A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
March 19, 2015
- Breast Biopsies Leave Room for Doubt, Study Finds
- WHO Issues its First Hepatitis B Treatment Guidelines
- New AMA, CDC Initiative Aims to “Prevent Diabetes STAT”
- AACC Cautions FDA against Over-regulating the Genetic Testing Technology Vital to Precision Medicine
- 6 in 10 Americans Interested in Genetic Testing, Survey Finds
- Researchers Print Needle-free Glucose Tests
- Johns Hopkins Researchers Engineer Custom Blood Cells
- Cholesterol Transport Linked to Diabetes Risk
- People with Type 'O' Blood Are Protected from Most Severe Forms of Malaria Infection
- WHO Charges Independent Panel to Examine Ebola Response
- Genital Herpes Vaccine Shows Promise in Mouse Study
- Misperceptions Keep Kids from Getting Lifesaving Treatment for Tick-borne Diseases
- Georgia Nation's Health IT Capital—Boom Statewide, but Particularly Strong in Metro Atlanta
- HIPAA Audits Still on Hold
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Breast Biopsies Leave Room for Doubt, Study Finds
Breast biopsies are good at telling the difference between healthy tissue and cancer, but less reliable for identifying more subtle abnormalities, a new study finds. Because of the uncertainty, women whose results fall into the gray zone between normal and malignant — with diagnoses like “atypia” or “ductal carcinoma in situ” — should seek second opinions on their biopsies, researchers say. Misinterpretation can lead women to have surgery and other treatments they do not need, or to miss out on treatments they do need. The new findings, reported in JAMA, challenge the common belief that a biopsy is the gold standard and will resolve any questions that might arise from an unclear mammogram or ultrasound. In the United States, about 1.6 million women a year have breast biopsies; only about 20 percent of the tests find cancer. Ten percent identify atypia, a finding that cells inside breast ducts are abnormal, but not cancerous. About 60,000 women each year are found to have ductal carcinoma in situ, or D.C.I.S., which also refers to abnormal cells that are confined inside the milk ducts and so are not considered invasive; experts disagree about whether D.C.I.S. is cancer. “It is often thought that getting the biopsy will give definitive answers, but our study says maybe it won’t,” said Dr. Joann G. Elmore, a professor at the University of Washington School of Medicine in Seattle and the first author of the new study on the accuracy of breast biopsies.
WHO Issues its First Hepatitis B Treatment Guidelines
WHO issued its first-ever guidance for the treatment of chronic hepatitis B, a viral infection which is spread through blood and body fluids, attacking the liver and resulting in an estimated 650 000 deaths each year – most of them in low- and middle-income countries.
Key recommendations include:
- the use of a few simple non-invasive tests to assess the stage of liver disease to help identify who needs treatment;
- prioritizing treatment for those with cirrhosis - the most advanced stage of liver disease;
- the use of two safe and highly effective medicines, tenofovir or entecavir, for the treatment of chronic hepatitis B; and
- regular monitoring using simple tests for early detection of liver cancer, to assess whether treatment is working, and if treatment can be stopped.
New AMA, CDC Initiative Aims to “Prevent Diabetes STAT”
Chicago – With more than 86 million Americans living with prediabetes and nearly 90 percent of them unaware of it, the American Medical Association (AMA) and the Centers for Disease Control and Prevention (CDC) announced that they have joined forces to take urgent action to Prevent Diabetes STAT and are urging others to join in this critical effort. Prevent Diabetes STAT: Screen, Test, Act - Today™, is a multi-year initiative that expands on the robust work each organization has already begun to reach more Americans with prediabetes and stop the progression to type 2 diabetes, one of the nation’s most debilitating chronic diseases. Through this initiative, the AMA and CDC are sounding an alarm and shining a light on prediabetes as a critical and serious medical condition.
AACC Cautions FDA against Over-regulating the Genetic Testing Technology Vital to Precision Medicine
AACC sent formal comments to the Food and Drug Administration (FDA) on the agency's proposed regulation of next-generation sequencing tests. AACC appreciates FDA's efforts to seek input from the healthcare community before developing new policy in this area, but is concerned that FDA regulation of next-generation sequencing could impede the advancement of precision medicine. After reviewing FDA's preliminary discussion paper on the topic, "Optimizing FDA's Regulatory Oversight of Next-Generation Sequencing Diagnostic Tests," AACC recommends that oversight of next-generation sequencing remain under the Clinical Laboratory Improvement Amendments (CLIA) like other laboratory developed tests. CLIA-regulated laboratories conducting next-generation sequencing testing are experienced in developing, verifying, and performing clinical tests. AACC believes that CLIA-recognized accrediting bodies and professional societies should continue to take the lead in providing oversight and guidance for next-generation sequencing testing in the absence of specific, identified problems with this approach.
