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February 5, 2016   Download print version

Brazil Zika cases raise concern of virus transmission beyond mosquitoes

C.D.C. issues Zika advisory for pregnant women and sex partners

FBI probe at Broward Health allegedly blocked by district’s lawyer

Merit Medical acquires the HeRO Graft From CryoLife, Inc.

New ethics standards for DNA replacement therapies

Untold cities across America have higher rates of lead poisoning than Flint

AHRQ study: Joint replacement to become the most common elective surgical procedure in the next decades

White House proposes new funding for heroin, prescription opioid abuse

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Self Study Series:
February 2016

Measuring the efficacy of manual endoscope cleaning
by Grace Thornhill

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Brazil Zika cases raise concern of virus transmission beyond mosquitoes

Two cases of Zika being transmitted through blood transfusions were reported in Brazil on Thursday, adding to concerns over the virus that has been linked to severe birth defects and is typically spread through mosquito bites.

The disclosure of the blood transfusion cases in the industrial city of Campinas near Sao Paulo came two days after Texas authorities said a person became infected through sex. Concern over the virus is mounting as Brazil prepares to host the Olympic Games in August, with tens of thousands of athletes and tourists anticipated.

There is no vaccine or treatment for Zika, which has caused outbreaks in at least 26 countries in the Americas. Brazil researchers hope to develop a treatment that could be tested in humans in a year.

Dr. Marcelo Addas Carvalho, director of the blood center at the University of Campinas, said genetic testing confirmed that a man who received a blood transfusion from a Zika-infected man in March 2015 became infected with the virus, although he did not develop symptoms. Another man, who had suffered gunshot wounds, became infected with Zika after receiving multiple blood transfusions that included blood donated by an infected person in April 2015, Carvalho said.

Carvalho said that infection probably was caused by the transfusion but genetic tests have not yet been conducted to confirm it. He said it was very unlikely the infection was caused by a mosquito bite because the patient was in a hospital intensive care unit for three months.

Florida Governor Rick Scott on Thursday expanded a Zika public health emergency in the state, adding a fifth locale, Broward County, to the four counties he announced on Wednesday. "With over 20 million residents and 100 million tourists, we must stay ahead of the possible spread of the Zika virus and take immediate action to ensure Florida is prepared," Scott said.

Florida Senator Bill Nelson, a Democrat, called for President Barack Obama to appoint a Zika "czar" to coordinate the federal government's response as Obama did during the Ebola outbreak last year.

Sexual contact and blood transfusions as modes of transmission have been matters of concern for experts since the Zika outbreak's outset, said infectious diseases expert Dr. William Schaffner of the Vanderbilt University School of Medicine in Nashville, TN.

But Schaffner questioned whether either will lead to widespread Zika transmission.

Procedures for blood donations have been tightened in countries including Brazil to protect blood supplies from Zika. U.S. health officials are still working on national guidelines.

Following word of the Texas case on Tuesday, U.S. health officials urged the use of condoms to prevent spreading sexually transmitted infections.

Brazil said it was reinforcing instructions to blood banks that people infected with Zika or dengue not be permitted to donate blood for 30 days after full recovery from the active stage of Zika infection.

The American Red Cross has urged prospective donors who have visited Zika outbreak zones to wait at least 28 days before giving blood, but called the risk of transmitting it through blood donations "extremely" low in the continental United States.

In the Texas case, authorities said a person in Dallas became infected with Zika after having sex with another person who had traveled in Venezuela, where the virus is circulating. Local health officials said on Thursday both those people have fully recovered from the virus.

Schaffner said uncertainties remain about sexual transmission of the virus, including how long a person might be able to transmit it or whether an infected person must have had symptomatic Zika in order to be able to transmit Zika through sex. Most infected people do not develop any symptoms.

New York Governor Andrew Cuomo expanded his state's free Zika testing to include all pregnant women who have traveled to countries where people have been infected.

Visit Reuters for the article.



C.D.C. issues Zika advisory for pregnant women and sex partners

Pregnant women whose male sexual partners have spent time in a country with confirmed transmissions of the Zika virus should either abstain from sex or use condoms during intercourse for the duration of their pregnancy, the Centers for Disease Control and Prevention has announced.

