Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards

October 24, 2013

News Highlights

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Blood Test Distinguishes Early Lung Cancer From Benign Nodules

A blood test for early-stage lung cancer that can distinguish malignant from benign lung nodules with 90% negative predictive value could reduce the number of unnecessary lung biopsies dramatically, according to a study published online October 16 in Science Translational Medicine. However, "I don't think it's a game changer," pulmonologist Norman H. Edelman, MD, chief medical officer at the American Lung Association, who was not involved in the study, told Medscape Medical News.
The screening tool tests for levels of 13 proteins that differentiate benign from malignant lung nodules identified on CT scans. Xiao-jun Li, director of Bioinformatics for Integrated Diagnostics (known as Indi) in Seattle, and colleagues developed the 13-protein panel by first testing 371 candidate proteins with a technique called multiple reaction monitoring mass spectroscopy. Such a test could go some way toward reducing unnecessary biopsies. "The classifier provided insightful assessment on the disease status of lung nodules beyond the clinical risk factors currently used by clinicians," the researchers write.
Source: http://www.medscape.com/

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Blood Test 'Detects Sepsis in Hours'

A rapid blood test to diagnose blood poisoning, or sepsis, at the hospital bedside could potentially save thousands of lives, say researchers. Early studies at King's College London suggest the condition can be diagnosed in two hours using a simple blood test. Current diagnostic methods take up to two days, which may delay treatment with life-saving antibiotics. In the study, published in the journal PLOS ONE, researchers identified a biomarker for diagnosing sepsis rapidly in blood samples. It is based on detecting nucleotides specific to sepsis to rule out similar conditions that can mimic its symptoms.
Source: http://www.bbc.co.uk/

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Nanotechnology Urine Test Could Detect Deadly Blood Clots

Blood clots, often unexposed until they break away and result in a stroke or heart attack, can form for a number of reasons in anyone. But now, researchers from MIT have developed a simple urine test that uses nanoparticles to detect thrombin, a major blood-clotting element. The researchers, who published the details of their system in the journal ACS Nano, hope this test could be used to monitor patients who are at high risk for blood clots.
Source: http://www.medicalnewstoday.com/

MicroRNA Profiling May Provide Biomarkers for Monitoring MS

Circulating microRNAs could be a readily accessible blood biomarker for diagnosing multiple sclerosis (MS) and monitoring disease activity, new research suggests. "We found that circulating miRNAs are differentially expressed in relapsing-remitting MS, secondary progressive MS, and healthy control subjects," explained Howard Weiner, MD, codirector of the Center for Neurologic Diseases and director and founder of the Partners Multiple Sclerosis Center at Brigham and Women's Hospital, and Robert L. Kroc professor of neurology at the Harvard Medical School in Boston, Massachusetts. The identification of immune biomarkers will allow a better understanding of an individual patient with MS, including response to therapy and disease stage, and progressive forms of MS, he explained.
Source: http://www.medscape.com/

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Gene Expression Test Clarifies Thyroid Biopsies

Data from real-world experience with a new gene expression test support earlier findings that the screen can pick out which indeterminate thyroid nodules don't need to be removed, researchers reported. Among nearly 340 biopsies, the Afirma test by Veracyte found about half (51%) to be benign, rendering surgery unnecessary, Erik Alexander, MD, of Brigham & Women's Hospital, and colleagues reported at the American Thyroid Association meeting.
Source: http://www.medpagetoday.com/

Good Start Genetics Touts In-Vitro Test for Cystic Fibrosis

Molecular diagnostics developer Good Start Genetics Inc. presented positive data on its next generation sequencing technology. According to the Cambridge, Mass., company the data, from 16,500 patients presented at the American Society for Reproductive Medicine (ASRM) annual meeting on its GoodStart Select carrier screening test, showed that 8.4 percent of carriers or genetic diseases such as cystic fibrosis would have been missed using other technologies available in the market today.
Source: http://www.bizjournals.com/

