes (ACMUI)
in the development of its recommendations.
In SECY-05-0234, dated December 7, 2005, the NRC staff submitted recommendations to improve public understanding of the risks associated with MEs, and in SRM-SECY-05-0234, dated February 15, 2006, the Commission approved those recommendations. The staffs recommendations were based on certain guiding principles, a recommendation, and a suggestion developed by the ACMUI. The SRM can be viewed on the NRC public web site, at http://www.nrc.gov/reading-rm/doc-collections/commission/srm/2005/2005-0234srm.html. This RIS is one of the mechanisms that the Commission approved for improving public understanding of the risks associated with medical events (MEs).
SUMMARY OF ISSUE
For all medical uses, without exception, there are two criteria that apply to reporting an ME.
These criteria appear in 10 CFR 35.3045(a). One criterion is the percent variation of delivered dose from prescribed dose exceeding a threshold; it is referred to as the variance threshold.
The other criterion is the difference between the delivered dose and the prescribed dose (or dose that would have resulted from the prescribed dosage) exceeding a threshold; it is referred to as the difference-in-dose threshold.
The variance threshold for licensee submission of an ME report is an administered total dose (or dosage) that differs by +/- 20 percent from the prescribed dose (or dosage) defined in the authorized user (AU) physicians written directive (WD). Since WDs are required primarily for administrations intended for therapeutic purposes, a +/- 20 percent variance can correspond to intended target doses reduced by or exceeded by approximately 0.5 Gray (Gy) (50 rads) to 18 Gy (1800 rads).1 The basis for this variance threshold for reporting an ME, as discussed below, is that variances of this magnitude may reflect quality assurance (QA) problems with the licensees programs and also have the potential, though not the certainty, to result in harm to the involved patients or human research subjects.
The basis for the variance threshold for reporting an ME, in part, reflects a general consensus among the members of the ACMUI active during the general revision of 10 CFR Part 35 concluded in 2002, and among recent past and current members of the ACMUI. The consensus is that a variance in total delivered dose, or dosage, of 20 percent or more from that intended (prescribed) (1) has a significant potential, though not a certainty, to cause harm to the involved patient or research subject and (2) could indicate a deficiency in the licensees program for ensuring that byproduct material is used as directed by the AU, even if the variance did not necessarily indicate a significant risk to the involved patient or research subject. The ACMUI rationale for this position is that the +/- 20% variance threshold is a reasonable threshold for identifying events indicative of treatment delivery problems in accurately realizing AUs clinical intentions. NRC staff agrees with the ACMUI rationale for this variance threshold criterion for ME reporting and notes that no events involving medical use have resulted in this threshold being questioned.
1 Both Gray and rad are units of radiation dose, reflecting the amount of energy deposited in a given quantity of matter, in this case, tissue. The consensus of the ACMUI was that a total dose error of 20 percent in a cancer treatment regimen could lead to inadequate treatment of the cancer (underdosing) or to an increased likelihood of complications (overdosing). However, a variance threshold of 10 percent was considered to be too low for reporting MEs, since such differences were well within the range of standard-of-care variations from one practitioner to another. In contrast, for the difference-in- dose thresholds criterion for MEs,2 a diagnostic radiopharmaceutical over-dosing error that resulted in either the excess effective dose equivalent slightly exceeding 0.05 Sv (5 rem) or the excess organ, tissue, or skin dose slightly exceeding 0.5 Sv (50 rem) would only rarely, if ever, result in actual harm to the patient or research subject. However, the absolute magnitude of the dosage error would likely be large enough (considerably exceeding 20%) to warrant reporting. The consensus of the ACMUI was that the NRC would have a legitimate interest in over-dosages where either of these difference-in-dose thresholds for ME reporting was exceeded.
