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Welcome to NewsWire! This bi-weekly e-newsletter from the American Registry for Diagnostic Medical Sonography® (ARDMS®), offers its Registrants and members of the sonography community current and innovative news and technology related to the field of sonography.
We want to hear from you! NewsWire was designed to serve as an informational forum. As such, we welcome your article suggestions, questions, comments and feedback on ways to make this resource a more valuable tool in your day-to-day professional life. Please write to us at: communications@ardms.org |
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April 10, 2009
ARDMS Headlines:
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New Mexico is the first state to require licensure of all medical imaging professionals,
including sonographers, as Governor Bill Richardson signed bill HR498 into law this week. The new law is designed to maintain and ensure patient safety which is a focal point for ARDMS. This link* will take you to view the New Mexico bill.
For more information about the bill itself, please scroll down to the first article under "Headlines in the News."
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SPI Examination Webinar *
Click the link above for access to the full recorded version of the recent ARDMS and SDMS informational webinar on the SPI examination.
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Prerequisite & Requirement Eligibility Program (PREP)!!!!!! *
This online guidance tool helps first-time applicants select the appropriate application prerequisite or requirement.
*Note: by clicking on these links, you will be redirected to the ARDMS website.
Headlines in the News:
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New Mexico Sonographer Licensure Law Signed
On April 6, 2009, New Mexico Governor Bill Richardson signed the historic bill that, for the first time in the United States, requires licensure of sonographers.
The bill adds sonographers (and MRI technologists) to the list of medical imaging professionals licensed by the State of New Mexico. Until now, anyone could perform sonograms in New Mexico. Prior to the passage of the New Mexico licensure law, virtually all other health care providers and professionals had to be licensed. As a result, the public is often surprised to learn that the person performing a medical sonogram does not have any state licensure or national certification requirements.
The original New Mexico bill stemmed from concerns expressed about the lack of minimum requirements by a SDMS member, Darla Matthew (Las Cruces, NM) to her State Representative, Jeff Steinborn. Although the SDMS opposed the original bill as written, Rep. Steinborn did a tremendous job of helping to facilitate significant revisions in the New Mexico Senate to construct a better bill. Within a few days, more than 60 amendments had been incorporated into the bill resulting in the bill's unanimous passage in the Senate. When the Senate debated the bill, two Senators mentioned the large number of calls they received from sonographers regarding the bill, a testament to the grass roots
efforts.
In the past, SDMS has opposed specific efforts to create state-by-state licensure and has instead worked for federal requirements. In part, this strategy has been based on the enormous amount of work required to ensure passage of a licensure bill in each state. But ultimately, even federal requirements would not stop what is now commonly occurring...people with a weekend course (or less) in ultrasound and enough money to buy a machine, are setting up shop 'taking baby pictures' or providing 'medical' sonograms without the proper education or certification. In Oregon, a state also considering a sonographer licensure bill (HR 2245), the idea for
sonographer licensure came because a sonographer whose credentials were revoked but continues to provide sonograms in Oregon.
SDMS remains concerned about a state-by-state approach resulting in significant differences in licensure between the states. The legislative process is imperfect and the best of intentions can have negative impact on sonographers. However, SDMS also recognizes that it must work toward addressing the concerns raised by the states about unlicensed health care providers. Some of the key elements of a sonographer licensure bill identified during the development of the New Mexico and Oregon sonographer bills include:
- Reasonable licensure fees
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- State recognition of national certification examinations and continuing education to reduce bureaucratic burden on sonographers
- Representation of sonographers on the regulatory board. The regulatory board should also include:
- Physicians that use a wide variety of imaging modalities not just radiologists
- Members of the general public (the ultimate consumers of the medical imaging)
- Representation of knowledgeable, experienced sonographers on any disciplinary panel considering action against a sonographer
- Reduction of barriers to sonographers who wish to move from state to state or work in more than one state
The responsibility for administering the NM sonographer licensure program would rest with the New Mexico Environment Department. Although this was not the first choice in most sonographers' minds, the Environment Department currently manages the radiologic technology licensure program so the administrative infrastructure is already in place. By ensuring the creation of an advisory council that includes representation by each medical imaging and radiation therapy modality regulated, the bill helps ensure that the Department's other areas of emphasis do not detract from sonographer licensure.
Several members have also asked why the New Mexico and Oregon licensure bills link sonography with ionizing radiation and radiologic technology, when in reality, sonography is often done outside of the radiology department. Many would advocate establishing a separate "sonographer" licensing board. However, today's practical realities in state government where severely limited resources and tough economic times dictate policy decisions, a separate licensure board is simply not viable. Radiologic technology licensure programs are in place in most states and adding another imaging modality is much more feasible than creating a new licensure board
and licensing system. Another downside is that each state's radiologic technology licensure act is different and will require careful consideration of how sonography can be incorporated.
