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
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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. |
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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. |
Letter to SNMMI President
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. Download. |
Public Comment for Rulemaking
Date: May 24, 2023
Summary: 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. 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. |
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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. |