ML24178A339
| ML24178A339 | |
| Person / Time | |
|---|---|
| Issue date: | 06/17/2024 |
| From: | Advisory Committee on the Medical Uses of Isotopes |
| To: | |
| References | |
| NRC-2869 | |
| Download: ML24178A339 (1) | |
Text
To Whom It May Concern:
Thank you for considering this public statement regarding the June 17th meeting to discuss the ACMUIs subcommittee report on the NRC staffs proposed changes to NRCs requirements for medical use of byproduct material to address reporting of nuclear medicine injection extravasations as medical events.
I am Daniel G. Guerra Jr., founder and CEO of Altus, a technology services company that focuses on radiation technologists who work in clinics and hospitals to keep patients safe during medical imaging such as CT scans and radiation therapy. Altus offers a range of products including continuing education courses for radiation technologists, tools for clinics to organize their credentialing requirements, and webinars for scientific device manufacturers.
I have followed with great interest the actions of NRC, ACMUI, and Congress regarding medical event reporting of nuclear medicine extravasations. A couple of years ago, Altus hosted a panel discussion focusing on how radiopharmaceutical extravasation affects the quality and quantification of nuclear medicine imaging studies, and a series of interviews with subject matter experts on the topic.
From lobbying disclosure records and a recent critical report by NRCs Office of the Inspector General, I have become aware that professional societies that represent nuclear medicine physicians, whose members populate ACMUI, are engaged in lobbying against medical event reporting of large extravasations. This policy position is counter to the views of prominent individual physicians and subject matter experts, and counter to the view of a large coalition made up of dozens of patient advocacy organizations.
I think all parties involved would agree this is an important issue for patient safety and transparency. I also believe it is critical that policymakers and regulators benefit from honest, unbiased, and unconflicted advice as they decide this policy issue. NRC, Congress, and the public must hear an open exchange of views on this matter, in which statements not borne out by scientific and clinical evidence can be challenged and debunked. Policy must be based on the best scientific evidence for the benefit of patients, not predetermined by well-placed insiders.
That is why I offer the services of Altus to host an online forum featuring proponents and opponents of medical event reporting of large extravasations can make their arguments and challenge statements that they believe to be false. I believe this would be illuminating and helpful for policymakers, regulators, and the public. I hope NRC and ACMUI consider this good-faith proposal and accept it in the spirit of supporting the best science for the benefit of patients.
I look forward to hearing from NRC and ACMUI about this possibility.
Daniel G. Guerra Jr., CEO Altus l PO Box 910 l Madison, WI 53701 Direct: 608-212-2391 l Email: dguerrajr@altusinc.co Website: https://altusinc.co l https://thenhti.org
I am writing to express my concerns regarding the NRC rulemaking process and the proposed rule.
The public is being asked to provide comments and questions regarding the recently announced ACMUI subcommittee report on NRCs proposed rulemaking for the reporting of extravasations. I have no insight into the what the report says and was given an extremely short turnaround time to submit a comment. Additionally, the published Special Investigation report from the OIG would lead me to believe that the two individuals accused of violating federal ethics rule should recuse themselves from discussing this of the ACMUI. The recommendation to use qualitative reporting criteria for patient injuries related to extravasation of radiopharmaceuticals is alarming. It disregards the longstanding reasons for dismissing such criteria, which were clearly outlined in the 1980 Federal Register.
The proposed rule by the NRC exacerbates the problem for patients. Most patients are unaware they are being injected with radiation during nuclear medicine scans. Many patients believe they are being injected with some kind of contrast or dye. Additionally, it is a well-known fact that patients are not given information about the symptoms of ionizing radiation damage. Without monitoring for extravasations and without crucial information of symptoms that may arise weeks, months, or even years later, patients will not know they Additionally, I have come to understand that nuclear medicine physicians typically do not take patient appointments. Even if they did, the question arises: who would bear the cost uld not have to shoulder.
My concerns extend to the broader issue of healthcare inequities and systemic racism in healthcare facilities. Qualitative patient-reported injury criteria disproportionately impact minorities. Since your committee lacks diversity, ACMUI may not fully grasp how unlikely it is for patients of color to report, much less convince a physician, that an injury is related to radiation exposure when there is no documentation of extravasation and potentially no for patients of color, further deepening the disparities in healthcare.
My stake in this issue is deeply personal. I started the New Day Foundation for Families in y sons receive yearly nuclear medicine scans due to their high risk of developing cancer. Without accurate.
Unfortunately, I cannot attend the June 17meeting due to previous commitments for my advocacy organization. I have two questions that I hope ACMUI will address during the meeting.
- 1. Have any of your members (on the subcommittee or the whole ACMUI) had any conversations with members of the professional societies regarding the subcommittee report before the June 17
- 2. Will the NRC and ACMUI reconsider the implementation of qualitative reporting imperative that we maintain objective, transparent, and accurate reporting standards to ensure patient safety and equity in healthcare. Large extravasations that exceed the existing NRC dose thresholds for a reasonable volume of healthy tissue indicate a potential problem in the handling of y than any other medical event. Not reporting these will continue to allow nuclear medicine centers to avoid improving their processes.
In summary, as a patient advocate, I do not feel that patients are being adequately represented in this process. I reiterate my concerns regarding the proposed rulemaking.
Existing objective medical event criteria should be followed.
Thank you for your attention to this critical matter.
