viernes, 8 de agosto de 2014



Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information 
from The Division Of Laboratory Programs, Standards And Services


August 07, 2014

  • Infection Prevention and Control Recommendations for Hospitalized Patients with Known or Suspected Ebola Hemorrhagic Fever in U.S. Hospitals
  • FDA Takes Steps to Help Ensure the Reliability of Certain Diagnostic Tests
  • Survey Shows Doctors' Challenges, Labs' Opportunities in Better Test Ordering and Interpretation
  • What Is the Role of the Clinical Laboratory in the New ACC/AHA Guidelines for the Treatment of Blood Cholesterol in Adults?
  • Blood Test Could Give Early Breast Cancer Warning:
  • Blood and Saliva Tests Help Predict Return of HPV-Linked Oral Cancers
  • Potential Biomarker Identified for Alzheimer's Disease
  • Pancreatic Cancer Study Finds New Genetic Risk Markers
  • C. difficile Vaccine 100 Percent Effective in Animal Models
  • Pill-a-Month Hinders Malaria in Kids
  • CMS Finalizes ICD-10 Compliance Date
  • Smartphone App Could Simplify Diagnosis of Hereditary Diseases


View Previous Issues - Healthcare News Archive


Leading News

Infection Prevention and Control Recommendations for Hospitalized Patients with Known or Suspected Ebola Hemorrhagic Fever in U.S. Hospitals
Standard, contact, and droplet precautions are recommended for management of hospitalized patients with known or suspected Ebola hemorrhagic fever (Ebola HF), also referred to as Ebola Viral Disease (EVD). Note that this guidance outlines only those measures that are specific for Ebola HF; additional infection control measures might be warranted if an Ebola HF patient has other conditions or illnesses for which other measures are indicated (e.g., tuberculosis, multi-drug resistant organisms, etc.). Though these recommendations focus on the hospital setting, the recommendations for personal protective equipment (PPE) and environmental infection control measures are applicable to any healthcare setting. For information on symptoms of Ebola Hemorrhagic Fever infection and modes of transmission, see the CDC Ebola Hemorrhagic Fever Website

FDA Takes Steps to Help Ensure the Reliability of Certain Diagnostic Tests
U.S. Food and Drug Administration took important steps to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent and reliable results.
First, the FDA is issuing a final guidance on the development, review and approval or clearance of companion diagnostics, which are tests used to identify patients who will benefit from or be harmed by treatment with a certain drug. Companion diagnostic tests are intended to aid physicians in selecting appropriate therapies for individual patients. These tests are commonly used to detect certain types of gene-based cancers.
Second, consistent with the requirements of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), the agency is notifying Congress of its intention to publish a proposed risk-based oversight framework for laboratory developed tests (LDTs), which are designed, manufactured and used within a single laboratory. They include some genetic tests and tests that are used by health care professionals to guide medical treatment for their patients. The FDA already oversees direct-to-consumer tests regardless of whether they are LDTs or traditional diagnostics.
“Ensuring that doctors and patients have access to safe, accurate and reliable diagnostic tests to help guide treatment decisions is a priority for the FDA,” said FDA Commissioner Margaret A. Hamburg, M.D. “Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether. This action demonstrates the agency’s commitment to personalized medicine, which depends on accurate and reliable tests to get the right treatment to the right patient.” Web Site Icon 

Laboratory Developed Tests
A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. LDTs can be used to measure or detect a wide variety of analytes (substances such as proteins, chemical compounds like glucose or cholesterol, or DNA), in a sample taken from a human body. Some LDTs are relatively simple tests that measure single analytes, such as a test that measures the level of sodium. Other LDTs are complex and measure or detect numerous analytes. For example, DNA variations can be detected from a blood sample, which can be used to help diagnose a genetic disease. Various levels of chemicals can be measured to help diagnose a patient’s state of health, such as levels of cholesterol or sodium. While the uses of an LDT are often the same as the uses of FDA-cleared or approved in vitro-diagnostic tests, some labs may choose to offer their own test. For example, a hospital lab may run its own vitamin D assay, even though there is an FDA-cleared test for vitamin D currently on the market. The FDA does not consider diagnostic devices to be LDTs if they are designed or manufactured completely, or partly, outside of the laboratory that offers and uses them.