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Low-Cost Device Quickly Isolates Blood Plasma

When testing for some infectious diseases, doctors need to look for viruses lurking in blood plasma. In a new study, researchers report a 1.5-inch-tall filtration device that separates plasma from blood cells at larger sample volumes than other low-cost devices can handle (Anal. Chem. 2013, DOI: 10.1021/ac402459h). The filter system could serve as a component of a point-of-care device for monitoring viral loads in HIV patients, the researchers say.
Source: http://cen.acs.org/

Why Doctors Must Discuss Costly Treatment Before Patients Receive Bills

A $1,000 bill for a $30 Pap smear test. A $55,000 bill for out-of-pocket costs for breast cancer treatments. A patient who loses her home because of astronomical medical expenses. All true accounts of the reality facing patients and all because physicians failed to discuss the costs of test and therapies with patients before they ordered them. Physicians need to consider out-of-pocket costs as a "side effect" to treatment when they make decisions about their patients care, according to one of two perspectives published in the New England Journal of Medicine. The two perspectives illustrate why it is imperative that physicians discuss costs with their patients and understand the role they can play in helping rein in escalating healthcare costs
Source: http://www.fiercehealthcare.com/

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Lyme Disease Tests Draw Scrutiny

The announcement spread quickly through the Web to Lyme disease patients across the United States. A small private lab had made an exciting breakthrough, the e-mail said, developing a surefire way to identify the debilitating disease in people. “This test is being rolled out gradually, with no big public announcements yet,’’ wrote Joseph Burrascano Jr., a New York doctor and leading Lyme patient advocate. Describing himself as a consultant to the lab, Burrascano said he was e-mailing doctors “so you can be among the first to be able to order this testing, before the lab gets swamped.’’
To throngs of sick people in New England, where Lyme disease has become a major health concern, the note offered hope that finally, they would have proof that their chronic health problems were caused by Lyme disease. Two years later, Advanced Laboratory Services has conducted more than 4,200 Lyme tests, but the Pennsylvania company’s methods are being scrutinized by scientists and regulators. New York banned the test because there is no proof it works, and the state’s inspectors uncovered “broad substandard’’ lab practices. A federal scientist has raised contamination concerns. Advanced Laboratory’s path underscores the often unregulated and confusing world of Lyme testing. It and other companies take advantage of an exemption in US Food and Drug Administration regulations that frees them from having to prove that their tests correctly diagnose the disease, leaving patients and doctors to decide for themselves which ones are legitimate.
Source: http://convergence.llesiant.com/

Claritas Genomics to Sequence Exomes for VA Million Veteran Program With Ion Torrent Next-Generation Sequencers

Claritas Genomics, together with partners Life Technologies (NASDAQ: LIFE) and Lockheed Martin (NYSE: LMT), announced that the Department of Veterans Affairs has awarded Claritas a $9 million contract for exome sequencing of Veteran samples, including those from the Million Veteran Program (MVP) over the next 12 months. The project is one of the largest sequencing initiatives ever undertaken in the U.S.
Source: http://www.sacbee.com/

QuantuMDx Gets $1.6M From UK Government for Drug-resistant TB Test

QuantuMDx said that it has received a £1 million ($1.6 million) grant from the UK government's Technology Strategy Board to fund a project to develop a rapid test for multi-drug resistant tuberculosis. The Newcastle, UK-based molecular diagnostics company is involved in a three-year, £2 million effort to advance its Q-TB test, which will be used to analyze sputum samples for MDR-TB at the point-of-care within 15 minutes. Such a test would enable public health officials to identify areas where drug resistance is emerging and then treat those patients accordingly. QuantuMDx said it plans to integrate its DNA analysis device and a TB biomarker panel developed by St. George's Hospital, University of London, and other partners into a test cartridge. This disposable cartridge will operate on the company's Q-POC handheld diagnostic device. It will use lab-on-chip technologies to extract, amplify, and detect the TB, and then to provide diagnostic and drug susceptibility results.
Source: http://www.genomeweb.com/

