IOM Recommends Scrapping FDA Device Approval Process

Published on the July 29, 2011 DiagnosticImaging.com Web site

By Whitney L.J. Howell

The Institute of Medicine (IOM) released this morning a recommendation for the FDA to abandon its current process for clearing some medical devices for use.

In an unexpected move, the IOM called for an end to the 510(k) clearance process that has been under revision for the past year and proposed that Congress enact legislation for a new regulatory system after the FDA determines how to create one. The 510(k) process is the current pathway that authorizes low-risk medical devices, including those for imaging.

The FDA published its own new recommendations on Tuesday encouraging medical device manufacturers to submit new 510(k) clearance applications when making a change to previously approved devices. The agency also encouraged manufacturers seeking to avoid a second approval to provide scientific justification for any modifications that wouldn’t affect a device’s safety of efficacy.

According to the IOM report, however, current 510(k) revision attempts aren’t sufficient to protect patients or industry.

To read the story in its entirety: http://www.diagnosticimaging.com/practice-management/content/article/113619/1916209

New Imaging Agent Being Tested for Early Detection of Alzheimer’s

Published on the July 25, 2011, DiagnosticImaging.com

By Whitney L.J. Howell

A new imaging agent currently in Phase III clinical trials could soon make it possible for more radiologists to see beta-amyloid — the brain plaque associated with suspected Alzheimer’s disease — through PET scans.

According to David Wolk, MD, University of Pittsburgh neurology professor, flutemetamol, a tracer molecule associated with the isotope Fluorin-18, brings the same benefit to real-time patient care that Pittsburgh B-Compound (PiB) can only bring to neurological investigations.

“Because of the PiB compound’s 20-minute half-life, it’s really only played an active role in research. It degrades so quickly that it’s not practical to use with patients in the real world — only tertiary care centers have the machinery to make PiB onsite,” said Wolk, who presented his research on flutemetamol in living patients at the International Conference on Alzheimer’s Disease in Paris last week.

“With a nearly two-hour half-life, you can have flutemetamol manufactured elsewhere and delivered to you for medical scans.”

To read the article in its entirety: http://www.diagnosticimaging.com/pet-mr/content/article/113619/1913011

Medical Schools Reach Out to Native American Groups

Published in the July 2011 AAMC Reporter

By Whitney L.J. Howell

Fred Redwine’s medical school experience could have ended with anatomy class.

“The basic sciences are tough,” said the 39-year-old first-year student at the University of North Dakota (UND) School of Medicine and Health Sciences. “I would likely have failed if I hadn’t had access to my tutor.”

Luckily for Redwine, an American Indian from the Choctaw tribe, he came to medical school as part of North Dakota School of Medicine’s Indians into Medicine (INMED) program, a nearly 40-year-old initiative that not only recruits American Indian students to medical school but supports them with tutoring and other targeted resources.

Although American Indians make up only about 1 percent of matriculated medical students, according to AAMC data, their numbers are growing. In 2010, the population of American Indian medical students swelled by nearly 25 percent, thanks in part to efforts like those from North Dakota and other schools, such as the University of New Mexico School of Medicine. The ultimate goal, coordinators said, is to provide a needed infusion of physicians into tribal communities, which are plagued by numerous health problems including diabetes, conditions related to substance abuse, and many others.

Henry Sondheimer, M.D., AAMC’s senior director for student affairs and student programs, attributed the growth to burgeoning relationships between schools of medicine and health sciences. These partnerships, including the Four Corners Alliance of New Mexico, Arizona, Colorado, and Utah universities, as well as collaborations with the Association of American Indian Physicians (AAIP), identify talented American Indian students early on and work to increase the likelihood they will study medicine.

The key is recruiting students in a culturally sensitive way. Recruiting materials that incorporate elements reflecting American Indian culture are an important start, said Norma Poll-Hunter, Ph.D., director of the human capital portfolio in the AAMC’s diversity policy and programs unit.

INMED has worked toward this goal since 1973, accepting seven North Dakota medical school students each year from federally recognized tribes. Through tutoring, a dedicated library, counselors, and emergency financial aid, INMED gives its students resources to succeed academically. To date, 196 INMED students have graduated medical school, with 70 percent of them returning to their tribal communities.

Program director Eugene DeLorme, J.D., credits tribal group support and INMED’s welcoming atmosphere with helping students acclimate and feel comfortable in class.

“We’ve flourished because we have buy-in from tribal communities. They have as much ownership over INMED as the institution does,” he said. “But we also create an environment where students know they aren’t alone. They don’t feel isolated because they have personal, social, economic, academic, and spiritual resources.”

North Dakota’s school of medicine also helps to prime the medical education pipeline with three six-week summer programs associated with INMED—Summer Institute, Pathway at UND, and Med Prep at UND—that introduce health affairs courses and practicing American Indian health professionals to students from junior high school through college. The programs present the prospect of medical school long before students begin to apply.