6 in 10 Americans Interested in Genetic Testing, Survey Finds
A majority of Americans taking part in a new poll said they'd be interested in genetic testing to see if they or their children are at risk for serious illnesses. A team at the University of Michigan's C.S. Mott Children's Hospital looked at data from a national online survey. The researchers found that 59 percent of respondents, including parents and adults without children, were interested in "whole genome sequencing," which maps a person's full complement of DNA. Nearly 62 percent of parents said they would want genetic testing for themselves. And 58 percent of parents were interested in genetic testing for their children, according to the study published online recently in the journal Public Health Genomics.
Researchers Print Needle-free Glucose Tests
Researchers at the University of Newcastle have developed a saliva-based glucose test using a 2D printer, which could spell the end of needles and blood tests for diabetics. The simple-to-use test, which detects concentrations of glucose and is up to 100 times more sensitive than current blood sensors, integrates bio-sensors or chemical signatures into printed transistors. "We print electrical components using an ink that is a semi-conductor, mixing in the enzyme which will detect the presence and level of glucose when a diabetic places a sample of their saliva on the test. Estimated to cost as little as one cent per test, Professor Dastoor said he and his team were now investigating the logistics of printing the tests on a large scale.
Are You Ready for an Emergency Event?
As part of their accreditation, clinical laboratories are required to have plans in place to respond to natural disasters and other emergency events. However, getting these plans on paper is not the same thing as practicing, analyzing, and improving them. Moreover, laboratories must be sure not to neglect internal threats such as a fire, chemical spill, or other emergencies even as they focus on larger-scale disasters like hurricanes or tornadoes. One way to approach emergency planning that incorporates documentation, planning, and practice is the Six Sigma methodology. The goal of the Six Sigma methodology is implementing a measurement-based strategy that focuses on process improvement and variation reduction through the application of Six Sigma improvement projects. Often applied to improve efficiency, productivity, and quality within a clinical laboratory, a Six Sigma project can be employed to focus on other areas, including emergency preparedness.
ADVANCE Examines the Laboratory's Role in Stroke Care
The impact of the work done in laboratories can be seen all across the spectrum of the healthcare industry - from general pathology to specialties like histology and even cardiology, but what about stroke care? For incoming patients with stroke symptoms, the efficiency and turnaround time of laboratory testing is vital. In a recent interview with ADVANCE, Deborah Murphy, MSN, RN, CNRN, SCRN, CRNP, clinical director of the Neurosciences Institute at Abington Memorial Hospital, discussed the laboratory's role in stroke diagnosis and treatment. "With our stroke protocol, it's really important that these patients are identified quickly," said Murphy. "There's a series of diagnostic tests that have to be run in order for us to treat the patients in the safest manner." Apart from imaging, physicians must also rely on all lab results for hemorrhagic stroke, rather than simply relying on the blood glucose and INR results. Of course, stroke testing includes several different panels - all of which are important to the patient at hand -- but these two are all that's needed to start the initial treatments for ischemic stroke patients. When taking action in a hemorrhagic stroke, however, the treating doctors must have the complete knowledge of a patient's test results before acting - including hematic rate, platelet counts, PT and APTT numbers. In order for any clinical decisions to be made, the results of the initial blood work determines the proper actions to be performed in order to diagnose and treat effectively.
‘Liquid Biopsies’ Could Help Spot Genetic Faults in Lung Cancer
Blood samples could offer an alternative to tumour biopsies in lung cancer patients, according to European researchers. They found that the tumour DNA present in blood samples could be used to identify different types of tumour-causing genetic faults in a gene called EGFR. The study, published in the journal JAMA Oncology, analyzed blood samples from 97 patients who took part in the EURTAC clinical trial. And in 78 per cent of the blood samples tested, two important genetic faults were successfully identified. The researchers believe their findings raise the question of whether the tumour DNA present in blood samples could offer a less invasive way of searching for key genetic faults in the future.
