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.

Coalition Position Statements & Policy Recommendations

​Office of Inspector General (OIG) Complaint

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 October 2022, January 2023, and February 2023, we provided further information. We have, however, continued to see evidence that indicate NRC management has failed to appropriately address the patient safety matter of large extravasations.
October 23, 2023
Download

​Letter to NRC Commissioners

We have recently become aware of two published papers that 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 clearly supported by another paper published a dozen years earlier by Chamberlain, Koniaris, Wu, and Pawlik.
October 3, 2023
Download

Letter to SNMMI President Dr. Helen Nadel

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.
July 10, 2023
Download

Public Comment for Rulemaking

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.
May 24, 2023
Download

Public Comment for May 15 ACMUI Meeting

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.
May 9, 2023
Download

Supporting Information Correction Request

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.
March 3, 2023
Download

Coalition Disappointed in NRC Decision

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.
January 9, 2023
Download

Information Correction Request to the NRC

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.
June 2, 2022
Download

Coalition Fears the NRC is Unduly Influenced

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.
January 18, 2022
Download

    Contact us
Proudly powered by Weebly