Because sonographers have never had to be licensed before, they frequently do not see or understand the distinction between state licensure and national certification. National certifications or credentials issued by voluntary organizations such as ARDMS, CCI, ARRT have little legal weight. The certification process and resulting credential are valuable tools in ensuring sonographers have met minimum education and knowledge requirements but do not really regulate anyone's ability to perform sonography. In an ideal world, no additional regulation of sonography would be required. However, as everyone knows, more and more people are taking weekend
courses and buying ultrasound equipment without understanding the ramifications of using ultrasound technology (e.g., ALARA).
The NM bill will help ensure that physicians receive quality sonograms, that their treatment decisions are based on the best available information, and that those paying for sonograms will not have to pay to have the study repeated because the first person who performed it did not how to perform the study properly.
Under the bill passed by the New Mexico legislature, national credentials/certifications should provide evidence of meeting the state's standards. All sonographers who are performing these critical medical imaging services in New Mexico will be required to meet national certification standards. As a result, there would be no additional exams in New Mexico beyond the national certification exams. The bill also requires the state to recognize the continuing medical education completed for national certification renewal.
The most visible impact on New Mexico sonographers will be a license fee. However, the legislation caps the license fee at $100 per two-year license. In addition, only the New Mexico Legislature can change this cap. We expect that many employers will pay or provide reimbursement for the license fee (as they often do for other licensed health care professionals). The license fees go toward administering the licensure program including paying for investigations or disciplinary actions when necessary. With approximately 350 certified sonographers in New Mexico, it will barely cover the cost of the program...but the public safety benefits far
outweigh the cost! When needed, the state agency can conduct investigations of those who fail to meet the standards or who cause harm to their patients. Ad hoc disciplinary committees will be created to review and consider disciplinary actions against sonographers. The legislation ensures that when needed these ad hoc disciplinary committees include sonographers (with similar knowledge and experience), a physician, and a neutral, public member.
Another benefit related to the New Mexico bill is that despite years of discussion about the creation of 1) ultrasound practitioner, 2) advanced practice sonographer or 3) clinical sonographer specialist, there has been little movement toward establishing an advanced level sonographer. However, the New Mexico bill includes a specific provision that requires adoption of rules and regulations related to creation of advanced levels. This is an important first step toward establishment of an advanced level sonographer.
What is next for New Mexico licensure? The process of developing administrative rules to implement the legislation will now begin. New Mexico sonographers will certainly have an opportunity to review and comment on any administrative rules under consideration by the New Mexico Environment Department. The Medical Imaging and Radiation Therapy Advisory Council
will need to be formed as well. Once the administrative rules have been implemented, sonographers in New Mexico will need to apply for licensure and pay the license fee (student sonographers will have to register but are not required to pay a license fee). At this time, it is not known how long the implementation process will take. SDMS will be working closely with state officials and sonographers as the licensure bill is implemented and will provide updates to SDMS members as information becomes available.
What is next for sonographer licensure? Sonographer licensure can be very complex. Add to this, the complexities of other imaging modalities and you have a formula for potential problems! A thorough understanding of the ramifications of the existing state statute and any proposed licensure language is critical to ensure that the intended effects are achieved without undue burden on sonographers. SDMS expects other states will consider adoption of sonography licensure in the next few years and will be working to ensure the adoption of appropriate legislation. SDMS plans to host a webinar later this year to discuss why sonographer licensure
is needed and how it could affect you. If you hear of a sonographer licensure bill in your state, please contact the SDMS as soon as possible!
View the article online.
Article written by staff at sdms.org and adapted for the purposes of this newsletter.
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AIUM Meeting Sharpens the Focus on Ultrasound As a Premier Imaging Option
The American Institute of Ultrasound in Medicine (AIUM) held its annual convention in New York last week, combining education sessions, poster presentations, research updates, awards, vendor exhibits and other clinical and practice related programs.
A unique modality that is applied to many clinical purposes, ultrasound practitioners include sonographers, sonologists, radiologists, specialists in cardiology, vascular medicine, internal medicine, breast imaging, orthopedics, thoracic, renal, neurosonology, neonatal and pediatrics, and of course OB/GYN.
One major highlight of the meeting was the William J. Fry Memorial Lecture, given by radiologist Alfred Kurtz, MD. Dr. Kurtz recapped the extraordinary journey that medical ultrasound has taken from the early history of outsized transducers to today's multi-planar 3-D and 4-D real-time motion picture technology. "Images have become spectacular with remarkable detail," he said.