New Predictive Model for Prostate Cancer Recurrence and Successful Radiation Therapy
A new study led by researchers at the Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) revealed that a specific group of molecules expressed in prostate cancer cells can predict cancer recurrence and the response to radiation therapy in patients who have undergone prostate removal. The study was published in the journal PLOS ONE and is entitled “A Novel MiRNA-Based Predictive Model for Biochemical Failure Following Post-Prostatectomy Salvage Radiation Therapy.” In this study, preserved tumor samples from 43 patients with prostate cancer who had undergone radiation therapy after radical prostatectomy were analyzed; follow-up data of more than 4 years was available for these particular patients. RNA was isolated from the samples and analyzed for the expression of eight hundred different microRNAs (miRNAs), small non-coding RNA molecules that play essential roles in the regulation of gene expression.
Predicting Cardiovascular Disease Events
New research indicates that four of five popular standardized risk calculators used by physicians to assess a patient’s risk for cardiovascular disease (CVD) events and to guide treatment decisions “significantly overestimate” risk, according to a prepared statement. The analysis suggests that clinicians should consider each patient’s CVD risk in the context of his or her overall health and lifestyle. "Our results reveal a lack of predictive accuracy in risk calculators and highlight an urgent need to reexamine and fine-tune our existing risk assessment techniques," said senior investigator Michael Blaha, MD, MPH, director of clinical research at the Ciccarone Center for the Prevention of Heart Disease and assistant professor of medicine at Johns Hopkins University in Baltimore, Maryland. "The take-home message here is that as important as guidelines are, they are just a blueprint, a starting point for a conversation between patient and physician about the risks and benefits of different treatments or preventive strategies." The findings, published inAnnals of Internal Medicine, come from an ongoing analysis of the Multi-Ethnic Study of Atherosclerosis (MESA), which is following nearly 7,000 participants ages 45 to 84 at baseline who were free of CVD when recruited in 2000 to 2002.
Genetic Markers of PTSD Linked to Immune System Reponse
A new study of blood samples from US Marines has identified genetic markers associated with post-traumatic stress disorder that are also linked to the immune system response. The research team - from the US and UK - says the discovery could lead to new diagnostic techniques and treatments for the condition, as well as predict which individuals are most at risk for the disorder. Previous studies have aimed to uncover genetic markers of PTSD by investigating differences in gene expression between people with the disorder and those without it. But the team involved in this latest research decided to adopt a "systems-level approach," which involved using whole transcriptome RNA sequencing on blood samples of US Marines with and without PTSD. Using whole transcriptome RNA sequencing to analyze the blood samples, the team identified groups of genes that regulate the innate immune system and interferon signaling that were also linked to PTSD.
Blood-Based Genetic Biomarkers Identify Young Boys with Autism
In a study published in the current online issue of JAMA Psychiatry, an international team of scientists, led by researchers at the University of California, San Diego School of Medicine, report finding a highly accurate blood-based measure that could lead to development of a clinical test for autism spectrum disorder (ASD) risk in males as young as one to two years old. The test could be done in community pediatric settings. The degree of accuracy, they said, out performs other behavioral and genetic screens for infants and toddlers with ASD described in literature. The causes of ASD are complex and diverse, making it difficult to conclusively diagnose the disease much before a child’s fourth year of life. Indeed, the median age of diagnosis in the United States is 53 months.
Source: Source: http://www.technologynetworks.com/
Johns Hopkins Researchers Engineer Custom Blood Cells
Researchers at Johns Hopkins have successfully corrected a genetic error in stem cells from patients with sickle cell disease, and then used those cells to grow mature red blood cells, they report. The study represents an important step toward more effectively treating certain patients with sickle cell disease who need frequent blood transfusions and currently have few options. The results appear in an upcoming issue of the journal Stem Cells. To solve that problem, the researchers started with patients’ blood cells and reprogrammed them into so-called induced pluripotent stem cells, which can make any other cell in the body and grow indefinitely in the laboratory. They then used a relatively new genetic editing technique called CRISPR to snip out the sickle cell gene variant and replace it with the healthy version of the gene. The final step was to coax the stem cells to grow into mature blood cells. The edited stem cells generated blood cells just as efficiently as stem cells that hadn’t been subjected to CRISPR, the researchers found.
Cholesterol Transport Linked to Diabetes Risk
A group of Dutch researchers has found that the prevalence of type 2 diabetes is lower among those with familial hypercholesterolemia than among their unaffected relatives. As they report in JAMA, people with familial hypercholesterolemia had a 51 percent lower T2D risk than their relatives,though NPR notes that the diabetes risk for both groups was rather low to begin with. The risk also varied based on genetic mutation, the researchers add. Diabetes prevalence was lower among APOB and LDLR mutation carriers.
