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September 2, 2015   Download print version

Google pairs with Sanofi to move diabetes patients to cloud

AAMI white paper names risk principles for medical devices in postmarket setting  

Vegas health clinic gambles on a new brand of primary care

Health plans leading the way to improve adult vaccination rates

Antibiotics linked to Type 2 diabetes risk

Antibiotic resistant Salmonella in Kapowsin pork sickens 152

Few Health Savings Accounts owners choose to invest that money, study finds

MEDICA HEALTH IT FORUM reflects forward-looking trends in the field of health IT

 



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Self Study Series:
September 2015

CQI in device decontamination: the role of washer indicators

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Google pairs with Sanofi to move diabetes patients to cloud

Google Inc.’s life science unit is still seeking a name but it already has a foe: diabetes. The U.S. Internet giant on Monday agreed to work with French drugmaker Sanofi to devise new ways of managing a disease that afflicts 382 million people worldwide, adding to recent deals with Novartis AG and DexCom Inc. The companies didn’t disclose financial details of the agreement.

Andy Conrad, the head of Google’s life science team, said diabetes is precisely the kind of disease in which technology can help patients, whose bodies can’t manage sugar, by keeping track of their blood and insulin measurements -- and avoiding discomforts that range from daily finger pricks to more gruesome limb amputations.

Google last year agreed to work with Novartis to develop contact lenses that use tiny sensors to read blood-sugar levels from tears. Tests on that product will begin next year, Conrad said. This month, Google also said it would work with DexCom on a bandage-sized sensor connected to the cloud. Sanofi, the maker of Lantus, the world’s best-selling insulin, will work on new ways of delivering the hormone, such as Bluetooth-enabled pens that let a physician monitor how much insulin their patient is using, and when.

“That’s the system that we’re endeavoring to build: smart insulin delivery devices, smart measurement devices, and an interface and an integrating platform that helps physicians and patients see how they’re doing,” said Conrad, whose division will be renamed in the coming months as a unit of Google’s new holding company, Alphabet Inc.

Google and Sanofi will develop ways to store and analyze glucose levels in real time, enabling patients and their doctors to respond more quickly to peaks and troughs in blood sugar and avoid long-term complications associated with poor management of the disease, which include heart attacks and cancer. Visit Bloomberg for the article.

AAMI white paper names risk principles for medical devices in postmarket setting  

A new white paper drafted by a special AAMI working group lays out six principles - developed jointly by industry and the U.S. Food and Drug Administration - to guide the management of risk of medical devices in the postmarket setting.

The complimentary paper seeks to offer a “shared understanding” of risk principles, an important milestone in the ultimate goal of having better coordination and interaction between manufacturers and regulators when it comes to postmarket activities.

The six risk principles are the following:

1.    Informed judgment in risk and benefit evaluations

2.    Loss-of-benefit assessment

3.    Populations

4.    Use environment and clinical assessment

5.    Communication

6.    Risk control and recovering loss of benefit

The paper covers specifics for each risk principle, and it includes a long list of factors to consider when applying those risk principles, such as complexity of use, software dependency, clinical impact on patients, and risks with alternative choices.

Beyond its clear delineation of six risk principles, the white paper succeeded on a broader level, simply by fostering and supporting an open discussion between medical device manufacturers and CDRH staff. Additionally, those involved in the white paper believe it can be instrumental in guiding the future work of a standards committee, ISO Technical Committee 210, that maintains a crucial risk management standard for medical devices, 14971.

Significantly, AAMI and the working group see the white paper as “a starting point” in developing a more productive and efficient approach to risk management in the postmarket setting.

The complete white paper, which includes a list of the working group members, can be downloaded here

Vegas health clinic gambles on a new brand of primary care

Walk into Turntable Health in downtown Las Vegas and you’d be forgiven for thinking you had stepped into a trendy technology start-up rather than a doctor’s office.

Most of the patients are hip casino workers and techies in their 20s and 30s. While waiting to see the doctor, they spin records on the turntable, play video games on the Xbox or stretch out at the in-house yoga studio.

Turntable Health is no ordinary primary care clinic. The idea stemmed from a conversation between Tony Hsieh, CEO of the online shoes and clothing emporium Zappos.com, and Stanford University-trained physician Zubin Damania.

In 2012, Hsieh formally recruited Damania to head up healthcare development for his “Downtown Project,” a $350 million plan to create a hub of technology and the arts in Las Vegas, a city known for casinos and tourism. About $50 million of the fund was earmarked for health and education initiatives, such as Turntable Health.

Damania had his work cut out for him. Las Vegas was recently ranked the seventh-least healthy metro area in the nation. Despite the roll out of the Affordable Care Act (ACA), about 10% — or 300,000 people in Nevada — still go without health insurance.

Early on, Damania prioritized partnerships with health insurance companies offering low-cost options, including Nevada Health Co-Op, which was created under ACA. For those not covered by insurance, the per-month fee for unlimited access to primary care is $80 for adults and $60 for children.

The Downtown Project has experienced its fair share of struggles in months, including a recent round of layoffs and a wave of community resistance. But Hsieh told USA TODAY he remains committed to Turntable Health, calling it a “fun, collaborative culture that is generally missing from most people’s health care experience.”

Damania’s plan to keep people healthy in downtown Vegas isn’t just fun and games: It involves engaging patients before they end up seriously ill or in the hospital.

During a 10-year stint at Stanford, prior to starting Turntable Health, he noticed that many doctors spent very little time with their patients and rarely checked in between visits. Damania channeled his frustrations into a series of medical rap parody YouTube videos, where he goes by the persona “ZDoggMD.”

Turntable Health opened its doors in December 2013. Damania partnered early on with Iora Health, a primary care chain that makes its money by keeping patients out of the emergency room. Iora’s model is to work with an employer or union that already pays for health care, and keep that population healthier by encouraging access to high-quality primary care.

Turntable Health caters to millennial patients by offering them a “health coach,” who checks in via phone or email between visits to give advice on exercise and nutrition.

Turntable Health may seem like an anomaly, with its record player and health coaches. But health experts say it is just one of a growing number of membership-based primary care practices across the United States that are taking a patient-centered approach. Visit USA Today for the story.

Health plans leading the way to improve adult vaccination rates

Each year, millions of adults end up missing out on their recommended immunizations, and it’s a dangerous trend that leaves individuals and families at risk for serious diseases. Health plans have made improving adult immunization rates a top priority, recognizing that immunizations are one of the best ways to keep patients healthy and reduce the risk of vaccine-preventable deaths and hospitalizations.

Earlier this year, AHIP hosted a National Vaccine Roundtable to identify barriers to boosting adult immunization rates and to increase awareness among adults about the importance of keeping up with recommended vaccines even after childhood. AHIP’s newly released report highlights the perspectives of health plan leaders, federal government officials, public health organizations, clinicians, consumers, and pharmacies, who all agreed on the need to work together to reduce vaccine-preventable diseases.

Health plans use a variety of tools to ensure that adults get the vaccines they need, including assisting providers with processing claims quickly, improving methods to keep track of patients’ immunization information, sending reminders for necessary vaccines, and identifying immunization gaps among patients.

The report identifies areas with potential for progress, including incorporating adult immunization screening and awareness into health plan enrollment processes, expanding access for all recommended immunizations to pharmacists and convenience care clinics, and encouraging community partnerships with entities that serve diverse populations to raise awareness about the importance of vaccinations and how and where they can be accessed.

While there are many challenges involved with improving adult immunization rates, health plans and other stakeholder partners remain focused on enhancing vaccination efforts, and the cost savings and health benefits that would ensue. Visit AHIP for the report.

Antibiotics linked to Type 2 diabetes risk

Taking antibiotics might increase the risk of developing type 2 diabetes, new research suggests. Danish researchers found that people with type 2 diabetes tended to take more antibiotics in the years leading up to their diagnosis than Danes without the condition.

Although the researchers uncovered an association between antibiotic use and type 2 diabetes, it's important to note they did not establish a direct cause-and-effect relationship. The more prescriptions, the more likely those people were to have type 2 diabetes, the researchers found.

People with type 2 diabetes don't make enough of the hormone insulin, or the insulin doesn't work well to clear sugar from the blood. About 29 million Americans have type 2 diabetes, which increases the risk of heart disease and other problems.

Those who took an antibiotic, regardless of the type, were 50 percent more likely to get a diabetes diagnosis if they had filled five or more prescriptions compared to those who filled none or one. Narrow-spectrum antibiotics such as penicillin V conferred a slightly higher risk than broad-spectrum antibiotics.

The study was published in the Journal of Clinical Endocrinology & Metabolism. (HealthDay) Visit NIH for the study.

Antibiotic resistant Salmonella in Kapowsin pork sickens 152

Antibiotic resistant Salmonella in pork from Kapowsin Meats of Graham, WA, has sickened 152 people, sending 24 of them to the hospital, according to the latest update from the Centers for Disease Control and Prevention (CDC). All of the illnesses have occurred in Washington and many of those who were sickened attended events where whole pigs were roasted.

Kapowsin has temporarily suspended all operations and as recalled all of its products. The recall includes 523,380 pounds of pork products distributed to Alaska, Oregon and Washington that may be contaminated with an antibiotic resistant strain of Salmonella I 4,[5],12:i:-.

The CDC has determined that the outbreak strain is resistant to ampicillin, streptomycin, sulfisoxazole, and tetracycline. Salmonella causes symptoms including nausea, vomiting, fever and diarrhea that usually develop within six to 72 hours of exposure and last up to a week. Those sickened in this outbreak reported onset of illness dates from April 25, 2015 to August 1, 2015. Visit Food Poisoning Bulletin for the report.

Few Health Savings Accounts owners choose to invest that money, study finds

Only a tiny fraction of the growing number of people with health savings accounts invests the money in their accounts in the financial markets, according to a recent study. The vast majority leave their contributions in savings accounts instead where the money may earn lower returns.

People who have had their health savings accounts for a longer period of time are more likely to invest their contributions, suggesting that there’s a learning curve in grasping how the accounts work and how to use them, says Paul Fronstin, director of the Health Research and Education Program at the Employee Benefit Research Institute (EBRI) and the study’s author.

Forty-seven percent of HSAs with investments were opened between 2005 and 2008; in 2014, just 5 percent of HSAs that were opened had investments.

Since they were introduced in 2004, health savings accounts have offered people with high-deductible health plans that meet certain criteria a way to set aside money tax-free to cover medical expenses. HSA contributions are deposited pre-tax, grow tax-free and aren’t taxed when distributed if they’re used for qualified medical expenses. If an HSA is offered through an employer, both the employer and employee can contribute to the accounts, and the money belongs to the individual if he leaves his job.

This year, plans that link to HSAs must have a deductible of at least $1,300 for single coverage and $2,600 for family coverage, among other requirements.

About two-thirds of health savings accounts offer individuals the ability to use an investment option, says Eric Remjeske, president of Devenir, an investment adviser for health savings accounts. Yet few consumers are taking advantage of the investment options.

The EBRI study found that 6.4 percent of people with HSAs invested their health savings account contributions in mutual funds or other financial vehicles. The remainder left the contributions in savings accounts, where their money isn’t at risk from market fluctuations. The study examined 2014 data from 2.9 million health savings accounts with $5 billion in assets, covering about 20 percent of the HSA market.

People with investment accounts didn’t refrain from using their HSA for medical expenses, however. Average annual distributions for medical claims were $1,777 for HSAs with investments and $1,293 for those without. Visit Kaiser Health for the article.

MEDICA HEALTH IT FORUM reflects forward-looking trends in the field of health IT

What benefits do new technologies bring with reference to health and patient data – and what risks? And how can digital processes that generate additional data end up serving the growing need for patient safety? Those are topics at the MEDICA HEALTH IT FORUM held during MEDICA 2015. The world's largest medical trade fair will be held from November 16 - 19, 2015 at the fairgrounds in Düsseldorf, Germany.

Collecting data is a method of choice to disclose problems with, for example, medical devices more quickly. In this connection, the ongoing work on the European Medical Device Regulation is a reaction to the worldwide scandal surrounding substandard breast implants by a French manufacturer.

A new obligation that entails providing clear and individual identification markings on medical devices should become an integral part of these measures. This obligation to provide standardized identification is also being negotiated as a module of the free-trade agreement, "Transatlantic Trade and Investment Partnership" (TTIP). Currently, the U.S. is the forerunner concerning this information with the FDA already stipulating Unique Device Identification (UDI) for medical devices.

Professor Christian Dierks, lawyer at the law office, Dierks + Bohle, says: "Medical devices with a UDI can also be used for a further collection of data within the scope of clinical routine." Completely recording this data could be started in a different way. "Imagine that an individual with a femoral head implant could measure the amount of stress on his femoral head by means of an app.” 

A hip prosthesis with integrated sensors capable of wireless data transmission had already been conceived by the Fraunhofer Institute. Prof. Dierks said that he was expecting the regulation to go into effect next year. He pointed out that, when it is announced, a European regulation would also apply for all EU nations.

This and other IT topics such as data collection and analytics, telemedicine and wearable technologies will be explored at the FORUM.

In addition, the "eHealth Venture Summit” is entering a new round. Last year, the international format already attracted 26 startups from around the world. Startups presented their ideas to a high-ranking expert panel consisting of investors, industry and science. The winner received a trophy with a video on presenting the product. Last year, ideas presented included diabetes tracking as well as online physiotherapy.

Information on MEDICA 2015 exhibitors, product information, news on companies and the program of the accompanying conferences and forums such as the MEDICA HEALTH IT FORUM and the MEDICA CONNECTED HEALTH FORUM, are available online at www.medica-tradefair.com.