INMED also has a strategy to help its students feel like part of the larger medical school class, said DeLorme. Before classes start, INMED hosts a dinner to introduce new students to the program’s upperclassmen. In addition, DeLorme gives a three-hour presentation to the entire first-year class, providing details about INMED and tribal health care. Lastly, UND ensures INMED students work with peers from majority groups in all parts of its patient-centered curriculum.

For students like Redwine, INMED made medical school possible.

“Being in INMED provides an incredible support network of people who understand your circumstances and difficulties. We’re very connected to each other and share similar circumstances despite being from different tribes,” Redwine said. “Of course we hang out and socialize with other students, but we have camaraderie—we encourage and urge each other to never give up.”

Upon graduation, Redwine said, he plans to return to the federally protected Choctaw estate in Oklahoma to focus on health policies affecting his community.

Like North Dakota, New Mexico attracts American Indian students by presenting medical school to younger students. The institution’s B.A./M.D. program reserves room in medical school for incoming college freshmen from diverse backgrounds—including the Navajo tribe— who make a pledge to practice in the state’s underserved communities. Each year, the B.A./M.D. program reserves 23 spots in the incoming medical school class.

In April, as part of the Four Corners Alliance, New Mexico hosted a pre-admission workshop, in collaboration with the AAIP and several other medical schools, for undergraduates interested in applying to health affairs schools. According to Valerie Romero-Leggott, M.D., vice president of New Mexico’s Health Science Center Office of Diversity, the conference gave aspiring doctors, nurses, pharmacists, and physician assistants inside information on how to be a successful applicant. Students went through mock interviews after learning how best to present themselves, received guidance on writing personal statements, and gathered information on financial aid.

These programs are designed to let American Indian students see early on that, despite financial or personal challenges, they belong in and can achieve much in medical school, Romero-Leggott said. They are, in fact, a critical component of the future of American Indian health.

“Our programs are beneficial because students overall must feel safe and supported in their surroundings if they’re going to succeed,” Romero-Leggott said. “With all of our different programs, we’ve created that climate and constantly reinforce that message to our students. They are part of a community. They are not an island.”

To read the article on the original Website: https://www.aamc.org/newsroom/reporter/july11/254630/native-american.html

IBM’s Watson: Handy Radiologist Aide?

Published on the July 13, 2011, Diagnostic Imaging Website

By Whitney L.J. Howell

Since IBM’s supercomputer Watson bested numerous Jeopardy contestants early this year, predictions have swirled about computers replacing humans. In reality, the technology isn’t there yet, but that doesn’t mean it won’t soon impact radiology.

According to its creators, Watson is intended to be an electronic health record super-reader. Currently, the technology makes diagnoses by searching its vast database of medical texts and journals after you provide a patient’s symptoms.

Once programmed for radiology, this technology will save time and will be a handy assistant, said Eliot Siegel, MD, University of Maryland School of Medicine radiology professor and imaging informatics vice chair.

“As a radiologist, it can take you between five minutes to an hour to read a patient’s complete history and get a full understanding of the reason behind the scan and what their recent treatments have been,” Siegel said. “There’s great potential for Watson to truncate that time, help with diagnosis, offer treatment summaries, synthesize charts, and perform safety checks.”

 

To read the remainder of the article: http://www.diagnosticimaging.com/practice-management/content/article/113619/1904535

The Decision to Nighthawk Isn’t Always Crystal Clear

Published in the July 2011 American Hospital Association Hospitals & Health Networks

By Whitney L.J. Howell

Teleradiology is growing, but experts caution about potential pitfalls

Hospitals never close, but that doesn’t mean someone from every specialty is always on call. A growing number of facilities aren’t scheduling radiologists for overnight and weekend shifts, and others no longer have them on staff. Instead, they rely on teleradiology companies to fulfill their imaging needs.

Also known as nighthawking, teleradiology steadily has grown in popularity in recent years. A 2009 study by VHA Inc., a nationwide network of community-owned health systems, reported 56 percent of U.S. hospitals use it. Many hail the service for its convenience and instant subspecialty coverage.

“Teleradiology is essential for small, rural practices that want to deliver high-end care, but don’t have enough volume to offer fellowships for subspecialty providers or that can’t afford to hire more staff to cover nights,” says William Bradley Jr., M.D., University of California–San Diego’s radiology chair. “Diagnosis quality also goes up because radiologists’ reading scans are already awake and alert. Someone who’s been awakened in the middle of the night is likely to miss finer details.”

Contracting with a teleradiology company also can help hospitals attract and retain talented radiologists, says Michael Modic, M.D., chairman of the Cleveland Clinic’s Neurological Institute. “Some radiologists are willing to forgo the additional reimbursement—sometimes as much as 10 to 15 percent of business—if they can avoid the night shift,” Modic says. “They want more work-life balance, and hospitals use teleradiology to retain them.”