Contrast-enhanced ultrasound was a much-talked about topic at the event since it holds great promise. "At the moment, we do have a problem in the U.S. The FDA has approved only two agents for cardiac microbubbles," Dr. Kurtz said. He noted that clinical opinion leaders are talking to the FDA through a multi-specialty task force with vendors to urge further approvals. "The world has access to ultrasound contrast agents; we [in the U.S.] have only limited access," he said, noting its applicability to examining the spleen, liver, and vascular anatomy. Meanwhile, elastography has recently been developed and is being refined to enhance characterization of tumor tissue, also a method
applicable to examining liver disease such as chronic hepatitis.
Dr. Kurtz also updated attendees on the status of practice guideline adoption with 20 now in place covering physician qualifications, exam procedures, equipment safety and other important topics to standardize care. He noted that a voluntary quality accreditation is also available.
Quality practice standards remain a problem in ultrasound as in many areas of medicine. About 120,000 ultrasound exams are done each year with as many as 40 percent by uncertified or non-credentialed practitioners. AIUM is taking the lead and collaborating with many specialties to develop new practice guidelines and physician training.
He noted that ultrasound competes with CT, MR and PET for patients and for reimbursements. Dr. Kurtz called for more uniformity in diagnosis and faster scan times for exams. Many diagnoses remain challenging such as benign liver disease, gall bladder disease, kidney and thyroid disorders and ovarian follicles and cysts.
"We need more uniformity in diagnosing and recording following exams and/or biopsies," Dr. Kurtz said.
Worldwide Challenges
Developing nations are in need of ultrasound for its affordability as well as versatility. Dr. Kurtz said the technology is low-cost, portable and durable but suffers from limited global access to equipment and training. Government bureaucracies remain obstacles to adoption even though the World Health Organization has favorably labeled ultrasound as "sustainable."
Inconsistency in education and training is a problem and a global ultrasound curriculum is being developed for web-based delivery. Another eminent physician in the field, Dr. Barry B. Goldberg of Thomas Jefferson University Hospital in Philadelphia has undertaken the teachers program in the Jefferson Ultrasound Research and Education Institute to expand training of certified technologists and clinicians worldwide.
On the international equipment end, major OEMs including GE, Siemens and Philips have donated hundreds of machines.
In terms of technologies for the future Dr. Kurtz envisioned more auto image optimization, improved microcalcification imaging of the thyroid, CAD, the use of new agents and fusion of modalities such as CT and ultrasound in order to localize and characterize tumors for biopsy. Other trends include volume acquisition for increased speed and offline evaluation.
View the article online.
Article written by staff at dotmed.com and adapted for the purposes of this newsletter.
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Ultrasound in evaluation of post-interventional femoral vein obstruction: a case report
Ultrasound is the preferred imaging modality in diagnosis of vascular complications following cardiac catheterization and intervention. In some cases, however, bleeding surrounding the femoral vessels, may severely distort the color Doppler images, making detection of venous complications especially difficult.
This report refers to such a case where post-catheterization hematoma was suspected to cause an obstruction of the femoral vein. Spectral Doppler recordings of blood flow in the common femoral vein, up-stream, distal to the hemorrhagic area, confirmed the diagnosis of obstruction by demonstrating changes in the venous flow pattern in the common femoral vein, consistent with venous hypertension.
Due to the poor quality of the ultrasound images, the exact cause of the obstruction had to be established by another imaging modality, not affected by hemorrhages. CT showed that the common femoral vein was compressed at the puncture site by surrounding hemorrhages.
Thus, when bleeding due to cardiac catheterization is associated with possible venous obstruction and findings by color Doppler are equivocal due to degradation of the color-Doppler image, detection of venous hypertension by spectral Doppler, performed distal to the bleeding area, strongly supports the presence of venous obstruction where the exact cause may be established by CT.
View the article online.
Article written by staff at 7thspace.com and adapted for the purposes of this newsletter.
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Nanotechnology could unlock safer cancer treatments
A team of researchers at the University of Alberta is developing a set of advanced nanotechnology particles that could one day replace radiation and chemotherapy as a cancer treatment.
The miniscule nanoparticles, about 100 times smaller than the width of a human hair, have the ability to deliver genetic material and medicines to targeted cells.
Dr. Jie Chen, an associate professor of electrical engineering with a focus in biomedical nanotechnology, patented the particles, called M-nanodarts, in November 2008.
"I got interested in this research because I think this is the next wave of technology. People live longer, and they want a better quality of life. Because nano is small [...] nano as a medicine for diagnosis and improving treatments is very promising," Chen said.