The recommendation on Wednesday came a day after public health officials in Dallas reported the first case in the United States of the Zika virus being transmitted by sex. The disease, which is primarily transmitted by mosquitoes, has been recorded in more than 24 countries, primarily in Latin America and the Caribbean.

Global health officials are investigating a potential link between pregnant women infected with the virus and the development of birth defects, including brain and cranial abnormalities, in their newborns.

“The potential hazard to the fetus is so substantial and so tragic that this looks like a very prudent recommendation until we learn more,” said Dr. William Schaffner, an infectious disease specialist from Vanderbilt University Medical School.

Visit the New York Times for the story.



FBI probe at Broward Health allegedly blocked by district’s lawyer

Broward’s Health’s general counsel failed to cooperate with the FBI and withheld evidence, according to an explosive e-mail sent last week by a private investigator hired by the late Dr. Nabil El Sanadi, to look into alleged corruption at the public hospital system.

The email, obtained by, is from Wayne Black, a noted Miami-based investigator, and was received at Broward Health’s headquarters on Friday, just hours after El Sanadi’s memorial service following his death by suicide. El Sanadi had been president and chief executive of taxpayer-supported Broward Health for 14 months.

Black’s email blasted Broward Health General Counsel Lynn Barrett. “I can no longer sit quietly while needed evidence and information is being withheld from the corruption squad at the FBI,” Black told Barrett. Black wrote that Barrett had shut him out of “various investigations” and accused her of wrongfully asserting a claim of legal privilege to block law-enforcement access to a laptop used by an executive suspected of improprieties.

Black’s email was sent to Barrett, with copies to members of Broward Health’s board of commissioners. The day it arrived, Florida’s chief inspector general also informed Broward Health that she has opened an inquiry into millions of dollars in contracts that the hospital district has awarded since July 2012.

Black’s email states that El Sanadi hired him in April 2015 at the direction of David Di Pietro, the board chairman, to investigate “information and allegations of corruption at Broward Health” given to him by El Sanadi.

“I discovered the irregularities in the security RFP [request for proposals] and Nabil put a hold on the RFP process at my request. There was obvious corruption and the matter is still not resolved to this day. I later developed witnesses regarding kickbacks and other crimes and immediately referred the matter to the FBI corruption squad,” Black wrote. “We [myself and FBI agents] promised witnesses that they would not be known unless they testified. We kept that promise and will continue to do so.”

El Sanadi was informed and told Black to keep working. Black’s frustrations with Barrett, who was hired last summer, began shortly after her arrival when “one of your outside attorneys demanded that I turn over the names of FBI witnesses in the ongoing federal investigation. I refused, of course.”

The two “bumped heads” again later, Black wrote. “You had no experience with evidence handling in ongoing criminal investigations and I wrote you about that several times. Rather than turning over potential evidence to me for the FBI, your outside law firm, under some privilege argument, made copies and did their ‘privilege research,’ which I am sure, resulted in huge billings to the taxpayers of Broward County. I then wrote you that long memo about obstructing justice appearances.”

Black and Ryan Stumphauzer, a former Miami federal prosecutor working with him, asked El Sanadi “to simply make a decision on who was doing the corruption investigation internally … us or you and your Tampa law firm” — identified by Broward Health officials as Foley Lardner.

The email suggests a possible change of heart by El Sanadi for the corruption investigations he’d initiated.

Black indicated he’s surprised the FBI has yet to serve subpoenas in the case.

Visit the Miami Herald for the story.



Merit Medical acquires the HeRO Graft From CryoLife, Inc.

Merit Medical Systems, Inc., a manufacturer and marketer of proprietary disposable medical devices used in interventional and diagnostic procedures, particularly in cardiology, radiology and endoscopy, announced that it has purchased the HeRO Graft device and related assets from CryoLife, Inc.