Counseling With HIV Testing May not Help Prevent Future STDs

Study saw no decrease in infection rate among at-risk recipients given behavior-change advice
Contrary to what experts have believed, briefly counseling people who take a rapid HIV test on how to reduce their risk for sexually transmitted diseases (STDs) is not effective, a new study shows. Counseling for these at-risk patients did not reduce the incidence of STDs up to six months after patients were tested for HIV, the study found. A more focused approach to providing information at the time of testing may be needed, the authors said, since counseling requires valuable resources of time, money and personnel. "Overall, these study findings lend support for reconsidering the role of counseling as an essential adjunct to HIV testing," study author Lisa Metsch, at Columbia University's Mailman School of Public Health, and colleagues wrote in the Oct. 23 issue of the Journal of the American Medical Association.
Source: http://consumer.healthday.com/

New Guideline Takes on Tough HER2 Cases

In HER2 testing for breast cancer, the term “equivocal” verges on being a four-letter word. If the patient has a clearly positive test result, therapies targeting HER2 become a treatment option, and a highly successful one at that. If the result is clearly negative, HER2-targeting drugs are off the table; the patient isn’t expected to benefit from the drugs, which are expensive and can be cardiotoxic. But if the result isn’t clear? David Hicks, MD, can still remember the first time he reported a HER2 breast cancer result as “equivocal.” “We provide clear instructions and clear recommendations on how to handle difficult cases and how to reduce areas of uncertainty,” says Antonio Wolff, MD, who was the principal oncologist author of both guidelines.
Source: http://digital.olivesoftware.com/

BRCA1/2 Mutations May Alter Endometrial, Ovarian Function

Scientists have detected significant differences in endometrial thickness and hormone levels in women with and without BRCA1/2 mutations that may play a role in cancer susceptibility or development. “Our findings suggest that BRCA1/2 germline mutations are driving carcinogenesis only in part via altered molecular pathways (eg, those involved in DNA repair) in the organ at risk, and that BRCA1/2-associated changes in the endocrine system are additional factors,” write Martin Widschwendter (University College London, UK) and co-authors.
Source: http://www.medwirenews.com/

No Proven Benefit for Routine Dementia Screens

Screening tests for cognitive impairment can successfully identify patients with early-stage dementia, but the benefits of doing so remain unproven, according to a review for the U.S. Preventive Services Task Force (USPSTF). "There is no empirical evidence on whether interventions affect clinician, patient, or family decision making," wrote Jennifer S. Lin, MD, MCR, of Kaiser Permanente Center for Health Research Northwest, in Portland, Ore., and colleagues online in Annals of Internal Medicine, after reviewing more than 300 studies.
Source: http://www.medpagetoday.com/

A New Biological Clock Measures Altered DNA, not Birthday Candles

Move over birthday candles, and step aside telomeres; there may be a new kind of biological clock in town. And this one may prove useful in predicting where age-related diseases such as cancer are most likely to strike. The proposed new body clock measures DNA methylation -- the process by which genes are altered as the body's cells differentiate and their genetic programs change to meet new demands. Researchers pored over the DNA of some 8,000 samples from 51 different tissues and cells -- including blood, brain, muscle, heart, lungs, liver and pancreas -- to devise a formula by which DNA methylation could be used to determine the age of the tissue from which the tested cells are drawn.
Source: http://www.latimes.com/

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FDA to Collect 2014 User Fees With End of Shutdown

Because the government shutdown is over, the FDA can start collecting fiscal 2014 user fees from medical device-makers, which include an overall increase of 4.2% from the previous year. Applications for 510(k) clearances are now $2,585 for small businesses and $5,170 for large companies, while premarket approval applications now cost $64,630 for small businesses and $258,520 for large corporations. The new rates went into effect Oct. 1.
Source: AdvaMed SmartBrief advamed@smartbrief.com http://www.massdevice.com/