Survey Shows Doctors' Challenges, Labs' Opportunities in Better Test Ordering and Interpretation
It's no secret that doctors sometimes find themselves befuddled by a laboratory test menu of at least 3,500 tests, double the number available 20 years ago, and one that is riddled with confusing nomenclature. New research, however, has pinpointed the bottlenecks that an important subset of providers—primary care physicians (PCPs)—face in ordering and interpreting tests, as well as tangible opportunities for labs to help PCPs use tests better. The insights come from a survey conducted by the Centers for Disease Control and Prevention's (CDC) Clinical Laboratory Integration into Healthcare Collaborative (CLIHC), an ambitious project of the agency's Division of Laboratory Science and Standards aimed at filling gaps that impede practicing clinicians from effectively utilizing lab services for better patient care. The survey was the last in a series of CLIHC initiatives to gather data about diagnostic test utilization. The survey questionnaire, which grew out of three focus groups CLIHC held, was sent in late 2011 to 31,689 PCPs, of whom 1,768 (5.6%) responded (J Am Board Fam Med 2014;27:268–74).

ASC Representatives Work With CAP to Support Adequate Payments for Pathology Services in the Medicare 2015 PFS, Final Rules Releases in November 2014
In July 2014, CMS released two important proposed rules.  The rules propose changes in Medicare payment rates for 2015 for the physician fee schedule and for hospital outpatient departments.  Overall, the proposed changes are positive for pathology: CMS estimates that payments for pathology services on the physician fee schedule will INCREASE by one percent in 2015, and that payments to clinical laboratories will INCREASE by three percent. Despite having new authority to expand its “misvalued codes” initiative, CMS has proposed to re-value only one pathology code.  Further, the agency has accepted three new pathology quality (PQRS) measures developed by the CAP. These are proposed rules and are not fully analyzed yet.  The final rule is typically released in early November.
Source: Web Site Icon



Laboratory Testing / Diagnostics

What Is the Role of the Clinical Laboratory in the New ACC/AHA Guidelines for the Treatment of Blood Cholesterol in Adults?
Recently, a panel of the American College of Cardiology (ACC) and the American Heart Association (AHA) released guidelines for the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults. Essentially, it identified four statin benefit groups: (1) individuals with clinical atherosclerotic cardiovascular disease (ASCVD), (2) individuals with primary elevation of low-density lipoprotein cholesterol (LDL-C) higher than 190 mg/dL, (3) individuals aged 40 to 75 years with diabetes with an LDL-C between 70 and 189 mg/dL, and (4) individuals without clinical ASCVD or diabetes aged 40 to 75 years with an LDL-C from 70 to 189 mg/dL and an estimated 10-year atherosclerotic cardiovascular risk of 7.5% or higher.
In conclusion, the ACC/AHA panel, while veering away from the ATP III regarding target goals for LDL-C, clearly recommends conducting a lipid panel at baseline in patients who are not receiving statin therapy and monitoring the lipid panel, especially LDL-C levels as judged by the clinician following treatment. Finally, regarding the novel risk markers, the panel believes that hs-CRP levels will help inform the clinician about patients who do not fall into the four clear categories as defined by the panel. It is reassuring for the clinical laboratory that its crucial contribution to the risk assessment and management of cardiovascular disease continues as it strives to provide precise and accurate assays for lipids, lipoproteins, and hs-CRP, as well as other emerging biomarkers such as apolipoprotein B.

Blood Test Could Give Early Breast Cancer Warning
Scientists identify epigenetic signature that can predict years in advance if women will develop breast cancer.
A simple blood test to predict a woman’s likelihood of developing breast cancer is being developed by scientists at University College London (UCL). Their research, published in the journal Genome Medicine, would, for the first time, provide a means of assessing whether a woman is at risk even if she has no genetic predisposition. The research team at UCL initially identified an epigenetic signature in the blood of women who possess the BRCA1 mutation. Carriers of BRCA1 have an 85% chance of developing breast cancer. BRCA1, however, only accounts for about 10% of all cases of breast cancer; the other 90% are unexplained and difficult to assess. The epigenetic signature that was identified is a DNA methylation. The researchers then analyzed blood samples collected from two large cohorts of women in the United Kingdom. The samples were taken several years before any of the women developed breast cancer. They found the same DNA methylation signature in women without the BRCA1 mutation. "The data is encouraging," writes Martin Widschwendter, lead author of the study and head of UCL’s Department of Women’s Cancer, "since it shows the potential of a blood-based epigenetic test to identify breast cancer risk in women without known predisposing genetic mutations."

