ML22138A437
| ML22138A437 | |
| Person / Time | |
|---|---|
| Issue date: | 05/17/2022 |
| From: | Sarah Lopas Office of Nuclear Material Safety and Safeguards |
| To: | Garner R - No Known Affiliation |
| S. Lopas, NMSS/MSST | |
| References | |
| LTR-22-0141 | |
| Download: ML22138A437 (4) | |
Text
From: Lopas, Sarah To: randrewgarner@bellsouth.net Cc: Valentin-Rodriguez, Celimar; Clark, Brooke; McCloskey, Bridin; Einberg, Christian; Bavol, Rochelle
Subject:
Following up on your emails regarding nuclear medicine extravasations Date: Tuesday, May 17, 2022 6:00:55 PM Attachments: image001.png Good afternoon Mr. Garner, My name is Sarah Lopas, I am a Medical Radiation Safety Project Manager at the U.S. Nuclear Regulatory Commission (NRC) and am the point-of-contact for the NRC staffs evaluation of reporting extravasations as medical events. Ms. Jamerson received your email dated July 11, 2021, in which you submitted a written statement for the consideration of the Advisory Committee on the Medical Uses of Isotopes (ACMUI) for their September 2, 2021, meeting on extravasations. The ACMUI reviewed your written statement, and it was appended to the September 2 ACMUI meeting transcript, which is available at https://www.nrc.gov/docs/ML2128/ML21286A807.pdf. A summary of the September 2 meeting is available at https://www.nrc.gov/docs/ML2126/ML21267A021.pdf and the ACMUI extravasation subcommittees final report is available at https://www.nrc.gov/docs/ML2128/ML21288A125.pdf.
Thank you very much for taking the time to provide your perspective on extravasations as a nuclear cardiology patientI also remember your participation in the staffs December 2020 public meeting.
The NRC staff considered your July 11 written statement and December 8 public comment, along with other public comments, in its evaluation of whether extravasations should be reported as medical events. The Commission is now considering the staffs evaluation and recommendations. If you would like to be notified when the Commission makes a decision about regulating extravasations, please let me know and I will add your email to the NRCs medical announcements email distribution list, which provides timely notification of medical-related NRC regulatory actions.
If you have any questions or need additional information, please contact me.
Thank you again, Sarah Lopas Sarah L. Lopas (she/her)
Project Manager MSST Vision:
Medical Safety and Events Assessment Branch Active partnership and Division of Materials Safety, Security, trustworthy leadership for...
State, and Tribal Programs safety and security, Office of Nuclear Material Safety and Safeguards engaged people, U.S. Nuclear Regulatory Commission reliable relationships, and Sarah.Lopas@nrc.gov l 301-415-6360 smart regulatory solutions HQ T-5D37 most Tuesdays and Thursdays From: randrewgarner@bellsouth.net <randrewgarner@bellsouth.net>
Sent: Sunday, July 11, 2021 2:39 PM To: 'Kellee.Jamerson@nrc.gov' <Kellee.Jamerson@nrc.gov>
Cc: 'David.Crowley@dhhs.nc.gov' <David.Crowley@dhhs.nc.gov>
Subject:
Written statement for the July 15, NRC ACMUI meeting Good afternoon, Ms. Jamerson.
My name is Drew Garner. I am a recently retired executive with a finance background. I understand the importance of processes in getting repeatable results. I understand the need for quality control, checks, and balances, and for transparency. During my 40+ year career I was the Chief Financial Officer at several large organizations. While the financial processes were very similar from one business to the next, I had to quickly learn about the markets, customers, and product technical details for each new business I joined. As a result, I am no stranger to new concepts. When I became a nuclear medicine cardiology patient, I wanted to learn all about these processes, too. As a result, I became aware of the extravasation issues several years ago. As you may recall, I participated in, and provided a comment during, the December 8, 2020, public comment meeting.
Thank you for providing the opportunity then and this opportunity now. I am also providing these comments to my representatives in Congress, as I have done in the past.
I was pleased to see that the last two ACMUI patient advocates who completed their terms, Dr.
Darrell Fisher through public comment and Ms. Lara Weil through a dissenting opinion as a member of the Subcommittee on Extravasations, both support the reporting of significant extravasations.