CIOs Push for Patient ID Progress

The patient identification issue refuses to go away, mainly because nobody has quite figured out how to assure proper patient identity when engaging in health information exchange. At the College of Healthcare Information Management Executives Fall CIO Forum in Phoenix last week, some leading hospital CIOs emphasized the operational, clinical and financial importance of accurate patient matching.
Source: http://www.healthcareitnews.com/

GAO Pushes for Removal of Social Security Numbers From Medicare IDs

The Centers for Medicare & Medicaid Services has been slow to act on data it has collected that could help it implement a technical solution for removing Social Security numbers from Medicare cards, a newly released Government Accountability Office report concluded. Such a solution, according to GAO, could be part of ongoing CMS efforts to "establish an architecture to support 'shared services'--IT functions that can be used by multiple organizations and facilitate data sharing." However, despite having already identified two potential approaches for removing SSNs--replacement via a new Medicare Beneficiary Identifier or masking the first five digits of SSNs displayed on Medicare cards--CMS has yet to establish a business case for an IT project to spearhead such an effort.
Source: http://www.fiercehealthit.com/

St. Luke’s Lab Loses a Seal of Approval

The College of American Pathologists ended its accreditation for the Phoenix hospital’s main laboratory in September following a survey of the lab’s operations. Nearly all major Arizona hospital labs are accredited by the organization, CAP, which is recognized by Medicare for its stringent inspections. With CAP’s accreditation decision, it’s unclear whether Medicare or state health inspectors with the Arizona Department of Health Services will conduct a followup inspection of the Phoenix hospital.
Source: http://www.azcentral.com/

Pentagon Maintains Focus on Biological Threats

The Pentagon's focus on biological threats to troops and population centers ramped up another level this week with a $13.5 million research contract to a pharmaceutical company that uses compounds with the chemical boron to stop diseases often found in Asia and tropical climates. Anacor Pharmaceuticals, based in Palo Alto, Calif., was awarded the contract by the Defense Threat Reduction Agency (DTRA), the Pentagon office responsible for dealing with potential chemical, nuclear and biological threats. The main focus for the research, DTRA documents show, are "novel therapeutics" for two bacteria — B. pseudomallei and Francisella tularensis:
Source: http://www.usatoday.com/

Bacteria-eating Viruses Found That Fight C. diff 'Superbugs'

A potential new victory in the war against antibiotic-resistant "superbugs" lies in the discovery of specific viruses that eat bacteria - called bacteriophages. Researchers in the UK have isolated certain phages, which have been shown to target the infectious hospital bug Clostridium difficile. C. diff, as the superbug is known, is responsible for 250,000 infections in the US each year and results in 14,000 deaths, the researchers say. Unlike antibiotics, Dr. Clokie says phages "are specific in what they kill," noting that they usually infect only one specific species or strain of bacteria. By injecting their DNA into the bacterium, she notes that phages then replicate and cause the bacterial cell to "burst open." Once the dead bacterium is opened, the phages can then repeat the process on other host cells.
Source: http://www.medicalnewstoday.com/

Taking Out the Brain's Trash: It May Be Why We Need Our Sleep

Among the many vital roles that sleep plays in our lives, our nightly rest may give us the chance to take out the cerebral trash, says a new study. No, we're not talking about some kind of Ambien-induced sleep-housework. We're talking about the process by which the brain refreshes itself by removing the build-up of mental metabolites such as beta-amyloid and tau -- the byproducts, if you will, of a day's cogitation.
Source: http://www.latimes.com/

U.S. Teens More Vulnerable to Genital Herpes, Study Suggests

They may have lower levels of protective antibodies to the virus than in years past.
This increase in risk may be the result of fewer teens being exposed in childhood to the herpes simplex virus type 1 (HSV-1), a common cause of cold sores, researchers reported Oct. 17 in the online edition of the Journal of Infectious Diseases. "HSV-1 now is the predominant herpes strain causing genital infection," explained Dr. David Kimberlin, chair of infectious diseases at the University of Alabama at Birmingham School of Medicine, and the author of a journal editorial. According to Kimberlin, the new findings suggest that almost one in 10 adolescents who a decade ago would have already acquired HSV-1 and built up some immunity may now encounter HSV-1 when they first become sexually active. That could leave them more susceptible to genital herpes than young people were in the past.
Source: http://consumer.healthday.com/