The ACMUI recommended in July 2005, as general guiding principles, that NRC consider MEs as performance indicators of technical or QA problems in accurately realizing clinical intentions of AUs, but not as indicators of actual or probable patient harm. NRC staff endorses and supports this ACMUI position, which is consistent with the position NRC stated in the supplementary information accompanying publication of the 2002 Part 35 rule, at 67 FR 20330
(April 24, 2002).
At its meeting in October 2005, the ACMUI offered an additional recommendation and a suggestion on the issue of improving public understanding of the risks associated with MEs.
The NRC staff generally supports the ACMUI recommendation not to disclose/release event information to the public until the event has been confirmed to be a reportable ME, but with one modification. Specifically, in the interest of openness and timeliness, the NRC has determined that information should be provided to the public about events reported as MEs when the events have been confirmed to be MEs or after five calendar days have passed, even if the events have not yet been confirmed as MEs. The staff also endorses and has implemented the intent of the ACMUI suggestion to footnote each Event Summary released to the public as a reportable ME to indicate that the thresholds in NRCs ME criteria, if exceeded, are not necessarily indicative of patient harm.
In summary:
1. NRCs ME criteria provide thresholds for identifying events indicative of technical or QA
problems in accurately achieving the clinical intentions (prescriptions) of AUs;
2. Thresholds in NRCs ME criteria, if exceeded, are not necessarily indicative of patient harm.
2 A difference in effective dose equivalent of 0.05 Sievert (Sv) (5 rem) from prescription or a difference in organ, tissue, or skin dose of 0.5 Sv (50 rem) from prescription. This summary has been incorporated into an NRC fact sheet, available on the NRC public web site, located at http://www.nrc.gov/reading-rm/doc-collections/fact-sheets/risks-assoc-medical- events.html.
BACKFIT DISCUSSION
This RIS requires no action or written response. Any action on the part of addressees in accordance with the guidance contained in this RIS is strictly voluntary and, therefore, is not a backfit under any regulatory requirement in Title 10, Code of Federal Regulations.
Consequently, the staff did not perform a backfit analysis.
FEDERAL REGISTER NOTIFICATION
A notice of opportunity for public comment on this RIS was not published in the Federal Register because this RIS is informational and does not represent a departure from current regulatory requirements.
PAPERWORK REDUCTION ACT STATEMENT
This Regulatory Issue Summary contains information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These information collections were approved by the Office of Management and Budget, approval number; 3150-0010.
Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number
CONGRESSIONAL REVIEW ACT
This RIS is not a rule as designated by the Congressional Review Act (5 U.S.C. §§ 801-886)
and, therefore, is not subject to the Act.
CONTACT
This RIS requires no specific action or written response. If you have any questions about this summary, please contact the individual listed below or the appropriate regional office.
/RA/
Janet R. Schlueter, Director Division of Materials Safety and State Agreements Office of Federal and State Materials and Environmental Management Programs
Technical Contact:
Ronald Zelac, FSME
(301) 415-7635 E-mail: rez@nrc.gov Enclosure: List of Recently Issued NMSS/FSME
Generic Communications
CONTACT
This RIS requires no specific action or written response. If you have any questions about this summary, please contact one of the individuals listed below or the appropriate regional office.
/RA/
Janet R. Schlueter, Director Division of Materials Safety and State Agreements Office of Federal and State Materials and Environmental Management Programs
Technical Contact:
Ronald Zelac, FSME
(301) 415-7635 E-mail: rez@nrc.gov Enclosure: List of FSME/NMSS
Generic Communications (2007)
OFFICE MSSA/MSEA Tech. Editor DMSSA/MSEA DMSSA/MSEA DMSSA/MSEA
NAME RZelac QTE via email CFlannery AMcIntosh SWastler DATE 11/6/07 11/08/07 11/16/07 11/08/07 / /07 OFFICE OIS OGC - NLO OGC - CRA DMSSA DMSSA
NAME TDonnell FCameron TRothschild RLewis JSchlueter DATE 5/17/07 10/09/07 10/18/07 12/5/07 12/5/07 OFFICIAL RECORD COPY
RIS 2007-27 List of Issued FSME/NMSS Generic Communications (2007)
Date GC No. Subject
Addressees
02/02/07 IN-07-03 Reportable Medical Events All U.S. Nuclear Regulatory Involving Patients Receiving Commission medical use licensees Dosages of Sodium Iodide Iodine- and NRC Master Materials Licensees.
