DAILY UPDATE

The 'dirty little secret' of low cancer surgery volumes

Seasoned healthcare data junkies may know this dirty little secret in surgical care: A surprisingly large number of hospitals very rarely perform some common, elective surgery types. But some analysts said they were surprised when they realized just how many times extremely low volumes were reported for 11 types of cancer surgery throughout California's hospitals.

The analysis of more than 300 hospitals from Crescent City to the Tijuana border revealed that for nine types of common elective cancer surgery, between 12% and 63% of hospitals that performed one or more types of procedure performed just one or two of that type in 2014. According to the report, nearly 700 patients had cancer surgery at a hospital that did just one or two of that type that year. And thousands had cancer surgery at a hospital that performed no more than five of the procedures.

These are skill- and team-sensitive surgeries for which there is good evidence that more procedures also equate to reduced re-admissions, fewer repeat surgeries, and lower rates of cancer recurrence. Experts agree that while there is some evidence for volume thresholds for some types of cancer surgeries - for example, 15 or 20 a year - no hospital should be performing only one or two.

The statistics didn't get better for hospitals doing between one and five cancer surgeries in any of the 11 types. The report revealed that between 14% and 75% of the hospitals that performed any of 11 types of cancer surgery performed the procedure only five times or less.

Report contributor Karl Bilimoria, MD, a surgical oncologist and the director of surgical outcomes and quality improvement at the Feinberg School of Medicine at Northwestern University in Chicago, said the California data show what has long been known to happen in other states.

Bilimoria, who is heavily involved with the ACS's National Surgical Quality Improvement Program, was asked why hospitals persist in allowing such small surgical volumes when there is a much greater chance that something can go wrong; he put some of the blame on referring doctors: "Patients are often referred within their system, and often follow their doctor's referral recommendation.”

One of the leading proponents of establishing volume thresholds is surgery researcher John Birkmeyer, MD, a general surgeon and executive vice president of Dartmouth-Hitchcock in New Hampshire. He has suggested that volume thresholds should become a criteria for hospital medical executive committees and their staff privileging oversight.

In May 2015, he and Peter Pronovost of Johns Hopkins and colleagues at the University of Michigan launched their "take the volume pledge" campaign, in which 15 hospitals affiliated with those systems would not allow surgeries unless each surgeon and hospital maintained certain volumes in 10 procedures.

Visit MedPage Today for the article.

BD and Vancive Medical Technologies launch new vascular dressings with CHG antimicrobial

BD (Becton, Dickinson and Company) and Vancive Medical Technologies, an Avery Dennison  business, launched a line of transparent vascular dressings with chlorhexidine gluconate (CHG) antimicrobial preservative that are designed to enhance patient care and be easy for clinicians to apply and remove.

The new BD ChloraShield dressings, which feature BeneHold CHG, an innovative adhesive technology from Vancive Medical Technologies, comfortably secure the dressing to the skin, absorb fluids and protect the site from external contaminants. The CHG incorporated within the adhesive preserves the dressing from microbial growth, making them well-suited for catheter insertion sites. The Infusion Nurses Society recently released guidelines recommending the use of CHG dressings.

BD ChloraShield dressings are available in a variety of designs including bordered and non-bordered as well as sizes commonly used for peripheral IVs and PICCs.

Visit BD for more information.

Six little molecules could help stop both Ebola and cancer

University of Virginia School of Medicine researcher Christopher Stroupe has his eye on six little molecules that could be the key to new treatments for both Ebola and cancer.

The molecules, which act together as a single unit known as HOPS, are essential for Ebola to infect cells and for cancer cells to grow and survive. As such, they represent a shared weakness – a weakness Stroupe is seeking to exploit.

To do that, he is creating a new tool to produce a purified form of HOPS that would facilitate the development of drugs targeting the molecules. By blocking HOPS in human cells, he hopes, doctors can cut the legs from under Ebola and cancer.

So what do HOPS actually do? For one thing, the protein molecules play a critical role in the functioning of the lysosome, an organelle inside cells that high school biology has long labeled the cellular garbage dump, where damaged materials were degraded. But Stroupe likens the lysosome more to a recycling center, where useful materials are repurposed, and that's why targeting HOPS could be beneficial.

So by targeting HOPS, doctors could deny cancer cells the sustenance they need, making them more vulnerable to cancer-killing treatments.

The Ebola virus, like all viruses, has evolved to hijack the internal workings of the cell in order to replicate and infect its host. Ebola takes a circuitous route as it invades cells, tunneling a path to the lysosome along the way. To do this, Ebola essentially hitches a ride on HOPS. And so Stroupe believes that drugs that block the action of HOPS may be not only powerful anti-cancer agents, but also useful against Ebola.