Blood and Saliva Tests Help Predict Return of HPV-Linked Oral Cancers 
Physicians at Johns Hopkins have developed blood and saliva tests that help accurately predict recurrences of HPV-linked oral cancers in a substantial number of patients. The tests screen for DNA fragments of the human papillomavirus (HPV) shed from cancer cells lingering in the mouth or other parts of the body. A description of the development is published in the July 31 issue of JAMA Otolaryngology – Head & Neck Surgery.
“There is a window of opportunity in the year after initial therapy to take an aggressive approach to spotting recurrences and intensively addressing them while they are still highly treatable,” says Joseph Califano, M.D., professor of Otolaryngology - Head and Neck Surgery, member of the Johns Hopkins Kimmel Cancer Center, and medical director of the Milton J. Dance Jr. Head and Neck Center at the Greater Baltimore Medical Center. “Until now, there has been no reliable biological way to identify which patients are at higher risk for recurrence, so these tests should greatly help do so,” he adds.

Could a Simple Blood Test Predict Risk of Suicide?
Being able to identify those at high risk for suicide is vital for prevention, but there is not currently a reliable way to predict this risk. Now, researchers from Johns Hopkins University School of Medicine in Baltimore, MD, say they have found a chemical alteration in a gene linked to stress responses that could enable the creation of a blood test to predict a person's risk of suicide consistently. The study, led by Zachary Kaminsky, assistant professor of psychiatry and behavioral sciences at Johns Hopkins, is published in The American Journal of Psychiatry. Their findings suggest that alterations in a gene that plays a role in the brain's response to stress hormones is involved in turning ordinary reactions to everyday stresses into suicidal tendencies. To conduct their study, Kaminsky and his team aimed their attention at a genetic mutation in a gene called SKA2. They analyzed brain samples from deceased people, some of whom had been mentally ill and some of whom had been healthy. They found that the samples of people who died by suicide had significantly reduced levels of this gene.
Source: Web Site Icon


Research and Development

Potential Biomarker Identified for Alzheimer's Disease
Researchers from Boston University School of Medicine (BUSM) report variants in a new gene, PLXNA4, which may increase the risk of developing Alzheimer's disease (AD). The discovery of this novel genetic association may lead to new drug treatment options that target PLXNA4 specifically. These findings appear in the Annals of Neurology. AD is the most frequent age-related dementia affecting 5.4 million Americans including 13 percent of people age 65 and older, and more than 40 percent of people age 85 and older. Genetic factors account for much of the risk for developing AD with heritability estimates between 60 percent and 80 percent. However, much of the genetic basis for the disease is unexplained. Less than 50 percent of the genetic contribution to AD is supported by known common genetic variations.

Pancreatic Cancer Study Finds New Genetic Risk Markers
After comparing the DNA of thousands of people with and without the disease, a new study has identified five genetic markers for pancreatic cancer that raise the risk for developing the deadly disease. The international consortium of scientists reports the findings in the journal Nature Genetics. The discovery is the result of a third project in a series of genome-wide association studies that began in 2006 under the auspices of the National Cancer Institute (NCI) Cohort Consortium. Pancreatic cancer is a cancer that occurs in the cells lining the ducts or the islet cells of the pancreas, a digestive organ that sits in the upper abdomen surrounded by the stomach, small intestine, liver, spleen and gall bladder. There is no effective screening test for pancreatic cancer, one of the leading causes of cancer deaths in the US. The PanScan project, which the NCI set up in 2006, is identifying genetic and environmental factors that contribute to the development of pancreatic cancer, together with ways to screen and improve the diagnosis of the disease so it can be detected earlier.

Molecule Enhances Copper’s Lethal Punch Against Microbes
Harnessing a natural process in the body that pumps lethal doses of copper to fungi and bacteria shows promise as a new way to kill infectious microbes, a team of scientists at Duke University report. In a study published in the journal Chemistry & Biology, the researchers describe a way of exploiting the unique chemical response from the body’s immune system to attack pathogens using copper, long known for its antimicrobial properties, in a way that minimizes harm to the rest of the body. Senior author Dennis J. Thiele, PhD, says future studies will focus on enhancing the molecule’s drug-like properties to optimize its ability to fight additional fungal and bacterial infections in animal models. 

Blood Cell Genetic Variants That Reduce Sickle Cell and Thalassemia Symptoms Originated In Africa
Sickle cell anemia and beta thalassemia are both inherited blood disorders occurring due to defects in the gene controling red blood cell development. But scientists have found that certain people, who experience milder symptoms of these conditions, carry two variants of this gene that enables them to make fetal hemoglobin in their bodies even in adulthood. Using worldwide genomic studies, the scientists from King's College London, found that these beneficial genetic variants have spread from Africa into nearly all human populations across the globe.  