However, as I mentioned during the December 8th meeting, it is concerning to me that the patient voice is typically not reflected in many of the conversations regarding extravasations. To help ensure the patient perspective is heard, I have continued to research the extravasation topic, including the associated physics, and I have several comments to provide the NRC and the ACMUI. I also have specific questions for the ACMUI members and would appreciate hearing their responses during the meeting.
In 2019, the ACMUI Subcommittee on Extravasations recommendations referenced the 2008/2009 ACMUI decision to retain the exemption. A review of the actual transcripts of these meetings (not just the final recommendation) showed that the previous ACMUI members discussed that diagnostic extravasations were common, that doses could easily exceed reporting limits, and that they could be avoided if licensees used the more careful therapy administration technique for diagnostics administrations. Comments regarding the causes of extravasations focused on the experience level and training of the technologists performing the administrations, as well as their techniques and injection tools that they used. Despite all the discussion of points that suggested the exemption should be removed, the transcripts provide insight into the reason the ACMUI supported the retention of the reporting exemption. ACMUI member Dr. Nag, discussing doses of 3-5 Sv that exceeded the reporting limit and would qualify as medical events without the exemption in place, said: However the first thing before us is, should NRC consider it as a medical event. Now if we consider this as a medical event, if we go through all the procedures and identify whatever-3 or 4 or 5-- the patient will have to be informed; the physician will have to be informed, blah blah blah, and the - you have to go into all the reporting mechanisms. And therefore, I am thoroughly against this being reported as a medical event.
Did the subcommittee members or any of the ACMUI members read the actual transcripts of these meetings? If not, why not? If so, what has happened since 2009 that has resulted in passive patient intervention to be the cause of extravasations rather than the causes your predecessors outlined several years ago? If so, why did they ignore the evidence that the exemption should be removed? And how could they endorse this previous recommendation that traded patient safety for keeping clinician reporting to a minimum?
It is my understanding that the reason that the NRC initially exempted extravasations from being reported in 1980 is because the NRC was told that extravasations were nearly impossible to avoid.
Since one of the reasons for misadministration or medical event reporting is to share learnings from these events to prevent them from occurring again, I am assuming the NRC concluded that if these events are impossible to avoid then they should not be reported. I read the Association for Vascular Access position statement. I also attended a recent webinar to hear what vascular access experts had to say about radiopharmaceutical administration techniques. All of these vascular access experts clearly state extravasations can be avoided. They also claim it is NOT the patients fault. I also have read many examples in the literature that show definitive, immediate reduction in extravasation
rates from hospitals that actively monitor their administrations. I also saw an interesting letter submitted on March 16, 2021, by Dr. Daniel Fass. Dr Fass and several other experts highlighted a statement by an SNMMI leader. This leader submitted a comment to NRC that monitoring is not expected to improve administration techniques. However, this same leader co-authored a poster presented at an SNMMI meeting. In the poster, he clearly stated that active monitoring did in fact improve administrations and ongoing monitoring was important to ensure technologists did not return to their previous ineffective techniques.
What specific evidence did the Subcommittee on Extravasation members find that would support the 1979-1980 comment that extravasations are nearly impossible to avoid? Have the members talked to vascular access experts about passive patient intervention, and if so, what did the experts say?
The subcommittee members also concluded that no diagnostic radiopharmaceutical extravasation could in fact, exceed the reporting limit of 0.5 Sieverts. I understand that diagnostic isotopes produce gamma rays that will not deposit significant energy in patient tissue, but in that same webinar, I heard Dr. Fisher explain that these isotopes also have other energy emissions. I also read Dr. Sheetz comments in the March 16, 2021, transcripts regarding the cystic model of radioactivity in the tissue.