Gina Kell Spehn New Day Foundation for Families FoundationForFamilies.org
Paul E. Wallner, DO, a radiation oncologist, representing the American College of Radiology. Please include my name as participating in the subcommittee Teams call today, and as I indicated in my oral comments, these are the remarks that I would request be appended to the meeting transcript:
For your report of recommendations, the ACR asks ACMUI to consider making these 3 additional recommendations to NRC staff
- 1. Recommend that a radiation injury require medical intervention, such as surgery, to be reported as this proposed Medical Event type. The Commissioners decision explicitly directed NRC staff to focus on radiation injuries requiring medical attention, which indicates a higher level of safety concern than is evident in the draft proposed rule. Importantly, this rulemaking is about what patient data is collected in a federal database without a patients consentit should be of radiation safety significance and of actionable concern to NRC. In this regard, if a CTCAE grade is to be included in the recommendations, the minimum reporting grade should be grade 3.
- 2. Also, for the radiation injury regulatory definition, recommend changing the speculative verbiage can be attributed to radiation to the more explicit has been attributed to radiation or is most likely to be attributed to radiation. Radiation attribution is key. This ensures data is correctly scoped to NRCs authority over byproduct material, and that NRC is not collecting common reactions to sterilization, needle puncture, non-radioactive substances, adhesive, or bandaging.
- 3. In the regulatory language for the new Medical Event type, recommend deleting or has the potential to result in (a radiation injury). This is speculative and likely to result in downstream compliance burden and confusion by investigators or licensees.
Thank you.
Paul E. Wallner, DO
Simon Davies Executive Director Teen Cancer America Tel: 310 208 0400 11845 Olympic Blvd. #775W Los Angeles, CA 90064 simon@teencanceramerica.org www.teencanceramerica.org
My name is Stephen Harris and I am a vascular access nurse and the Director of Research and Development for Vascular Wellness. Vascular Wellness is a multi-state vascular access company with a very high understanding of vascular access and the tools, training, and skills required to properly place and maintain vascular access. I have also previously been a clinical educator for Bard Access, a medical device company specializing in vascular access. Furthermore, I am also a co-author of a joint Vascular Access and Nuclear Medicine Technologist Expert peer-reviewed paper (https://www.frontiersin.org/articles/10.3389/fnume.2023.1244660/full) on the current manuscript was published, at the Annual SNMMI meeting a year ago in Chicago. I believe many you need to see my credentials, please reach out to me on our company website Since, my position involves an extensive amount of traveling to help hospitals across the Southeast written comment regarding the ACMUI subcommittee report on the proposed NRC rule and guidance for the reporting of large extravasations. In fact, I am drafting this comment now from a hospital based in southern Virginia and I will be traveling on June 17.
I also appreciate the opportunity to comment for another important reason. I have reviewed the an expert in vascular access.
er 20 years and have extensive experience working with nuclear medicine technologists trying to gain access in nuclear medicine the extravasation discuss from my review in any of the history of this issue. In fact, the only vascular access connection I have found is a public comment from one of the leading vascular access societies, the Association for Vascular Access (AVA). AVA made several important statements(emphasis added)that should be reconsidered here:
Many adverse outcomes related to vascular access are immediately recognized while others, like extravasation of radiopharmaceuticals, may go unrecognized for a prolonged period of time (sometimes years) and may be associated with negative outcomes including missed diagnosis or suboptimal treatment of nuclear therapy used to treat malignancies.
Clinician education is essential to avoid negative complications associated with venous access. Consistent, evidence-based education is lacking among clinicians who are expected to perform the procedure.
Monitoring a vascular access device for complications like extravasation is a critical responsibility of the healthcare provider. Prevention and reduction of device complications may be achieved through clinician education, evidence-based education, and avoiding blind-stick insertions. Finally, healthcare consumers must be educated about the risks associated with vascular access and enable them to become advocates for safe vascular access in all care settings.
I make these points because I do not have access to the ACMUI subcommittee report on the NRC having access to the report, I can only comment on the proposed rule as I know it. And my
comments on the proposed rule are in agreement with the AVA - monitoring for a complication like extravasations is a critical responsibility of the healthcare provider. Our Best Practices manuscript clearly shows that nuclear medicine technologists are not using anything close to the current best practices in vascular access. Conversations with nuclear medicine technologists online also show they have not been taught best practices. These knowledge and training gaps indicate that the onus is on the provider to close them. It is not in any way the responsibility of patients. As a vascular access expert, I want to be perfectly clear in my comments.
Putting any responsibility on patients to monitor for or identify when they have been extravasated is entirely inappropriate. It is the responsibility of the nuclear medicine team to monitor for and identify extravasations when they happen. And then take the necessary steps to mitigate patient harm. Waiting to see if extravasated patients report injury has no place in vascular access management and especially when the purpose of vascular access is for the administration of radioactive drugs.
I would also like to make one other observation for the ACMUI and NRC to consider. Recently, a paper was published from the south of India. Nuclear medicine physicians found that without the tients with darker skin more frequently than those with lighter skin. Based on my experience, this does not surprise me. And highly likely that patients of color are being extravasated at a higher rate than those with lighter color skin. A proposed rulemaking that puts the reporting requirements on patients will lead to an increase in health inequity. It is well known that patients of color are far less likely to report errors in their care than Caucasian patients.
My view as a vascular access expert is simple. NRC should scrap any idea of having patients play a role in monitoring and reporting poor quality administrations. If the NRC wants to protect patients, I suggest they treat extravasations like any other medical event. Centers that routinely have extravasations will then be forced to take the steps appropriate for their center to resolve their high absolutely the right recommendation for patients and healthcare.
I welcome any questions from any member of the NRC or ACMUI, and thank you for the opportunity to provide comment. You have my email address.
Stephen Harris CRNI, VA-BC Director, Research and Development Vascular Wellness 919-623-0675