NIH Launches New Program to Find Potential Drug Targets
National Institutes of Health leaders have announced a new collaborative initiative to improve human health by exploring poorly understood genes that have the potential to be modified by medicines. The effort is part of an NIH Common Fund three-year pilot project called Illuminating the Druggable GenomeExternal Web Site Icon (IDG). For the initial phase of the program, NIH has awarded $5.8 million to eight institutions. As many as 3,000 genes express proteins that could have their activities altered by medicines, according to predictions based on genomic information. Yet only about 10 percent of these so-called “druggable genes” are targeted by FDA-approved drugs. The IDG program is designed to address this gap by supporting research of understudied genes in four important druggable gene families: nuclear receptors, ion channels, protein kinases and G-protein coupled receptors, often called GPCRs.

Researchers Discover Key to Aging Immune System
There's a good reason people over 60 are not donor candidates for bone marrow transplantation. The immune system ages and weakens with time; making the elderly prone to life-threatening infection and other maladies, and a UC San Francisco research team has now discovered a reason why. "We have found the cellular mechanism responsible for the inability of blood-forming cells to maintain blood production over time in an old organism, and have identified molecular defects that could be restored for rejuvenation therapies," says Emmanuelle Passegué, a professor of medicine and a member of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at UCSF. Passegué, an expert on the stem cells that give rise to the blood and immune system, led a team that published the new findings online July 30, 2014 in the journal Nature.

Diet Affects Men’s and Women’s Gut Microbes Differently
The microbes living in the guts of males and females react differently to diet, even when the diets are identical, according to a study by scientists from The University of Texas at Austin and six other institutions published in the journal Nature Communications. These results suggest that therapies designed to improve human health and treat diseases through nutrition might need to be tailored for each sex. The researchers studied the gut microbes in two species of fish and in mice, and also conducted an in-depth analysis of data that other researchers collected on humans. They found that in fish and humans diet affected the microbiota of males and females differently. In some cases, different species of microbes would dominate, while in others, the diversity of bacteria would be higher in one sex than the other.

'New Drug Target for Leukemia Identified'
A new drug target for treating leukemia has been identified as part of the largest ever genetic analysis of tumor growth in childhood blood cancer. T-cell acute lymphoblastic leukemia is one of the most common and aggressive childhood blood cancers. Every year, an estimated 500 American adolescents with this blood cancer fail to achieve remission through standard chemotherapy. Using genetic scanning techniques, researchers at NYU Langone Medical Center identified 6,023 long, non-coding strands of RNA active in immune system T cells taken from a group of T-cell acute lymphoblastic leukemia patients.

“Rewired” Mice Show Signs of Longer Lives With Fewer Age-related Illnesses 
While developing a new cancer drug, researchers at The Wistar Institute discovered that mice lacking a specific protein live longer lives with fewer age-related illnesses. The mice, which lack the TRAP-1 protein, demonstrated less age related tissue degeneration, obesity, and spontaneous tumor formation when compared to normal mice. Their findings could change how scientists view the metabolic networks within cells. The Wistar team’s report, which appears in the journal Cell Reports (available online now), shows how “knockout” mice bred to lack the TRAP-1 protein compensate for this loss by switching to alternative cellular mechanisms for making energy.
Source: Web Site Icon


Public Health and Patient Safety

C. difficile Vaccine 100 Percent Effective in Animal Models
An experimental vaccine protected 100 percent of animal models against the highly infectious and virulent bacterium, Clostridium difficile, which causes an intestinal disease that kills approximately 30,000 Americans annually. The research is published ahead of print in Infection and Immunity. "Animals that received two immunizations did not get sick or show signs of C. difficile-associated disease," says corresponding author Michele Kutzler, of Drexel Univ. College of Medicine, Philadelphia. The cost of fighting the half million C. difficile infections that occur annually in the US is estimated to be nearly $10 billion, most of which could be saved by a successful preventive vaccine, says Kutzler. Morbidity and mortality have risen over the last decade, likely due to increased prevalence of relapsing disease, and hypervirulent strains, she adds.

Pill-a-Month Hinders Malaria in Kids
A monthly pill appears to protect infants against malaria in regions where the mosquito-borne disease is transmitted year round, researchers reported. In a randomized open-label trial, dihydroartemisinin-piperaquine (Duo-Cotecxin) had a protective efficacy of 58% compared with no medication, according to Grant Dorsey, MD, of the University of California San Francisco, and colleagues. The drug combination -- known as DP in the trial -- also outperformed other antimalaria drugs in protecting infants, Dorsey and colleagues reported online in PLOS Medicine.