Mr. Sheetz is a radiation safety officer. Can he explain his cystic comment that he made to Dr.
van der Pol? Does he think that the extravasated radioactivity is somehow not irradiating tissue in the area near the injection site? Can he describe what happens when 10 mCi of 18F is extravasated during an FDG injection like the recent case from North Dakota that the NRC asked the center to retract? Isnt a positron essentially a positively charged electron? If the fluorine atoms can be imaged in an area of arm tissue near the injection site, wouldnt all of the positron energy be deposited within in just a few millimeters of the fluorine atoms? If you know that you injected the entire dose into the tissue and you determine the amount of extravasated activity at time of imaging, Dr. Fisher says you can estimate biological clearance; in this case, would not the absorbed dose to 5-10 cm3 of arm tissue be far greater than 0.5 Gy?
In the recent NRC staff report on medical events, a patient received a dose of 7 sieverts when a Lu-177 therapeutic radiopharmaceutical leaked on their skin during a procedure. The patient confirmed that her tissue did experience radiation injury. My understanding is that the unit of measure, sieverts, takes into consideration the type of energy emission.
So, isnt the 7 sieverts irradiation from F-18 the same as 7 sieverts from Lu-177 in the medical event accepted by the NRC? If so, other than the 1980 policy, does it make any sense that the North Dakota case is not a medical event? Shouldnt we follow this patient to see if tissue damage happens later?
As I noted earlier, I attended a webinar in May where experts discussed radiopharmaceutical extravasations. Two vascular access experts showed an image of patient that had gone through the same cardiology study that I went through. Unfortunately, it appeared that much of the Tc99M radioactivity from both injections was extravasated. Dr. Fisher described that Tc99M is more than a gamma emitter. That ~12% of the energy emitted are conversion electrons, Auger electrons, and low energy gamma rays, while I am not sure what all this energy actually is, by the end of the week, the patient began experiencing very disturbing tissue reactions. This leads me to two questions.
Didnt this diagnostic radiopharmaceutical extravasation obviously exceed the reporting limit?
Since radiation injury can take weeks, months, or more likely years to show, how does a licensee, how do the societies, how does the ACMUI actually know that tissue doses are not exceeding either the reporting or adverse tissue reaction thresholds if hospitals do not perform dosimetry on these extravasations?
I would like to make one final observation; this is directed for the NRC staff. There seems to be a belief that there is a conflict of interest regarding the petition. As a patient, here is what I have seen and heard. There have been comments that the company Lucerno Dynamics has a product to sell that can help solve this problem. If so, what is the problem? In the NRC request for public comments the NRC stated that they encourage authorized users to use the latest technology to help them deliver radioactive material safely. It seems to me that this company has developed technology that cannot only help clinicians know when they have an extravasation, but also help technologists
improve their technique and to determine the biological clearance of a radiopharmaceutical. I think the device can provide the technologist insight right away if there may be a problem. From the patient perspective, I would be asking the NRC and providers why arent you REQUIRING this process be monitored with that device? Again, from the patient perspective, if this company discovered that the 1980 exemption is incorrect, why do I care if they sell their products to hospitals to help them fix this issue. To me the really important question that has come from my researching this issue is the fact that the ACMUI has the true conflict of interest. Dr. Nags specific comment is very disturbing.
The ongoing ACMUI focus on blaming patients for extravasations makes me question the ACMUIs motives. And then I read the transcripts of the meeting between the subcommittee members and the NRC Commissioners. The changing stories, the evasion, and the misinformation shared with the Commissioners is not what I expect as a taxpayer paying these members to advise the NRC. My concerns were certainly reinforced by Dr. Schleipmans comments in the December 8 meeting. He mentioned his role in the ACMUI and then went on to describe a very large study. He implied to the NRC and to all who were listening that if extravasations were an issue, they would have been described in this million-patient study on adverse events. His comments made me take pause before I decided to speak at that meeting and certainly tempered the public statements I did eventually make at the end of that same meeting. Then, months later, I read the comment from Dr. Daniel Fass that pointed out that Dr. Schleipman had failed to mention that extravasations and any issues from extravasations had been specifically excluded from the million-patient study. I thought that was completely unacceptable and it frankly makes me question the credibility of the ACMUI. I would encourage the NRC and Congress to reevaluate the role that the ACMUI specifically plays and should play when it comes to discussing the merits of regulations intended to protect patients from inadvertent radiation doses.
Thank you again for providing me an opportunity to offer my opinions as a nuclear medicine patient.
Sincerely, Drew Garner