We ask the NRC to immediately issue interim guidance on these three items.
1. Patients must be informed when they have experienced a radiation safety- and procedure-significant extravasation. This is a basic patient right. They need to know as soon as it happens to mitigate tissue damage. And they need to know how much radiation has entered their tissue, so they better understand the impact to their procedure and care.
2. Patients must be provided with simple, written information to help identify symptoms of extravasation injuries, and they must know when these symptoms might appear. Often there are no visible symptoms of underlying tissue injury.
3. Patients must be given written instructions from their provider explaining where to go and whom to talk to if they experience symptoms. This is necessary to ensure that their suspected radiation injury is, in fact, reported to NRC.
2. Patients must be provided with simple, written information to help identify symptoms of extravasation injuries, and they must know when these symptoms might appear. Often there are no visible symptoms of underlying tissue injury.
3. Patients must be given written instructions from their provider explaining where to go and whom to talk to if they experience symptoms. This is necessary to ensure that their suspected radiation injury is, in fact, reported to NRC.
Coalition Position Statements & Policy Recommendations
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Letter to incoming SNMMI President, Dr. Nadel
Date: July 10, 2023
Summary: We value the benefits of nuclear medicine procedures. But we are concerned that SNMMI does not share our focus on ensuring safer and transparent care. While SNMMI claims to have an “Eye on the Patient,” in public comments, on-line discussions by your members, publications from your medical journal, and activities during your recent annual meeting do not match your words. |
Public Comment for Rulemaking
Date: May 24, 2023
Summary: We respectfully urge the NRC to seriously consider the harm caused to patients by extravasation. Unfortunately, recent instructions by the Commissioners to the NRC medical staff will only make matters worse for patients. Patients should not be required to report extravasations. Nuclear medicine providers should be responsible for reporting these misadministrations. |
Public Comment for May 15 ACMUI Meeting
Date: May 9, 2023
Summary: The NRC Commissioners’ decision places additional burdens on patients. The NRC is essentially creating rules that impose upon patients the responsibility of monitoring themselves for an indefinite period, which could range from weeks to months, or even years, to detect radiation injury, despite their inability to discern if they have been extravasated. |
Supporting Information Correction Request
Date: March 3, 2023
Summary: The coalition supports the Information Correction Request in response to Commission Paper SECY-22-0043, which was used in the drafting of the Nuclear Regulatory Commission’s (NRC) response to Petition for Rulemaking regarding extravasation reporting. |
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Coalition Disappointed in NRC Decision
Date: January 9, 2023
Summary: While acknowledging that the reporting exemption for extravasations is no longer supportable, the NRC is initiating a rulemaking that would place responsibility for identifying a radiation safety-significant extravasation on the patient. Letter to Health Physics Society (HPS)
Date: October 4, 2021
Summary: We contacted the HPS to raise concern about public comments submitted to the NRC in 2020 regarding petition PRM-35-22. We believe the statement from HPS does not reflect “excellence in the science and practice of radiation safety.” |
Information Correction Request to the NRC
Date: June 2, 2022
Summary: Thousands of patients represented by the Patients for Safer Nuclear Medicine Coalition, and the 620 individual signatories, request that the NRC correct inaccurate information that was published in the Federal Register regarding nuclear medicine extravasations Response to Patient Injury Recommendation
Date: September 10, 2021
Summary: Disappointed by the September 2 Advisory Committee on the Medical Uses of Isotopes (ACMUI) discussion of nuclear medicine extravasations. The ACMUI recommended a course of action that prioritizes the interest of nuclear medicine practices at the expense of patient care. |
Coalition Fears the NRC is Unduly Influenced
Date: January 18, 2022
Summary: This letter was spurred by the Dec. 27 opinion piece in STAT by Dr. Dan Fass. He believes the NRC is allowing the industry it regulates to influence whether medical events remain hidden from patients. The piece is accompanied by supportive comments from experts. Public Comment for 9/2/21 ACMUI Hearing
Date: August 27, 2021
Summary: We ask the NRC to adopt recommendations made in the petition in Docket: NRC-2020-0141. We believe that patients, their physicians, and the NRC should all be made aware of radiopharmaceutical extravasations that exceed the medical event reporting limit. |
OAS Agrees with Coalition Position on Extravasation
Date: October 20, 2021
Summary: We commend the Organization of Agreement States (OAS) and fully agree that the petition before the NRC should be immediately accepted. Requiring the reporting of extravasations is medically necessary and will encourage providers to ensure nuclear medicine is as safe and effective as possible. Coalition Asks CORAR to Educate SNMMI
Date: July 27, 2021
Summary: We are encouraging Council on Radionuclides and Radiopharmaceuticals (CORAR) Trade Association, to educate SNMMI members on the negative effects of radiopharmaceutical extravasations and the need to report significant occurrences. |