Call for 'Radical action' on Drug-resistant Malaria
Drug-resistant malaria is spreading in South East Asia, and has now reached the Cambodia-Thailand border, according to a study. "Radical action" is needed to prevent further spread of malaria parasites resistant to key drugs, say scientists. The spread could undermine recent gains in malaria control, they report in the New England Journal of Medicine. No evidence was found of resistance in three African sites - Kenya, Nigeria and the Democratic Republic of Congo. The study analysed blood samples from more than 1,000 malaria patients in 10 countries across Asia and Africa.

Whooping Cough Vaccine Safe for Pregnant Women
Pregnant women in their third trimester can safely receive the whooping cough vaccine to prevent infections in newborns, a recent study from the UK suggests. Whooping cough, or pertussis, is a highly contagious disease. Its symptoms are initially mild but it can lead to serious and fatal complications, particularly for children under three months old. Recent increases in whooping cough infections, some resulting in deaths of newborns, prompted the UK to develop a new vaccine program in 2012. The program offered combined vaccines against diphtheria, pertussis and polio to over 700,000 women in the third trimester of pregnancy. “The benefit of maternal immunization is that the mother’s protective antibodies are passed on to the baby before it is born, giving it the best protection it needs before they are old enough to be vaccinated themselves,” Philip Bryan told Reuters Health in an email. He worked on the study at the Medicines and Healthcare Products Regulatory Agency (MHRA) in London. 

Hints of Help for Diabetes From Okra
Eating lots of okra, a staple of Southern cooking, may be a useful dietary treatment for Type 2 diabetes and cardiovascular disorders associated with obesity, according to a laboratory study reported in the Journal of Nutritional Biochemistry. The green seedpods of the okra plant are used in stews and curries or eaten raw when they are young. Okra is rich in disease-fighting compounds called flavonoids, of which two in particular may help to regulate glucose and fat metabolism through proteins in the liver, the study suggests.

4 Unexpected Patient Safety Hazards
As providers in the United States focus on patient-centered healthcare, the importance of patient safety increases. Some threats to patient safety are obvious, such as preventable medical errors (the third-leading cause of death in the United States, according to a recent report), hospital-acquired infections (which affect about one in 25 patients) and hospital violence. But these more obvious examples are far from the only obstacles to a safe patient population. To improve outcomes, healthcare leaders must consider other, less expected threats. FierceHealthcare breaks down four of these patient safety hazards.
  • Physician and clinician stress, fatigue
  • Drug abuse by healthcare workers
  • Workers' clothing
  • Handshakes and elevators
Source: Web Site Icon


Health IT

CMS Finalizes ICD-10 Compliance Date
After months of speculation, the U.S. Department of Health and Human Services, as expected, finalized Oct. 1, 2015, as the new compliance date for providers and payers to transition to ICD-10. An announcement from the Centers for Medicare & Medicaid Services said that ICD-9-CM contains "outdated, obsolete terms that are inconsistent" with current medical practices, adding that ICD-10 represents "a significant change." "ICD-10 codes will provide better support for patient care, and improve disease management, quality measurement and analytics," CMS Administrator Marilyn Tavenner said in a statement. "For patients under the care of multiple providers, ICD-10 can help promote care coordination."

Smartphone App Could Simplify Diagnosis of Hereditary Diseases
Certain hereditary diseases - such as cystic fibrosis and Huntington's disease - present an array of symptoms similar to that of other illnesses, making the conditions tricky to diagnose. Now, researchers have created a computer program that they say can simplify diagnosis of such diseases. The research team, led by Marcel Schulz of the Max Planck Institute for Informatics in Germany, first reported their creation in the American Journal of Human Genetics in 2009.  Now, the program - called "Phenomizer" - is available as a free Android app on Google Play for smartphones and tablets, making it available to doctors all over the world.  To use the program, the doctor inputs a patient's symptoms. The system then scans a large online database called the Human Phenotype Ontology, which stores over 10,000 disease characteristics and links them to 7,500 diseases. Within seconds of entering the data, the doctor is presented with a list of the most likely illnesses the patient has.