People with Type 'O' Blood Are Protected from Most Severe Forms of Malaria Infection
In a list of the world’s most deadly infectious diseases, malaria is ranked third, behind tuberculosis and HIV, when it comes to annual casualties around the world. While scientists have known for some time that people with blood type O are protected from the most severe (and deadly) forms of malaria, they have never understood the reasons why. Now, Scandinavian researchers explain how a protein secreted by malarial parasites makes its way to the surface of blood cells, where it acts like glue, and blocks blood flow (and ultimately leads to death). However, this protein only weakly bonds with type O blood cells, the researchers say, while it strongly bonds to type A.
Inappropriate Imaging in Both Breast and Prostate Cancer
At a regional level, inappropriate imaging rates for breast cancer are associated with inappropriate imaging rates for prostate cancer, according to new data. In other words, a man with prostate cancer has higher odds of undergoing inappropriate imaging if he lives in a region with higher rates of inappropriate breast cancer imaging, and to a lesser extent, vice versa. The finding is published online in JAMA Oncology. Using the Surveillance, Epidemiology, and End Results (SEER) Medicare-linked database, the authors identified 9,219 men with prostate cancer and 30,398 women with breast cancer, and found high rates of inappropriate imaging overall, for both prostate cancer (44.4%) and breast cancer (41.8%).
Researchers Identify Control Mechanism for Glutamine Uptake in Breast Cancer Cells
Researchers at Sanford-Burnham Medical Research Institute (Sanford-Burnham) have discovered a mechanism that explains why some breast cancer tumors respond to specific chemotherapies and others do not. The findings highlight the level of glutamine, an essential nutrient for cancer development, as a determinant of breast cancer response to select anticancer therapies, and identify a marker associated with glutamine uptake, for potential prognosis and stratification of breast cancer therapy. "Our study indicates that a protein called RNF5 determines breast cancer response to paclitaxel, one of the most common chemotherapy drugs," said Ze'ev Ronai, Ph.D., scientific director of Sanford-Burnham's La Jolla campus.
Mapping the Human Epigenome
In an effort to help with understanding of the ties between DNA and disease, researchers recently mapped—for more than 100 cell and tissue types—the human epigenome, the chemical tags on DNA that influence gene function. The effort provides “new insight into which parts of the genome are used to make a particular type of cell,” according to a press release from the National Institutes of Health (NIH) and the National Institute of Environmental Health Sciences. The NIH Common Fund’s Roadmap Epigenomics Program supported the effort. A description of the maps was published in the journal Nature, and the data is available on the National Center for Biotechnology Information website. Additionally, 20 more papers—explaining how the maps can be used in the future in order to study human biology—were published in Nature and other associated journals.
WHO Charges Independent Panel to Examine Ebola Response
The World Health Organization (WHO) has appointed a group of outside health experts to investigate the agency’s much-criticized response to the Ebola outbreak. The independent panel will spend the next two months questioning “all aspects” of the WHO’s efforts to fight Ebola in West Africa, according to a release. The WHO, a part of United Nations, has faced flak for its missteps while managing the international response to the Ebola outbreak. The agency’s director, Dr. Margaret Chan, has acknowledged many of the shortcomings, such as politically driven appointees in Africa who were ill-prepared to deal with a major disease outbreak.
Genital Herpes Vaccine Shows Promise in Mouse Study
There's a glimmer of hope for millions of people infected with genital herpes: A new study in mice hints at the success of a vaccine against the virus. Researchers at Albert Einstein College of Medicine in New York City report that the vaccine was safe and effective in protecting mice against herpes simplex virus type 2 (HSV-2), the virus that causes genital herpes. The vaccine also shows indications of being effective against oral herpes, which causes cold sores, according to the authors of the study published March 10 in the online journal eLife. While the findings are promising, experts note that results from animal studies often do not pan out in human trials.
Misperceptions Keep Kids from Getting Lifesaving Treatment for Tick-borne Diseases
Kids are five times more likely than adults to die from tick-borne diseases like Rocky Mountain spotted fever (RMSF). Doctors often avoid prescribing doxycycline, the most effective RMSF treatment, for young children because the drug’s warning label cautions that tooth staining may be a side effect in children younger than 8 years. A new study published in The Journal of Pediatrics suggests that for patients with RMSF, this warning may be doing more harm than good. The study led by experts at the Centers for Disease Control and Prevention (CDC) and Indian Health Service (IHS) found that short courses of the antibiotic doxycycline can be used in children under 8 years old without staining teeth or weakening tooth enamel.