The HeRO Graft is a fully subcutaneous vascular access system that is intended for use in maintaining long-term vascular access for chronic hemodialysis patients who have exhausted peripheral venous access sites suitable for fistulas or grafts. The product has received 510(k) clearance from the FDA and has the CE marking. Additional information can be reviewed at

Merit believes that during 2015, HeRO Graft revenues were approximately $7.5 million, and gross margins were approximately 55%. Merit purchased the HeRO Graft assets for $18.5 million and financed the deal under existing banking agreements.

Visit Globe Newswire for the release.



New ethics standards for DNA replacement therapies

In a news release medical researchers laid out ethical standards for clinical investigations into mitochondrial replacement therapy, or MRT. MRT is "ethically permissible" only when "significant conditions and principles are met," according to a new report from the National Academies of Sciences, Engineering, and Medicine.

Human MRT is not currently conducted in the United States, but the technology holds promise. The therapy involves the removal of nuclear DNA from the egg of a woman who is at risk of passing a mitochondrial DNA disease onto her child. The nuclear DNA is then transferred to a nuclear DNA-free egg provided by a woman with healthy mitochondria. The resulting egg would have genetic material from two women.

The new report suggests the FDA only review MRT clinical trials for women at risk of passing on a serious mitochondrial disease. Because mitochondrial DNA can only be passed on through the mother, researchers with the National Academies also recommend that only male embryos be implanted during initial clinical investigations to prevent heritability of changes.

"FDA could consider extending MRT research to include the transfer of female embryos if clear evidence of safety and efficacy from male cohorts using identical MRT procedures is available," researchers wrote.

Furthermore, the report recommends that only research clinics with "demonstrated expertise" be approved for such investigations -- and only after exhausting pretrial research options with in vitro tests, animal, and human embryos, nonviable whenever possible.

Researchers say strong standards need to be in place, as the stakes are high.

Visit UPI for the report.



Untold cities across America have higher rates of lead poisoning than Flint

By now, the public health emergency resulting from lead-contaminated water in Flint, MI, has been made abundantly clear. The city changed its water source from the Detroit system to the Flint River in April 2014 as a cost-saving measure, exposing its residents to untreated water replete with lead leached from aging pipes. Last September, a local health center found that the proportion of children with elevated lead levels in their blood had nearly doubled since the switch was made.

Flint has experienced “a man-made disaster,” a press release from the city said last December. Similar official declarations of emergency followed from county commissioners, Michigan Gov. Rick Snyder (R) and, most recently, President Obama.

As attention grew around the issue, so too did the public alarm — with good reason. Photos showed Flint residents standing in long lines to collect bottled water and get their children’s blood tested, or standing in court calling for compensation.

And then there were the photos of people holding up samples of the water that had come out of their taps for more than a year. The liquid appears a translucent yellow-brown instead of colorless and clear; if images could emit odor, these ones would be foul.

But the truly terrifying fact about the water crisis in Flint is invisible. It is the insidious effect of growing up or growing old while unknowingly allowing lead into your bloodstream. According to the World Health Organization, lead creates developmental and behavioral issues in children that are believed to be irreversible.

This is the real emergency for which city and state officials are bracing: the rising demand for special education and juvenile corrections programs that will emerge once lead is translated into reduced IQs, shortened attention spans and greater incidences of violence.

This is the poisoning that has occurred not just in Flint but all over the country, for decades — and not from water, but (primarily) from the paint that colors old homes.

Data collected by the Center for Disease Control and Prevention shows that over 40 percent of the states that reported lead test results in 2014 have higher rates of lead poisoning among children than Flint.

In Flint, 4 percent of kids aged five and under tested with blood-lead levels of at least 5 micrograms per deciliter, the threshold of lead intake that necessitates public health action, as defined by the federal government. Elsewhere in the country, 12 states reported that a greater percentage of kids under six years old met or surpassed that threshold. The most egregious example is Pennsylvania, where 8.5 percent of the children tested were found to have dangerously high levels of lead in their blood.

Only 27 states (including Washington, D.C.) reported childhood blood lead surveillance results to the CDC’s national database for 2014, the most recent statistical set available.

These represent just a slice of the infant population. In Texas, for instance, only 184 kids were tested for lead poisoning. The state’s population of kids under six exceeds 2 million.

