Wayne > wrote:
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Date: Mon, 11 Apr 2005 17:19:56 -0600
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From: "Wayne >To: Multiple recipients of list SONOGRAPHERS-CONNECTION <sonographers-connection@lists.uchsc.edu>
Subject: Re: Texas AG has taken action re: entertainment US
Audrey,
You make many interesting points. Nice argument. I would like to respond. First, the manufacturing and standards of performance for ultrasound devices are regulated by the FDA. However, the use of these devices is dictated by medical standards of practice which are outlined in each states medical practice act. So entertainment ultrasound could be argued to fall between the cracks. It does not involve preproduction equipment and does not involve medical practice. Just like you, I could call one of 15 contacts and have an ultrasound machine on the doorstep of my house tomorrow.
I agree with the whole 'abide by the rules' thing. But things may change in the next 15 years and I may want to test the waters. Sounds like you may too.
Restraint of Trade, by definition is "Illegally interfering with free marketplace participation" or "Descriptive of unreasonable acts or contracts which prevent a person from carrying on, or engaging in, their profession." If the courts rule that well qualified sonographers can not participate in these activities, but physicians can, this is restraint of trade. The FDA has done nothing meaningful to limit entertainment activities, thus they have not limited trade.
You state, "I would also argue that the world renowned physicians would be hesitant to set up a mall business or allow the machine to be taken into the baby store to scan people and put their name on it without having oversite"
Virtually all of these physicians have offices in medical office buildings or hospitals that they use to conduct these activities. I suppose I don't see the difference between conducting these types of activities in a hospital, a medical office building, a commercial property, or in the basement of your house. It is the activity that counts, not the setting. Our office (Platte River Perinatal Center) is smack dab in the center of the commercial district in Denver. Our building has (among others) real estate developers, e-learning companies, marketing firms and a hair dresser (I think that is what you call it). It used to be a casket factory! We are the only medical care provider in more than a mile in any direction. I don't think this has bearing on our professionalism or the appropriateness of the practice. It has more the do with the professionalism of the person providing the services than the setting of the services.
The oversite is another issue. Why is it necessary? Why wouldn't they demand oversight. I would if I were in their position. But I would be hard pressed to justify it.There are a number of professional sonographers who own their own imaging companies and contract out to physicians to provide interpretations. Years ago this was quite commonplace. Thus, and in opposition to the AMA position, physicians do not need to 'supervise' all ultrasound imaging activities. They merely need to be involved in the process (if the imaging is for medical purposes). I prefer to think of the physicians that I work with as my partners, neither superior nor inferior. They simply have a job that is different than mine.I absolutely do not believe the direct 'physician supervision' requirement is imperative in most settings.
You also state, "I also postulate that the physicians performing in-office entertainment exams do not provide them to any person who just shows up even if there has been no prenatal care. I will bet that befor the person pays their cash up-front money there is a pretty good assurance that the person has had medical care and the pregnancy is going as planned. And if a problem is found that the office physician is consulted and the patient counciled."
The AG's requirements do not address this. And frankly, I absolutely agree with you. Entertainment services should be provided only on patients who receive adequate prenatal care and have had 'official' ultrasound examinations. This can be a requirement in whatever setting the services are provided, so I don't understand the relevance of this argument. Careful standards can be applied and enforced irrespective of the setting or the health care provider. Obviously if you provided this service, you would have implemented a mechanism to alert physicians to potential complications were you to become suspicious. Appropriately qualified sonographers can do this. We do it every day. Are you suggesting that appropriately qualified sonographers should be prohibited from providing these services because they can not deal reasonably with these potential complications?
Here are some outtakes from a recent JAMA commentary on the topic. I have not included the who article but it is available from any medical library. (Read my final comment below):
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The Business of Baby Pictures
Controversy Brews Over "Keepsake" Fetal Ultrasounds
Rebecca Voelker
JAMA. 2005;293:25-27.
Fetal images created with 3-dimensional (3D) ultrasound as "keepsakes" for expectant couples have triggered a new debate about the provision of nonmedical services in physicians’ offices. The controversy stems from the advent of commercial operations in malls and other nonmedical settings offering fetal ultrasounds for the purpose of producing mementos, not diagnoses. These procedures may be performed by noncertified personnel with little more than a weekend’s worth of training. It’s difficult to estimate how many keepsake ultrasound businesses there are in the United States, but some claim to have branches in more than 20 states and others report that they perform more than 100 scans per month.
Earlier this year, as the popularity of the keepsake industry seemed to soar, the American Institute of Ultrasound in Medicine (AIUM) reaffirmed its stance against ultrasound used for nonmedical purposes. . . . "inappropriate and contrary to responsible medical practice."