131 less than the Prescribed All Agreement State Radiation Control Dosage Because of Program Directors and State Liaison Capsules Remaining in Vials after Officers.
Administration
02/28/07 IN-07-08 Potential Vulnerabilities of Time- All U. S. Nuclear Regulatory reliant Computer-based Systems Commission licensees and all Due to Change in Daylight Saving Agreement State Radiation Control Time Dates Program Directors and State Liaison Officers.
03/13/07 IN-07-10 Yttrium-90 Theraspheres and All U.S. Nuclear Regulatory Sirspheres Impurities Commission (NRC) Medical Licensees and NRC Master Materials Licensees. All Agreement State Radiation Control Program Directors and State Liaison Officers.
04/04/07 IN-07-13 Use of As-Found Conditions to All licensees authorized to possess a Evaluate Criticality-related Process critical mass of special nuclear Upsets at Fuel Cycle Facilities material.
05/02/07 IN-07-16 Common Violations of the All licensees who are implementing Increased Controls the U.S. Nuclear Regulatory Requirements and Related Commission (NRC) Order Imposing Guidance Documents Increased Controls (EA-05-090),
issued November 14, 2005 and December 22, 2005.
05/21/07 IN-07-19 Fire Protection Equipment Recalls All holders of operating licenses for and Counterfeit Notices nuclear power reactors and fuel cycle facilities; except those licensees for reactors that have permanently ceased operations and who have certified that fuel has been permanently removed from the reactor vessel; and except those licensees for decommissioned fuel cycle facilities.
06/11/07 IN-07-20 Use of Blank Ammunition All power reactors, Category I fuel cycle facilities, independent spent fuel storage installations, conversion facility, and gaseous diffusion plants.
RIS 2007-27 Date GC No. Subject
Addressees
07/19/07 IN-07-25 Suggestions from the Advisory All U.S. Nuclear Regulatory Committee on the Medical Use of Commission (NRC) medical-use Isotopes For Consideration to licensees and NRC Master Materials Improve Compliance With Sodium Licensees. All Agreement State Iodide I-131 Written Directive Radiation Control Program Directors Requirements in 10 CFR 35.40 and and State Liaison Officers.
Supervision Requirements in 10
CFR 35.27
08/08/07 IN-07-23 Inadvertent Discharge of Halon All holders of operating licenses for
1301Fire-suppression System from nuclear power reactors, except those Incorrect and/or Out-of-date who have permanently ended Procedures operations and have certified that fuel has been permanently removed from the reactor vessel. All holders of licenses for fuel cycle facilities.
08/13/07 IN-07-26 Combustibility of Epoxy Floor All holders of operating licenses for Coatings at Commercial Nuclear nuclear power reactors and fuel cycle Power Plants facilities except licensees for reactors that have permanently ceased operations and who have certified that fuel has been permanently removed from the reactor vessel.
09/13/07 IN-07-30 Radiological Controls Create All licensees authorized to possess a Criticality Safety Accident Scenario critical mass of special nuclear for Fissile Solution Container material.
Transport at Fuel Cycle Facility
09/28/07 IN-07-33 Exposures To Members Of The All U.S. Nuclear Regulatory Public Caused By Inadequate Commission Well Logging Licensees.
Controls Over Well Logging All Agreement State Radiation Control Sources Program Directors and State Liaison Officers.