On the federal level, then, there is no comprehensive understanding of the extent to which the population is being exposed to hazardous amounts of lead. While the percentage of children with more than 5 micrograms per deciliter of lead has been steadily declining, the CDC says no blood-lead level in children has been determined to be “safe.”

Lead poisoning has a variety of sources, nearly all of them household items. The most common source of lead poisoning is paint peeling inside older houses or apartment buildings.

As Flint has raised the specter of lead, advocacy groups elsewhere are seizing on the attention to raise awareness about contamination in their own jurisdictions.

At a press conference in Trenton, NJ, this week, a coalition of groups led by community development nonprofit Isles, Inc. urged Gov. Chris Christie (R) to devote $10 million towards the Lead Hazard Control Assistance Fund, which oversees the removal of lead from old homes and other lead abatement projects.

Using state data from New Jersey and Michigan, Isles pointed out that 11 New Jersey cities have a higher proportion of children with dangerous lead levels than Flint.

Meanwhile, in Michigan itself, reports from Detroit News and MLive have pointed out that several cities outside of Flint have higher rates of lead poisoning — again, not from water, but old paint and soil contaminated by factory emissions from yesteryears.

Visit the Washington Post for the article.  



AHRQ study: Joint replacement to become the most common elective surgical procedure in the next decades

By 2030, about 11 million Americans will have either a hip or knee replacement, making it one of the nation’s most common elective surgical procedures, according to an AHRQ-funded study.

Using data from AHRQ’s Healthcare Cost and Utilization Project State Inpatient Database, researchers analyzed general population trends by year, state, gender and age group from 1990 to 2010. In 2010, researchers estimate that approximately 7 million Americans had had a total hip or knee replacement, including 620,000 individuals who had both procedures, according to the study.

Researchers attributed the increase in joint replacement surgeries to several factors: the aging of the baby boomer population, high rates of diagnosis and treatment of arthritis and demands for improved mobility and high quality of life.

Also contributing to the trend are younger individuals undergoing these procedures, coupled with improvements in life expectancy. In some cases, researchers said, younger patients will outlive their implants and require expensive revision surgeries with substantial cost implications. The majority of the individuals (70 percent) who have undergone total hip and/or knee replacement surgery are alive today. The study and abstract were published in The Journal of Bone and Joint Surgery.

Visit NIH for the study.



White House proposes new funding for heroin, prescription opioid abuse

President Obama will seek an extra $1.1 billion to pay for drug treatment for people addicted to opioid medications and heroin, which the White House says kills more people than automobile crashes, officials said Tuesday. The extra money will be included in the upcoming fiscal year 2017 budget request.

Prescription opiods - which are painkillers - and heroin are closely linked. Healthcare providers wrote 259 million prescriptions for painkillers in 2012, enough to give every American adult a bottle of pills, according to the Centers for Disease Control and Prevention. Many believe people addicted to prescription painkillers are turning to heroin because it's cheaper and easier to get after government crackdowns on prescription drug abuse. Between 2002 and 2013, the rate of heroin-related overdose deaths nearly quadrupled, and more than 8,200 people died in 2013, CDC says.

This funding includes:

·         $920 million to support cooperative agreements with states to expand access to medication-assisted treatment for opioid use disorders. States will receive funds based on the severity of the epidemic and their strategy to respond to it.  States can use these funds to expand treatment capacity and make services more affordable.

·         $50 million in National Health Service Corps funding to expand access to about 700 substance use treatment providers, including medication-assisted treatment, in areas across the country most in need of mental health treatment.

·         $30 million to evaluate the effectiveness of treatment programs using medication-assisted treatment and help identify opportunities to improve treatment for patients with opioid use disorders.

The budget also includes about $500 million — an increase of more than $90 million — to build on efforts at the Justice Department and the Department of Health and Human Services to expand state prescription overdose prevention strategies, increase the availability of medication-assisted treatment programs, improve access to the overdose-reversal drug naloxone, and support enforcement activities. Part of the funding is directed specifically to rural areas. HHS Secretary Sylvia Burwell, who is from West Virginia, said the issue is a top priority of hers as her state is one of the most hard hit by drug abuse.

Visit USA Today for the announcement.