Task Force Takes New Look
However, the AIUM may be rethinking its position. A task force convened to examine the keepsake issue more closely had its first meeting in early October. The 8-member panel represents the fields of obstetrics and gynecology, radiology, sonography, and basic science.
For now, the group is assessing the legal, ethical, and professional ramifications of producing keepsake photos and videos in physicians’ offices. As the task force arrives at some conclusions over the next several months, the AIUM will then discuss the issue with other medical groups, such as the American College of Obstetricians and Gynecologists (ACOG) and the American Registry of Diagnostic Medical Sonographers (ARDMS), which have endorsed the "prudent use" statement.
Physicians and other professionals who use ultrasound in their practices seem to fall primarily into two camps: those who believe keepsake ultrasound products have no place in either physicians’ offices or commercial venues and those who believe a limited role to provide these mementos may exist in medical practice. Copel says the task force will try to determine the point where physicians would cross the line from professionalism to "hucksterism" if their practices offered keepsake ultrasound products. "We don’t want to look like we’re practicing medicine out of the back of a wagon," he says.
It has long been customary for physicians to give their pregnant patients fetal photos from prenatal ultrasound scans. More recently, as technology has evolved, some have also put the images onto compact discs (CDs) and 1- or 2-minute videotapes. Among them are Delores Pretorius, MD, a member of the AIUM task force and professor of radiology at the University of California, San Diego, School of Medicine, and Lawrence Platt, MD, former AIUM president and director of the Center for Fetal Medicine and Women’s Ultrasound in Los Angeles.
"There’s nothing wrong with this in concept," says Platt. "We have a copy for the record and one for the patient."
Prescription Device
According to US Food and Drug Administration (FDA) regulations, ultrasound machines are prescription devices that should be used only for medical purposes and with a physician’s order. The FDA also sets standards for ultrasound power settings. It has issued vigorous warnings against nonmedical uses of ultrasound, and the agency can seize machines used without a prescription for entertainment purposes.
While the FDA regulates the machines, individual states have jurisdiction over the qualifications and conduct of professionals who use the machines. The agency encourages states to take action against technicians who perform nonmedical ultrasounds, but to date, only two have proposed or passed legislation on keepsake ultrasounds. A bill pending in New York would make it a misdemeanor offense to administer ultrasound without an order from a physician, nurse practitioner, or midwife. Legislation that takes effect next year in California requires women who have keepsake ultrasounds to sign a waiver stating they know that the FDA opposes the procedure.
The FDA warns of potential harm from ultrasound energy, but some physicians say the potential for risk is overstated. "There is no independent, confirmed evidence of harm from diagnostic medical sonography," says Copel. "It probably is ethical to offer [keepsake ultrasound] to patients if there is no danger that we can discern."
Unpublished evidence from animal studies by Pasko Rakic, MD, PhD, and colleagues at Yale University indicates that ultrasound can disrupt normal movement of cells through the brains of unborn mice; however, the relevance of the findings for humans is unclear. The group has just begun a $3 million study funded by the National Institute of Neurological Disorders and Stroke to examine the effect of ultrasound scans on rhesus macaque monkeys exposed during gestation.
ETHICAL CONUNDRUM
Another ethical conundrum is whether physicians should charge a fee if they offer the products. Commercial operations charge anywhere from $75 to determine fetal sex to $300 or more for a full package of photos and a CD, DVD, or videotape.
"There is a real cost of the print photograph, and to pass a nominal cost for that on to the patient is not of concern," says Michael Goldrich, MD, chair of the American Medical Association’s (AMA’s) Council on Ethical and Judicial Affairs. "But if there is a substantial fee for the product, then there is significant concern for the impact of that on the physician-patient relationship." The AMA opposes profit-making sales of non–health-related goods in physicians’ offices.
Proponents say consumer demand for keepsake ultrasounds has grown so much in recent years that the only way to ensure patient safety is to bring the practice into medical settings, where appropriately trained personnel follow a protocol that does not violate FDA regulations or AIUM standards.
One reason for the increased popularity of keepsake ultrasounds is the development of 3D ultrasound in the last decade. This allows expecting parents to clearly see facial features, fingers, and toes instead of the vague gray outlines of 2D fetal ultrasound.
"When you show a family the 3D image, they are awestruck," says Robert Wolfson, MD, PhD, a Colorado specialist in maternal-fetal medicine. Wolfson advocates keepsake ultrasound in medical settings as a tool that helps soon-to-be parents develop a connection with their unborn child. He and other proponents say this connection facilitates compliance with medical advice, which improves health outcomes for the mother and child.