10/15/07 IN-07-32 Out-of-Service Equipment All licensees authorized to possess a Connected to In-service Process critical mass of special nuclear Line Results in Fissile Solution Spill material at Fuel Cycle Facility
10/17/07 IN-07-35 Varian Medical Systems All U.S. Nuclear Regulatory Varisource HDR Events: Commission medical use licensees Iridium-192 Source Pulled From and NRC Master Materials Licensees Shielded Position authorized to possess or use a Varian Medical Systems VariSource High Dose Rate Remote Afterloader (VariSource HDR). All Agreement State Radiation Control Program Directors and State Liaison Officers.
03/01/07 RIS-07-03 Ionizing Radiation Warning Symbol All U.S. Nuclear Regulatory Commission licensees and certificate holders. All Radiation Control Program Directors and State Liaison Officers.
RIS 2007-27 Date GC No. Subject
Addressees
03/09/07 RIS-07-04 Personally Identifiable Information All holders of operating licenses for Submitted to the U.S. Nuclear nuclear power reactors and holders of Regulatory Commission and applicants for certificates for reactor designs. All licensees, certificate holders, applicants, and other entities subject to regulation by the U.S. Nuclear Regulatory Commission of the use of source, byproduct, and special nuclear material.
03/20/07 RIS-07-05 Status and Plans for All NRC materials licensees, Implementation of NRC Regulatory Radiation Control Program Directors, Authority for Certain Naturally- State Liaison Officers, and NRCs occurring and Accelerator-produced Advisory Committee on the Medical Radioactive Material Uses of Isotopes.
04/05/07 RIS-07-07 Clarification of Increased Controls All U.S. Nuclear Regulatory for Licensees That Possess Commission licensees issued NRCs Collocated Radioactive Material Order Imposing Increased Controls During Transportation Activities and all Radiation Control Program Directors and State Liaison Officers
05/04/07 RIS-07-09 Examples of Recurring Requests for All holders of, and applicants for, a:
Additional Information (RAIs) for 10 (1) 10 CFR Part 71 certificate of CFR Part 71 and 72 Applications compliance (CoC) for a radioactive material transportation package; (2)
10 CFR Part 72 CoC for a spent fuel storage cask; and (3) 10 CFR Part 72 specific license for an independent spent fuel storage installation (ISFSI).
06/27/07 RIS-06-27, Availability of NRC 313A Series of All U.S. Nuclear Regulatory Suppl. 1 Forms and Guidance for Their Commission medical-use licensees Completion and NRC Master Materials licensees.
All Radiation Control Program Directors and State Liaison Officers.
05/15/07 RIS-07-10 Subscriptions To New List Server All U.S. Nuclear Regulatory For Automatic Notifications Of Commission medical-use licensees Medical-Related Generic and NRC Master Materials licensees.
Communications, Federal Register All Radiation Control Program Notices And Newsletters Directors and State Liaison Officers.
RIS 2007-27 Date GC No. Subject
Addressees
RIS-07-13 Verification of the Authenticity of All U.S. Nuclear Regulatory
08/31/07 Materials Possession Licenses Commission materials licensees. All Agreement State Radiation Control Program Directors and State Liaison Officers.
09/07/07 RIS-07-18 Data for Updating the Interim All U.S. Nuclear Regulatory Inventory of Radioactive Sources Commission (NRC) Part 40, Part 50,
Part 70, Part 72, and Part 76 licensees and certificate holders who are authorized to possess sources of radioactive material at the Category
3.5" activity or higher.
10/04/07 RIS-07-22 Status Update For Implementation All U.S. Nuclear Regulatory Of NRC Regulatory Authority for Commission materials licensees, Certain Naturally-Occurring and radiation control program directors, Accelerator-Produced Radioactive State liaison officers, and the NRCs Material Advisory Committee on the Medical Uses of Isotopes.
10/04/07 RIS-07-23 Date For Operation Of National All licensees authorized to possess Source Tracking System Category 1 or Category 2 quantities of radioactive materials. All Radiation Control Program Directors and State Liaison Officers.