Depending on what type of disease is being targeted, different types of organic matter are bound with the M-nanodots, which are then injected to the specific area and triggered by ultrasound waves.
"The particle itself is dumb, only sensitive to the ultrasound. So in order to target it to a specific tumor, you need to bind it with bio-molecules," Chen said.
"Right now we are working on binding it with a hormone for instance, which could be used to treat breast cancer."
Unlike radiation, the ultrasound waves that trigger a reaction in the particles aren't harmful to surrounding cells.
"The ultrasound will generate these microbubbles [...] when the bubble bursts, it will get the chemicals to damage the [cancer] cell membrane," he said.
The chemical portion of the treatment is the organic matter attached to the technology.
"There's a special bamboo that grows in China and Japan. On this bamboo there is a fungi, this fungi is sensitive to ultrasound," Chen said.
So far, others in the research community are wary of possible side effects because the particles don't break down and can disrupt functions in other parts of the body. However, Chen is optimistic that continued tests will demonstrate the strategy to be safe.
"We didn't do a systematic study yet for the toxicity. But what we're thinking about is, this particle is a natural product, it probably will deposit in the body," Chen explained. "What are the side effects? We'll need to wait and see. We did the mice study [and] it was okay."
If animal trials continue to be successful, testing the treatment on humans could begin as early as this fall. However, due to the lengthy approval process, Chen estimates widespread use taking about six to ten years.
The application of Chen's gene delivery particles is not limited to cancer alone. Magnetic forces can be used to pull the M-nanodarts, carrying specific genes, into the nuclei of modified stem cells. They can be grown in a lab for later transplant into a patient.
Diseases such as hepatitis, Alzheimer's, Parkinson's, and cystic fibrosis could possibly all be treated with the tiny particles.
This study appears in the April issue of the American Journal of Roentgenology.
View the article online.
Article written by staff at nanowerk.com and adapted for the purposes of this newsletter.
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| Israeli research gets to the heart of the matter
For children undergoing multiple heart surgery, the risks of vascular or cardiac injury are high. Scar tissue from previous procedures can either affect the functioning of the heart or obscure vital cardiac landmarks, making it difficult for surgeons to carry out the delicate and precise treatment required to make the operation a success.
Now a new biomedical product developed originally at the Hebrew University of Jerusalem, could change all that. The technology, which is being commercialized by US biomaterials company SyntheMed, is a tailor-made biodegradable polymer designed to prevent scar tissue in the wake of a surgery.
Called Repel-CV Adhesion Barrier, the product is a transparent bioresorbable film that can be inserted over the heart following open-heart surgery. The polymer, which degrades naturally, reduces the severity of scar tissue that forms between the surface of the heart and nearby tissue surfaces during the healing process.
According to the company, the product is easy to use, requires no changes to surgical technique and adds minimal time to the surgical process.
The Repel-CV, which is the first anti-adhesion product for cardiac surgery on the market, has been approved by the US Food and Drug Administration (FDA), for use in pediatric cardiac surgery patients (21 and younger), who are likely to need secondary open-heart surgery.
The end of a long process
"I am very excited that the long process started several years ago in our laboratory at the Institute of Chemistry of the Hebrew University with the design and synthesis of a family of biodegradable polymers was recently approved by the FDA," said Prof. Daniel Cohn, the award-winning Israeli professor who invented the polymer.
Today in the US, there are some 350,000 to 400,000 children with congenital cardiac abnormalities. Many of these children must undergo multiple surgeries to correct the defect, while others require additional operations as they grow. Each of these surgeries leaves a scar, and in some cases, these adhesions can be life threatening.
Cohn's biomedical product harnesses the unique properties of a class of custom-made, biodegradable polymers.
"Each and every surgery conducted inevitably results in post-surgical adhesions, and the polymeric film developed at the Hebrew University allows us to minimize those adhesions," said Cohn, who won first prize in last year's Hebrew University Kaye Awards for Innovation, for his work on polymers.
A widespread problem
The problem of post-operative adhesions is widespread and SyntheMed, which is based in New Jersey, bought the technology from Hebrew University through Yissum, the university's technology transfer company. The company developed the product and brought it to the clinic.
FDA approval came after SyntheMed, which specializes in developing and commercializing anti-adhesion products, received regulatory approval in Europe and Canada.
In clinical trials conducted at 15 pediatric cardiac surgery centers throughout the US, over 70 percent of the children treated with Repel-CV were completely free of clinically-significant adhesions, the most severe grade of scar tissue measured, compared to less than 30% of control patients.
The company is now developing a range of anti-adhesion products based on Cohn's polymer technology.
View the article online.
Article written by staff at israel21c.org and adapted for the purposes of this newsletter.
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