In recent years, Wolfson and several other physicians have worked with Arizona entrepreneur Berkeley Geddes, cofounder of the FlipDog.com online job search Web site, to develop criteria for the provision of keepsake ultrasounds in medical settings.
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I don't know who is on the AIUM Task Force, but I genuinely hope that there is an outspoken sonographer on the panel. Any ideas Paula?
Thanks for your thoughtful response Audrey!
Wayne
>----- Original Message -----
From: Dan
To: Multiple recipients of list SONOGRAPHERS-CONNECTION
Sent: Monday, April 11, 2005 3:55 PM
Subject: Re: Texas AG has taken action re: entertainment US
Wayne et all,
I am not sure what my ultimate position on this topic is either. I sometimes want to get into the entertainment business for the money and freedom but feel that I should abide by the rules. It's a tough call.
I thought ultrasound machines were regulated by the FDA. As a regulated medical device they are to be used under physician supervision. That's one thing that really irritates me. The manufacturers and resalers can get away with ignoring the FDA regulations by selling to non-physicians and not be held culpable for the violation but the end user can't. Seems like a major double standard to me.
I still have my RT (R) but that does not allow me to buy an x-ray machine and offer digital soft tissue profiles to hang on your office wall as a conversation piece. X-ray machines are regulated by the FDA. same as ultrasound machines.
I don't see how anybody could claim restraint of trade since the trade is already restrained by the current FDA regulations.
I would also argue that the world renowned physicians would be hesitant to set up a mall business or allow the machine to be taken into the baby store to scan people and put their name on it without having oversite. I also postulate that the physicians performing in-office entertainment exams do not provide them to any person who just shows up even if there has been no prenatal care. I will bet that befor the person pays their cash up-front money there is a pretty good assurance that the person has had medical care and the pregnancy is going as planned. And if a problem is found that the office physician is consulted and the patient counciled.
Audrey RDMS, RVS
-----Original Message-----
From: Wayne
Sent: Apr 11, 2005 4:21 PM
To: Multiple recipients of list SONOGRAPHERS-CONNECTION
Subject: Re: Texas AG has taken action re: entertainment US
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Interesting turn of developments. You (and many others) have been very clear about position on this issue in the past. I am not quite so convinced in one position of the other. Just to be clear, I do not have a financial interest in this topic, so my opinion is based on, what I perceive as a basic fairness issue.
I am concerned about infringement of trade. It appears as though the Texas legislation will limit keepsake or entertainment ultrasound providers to physicians. There are many obstetricians in Denver who keep their offices open in the evening to perform nonmedical ultrasound procedures for patient entertainment.
The AG's (and the AMA's) argument seems to be based on the presupposition that when ultrasound services are provided under the 'supervision' of a physician, they are somehow more credible. This is true even when the services are provided for entertainment purposes. I guess I disagree that a physician is inherently more ethical, thus should be trusted to only provide 'ethical' procedures. (Interestingly, the official SDMS statement is that these practices as unethical and as such is a breach of duty to a patient and society; a serious allegation that requires discipline.).
In my opinion, being a physician does not make one ethical, any more than being a sonographer makes one frugal. There are a lot of physicians making a lot of money on entertainment sonography. It appears as though physicians who own ultrasound equipment and use it for the same purposes do not have to adhere to the same standards as others. I think the right thing for the State of Texas to do was limit the provision of keepsake services by nonmedical people. Unfortunately, it appears as though they have 'lumped' credible sonographers with the unskilled, who wishing to capitalize on the technology for their own interest.
I am not saying that these four service providers are unskilled or should not be providing services. They clearly have acquiesced to the mandates of the AG.
The question I ask is, is it good for legitimate sonographers to limit their opportunity, while allowing physicians the unlimited opportunity to use the technology for just this purpose. According to the agreement, a physician can own and 'supervise' these services entirely legally and in any fashion he or she would like.
This is restraint of trade, any way you slice it.
There are a lot of credible and world renowned sonologists who are advocates of keepsake sonography including Peter Doubliet, Delores Pretoreus, and Stuart Campbell.
I would like to hear how these service providers feel about the subject, so I am forwarding this message to their web site contacts. I would be interested in hearing their positions on this subject.
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Wayne
>----- Original Message -----
From:
To: Multiple recipients of list SONOGRAPHERS-CONNECTION
Sent: Monday, April 11, 2005 7:30 AM
Subject: Texas AG has taken action re: entertainment US
fyi- The Texas AG has taken action re: entertainment US-
see: http://www.oag.state.tx.us/oagnews/release.php?id=885&PHPSESSID=ekount18e81h1trtivebc5bqd2
Dan