Low Vaccination Rates Likely behind Disney Measles Outbreak: Study
Pockets of unvaccinated children appear to have fueled the recent measles outbreak traced to Disney theme parks in California, researchers report. "The Disneyland outbreak is quite possibly a direct consequence of the growing anti-vaccination movement in the United States," said study author Maimuna Majumder, a research fellow at Boston Children's Hospital. Although the person who started the outbreak has not been identified, the researchers analyzed outbreak data and found the rapid spread of the disease indicates that most of those infected were not vaccinated or were incompletely vaccinated.
Current Bird Flu in China Could Become ‘Pandemic’ Threat to Humans, Researchers Say
The virus causing a second wave of bird flu across China has mutated frequently and "should be considered as a major candidate to emerge as a pandemic strain in humans," researchers reported. While it is much too early to predict whether that might happen, one of the scientists said in an interview, there is cause for alarm because the H7N9 virus jumps to humans more quickly than its predecessors and previously has been found in mammals. "This virus is more dangerous," said Yi Guan of the University of Hong Kong, one of the authors of a research letter published online in the journal Nature. It's not clear why the outbreak, which began in late 2013, has re-emerged after fading. But by September 2014, it had infected 318 people and killed more than 100 of them, twice as many as the first wave, the scientists reported. Many people suffer severe pneumonia if infected by this flu, which also has spread to China, Taiwan, Hong Kong, Malaysia and Canada, according to the World Health Organization.
Horse Dung Has Scientists on Scent of Antibiotic Success
UK - European biologists have discovered a bacteria-killing compound in common mushrooms that grow in horse dung. Unusually for an antibiotic, copsin is a protein; but laboratory trials showed it to have the same effect on bacteria as traditional antibiotics. They discovered copsin in the common inky cap mushroom Coprinopsis cinerea that grows on manure, while researching how the fungus and various bacteria affected each other's growth. According to lead researcher, post-doc Andreas Essig, horse manure's rich substrate is key. "Now copsin kills bacteria by binding to an essential cell wall building block," said Essig. "The cell wall you can consider like the achilles heel of bacteria, so when you disrupt the cell wall synthesis bacteria usually dies rapidly. The binding pattern of copsin on this building block is very unique and therefore copsin is active against bacteria resistant to conventional antibiotics. "The team has registered copsin for patent approval.
Exercise Found to Help Treat Breast Cancer
New research conducted on mice finds that a body that gets regular physical activity is a more hostile environment for cancer’s growth in breast tissue than is a sedentary body. And regular aerobic exercise makes a tumor more vulnerable to the effects of chemotherapy. The latest study, published in theJournal of the National Cancer Institute, echoes earlier work by the same authors on the effects of exercise on prostate tumor growth and treatment.
Georgia Nation's Health IT Capital—Boom Statewide, but Particularly Strong in Metro Atlanta
More than 250 health IT companies are located in the state, employing more than 30,000 workers, according to the Technology Association of Georgia. Companies in the industry offer a range of products and services, from electronic health records, medical billing and revenue management to diagnostics, preserving the security of information exchanges, and consumer health information. Health IT systems are also tracking medical outcomes of patients after they receive care, a big focus of the Affordable Care Act. The health reform law has led Medicare and private insurers to base payments increasingly on the quality of medical care delivered, rather than quantity of services. An industry magazine last year listed eight Georgia-based companies among its top 100 health IT companies in the United States in 2014, based on revenues from the previous year.
HIPAA Audits Still on Hold
Phase II of the federal HIPAA audit program remains "under development," Jocelyn Samuels, director of the Health and Human Services Department's Office for Civil Rights, said at the 23rd National HIPAA Summit in the District of Columbia. Samuels reiterated that OCR plans to use lessons learned from the program's first phase, which included 115 pilot audits. OCR's initial plan was to kick off the next round of audits last fall. Those plans, however, were temporarily derailed late last summer as the agency worked to tweak an online portal through which entities could submit information. That portal is still in the process of being set up, she said.
NIH: 'We Aim to Go Much Further'
The National Institutes of Health revealed plans to achieve breakthroughs in longstanding medical problems affecting millions of Americans. NIH director Francis Collins, MD appeared before the Senate Health, Education, Labor, and Pensions Committee last week and outlined several initiatives he said may result in significant improvements. "These are extraordinary strides,” Collins explained. “But we aim to go much further.” Technology development along with falling costs of DNA sequencing now enable innovative approaches to treatments that account for differences in patients’ genes, environments, and lifestyles. As a result, the NIH, through the President’s Precision Medicine Initiative, the Food and Drug Administration and the Office of the National Coordinator for Health Information and Technology, will collaborate to "revolutionize" health improvement programs and disease treatment, Collins said. For cancer research, precision medicine is being used by defining the driver mutations in individual tumors along with the design of patient-specific therapy.
