By Matt Fields, MD, FACEP
I’ve enjoyed having the opportunity to serve you as chair for the first few months. Here are some notable items on which we have been working:
Many of you may have heard about a letter sent from the FDA to multiple organizations and ultrasound companies. The letter states that the FDA has “concerns” about the marketing of ultrasound as “over-the-counter” where ultrasound is used and not interpreted by a “licensed practitioner”, citing ultrasound in this manner would be a violation of the Food and Drug Cosmetic Act. Additionally, the letter goes on to state that the “FDA strongly discourages such uses at exhibitions, trade shows, and other venues where ultrasound devices are demonstrated on humans”, stating that such uses are not in keeping with ALARA and may pose risk without benefit. The beginning of the letter seems, at first, to be targeting the marketing of ultrasound for use as an at-home pregnancy monitor. This seems agreeable; however, the second part of the letter targeting ultrasound use for device demonstration could have implications for ultrasound vendors at trade shows and educational programs. Overall, it is not clear what, if any, action is required. ACEP is currently working with AIUM on further clarifying and resolving this issue with the FDA. I will keep you updated as this process develops.
We will learn this month the outcome of the ABMS vote on whether to establish the CFE pathway as an alternative pathway for certification. I will update the section as soon as I hear from our ABEM liaisons.
In the previous newsletter, I mentioned my concern about APCA (a division of RDMS, which is now being called Inteleos). APCA represents the new branch created for physician certification. APCA will be launching the “POCUS Academy” this April, aimed at certifying emergency physicians in basic point of care ultrasound. I hope you share my sentiment that this is ludicrous. I want to reiterate that this violates the tenets of our own EUS Guidelines as well as an explicit resolution approved by ACEP Board of Directors in 2014. Please make your less ultrasound savvy colleagues aware that ACEP does not endorse this certification. Also, I implore everyone to realize that Inteleos does not have EM interests at heart. For those of you who have RDMS, I understand why in the past it was often necessary to obtain this, but things have changed. You are supporting a company that is attempting to profit by undermining our guidelines and methods of credentialing. Please do not renew any RDMS, RDCS, RMSK or other credentialing by non-EM based entities. Additionally, please discourage any residents or fellows from pursuing these merit badges.
Thank you so far for all of your contributions. We have had some turnover in committee leadership. Look for a survey to come out soon, asking everyone to reconfirm interest in staying on their respective committees, as well as to update contact information.
J. Matthew Fields, MD, FACEP
Chair, Emergency Ultrasound Section
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