But not everyone agrees teleradiology is financially sound or safe. Relinquishing additional reimbursement could have long-lasting effects, says David Levin, M.D., chairman emeritus of the department of radiology at Jefferson Medical College of Thomas Jefferson University. Having outside companies read scans could cause a permanent dip.

“It’s possible that reimbursement could start to drop because teleradiology companies bill less for reading scans,” he says. “If they’re billing $40 for reading an MRI, but hospitals bill $80, insurance companies will start wondering why they’re reimbursing at higher levels.”

Hospitals without in-house radiologists also lose an advantage when shopping for new imaging equipment, Levin says. Knowledgeable in-house radiologists can be intermediaries who negotiate with vendors for significant cost concessions on updated imaging equipment.

Levin disagrees that teleradiology improves diagnosis quality. Teleradiologists not only lack access to all patient records with potentially pertinent information that could alter a diagnosis, but neither can they consult with other providers if they have questions.

To read the article on the original Website: http://hhnmag.com/hhnmag_app/jsp/articledisplay.jsp?dcrpath=HHNMAG/Article/data/07JUL2011/0711HHN_Inbox_telehealth&domain=HHNMAG

Haute, Healthy, Local Cuisine Coming to a Hospital Near You

Published in the July 2011 Hospitals & Health Networks Magazine

By Whitney L.J. Howell

Food service departments are adding healthy choices to patient meals

Asian stir fry. Chicken marsala. Spanish rice with black beans. These are familiar dishes that wouldn’t normally raise an eyebrow—except they’re appearing on hospital menus nationwide. The trend is gaining ground as more facilities turn their food service into haute cuisine—and doing so with health in mind.

Improving the nutritional quality of patient meals supports a hospital’s underlying mission to heal, says Holly Emmons, food and nutrition manager at Union Hospital in Maryland. “As a hospital, we’re supposed to do no harm,” she says. “How can we safeguard people’s health if we aren’t feeding them food that’s better for their bodies while they’re with us?”

Union Hospital began working toward that goal in 2009. The facility now buys local, pesticide-free produce and puts those fruits and vegetables, as well as whole-grain pasta, on the menu to increase the fiber patients receive. Union also joined Health Care Without Harm’s Balanced Menu Challenge to attack cardiovascular disease. The effort asks hospitals to replace 20 percent of the red meat they serve with poultry or fish.

Despite the expense of implementing changes, Emmons says she sliced her cost per meal from $0.83 in 2009 to $0.67 for the first half of 2011. She credits the savings to spending less on red meat and relying more on fresh produce.

Better food could become more important as Medicare ties reimbursement levels to patient-satisfaction scores. However, pleasing patients—while serving multigrain breads and lowering sodium content—is already a high priority for Seattle Children’s Hospital.

“Better food is great, but if patients don’t feel better about eating it, it’s a bust,” says Walter Bronowitz, executive chef at Seattle Children’s Hospital. “Seeing a child who is battling nausea actually look forward to a meal and be able to eat it is a wonderful thing. The main goal for us is making our kids and their families happier.”

To sustain the better-food push, Vassar Brothers Medical Center in Poughkeepsie, N.Y., partners with the Culinary Institute of America, giving students firsthand health care food service experience, says Executive Chef Anthony Fischetti. Chefs-in-training observe food preparation and work with hospital nutritionists and dietitians to learn how to make meals that meet different health needs while still maintaining flavor.

“These students are programmed to think of restaurants and catering halls,” Fischetti says. “Working with us, they learn how to create quality food for people who often have strict dietary limitations.”

To read the article on the publication Website: http://hhnmag.com/hhnmag_app/jsp/articledisplay.jsp?dcrpath=HHNMAG/Article/data/07JUL2011/0711HHN_Inbox_patientcare&domain=HHNMAG

Pediatric CT Scan Rise

Published on the July 7, 2011 DiagnosticImaging.com

By Whitney L.J. Howell

The use of CT scans in children is rising. Although the improved technology makes scanning pediatric patients easier, many in the industry worry scans contain doses are too large for children’s body weight and size.

A study in the April Radiology revealed many reasons for the five-fold spike in pediatric CT scans from 1995 to 2008 in emergency departments nationwide. Eighty-five percent occurred in hospitals without a pediatric focus, and industry leaders say this presents an opportunity to educate providers and technologists who work mostly with adults.

“The data confirms the technology has improved, and we can handle motion in young patients with little to no sedation,” says study author David Larson, M.D., a Cincinnati Children’s Hospital Medical Center radiologist. “It also shows it’s important for community hospitals to partner with children’s hospitals or vendors to set protocols appropriate for kids.”

 

To read the article in its entirety, visit: http://www.diagnosticimaging.com/pediatric/content/article/113619/1900246