OIG: ONC's Inadequate Oversight Left EHRs Vulnerable to Hackers
The Office of the National Coordinator for Health IT's lackluster monitoring of the Authorized Testing and Certified Bodies (ATCBs) under the temporary certification program did not fully ensure that test procedures and standards could secure and protect patient information in electronic health record, according to a new report by the U.S. Department of Health and Human Services' Office of Inspector General (OIG). The report, released August 4, found that the ATCBs under the temporary certification program did not develop procedures to periodically evaluate whether certified EHRs continued to meet federal standards or develop training programs to ensure that staff were competent to test and certify EHRs and secure proprietary and sensitive electronic patient information. OIG pointed out that standards used met National Institute of Standards and Technology (NIST) requirements that ONC approved, but that they were not sufficient to ensure that EHRs were adequately secure. For instance, passwords were not sufficiently complex.

Do We Already Have Data Proving That EHRs Save Lives?
And the good news is, that study now exists and it has found that EMRs do have a measurable, positive impact on care as measured by clinical outcomes of risk-adjusted mortality rates. The preliminary analysis is the first fruit of an effort to connect data from the HIMSS Analytics Database, and its comprehensive EMR adoption model (EMRAM), with Healthgrades' own hospital performance database, which measures hospitals on mortality and complication rates across multiple service lines. Based on the joint study by HIMSS Analytics and Healthgrades, hospitals with high EMRAM scores showed improvement in the capture of data about the patient, measured by the predicted mortality rate in the Healthgrades model. And the actual performance (based on the actual number of mortalities) for hospitals with high EMRAM scores was significantly better than hospitals with low EMRAM scores in four specific conditions, indicating a relationship between the use of an EMR and the actual outcome.

Modeling Tool Sheds Insight on Physician Workforce Needs
In an effort to predict where the physician shortage will hit the hardest, researchers at the University of North Carolina, Chapel Hill have developed a web-based model to determine how many physicians each region, state and the nation needs. The FutureDocs Forecasting Tool focuses on the idea of plasticity--that physician specialists have overlapping areas of expertise, the announcement explains. "It's important to recognize that the national dialogue about physician supply has been narrowly focused until now," said Erin Fraher, Ph.D., leader of the development team at the Program on Health Workforce Research and Policy, part of the Cecil G. Sheps Center for Health Services Research at UNC-Chapel Hill.
Source: Web Site Icon

Other News

Medical Device Makers Face New Obstacles to European Approval
Medical device makers looking to bring new products to the European market will find a new layer of regulation before they can attain CE Mark approval. The European Commission's new hazardous substances restrictions now apply to medical devices for the 1st time, requiring that all products coming to the E.U. market after July 22, 2014, meet materials standards before they get market approval. The new Restriction of Hazardous Substances (RoHS-2) document became law in July 2011 and took effect last year. The original RoHS rules exempted all medical devices, allowing them to contain unspecified amounts of materials deemed otherwise toxic. RoHS-2 now only fully exempts "active implantable medical devices," bringing materials used in in vitro diagnostics and other medical devices under regulatory oversight. Medical devices already on the market before July 22, 2014, are protected for 5 years as they figure out how to achieve compliance.

Developing Guidelines for the Application of ‘Omics’-Based Tests
The Australian National Health and Medical Research Council (NHMRC) has released Principles for the translation of ‘omics’-based tests from discovery to health care for public consultation. The document offers a new framework to guide the development and application of ‘omics’-based tests, focusing on genomic testing. ‘Omics’ is a general term that covers transcriptomics, metabolomics, epigenomics and proteomics. NHMRC CEO Professor Warwick Anderson commented on the timeliness and necessity of this new guide. ‘This is an area that is continuing to evolve and grow, with other ‘omics’-based testing also on the rise. It is timely for Australia to agree to adopt principles to protect interests of consumers and to ensure research integrity.

'Sobriety Tags' to be Worn by Offenders of Alcohol-linked Crime in Pilot Scheme
People who repeatedly commit alcohol-related crime will be forced to wear ankle tags that monitor whether they are still drinking, under a year-long pilot scheme. The "sobriety tags", to be worn around the clock, will enforce abstinence by measuring a person's perspiration every 30 minutes and testing whether it contains alcohol. If any trace is found, an alert will be sent to the offender's probation officer and they can then be recalled to court, where they may be resentenced or face sanctions such as a fine. The tags register alcohol consumption but do not monitor movement or where people are.
Source: Web Site Icon

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.

External Web Site Policy This symbol means you are leaving the Web site. For more information, please see CDC's Exit Notification and Disclaimer policy.

No hay comentarios: