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DAILY UPDATE

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September 30, 2016   Download print version

Zika might spread in sweat and tears, doctors warn

3-D printed bone material acts like real bone for custom-made implant

New rule preserves patients' rights to sue nursing homes in court

Large majorities favor wide range of policy changes to curb prescription drug costs, including government role in negotiating or limiting prices

Dengue vaccine may cause disease, hospitalization in low, moderate transmission areas

Tissue, implant and consumable tracking software solutions available to Intalere members through agreement with TrackCore, Inc.

Halyard Health launches ‘Fist Bump For Heroes’ to celebrate first responders

CMS decision memo for screening for Hepatitis B Virus (HBV) Infection

 



Daily Update Archives

 
 
 
 

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September 2016

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Zika might spread in sweat and tears, doctors warn

The Zika virus may spread in sweat and tears in some cases, doctors cautioned Thursday. The case of a Utah man who infected his adult son before he died leaves no other alternatives, the team at the University of Utah School of Medicine said. And - more bad news - the 73-year-old patient who died really was not very sick before he caught Zika, which suggests that the virus can occasionally kill people who are not frail and ill.

Dr. Sankar Swaminathan and colleagues describe the case in the New England Journal of Medicine. "Given the very high level of viremia in patient 1, infectious levels of virus may have been present in sweat or tears."

The patient, who died in July, was the first in the 50 U.S. states to be killed by Zika. He'd been treated for prostate cancer but wasn't especially ill from that, the team wrote in their report. "Eight days before admission, he had returned from a 3-week trip to the southwest coast of Mexico, where Zika virus transmission had been reported. He was well during his trip but reported being bitten by mosquitoes," the team wrote. He developed muscle aches, diarrhea and other symptoms. The team thought he had dengue, a virus very closely related to Zika that's spread by the same mosquitoes.

He died from respiratory and kidney failure four days after being infected, they said. Later tests showed the older man in fact had Zika, and had an extraordinary amount of the virus in his blood - thousands of times more than usual. He'd had dengue in the past, but not recently.

Then his 38-year-old son got sick, and developed the rash that's characteristic of Zika infection.

"Patient 2 reported having assisted a nurse in repositioning Patient 1 in bed without using gloves. Patient 2 also reported having wiped Patient 1's eyes during the hospitalization but reported having had no other overt contact with blood or other body fluids, including splashes or mucous membrane exposure," the team wrote.

The younger man had not traveled, and the mosquitoes that spread Zika are not found in Utah. Investigators spent weeks trying to figure out how he got infected.

"Given the very high level of viremia in Patient 1, infectious levels of virus may have been present in sweat or tears, both of which Patient 2 contacted without gloves," Swaminathan's team concluded.

That's known to happen with Ebola, a different type of virus. When patients got extremely high levels of the virus in their blood, even their sweat became infectious to others. Also like Ebola, Zika virus has been found in the eyes of patients.

"These two cases illustrate several important points. The spectrum of those at risk for fulminant (sudden and severe) Zika infection may be broader than previously recognized, and those who are not severely immunocompromised or chronically ill may nevertheless be at risk for fatal infection," they said.

"Whether contact with highly infectious body fluids from patients with severe Zika virus infection poses an increased risk of transmission is an important question that requires further research."

Zika is mostly spread by mosquitoes, but the ongoing epidemic has shown it can also be spread through all forms of sex. The biggest danger is when a pregnant woman becomes infected, because the virus can get to the developing fetus and cause severe birth defects.

The virus can also cause a range of complications in some patients, including the paralyzing condition called Guillain-Barré syndrome, as well as inflammation of the brain and spinal cord.

Visit NBC News for the report.

 

3-D printed bone material acts like real bone for custom-made implant

Researchers have invented a new type of artificial bone that can be shaped using a 3-D printer for customized implants. The new material, which they call hyper-elastic bone, appears to act like natural bone in the body and can repair deformed bones and some injuries, the team reports in the journal Science Translational Medicine.

When the material was tested in a monkey, the bone fused to the animal’s skull, and new blood vessels grew into it, the team at Northwestern University said.

“Within four weeks, the implant had fully integrated, fully vascularized with the monkey’s own skull. And there is actually evidence of new bone formation,” Adam Jakus, a postdoctoral fellow in the department of materials science and engineering at Northwestern, told reporters in a telephone briefing.

They hope to gain permission to test the implants in people within the next five years. The material is cheap and appears to be useful for a range of bone injuries, including for the spine, skull and jaw, they said.

Currently, the best option is a bone graft from the patient, which can be painful and which doesn’t always work well, or donated bone from someone who has died. These transplants often do not heal well. Artificial bone grafts currently in development are often brittle and risk being rejected, also.

Jakus and assistant professor Ramille Shah developed a mixture of materials including hydroxyapatite, the main mineral component of natural bone tissue, which also lends itself to ink-jet printing.

“Despite the fact that it is majority ceramic, which is usually very brittle, it possesses very unique nano and micro-structural properties that makes it highly elastic,” Shah said. “The first time that we actually 3-D printed this material, we were very surprised to find that when we squeezed or deformed it, it bounced right back to its original shape.” It can be “easily cut, rolled, folded, and sutured to tissue. And since it is elastic, it can be pressed, fit into a defect, and expand to mechanically fix itself into a space without glue or sutures,” she added.

They stuck some under the skin of a mouse and it acted like natural tissue. Cells grew on it and blood vessels made their way into it, much like natural bone.

Visit Counton for the study.

 

New rule preserves patients' rights to sue nursing homes in court

The federal government has announced a new rule that guarantees the rights of patients and families to sue long-term care facilities.

The rule, released Wednesday by the Centers for Medicare & Medicaid Services, bans so-called pre-dispute binding arbitration clauses in nursing home contracts, which require patients and families to settle any dispute over care in arbitration, rather than through the court system.

The rule applies to facilities that receive money from Medicare or Medicaid - which is nearly all of them. It is scheduled to go into effect in November.

The change was originally proposed in July 2015, and the agency "received and reviewed almost 10,000 comments from the public."

The rule would address cases like that of Dean Cole, who NPR reported on in 2015. Just two weeks after Cole's wife arranged for him to move into a Minnesota nursing home, he was rushed to the hospital, severely dehydrated and in a coma, a lawyer for the family told NPR's Ina Jaffe.

Cole died a short while later. His wife, Virginia, could not sue the facility because she had signed a binding agreement to pursue arbitration for any dispute. Although she won the arbitration hearing before three judges, the fees for the proceedings amounted to more than $60,000, leaving her with a final settlement amount of only $20,000, her lawyer said.

The new rule will allow people like Virginia Cole to sue a nursing home in court. It also leaves the door open to arbitration in individual cases if both sides agree to it.

A 2009 study commissioned by the American Health Care Association, which represents most nursing homes, found the average awards after arbitration were 35 percent lower than if the plaintiff had gone to court.

The American Health Care Association opposed the arbitration rule change when it was proposed in 2015. Clifton Porter II, the AHCA's senior vice president for government relations, defended arbitration in a 2015 interview with NPR, saying "it actually allows consumers to get an expedited award."

In addition to the litigation changes, the new rule also includes expanded regulations regarding the food, medical treatment and personnel requirements for long-term care facilities. Nursing homes must provide "nourishing, palatable" food for residents and develop a care plan for each resident within 48 hours of their admission to the facility.

Amid increased fears of institutionally-spread infection and antibiotic resistance, the new rules also require nursing homes to develop an "infection prevention and control program," and a plan for monitoring the use of antibiotics.

Visit NPR for the article.

 

Large majorities favor wide range of policy changes to curb prescription drug costs, including government role in negotiating or limiting prices

Amid news reports about increases in the price for EpiPen and other drugs, the vast majority of Americans – including majorities of Democrats, Republicans and independents – support several policy changes to control the costs of prescription drugs, including some that would expand government’s role in drug pricing, the latest Kaiser Family Foundation tracking poll finds.

About eight in 10 Americans say they favor allowing the federal government to negotiate with drug companies to get a lower price on medications for people on Medicare (82%) and limiting the amount drug companies can charge for high-cost drugs for illnesses like hepatitis or cancer (78%). In addition, two-thirds (66%) favor creating an independent group that oversees the pricing of prescription drugs, as Democratic presidential candidate Hillary Clinton recently proposed.  Majorities also support requiring drug companies to release information to the public on how they set drug prices (86%) and allowing Americans to buy prescription drugs imported from Canada (71%).

A majority of Democrats, Republicans and independents support each of these five policy changes and also think each of them would be effective in keeping drug costs down.

Fewer overall and across parties favor two other potential policy changes: eliminating drug advertisements (47%) and encouraging consumers to buy lower-cost drugs by requiring them to pay more for similar but higher-cost ones (42%).

The survey probes the public’s views and experiences with prescription drugs more broadly. It finds a large majority (77%) perceive drug costs as unreasonable, while one in five (21%) say they are reasonable. The share who say drug costs are unreasonable is up somewhat from 72 percent a year ago in August 2015.

At the same time, relatively few Americans say they personally are having trouble paying for their medication. The survey finds about half (55%) of the public report currently taking prescription drugs, and the vast majority (73%) of them say paying for their medications is easy; far fewer (26% of those taking prescription drugs, or 14% of the total population) say it is difficult to pay for their drugs. Larger shares of those who report being in “fair” or “poor” health and those taking four or more medications say it is difficult to afford their prescriptions.

The survey finds the public remains divided in its view of the Affordable Care Act (ACA), with 47 percent reporting an unfavorable view and 44 percent reporting a favorable one.  As in the past, Democrats largely support the law, Republicans largely oppose it, and independents are in the middle, though leaning unfavorable. These divisions persist on other questions about views and facts related to the law’s impact.

For example, about half of the public (48%) say the ACA marketplace in their own state is working well, while 43 percent say it is not working well. When asked how well they think the marketplaces are working in the nation overall, perceptions shift slightly with about half (49%) saying they are not working well and 44 percent say they are working well. 

Majorities of Democrats perceive the marketplace in their state and marketplaces nationally as working well, while Republicans are more likely to say they are not working well. People living in states that have developed their own state-based marketplace are more likely to say the health insurance marketplace in their own state is working well - even when controlling for party identification and other demographic factors that tend to predict support for the ACA.

Visit Kaiser for the report.

 

Dengue vaccine may cause disease, hospitalization in low, moderate transmission areas

Routine administration of the Dengvaxia dengue vaccine in low-transmission areas could increase the number of patients hospitalized with severe secondary infections, according to study data, and led the researchers to recommend patients undergo serological testing before vaccination.

“Successful licensing of the first vaccine against a major global pathogen is a significant achievement,” Neil M. Ferguson, DPhil, director of the MRC Centre for Outbreak Analysis and Modeling, Imperial College London, and colleagues wrote in the journal Science. “However, the dependence of vaccine efficacy on prior immunity presents challenges to planning large-scale use.”

Using mathematical models of dengue transmission, the researchers simulated the effect of routine Dengvaxia (CYD-TDV, Sanofi Pasteur) administration with 80% coverage to examine the result of vaccinating children aged 2 to 18 years, although the vaccine is not approved for use in children aged younger than 9 years.

The researchers reported a modest benefit in high-transmission areas: 20% to 30% reductions in symptomatic disease and hospitalization. In low-transmission areas, however, they reported longer-term (30 years) effects of vaccination on symptomatic disease and hospitalization may be positive or negative, despite mostly positive short-term (10 years) effects.

They also reported a more than 90% reduced risk for hospitalization among seropositive patients who received the vaccine, although they wrote that vaccination put seronegative patients in low-transmission areas at a higher risk for being hospitalized with a secondary infection.

“In places with high transmission intensity, most people have been already exposed to dengue at the time of vaccination, and the vaccine has higher efficacy on average,” researcher Derek A.T. Cummings, PhD, biology professor at the University of Florida, said in a press release. “However, in places with lower transmission intensity, where individuals haven’t been previously exposed, the vaccine can place people at risk of severe disease and overall increase the number of hospitalized cases.”

Ferguson, Cummings and colleagues predicted that routine vaccination would reduce overall incidence of the disease by only 10% to 20%, and wrote that serological testing could help maximize the benefits of the vaccine.

“Our model refines estimates of which places would see a decline in dengue incidence with large-scale vaccination programs, and which places should not implement programs at this point in time,” Ferguson said in the release. “These results present the first published, independent predictions of the potential impact of vaccination that take account of recent data showing that the vaccine can increase the risk of severe dengue disease in young children.”

Visit Healio for the story.

 

Tissue, implant and consumable tracking software solutions available to Intalere members through agreement with TrackCore, Inc.

Intalere announces a new agreement with TrackCore, Inc. for tissue and implant tracking and compliance software solutions.

Through this agreement, Intalere members will receive negotiated pricing on TrackCore’s full suite of products for managing tissue, implants and consumables in all hospital departments. Among the products available to Intalere members is TrackCore Operating Room, the industry-leading tissue and implant tracking software clinically proven to cut operational costs and ensure full regulatory compliance.

Other solutions include TrackCore Interventional (implant and consumable tracking), fully integrated RFID-enabled enclosures, and TrackCore SameDay (bill-only implant tracking) which will be available in early 2017.

This contract is currently effective through July 31, 2019.

Learn more at www.implanttracking.com.

 

Halyard Health launches ‘Fist Bump For Heroes’ to celebrate first responders

 Halyard Health has launched its ‘Fist Bump for Heroes’ campaign to recognize and show support of first responders across the United States.

The ‘First Bump for Heroes’ program recognizes first responders – those heroes who work on the front lines, pulling double duty, to protect our communities. The program was inspired by the new, dual purpose BLACK-FIRE Nitrile Exam Glove that provides protection for the variety of jobs required of first responders.

Who do you consider a hero? Halyard invites you to nominate first responders, including firefighters, emergency medical technicians and law enforcement officials, who go above and beyond both on and off the job. Nominate your heroes now through December 31, 2016. All entries will be reviewed by a panel of judges and a winner will be announced in January 2017.

To nominate a hero, submit a photo of the individual you would like to recognize along with a few sentences about how he or she not only exceeds expectations while on the job, but how they give back outside the job. You can enter at www.halyardhealth.com/info/ems/fist-bump-for-heroes.aspx or by posting a public photo on Facebook, Twitter or Instagram using the hashtag #HeroFistBump.

 

CMS decision memo for screening for Hepatitis B Virus (HBV) Infection

The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence is sufficient to conclude that screening for Hepatitis B Virus (HBV) infection, consistent with the grade A and B recommendations by the U.S. Preventive Services Task Force (USPSTF), is reasonable and necessary for the prevention or early detection of an illness or disability and is appropriate for individuals entitled to benefits under Part A or enrolled under Part B, as described below.

Therefore, CMS will cover screening for HBV infection with the appropriate U.S. Food and Drug Administration (FDA) approved/cleared laboratory tests, used consistent with FDA approved labeling and in compliance with the Clinical Laboratory Improvement Act (CLIA) regulations, when ordered by the beneficiary's primary care physician or practitioner within the context of a primary care setting, and performed by an eligible Medicare provider for these services, for beneficiaries who meet either of the following conditions.

A screening test is covered for asymptomatic, nonpregnant adolescents and adults at high risk for HBV infection. "High risk" is defined as persons born in countries and regions with a high prevalence of HBV infection (i.e., ≥ 2%), US-born persons not vaccinated as infants whose parents were born in regions with a very high prevalence of HBV infection (i.e., ≥ 8%), HIV-positive persons, men who have sex with men, injection drug users, household contacts or sexual partners of persons with HBV infection. In addition, CMS has determined that repeated screening would be appropriate annually only for beneficiaries with continued high risk (i.e., men who have sex with men, injection drug users, household contacts or sexual partners of persons with HBV infection) who do not receive hepatitis B vaccination.

A screening test at the first prenatal visit is covered for pregnant women and then rescreening at time of delivery for those with new or continuing risk factors. In addition, CMS has determined that screening during the first prenatal visit would be appropriate for each pregnancy, regardless of previous hepatitis B vaccination or previous negative hepatitis B surface antigen (HBsAg) test results.

The determination of "high risk for HBV" is identified by the primary care physician or practitioner who assesses the patient's history, which is part of any complete medical history, typically part of an annual wellness visit and considered in the development of a comprehensive prevention plan. The medical record should be a reflection of the service provided.

Visit CMS for more information.