Scientists Uncover Breast Milk's Potential Secret Weapon Against HIV

A compound not previously thought to be a germ-killer may help shield babies from the virus.
Experts have long suspected that breast milk may have the power to prevent babies from getting infected with HIV, and new research gives insight into why that might be so. Researchers say they've discovered a component of breast milk that appears to kill the virus that causes AIDS, potentially preventing some babies from becoming infected by their mothers.
Source: http://consumer.healthday.com/

Iron Supplements for Children Found Beneficial

A recent study found that iron supplements for children may be helpful in safely reducing their risk of anemia. Anemia is a blood disorder in which the body does not have enough red blood cells or hemoglobin. Hemoglobin contains iron and is the primary component of red blood cells. Hemoglobin helps these cells carry oxygen throughout the body. Not all children necessarily need iron supplements. Parents should discuss with pediatricians whether their child might be at risk for not having enough iron.
Source: http://www.dailyrx.com/

High Cholesterol in the Womb May Affect Adult Levels

The risk for high cholesterol in adults may be partly explained by intrauterine exposure to high cholesterol, researchers presenting a new study at the Canadian Cardiovascular Congress (CCC) 2013 say[1]. Using multigenerational data from the Framingham Heart Study, they found that if mothers had high prepregnancy LDL levels (a surrogate for intrauterine exposure), their offspring had a fivefold higher risk of having dyslipidemia themselves, as young adults—independent of obesity, smoking, and genetic risk factors for high LDL cholesterol. This study hints that epigenetics—where genes are switched on or off by environmental factors such as exposure to high cholesterol in the womb—may have a lasting effect on regulating cholesterol levels decades later.
Source: http://www.medscape.com/

Flu Virus Wipes Out First Wave of Immune Response

The immune system has the capacity to "remember" particular viruses and store those details in B memory cells that reside in the lungs to help ward off future infections. But a new study shows the flu virus takes advantage of this and uses the way the memory cells store its details to recognize and kill them, thus wiping out the immune system's first wave of defense against virus re-infection. The study, which was led by the Whitehead Institute for Biomedical Research in Cambridge, MA, is published online in a recent issue of Nature.
Source: http://www.medicalnewstoday.com/

Flu Shots Tied to Lower Risk of Cardiac Events

Influenza vaccination was associated with a reduced risk of major adverse cardiovascular events among patients at high risk for heart disease, a meta-analysis showed. In pooled results from five published, randomized trials, the event rate in the first year of follow-up was 2.9% in those who received flu vaccine and 4.7% in those who didn't (risk ratio 0.64, 95% CI 0.48-0.86), according to Jacob Udell, MD, MPH, of the University of Toronto, and colleagues. And the apparent benefit was even greater among those with a history of acute coronary syndrome (ACS) in the year before randomization (RR 0.45, 95% CI 0.32-0.63), the researchers reported in the Oct. 23/30 issue of the Journal of the American Medical Association.
Source: http://www.medpagetoday.com/

Tufts Medical Center Gets $40 Million to See if Vitamin D Can Prevent Diabetes

A Tufts Medical Center researcher has received a grant of more than $40 million from the National Institutes of Health to head a multi-center clinical trial aimed at determining whether taking vitamin D supplements can help prevent type 2 diabetes in those at increased risk, Tufts announced. “The latest vitamin D studies have had some disappointing results,” said Dr. Anastassios Pittas, the Tufts researcher heading the study. Pittas has conducted smaller studies over the past decade that found that those at increased diabetes risk who took vitamin D supplements had improved blood sugar levels. “There is a lot of preliminary evidence that this might help, but we expect to get more definitive answers in this new study.”
Source: http://www.boston.com/

