Goals and strategic focus of PSNM
1. U.S. Nuclear Regulatory Commission (NRC) must treat large extravasations just like any other medical event, ensuring patient safety and transparency in care.
2. Clinicians must effectively monitor injections so if an extravasation occurs, clinician can take immediate steps to mitigate tissue damage, and can better understand how much radiation has entered the tissue and the impact to the patient's procedure and care.
3. Clinicians must inform patients if the patient has experienced a large extravasation. It is a basic patient right.
2. Clinicians must effectively monitor injections so if an extravasation occurs, clinician can take immediate steps to mitigate tissue damage, and can better understand how much radiation has entered the tissue and the impact to the patient's procedure and care.
3. Clinicians must inform patients if the patient has experienced a large extravasation. It is a basic patient right.
Coalition Position Statements & Policy Recommendations
Letter to NIH
Date: January 30, 2025 Summary: The coalition respectfully urges NIH to take the next step on extravasation policy by supporting a legislative solution, the Nuclear Medicine Clarification Act. Download. |
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Asking NRC to Respond
Date: November 21, 2024 Summary: The October 16 letter from the Coalition highlighted patient concerns regarding the flaws in DG-8062 and urged the NRC to reject it in favor of a common-sense solution making extravasations reportable like any other medical event. These concerns remain unaddressed. Download. |
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Comment on Draft Regulatory Guide DG-8062
Date: October 16, 2024 Summary: DG-8062 continues the pattern NRC has followed since PSNM first contacted the agency more than three years ago: half-hearted, deeply flawed attempts to placate the hundreds of thousands of patients we collectively represent. This draft guide is deeply problematic but there is still time to do the right thing. Download. |
Letter to HPS President Brackett
Date: August 8, 2024 Summary: The coalition asked the Health Physics Society (HPS), an organization dedicated to radiation protection and the advancement of safety practices, why they signed a letter to Congress that is clearly not aligned with radiation protection or advancing safety practices. Download. |
Letter to NRC Medical Staff
Date: August 8, 2024 Summary: A published case report in the journal of Pharmacology Research & Perspectives adds significant weight to the growing body of evidence that extravasations occur frequently and can cause considerable harm. Despite compelling evidence such as this recent case report, it appears to us that NRC continues to rely uncritically on the unfounded and self-serving claims of professional societies that extravasations are rare and inconsequential. Download. |
ASTRO Conflicting Remarks
Date: July 17, 2024 Summary: Seeking clarification regarding conflicting statements made by the American Society for Radiation Oncology (ASTRO) in two separate correspondences concerning radiopharmaceutical injections and their impact on patient safety. ASTRO has lost focus on patient safety and ensuring the highest standards of care. Download. |
Letter to ACMUI Patient Advocate
Date: July 8, 2024 Summary: It is time for more robust and inclusive engagement with patients. We ask ACMUI Patient Advocate, Josh Mailman, to actively solicit input from experts who have no conflicts of interest, from patients who have firsthand experience with extravasations, and with members of underrepresented groups to understand their unique perspectives. Download. |
Experts Dispel Inaccurate Information
Date: June 28, 2024 Summary: Coalition members authored a letter to Congress detailing the pattern of misinformation coming from medical societies. Experts shared 11 examples of extravasations taken from centers that are dedicated to reducing their error rate. Download. |
Response to ACMUI Meeting
Date: June 24, 2024 Summary: The proposed rule, using injury as a criterion, could result in subjective assessment of extravasations, which is not in patients' best interest. When determining whether an extravasation has the potential to result in radiation injury, we recommend that NRC define objective criteria for dosimetry of extravasations so that assessments and reports from all licensees can be compared. Download. |
Request for Comprehensive NRC Oversight
Date: June 24, 2024 Summary: This is our second request that the NRC Inspector General thoroughly investigate all allegations in a timely manner to ensure comprehensive oversight and accountability. Holding these allegations for over six months and then suggesting limiting the investigation to only one of the five allegations neglects the broader pattern of behavior and systemic issues within the NRC. Download. |
NRC Committee Violates Federal Ethics
Date: April 3, 2024 Summary: Throughout the rulemaking process, PSNM has been concerned not only about the failure of NRC to close the 44-year-old extravasation loophole, but also the improper influence exercised over NRC by the community the NRC is supposed to regulate. The OIG report makes clear that NRC used biased information from conflicted advisors to develop the rule that you are now advancing, which essentially requires patients to diagnose and report their own radiopharmaceutical extravasations. Download. |
Follow-up to Chairman Hanson Meeting
Date: February 15, 2024 Summary: Thank you for meeting with members of the PSNM coalition on February 7. We appreciate the opportunity to discuss our ongoing concern about the failure of the NRC to monitor and require reporting of large extravasations, and the concern about improper influence over NRC by the very community it is charged with regulating – in particular, the agency’s relationship with the Society of Nuclear Medicine and Molecular Imaging (SNMMI). Download. |
Letter to NRC Chairman Hanson
Date: February 6, 2024 Summary: We believe that the NRC is failing in their responsibilities to protect patients. So, we will continue to work with the Office of Inspector General to ensure that there is an investigation into the influence of the licensees. We are also working with key members of Congress to get us the protection we deserve to treat these events no differently than any other event. We will do everything we can to educate the public directly and through the media. Download. |
Office of Inspector General (OIG) Complaint
Date: October 23, 2023 Summary: Since our initial meeting in the Spring of 2022, we have provided the OIG with additional documentation on how NRC was being negatively influenced by the industry they regulate. In Oct 2022, Jan 2023, and Feb 2023, we provided further information. We have continued to see evidence that indicate NRC management has failed to address the patient safety matter of large extravasations. Download. Letter to NRC Chairman Hanson
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Letter to NRC Commissioners
Date: October 3, 2023 Summary: Two published papers support our position and that NRC should read. Dr. Tim Bartholow published a paper stating that physicians are ethically obligated to report large extravasations and that patients need to be told when these extravasations occur. This viewpoint is supported by another paper published earlier by Chamberlain, Koniaris, Wu, and Pawlik. Download. |
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Public Comment for May 15 ACMUI Meeting
Date: May 9, 2023 Summary: The NRC is 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. Download. |
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. Download. |
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. Download. |
Information Correction Request to the NRC
Date: June 2, 2022 Summary: 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. Download. |
Coalition Fears the NRC is 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. Download. |
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