University of Pittsburgh Medical Center Teams with Universities to Develop Data-based Health Innovations
Two Pittsburgh-area universities are teaming up with UPMC to revolutionize healthcare through big data. Carnegie Mellon University and the University of Pittsburgh, along with UPMC, make up the new Pittsburgh Health Data Alliance, which is committed to creating new data-based innovations, according to an announcement. Centers led by Pitt and CMU will carry out the work to create products and services using data that will focus on changing how diseases are prevented and how patients are cared for.
New York Grants one-year Reprieve on e-prescribing Requirement
New York governor Andrew Cuomo has signed legislation delaying mandatory use of electronic prescribing for one year, according to an announcement from the New York State Medical Society. The legislation, signed March 13, moves the deadline for complying from March 27, 2015, to March 27, 2016. The e-prescribing is part of a larger law called Internet System for Tracking Over-Prescribing Act of 2012 (I-STOP) that is intended to reduce drug diversion and doctor shopping. The law applies to all prescriptions and all prescribers except for veterinarians. New York is the first state to require e-prescribing.
High Value Health IT: Policy Reforms for Better Care and Lower Costs
Achieving better health outcomes at a lower cost and succeeding with payment reforms that shift from volume to value is difficult without health information technology (IT). Health IT can engage and support health care providers, patients, and consumers with access to timely and accurate clinical information from electronic health records (EHRs) and other sources. It can also provide access to cost and coverage information that avoids burdensome administrative processes and unexpected costs. Health IT can achieve these benefits through interoperability across information and data exchange platforms – avoiding duplicative parallel systems and additional data entry. Engaged patients and providers, supported by flexible, usable and useful health IT, can make informed shared decisions about testing and treatment which can lead to more timely, efficient, and higher-value health care.
WEDI Report Update Finds Progress on Health IT Goals, but Work Remains
An evaluation since the 2013 release of the Workgroup for Electronic Data Interchange (WEDI) roadmap for healthcare information exchange found progress was made during 2014, but the goal remains a work in progress. It grades the industry efforts on four key areas of focus:
- Patient Engagement
- Payment Models
- Data Harmonization and Exchange
- Innovative Encounter Models
Genetics Firm Plans Research Unit to Find Disease Cures
Personal genetics firm 23andMe is planning to use its database of health information to research possible cures for a range of diseases. Its new research group has appointed a head and will begin recruiting scientists next month. They will use the genetic data to help identify new therapies for common and rare diseases. Around 80% of 23andMe's 875,000 customers have agreed that it can use their health data for medical research. It will eventually share its research with drug companies, although the details are yet to be worked out.
Questioning the Value of Health Apps
A bodybuilder presses the iPhone’s camera with a fingertip, and his heart rate and blood oxygen levels appear on the screen. A fellow in pajamas steps onto a scale, peers at his smartphone, and sighs dejectedly. A runner races along the waterfront, a cellphone strapped to her pumping arms. Apple’s television commercials for the iPhone 5 portrayed the device as not just a smartphone, but a health and fitness tool. And indeed, iPhones, Androids and now even the Apple Watch provide countless applications to help with motivation and organization. But a subset of these apps go further, purporting to function as medical devices — to track blood pressure, treat acne, even test urine samples. Amid a proliferation of such apps, physicians and federal regulators are sounding an alarm, saying that programs claiming to diagnose or treat medical conditions may be unreliable and even dangerous. “There’s just no plausible medical way that some of these apps could work,” said Nathan Cortez, an expert in medical technology law and regulation at Southern Methodist University’s law school in Dallas. In an editorial in The New England Journal of Medicine last summer, Mr. Cortez cautioned that unreliable and unregulated health apps could pose a significant threat.
FDA Issues Final Rules on Endoscopes, Other Devices
Federal regulators issued final rules regarding the cleaning and disinfecting of reusable medical devices such as the endoscopes that have been responsible for outbreaks of drug-resistant bacteria at a number of hospitals. Product makers will be required, under the new guidance, to validate that the disinfecting instructions for their medical devices are effective before they can get Food and Drug Administration approval. Also recommended is that healthcare providers routinely test medical scopes for bacterial growth after they have been disinfected, something a number of hospitals have begun to do in light of the recent contamination involving the devices.
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