Technology in Healthcare: Why Docs Shouldn't Feel Threatened

While some, such as venture capitalist Vinod Khosla, have predicted that as much as 80 percent of a doctor's job could be replaced by computers in the decades ahead, the split in duties likely will end up more equal, a commentary published this week in National Journal argues. Commentary author Darius Tahir points to tools such as clinical decision support software as evidence that technology is important for helping doctors to provide quality care, as opposed to delivering that care outright.
Source: http://www.fiercehealthit.com/

New Technology Lets Doctors Watch Patients From Afar

Many people carry or own devices that can act as sensors. Smartphones have accelerometers that can measure physical activities and advanced cameras that can provide evidence for interpretation. These devices are becoming more sophisticated; Microsoft's Kinect camera, for instance, can estimate blood pressure based on how flushed a user appears. Consumers' willingness to carry sensors everywhere becomes important as providers are incentivized by the Affordable Care Act to keep costs down while improving outcomes. Acting on this newly available wealth of data—perhaps by intervening earlier, more cheaply and effectively—might benefit providers that are increasingly paid for quality, rather than volume, of care.
Source: http://www.nextgov.com/

Health IT Regulators Face Challenges as Medical Apps Proliferate

The regulation of health IT was always bound to unspool slowly, given the involvement of multiple agencies with overlapping jurisdiction and a rapidly changing and important industry. The first piece of finalized health IT regulation, which laid out rules for mobile applications, was released Sept. 23 following two years of debate. The government is required to outline its plans for the rest of the sector by January. Three agencies are charged with regulating the sector: the Food and Drug Administration, which will approve some apps and software and oversee the use of IT in clinical practice; the Federal Communications Commission, which manages wireless spectrum; and the Office of the National Coordinator for Health Information Technology, which oversees electronic medical records. The agencies have indicated they will take a flexible approach to health IT regulation in the hopes of encouraging innovation.
Source: http://www.nextgov.com/

IBM Unveils Two New Watson-Related Technologies

IBM Research has released details on two new Watson-related cognitive technologies that are expected to help physicians make more informed and accurate decisions faster and to cull new insights from electronic medical records (EMR).
The projects known as “WatsonPaths” and “Watson EMR Assistant” are the result of a year-long research collaboration with faculty, physicians and students at Cleveland Clinic Lerner College of Medicine of Case Western Reserve Univ. Both are key projects that will create technologies that can be leveraged by Watson to advance the technology in the domain of medicine. With the WatsonPaths project, IBM scientists have trained the system to interact with medical domain experts in a way that’s more natural for them, enabling the user to more easily understand the structured and unstructured data sources the system consulted and the path it took in offering an option. The Watson EMR Assistant project aims to enable physicians to uncover key information from patients’ medical records in order to help improve the quality and efficiency of care.
Source: http://www.laboratoryequipment.com/

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Decades Later, Condemnation for a Skid Row Cancer Study

A medical researcher from Columbia University, Dr. Perry Hudson, made the skid row alcoholics in Lower Manhattan an offer: If they agreed to surgical biopsies of their prostates, they would get a clean bed and three square meals for a few days, plus free medical care and treatment if they had prostate cancer. It was the 1950s, and Dr. Hudson was trying to prove that prostate cancer could be caught early and cured. But he did not warn the men he was recruiting that the biopsies to search for cancer could cause impotence and rectal tears. Or that the treatment should cancer be found — surgery to remove their prostates and, often, their testicles — had not been proven to prolong life. But he said in a recent telephone interview that he believed the treatments did prolong life. “I told them the cure rate is extremely high,” he said.
Two papers published in the American Journal of Public Health and the Bulletin of the History of Medicine prompted medical historians to denounce this largely forgotten chapter in the history of government-financed medical research on vulnerable populations. They said the Bowery study was unethical, because of both the powerlessness of the people who participated in it and the things done to them.
Source: http://www.nytimes.com/

Ethics: WMA Updates Declaration of Helsinki

The World Medical Association (WMA) has updated the ethical guidelines for clinical trials known as the Declaration of Helsinki. For the first time, the guidelines require that "Appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured." They also require that trials be registered before recruitment begins, and that "Researchers have a duty to make publicly available the results of their research on human subjects," including negative results.
Source: http://www.medpagetoday.com/

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Polio Outbreak Fears in War-ravaged Syria

The World Health Organization says it has received reports of the first suspected outbreak in the country in 14 years. Syrian's Ministry of Public Health is launching an urgent response, but experts fear the disease will be hard to control amid civil unrest. Immunisation is almost impossible to carry out in regions under intense shellfire. As a result, vaccination rates have been waning - from 95% in 2010 to an estimated 45% in 2013. At least a third of the country's public hospitals are out of service, and in some areas, up to 70% of the health workforce has fled.
Source: http://www.bbc.co.uk/

Hospital Laboratory Services Vital for Good Patient Care [UK]

The Minister was speaking as he visited the Northern Trust’s pathology laboratory at Antrim Area Hospital, where he was given a demonstration of the work undertaken by over 200 staff. The Minister said: “Hospital laboratory services play a vital role in ensuring patients are quickly and correctly diagnosed and receive the best possible care. Often the work done by the staff working in our laboratory services is invisible to patients and the public, but without their knowledge, skill, and expertise, our health service would be unable to deliver the quality of care and treatment that we all expect.” Around 80% of all clinical decisions are based on laboratory results, with the Antrim and Causeway laboratories processing in excess of three million tests per year.
Source: http://www.northernireland.gov.uk/

Clinical Labs Urged to Form Regional Network to Improve [Philippines]

Directors, pathologists and medical technologists from public and private clinical laboratories in the region were urged to form a network aiming to strengthen capabilities of laboratories in providing quality services. In a bid to improve laboratory services, the Department of Health (DOH) has been pushing for the implementation of the Strategic Plan for the National Health Laboratory Network (NHLN) initiative at the regional level. Pathologist Dr. Tomas P. Maramba, Jr., chair of the Technical Working Group on Strategic Plan for NHLN and Task Force Laboratory Network, recently introduced the national framework of NHLN to over 60 stakeholders in Davao Region, mostly medical directors, pathologists and medical technologists.
Source: http://news.pia.gov.ph/

EU Panel Approves FDA-like Requirements for Medical Devices

A European Parliament panel OK'd more stringent oversight of medical devices in the European Union that would require clinical trials for implants and other Class III devices across the pond. If enacted, the new regulations would require implants like heart pumps or joint replacements to undergo a process much more like the FDA's pre-market approval protocol in the U.S., under the purview of the European Medicines Agency. The vote by the EP's Committee for Environment, Public Health & Food Safety drew an immediate outcry from Eucomed, the European medtech lobbying group, which called the proposal "Kafkaesque" and said the regulations would "not only unnecessarily delay by 3 years patient access to the latest lifesaving medical technology, but also deliver a devastating financial blow to Europe's 25,000 small and medium-sized device makers," according to a press release.
Source: http://www.massdevice.com/

Cleveland Clinic Announces Top Ten Medical Innovations of 2014

A bionic retina, capable of restoring rudimentary sight in patients after years of near blindness, is the No. 1 medical innovation for 2014 at the Cleveland Clinic’s annual Innovation Summit.
Here are this year’s Top 10 innovations:

Retinal prosthesis system
Genome-guided solid tumor diagnostics
Responsive neurostimulator for intractable epilepsy
Direct-acting antiviral oral hepatitis C drugs
Perioperative decision support system
Fecal microbiota transplantation
Relaxin for acute heart failure
Computer-assisted personalized sedation system
TMAO assay: novel biomarker for the microbiome
B-cell receptor pathway inhibitors

Source: http://www.cleveland.com/

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Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.