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Sunday's Our View: Harnessing the cost of health care - SW Iowa News |
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Some will consider the announcement a turning point – a watershed event – in health care. Nine medical societies representing nearly 375,000 physicians joined forces to challenge the widely held perception that more health care is automatically better.
The medical groups that participated are: American Academy of Allergy, Asthma & Immunology, American Academy of Family Physicians, American College of Cardiology, American College of Physicians, American College of Radiology, American Gastroenterological Association, American Society of Clinical Oncology, American Society of Nephrology and American Society of Nuclear Cardiology.
Last Wednesday they released lists of tests and treatments their members should no longer order automatically. Key to the recommendations is that word “automatically.”
The 45 items listed – five from each of the organizations – included most repeat colonoscopies within 10 years of a first such test, early imaging for most back pain, brain scans for patients who fainted but didn’t have seizures and antibiotics for mild-to-moderate sinus distress.
Also on the list: Heart imaging stress tests for patients without coronary symptoms. A particularly sobering recommendation calls for cancer doctors to stop treating tumors in end-stage patients who have not responded to multiple therapies and are ineligible for experimental treatments.
Dr. Christine Cassel, president of the American Board of Internal Medicine, told the Associated Press the goal is to reduce wasteful spending without harming patients. She suggested some patients might actually benefit from the recommendations by avoiding known risks associated with medical tests, such as exposure to radiation.
“We all know there is overuse and waste in the system, so let’s have the doctors take responsibility for that and look at the things that are overused,” said Cassel. “We’re doing this because we think we don’t need to ration health care if we get rid of waste.” Her group sets standards and oversees board certification for many medical specialties.
Dr. James Fasules of the American College of Cardiology said the goal is to begin changing attitudes among patients and doctors.
“We kind of have a general feeling that if you don’t get a test, you haven’t been cared for well,” said Fasules. “That has permeated American culture now.”
The new advice isn’t meant to override a doctor’s judgment, Fasules added, but to inform and support decisions.
Eight other medical societies are developing additional recommendations.
The medical societies don’t have any power of enforcement, and fear of malpractice lawsuits – as much a part of the American culture as the notion that testing is the benchmark of good medical care – may well prompt many doctors to keep ordering as many tests as ever.
Unfortunately, that fear of malpractice may negate the positive efforts of the various medical societies.
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News Woodstock Region - Woodstock Sentinel Review |
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Six local dialysis patients will no longer have to travel to London for life-saving kidney treatment.
Woodstock Hospital announced last week that they have expanded dialysis care by three stations.
The additional capacity will increase the Woodstock dialysis unit to nine stations, increasing care from 30 to 36 patients.
“The ability to increase the number of dialysis treatments that we can provide is a real blessing to our community,” said Randy Hicks, director of critical care and dialysis. “Our patients’ experience long days when undergoing dialysis and being able to receive care, close to home reduces stress and allows patients to lead a fuller life.”
A satellite of London Health Sciences Centre, the unit provides hemodialysis treatment for people with chronic kidney disease.
Many of the unit’s patients are waiting for kidney transplants, with others may require dialysis for the rest of their life.
The unit operates six days a week, administering 4,430 treatments year.
Dialysis treatment can take up to five hours, three times per week.
Carol Rhiger, regional director of the Ontario Renal Network for the Southwest Local Health Integration Network, said additional dialysis capacity was needed to address current and future chronic kidney disease in the region.
“This funding will help area patients with chronic kidney disease by easing time, travel, cost and inconvenience of receiving care outside their community,” she said.
Woodstock Hospital, located on Juliana Drive, opened on Nov. 20, 2011 with six-dialysis chairs, but with the capacity to grow to up to 12 chairs.
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Docs warn of kidney drugs risk - Deccan Chronicle |
Health experts warn against the non-judicious use of erythropoiesis-stimulating agents (ESA) for chronic kidney patients, as clinical trials have revealed that the patients are far better off without the use of ESA. Even though leading health institutions around the world, including the American Society of Nephrology, reject non-judicious ESA use as an “unsafe medical practice”, many doctors in India continue to use ESAs for patients with kidney disease. ESAs not only drain a patient’s health, but also the hard-earned money, it doctors have stated.
A senior nephrologist explains: “Its over use is probably pharma company or physician-driven, as a patient spends between Rs 1200 and Rs 5000 every week on ESAs” In its latest guidelines for kidney doctors, the American Board of Internal Medicine points out: “ESAs have no survival or cardiovascular disease benefit and may be harmful. They should be used to maintain haemoglobin at lowest levels that minimise need for transfusion.”
Referring to the new American guidelines, Dr Mohammad Rafay, kidney specialist at Apollo Hospitals, Hyderabad, said they were more relevant in the Indian context. The use of ESA should be re-examined by all nephrologists and each prescription should be tailored to individual patient needs. Moreover, non-steroidal anti-inflammatory drugs (NSAIDS) should not be used for patients with hypertension or heart failure or chronic kidney disease of all causes, including diabetes, he said.
Dr Rafay warns that the use of NSAIDS can raise blood pressure, make anti-hypertensive drugs less effective, cause fluid retention and worsen kidney function. In his view, it is not safe to perform routine cancer screening for dialysis patients with limited life expectancies unless they are transplant candidates. It does not improve survival chances. As dialysis therapy is more readily available now, more patients are going for dialysis therapy than in the past.
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FDA fast-tracks approval process of 3 kidney devices - Fox News |
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The Food and Drug Administration announced plans to pilot a program meant to put new technology for end-stage renal disease in the hands of patients who need it.
The three products that have been chosen to participate in the FDA’s ‘Innovation Pathway’ program are an implantable renal assist device (iRAD) being developed by the University of California, San Francisco, a wearable artificial kidney (WAK) in development by Blood Purification Technologies Inc. of Beverly Hills, Calif., and a hemoaccess valve system (HVS) that has been designed by Greenville, S.C.-based CreatiVasc Medical.
There were 32 product applications submitted, in total. The majority of the applications came from small, start-up business or academic institutions, according to the FDA.
“The response from innovators exceeded our expectations and demonstrates that there is a desire from developers of innovative technologies for earlier and more collaborative agency interaction,” said Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH).
Innovation Pathway, a program that was first announced in 2011, is intended to shorten the time and cost it takes to develop, assess and review medical devices – especially those that could be considered breakthrough treatments.
End-stage renal disease is the loss of kidney function over months or years. Kidneys are essential organs in the body, filtering and removing waste and producing hormones to aid in calcium absorption and red blood cell production. More than half a million Americans suffer from the disease.
Click here to read more from the FDA.
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FDA launches Innovation Pathway 2.0 for pioneering end-stage renal disease ... - Mass Device |
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The FDA's Center for Devices & Radiological Health accepts 3 end-stage renal disease therapy devices in its Innovation Pathway 2.0 program, aimed at speeding pioneering, life-saving devices to market.
The FDA will pilot 3 kidney disease therapy devices through the federal watchdog agency's Innovation Pathway program, aiming to reduce the cost of getting life-saving devices to market.
The watchdog agency selected an implantable renal assist device under development at the University of California in San Francisco, a wearable artificial kidney by Blood Purification Technologies Inc. and a hemoaccess valve system from CreatiVasc Medical.
Each device meets a need in a the end-stage renal market, which Medicare alone paid $29 billion for in 2009, Center for Devices & Radiological Health chief Dr. Jeffrey Shuren said during a conference call today.
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The FDA will launch each project using a team-based approach and dedicated resources, including an assigned case manager to shepherd the devices from early research through clinical studies and finally to the market.
The FDA hopes that, in creating a road-map for review, they can avoid pitfalls for products that are so different from existing devices that decision-makers can't rely on precedent in managing scientific and risk-benefit concerns, often resulting in 4 to 7 years of back-and-forth between the device maker and the agency, Shuren said.
"Because we've done all this work in advance and we've cut out a lot of inefficiencies and we know a lot of the answers in advance, our sense is that many of these applications for the high-risk products are going to be more likely to fall in the category of timeframe that we are trying to achieve, and have yet to have achieved, for our expedited review, and that's approximately 180 days," Shuren said. "That's where we're kind of shooting for."
Although the program focuses on ESRD therapies, the federal watchdog agency plans to apply the lessons learned to future medical device review programs, and potentially to larger government initiatives.
"The FDA, in the course of 6 months, put together an amazing team of the best internal innovators at the centers and external entrepreneurs in residence, who teamed up in lean-innovation mode to put together this incredibly exciting new pathway and news tools that will be utilizable across all of the pre-market programs," the White House's brand-new chief technology officer Todd Park said during the call. "Actually, we've been so enthused about the success that we've been seeking to clone this innovation mode of development across HHS and potentially more broadly across the government as well."
The agency debuted its Innovation Pathway in February 2011 with a military project to create a prosthetic arm controlled by a brain-implanted microchip, granting the device priority review. The FDA announced in January that it would launch Innovation Pathway using its Entrepreneurs in Residence Program, a collaborative initiative aimed at bringing outside experts into the fold, including the recently retired CEO of Medtronic(NYSE:MDT), Bill Hawkins.
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