Report on Meeting of the American Institute of Ultrasound in Medicine, May 2004

Joseph Savino, MD
Chair, Committee on Governmental Affairs

I represented the SCA at the meeting of the AIUM at the Ritz-Carlton in Pentagon City, Virginia on April 22 and 23, 2004. The following is a brief review of topics discussed that might interest the membership of the SCA:

The two-day session was conducted with formal lectures followed by break out sessions. Attendance included representatives from the American Society of Echocardiography (Drs. John Gorscan and Randy Martin), American Society of Anesthesiologists (Drs. Chang and Porembka - CCM), National Board of Echcardiography (Dr. Edward Gaiser), American College of Surgery as well as professional societies representing radiologists, sonographers, urologists, and obstetricians and gynecologists. In addition, groups representing industry were present, including SonoSite, Philips, GE, Seimans, and others.

The major topic of discussion was the development of Compact Ultrasound. The key message was Compact US would grow and dominate the industry in the next decade with miniaturization of all components. Movement to silicon transduction (cMUTS) (semiconductor based) rather than conventional piezoelectric elements was forthcoming. Miniaturization would not hamper the continued development in 3-D technology and tissue characterization. AIUM discouraged and in fact asked that the term 'Hand Held Ultrasound' be abandoned, as it did not accurately characterize the technology.

After a brief history of ultrasound, the program rapidly progressed to defining the growing market of Compact Ultrasound and miniature technology. Compact US systems are not necessarily more inexpensive than conventional platform systems. 2003 Compact US consisted of 2% of United States sales with an annual growth of 6%. The technology is moving toward PC based systems, facilitated visualization, wireless transmission, and digital storage.... a PDA type system was envisioned.

Compact US systems are becoming available as 'fully featured systems' as well as limited capability (only 2 D). The world market of Ultrasound users is 40% Radiology, 25% Cardiology, 20% Ob-Gyn, 5% Vascular, and 10% other. The market has grown in the past decade from $10M (diagnostics only), to currently $160M (diagnostics and procedural) to a projected $1B by 2010 (diagnostics, procedural and imaging physicals). A significant portion of the 'procedural applications' of compact US are being performed by anesthesiologists in placement of central lines and guidance for nerve blocks.

The Ultrasound industry (Seimans, Philips, SonoSite, GE) voiced a clear imperative to take a new direction in their product development. Traditionally, industry has focused on a technology driven R&D strategy: develop new technologies (hardware and software) and seek out applications (e.g. AQ technology developed by Hewlett Packard, color kinesis, etc.). At this session, AIUM and industry suggested that future development should focus on 'service'... making it easier to perform, read and archive ultrasounds.

Two hours were devoted on the education of ultrasound providers. The general sense was that standardization was a sound idea, but most agreed that standardization of education would be done at a subspecialty level rather than having a global standardization process across all ultrasound disciplines. Breakout sessions were devoted on education, research/technology, clinical service, and reimbursement:

Education: Poor standardization exists across the disciplines (eg cardiac ultrasound versus prostate ultrasound versus renal ultrasound). It was emphasized that an effort to take Ultrasound out of the hands of clinicians (eg urologists doing prostate US) would not be in patients' best interest. However, should the family practitioner be doing prostate US as a screening tool? Currently there is little in regulatory control of such applications. Encouraged activities included introduction into medical school curricula, sonography training programs, and anatomy simulation. Europe and Asia have dedicated ultrasound training programs for medical students. It is a required course. Simulation of anatomy was considered an unexplored area: use of echo to teach gross anatomy, functional anatomy to medical students. Accreditation was discussed very briefly.

Research/Technology: most of the discussion focused on miniaturization and growth. R&D strategy was expected to change with increasing focus on defined service lines. Discussion lead to the request for outcomes research to determine if and how ultrasound makes a difference. The internal jugular vein IJV cannulation research done by cardiovascular anesthesiologists (US guided cannulation of the internal jugular vein) was offered as an example of clinical investigation that is directed at outcome and safety. With the projected increase in US, the issue of bio-effects was brought up but quickly set aside as it was determined not to be a major issue and not a focus of the meeting.

Reimbursement: A very difficult problem to determine if payors will pay for compact US. Will insurers pay for using US to cannulate the IJV? or to perform a nerve block? The questions were essentially unresolved.

Clinical Service: Continued growth of US in procedures and new growth in imaging physicals is anticipated. Cost barriers that would blunt this growth include hardware, training, and likelihood of very limited incremental reimbursement. The use of ultrasound as an entertainment tool was strongly discouraged. Apparently, there are malls in the United States where for $100 someone takes an ultrasound of your fetus and gives you a picture. In contrast, exploring the use of ultrasound as a screening tool was advocated. The patient evaluation in the near future might include a medical history and a physical examination using various tools and instruments that a clinician carries with them: stethoscope, otoscope, and a compact ultrasound machine.


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