Visit Medical Express for the report.

FDA issues draft guidance for the coordinated development of antimicrobial drugs and antimicrobial susceptibility test devices

The Food and Drug Administration has announced the availability of a draft guidance entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices.”

This draft guidance is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility test (AST) devices and who seek to coordinate development of these products such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. This draft guidance is not final nor is it in effect at this time.

This guidance, when finalized, is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and AST devices and who seek to coordinate development of these products such that the AST device could be cleared either at the time of new drug approval or shortly thereafter.

Specifically, the guidance intends to describe the interactions between drug sponsors and device manufacturers for coordinated development of a new antimicrobial drug and an AST device; explain the considerations for submitting separate applications to the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) when seeking clearance of an AST device coincident with, or soon following, antimicrobial drug approval; and clarify that the review of the new antimicrobial drug product and AST device(s) will remain independent, and that coordinated development does not influence the review timelines for either product.

Visit FDA for the guidance.

U.N. pledges to fight antibiotic resistance in historic agreement

Every year, more than 2 million Americans get sick with antibiotic-resistant infections, and tens of thousands die as a result, says the Centers for Disease Control and Prevention. Common diseases, like urinary tract infections and pneumonia, are becoming harder and harder to treat. And new superbugs are cropping up - even here in the U.S. - that are resistant to last-resort drugs.

Doctors have been warning about this problem for decades. But in the past year or so, another group of researchers has started taking interest in superbugs: economists. And they quickly realized the problem goes way beyond health.

A recent report from the U.K. government found that antibiotic-resistant bacteria could cost the world $100 trillion by 2050 if nothing is done about it. The World Bank predicts drug-resistant infections could damage the economy as much as - or even more than - the 2008 financial crisis. And annual global GDP could drop by 1 to 4 percent, the agency says.

On top of that, farmers around the world have come to rely on antibiotics to raise animals. The drugs make pigs, cows and chickens grow fatter more quickly - and keeps them healthy in densely packed quarters.

And that's why world leaders are now getting involved. The U.N.'s declaration requires countries to come up with a two-year a plan to protect the potency of antibiotics. Countries need to create ways to monitor the use of antibiotics in medicine and agriculture, start curbing that use and begin developing new antibiotics that work.

After two years, the U.N.'s secretary-general will assess each country's plan and check to make sure each is making progress.

Back in 2001, the U.N. made a similar declaration about the HIV pandemic. And that declaration had a big impact on curbing the spread of HIV around the world, says Ramanan Laxminarayan, who directs the Center for Disease Dynamics, Economics & Policy in Washington, D.C.

He says there are a few weaknesses in the U.N.'s new plan on antibiotic-resistant bacteria. For example, there are no hardcore targets for reducing antibiotic use by a certain amount in two years.

But he thinks the declaration could have the same impact on fighting antibiotic-resistant bacteria as the previous one had on fighting HIV. Since 2004, there has been a 45 percent drop in AIDS-related deaths in countries supported by global HIV campaigns.

Visit NPR for the report.

U.S. food supply poised to get safer as FDA rule takes effect

An estimated 1 in 6 Americans contracts a foodborne illness each year, but that figure should decline as a result of safety measures that thousands of food facilities must implement.

The September 19 deadline took effect for large food processors to meet new prevention-based regulations developed by the U.S. Food and Drug Administration (FDA), which oversees the safety of roughly 80 percent of the food supply - nearly everything except meat, poultry, and egg products.

The central element of FDA’s rule - and the law that authorized it, the FDA Food Safety Modernization Act (FSMA) - establishes that the companies growing and processing food have an affirmative, legally enforceable responsibility to take steps to prevent contamination of their products. Many Americans may assume that these FDA-regulated businesses already had such an obligation, but in fact, they have not until now.

Under the new national requirements, each facility must develop a food safety plan that identifies possible points of contamination throughout the production process, along with steps to mitigate them. Companies also must monitor the effectiveness of their efforts and, when problems arise, correct them.

FDA will be able to stop a large processing facility from making or distributing tainted products if it fails to meet the requirements, before a single person gets sick. No longer will the agency have to wait to act until a firm’s unsafe practices cause serious illnesses.

While many larger operations have prevention-based food safety programs in place, this approach may be new to many midsize and small farms and facilities. They are receiving more time to ramp up and be ready. Educating these smaller operations on the FSMA requirements has been, and will continue to be, a major focus at FDA.

Visit Pew Charitable Trusts for the announcement.

Does your favorite restaurant serve too many antibiotics?

Although you might pay attention to what kind of meat you buy at the grocery store - organic, grass-fed, cage-free - chances are, you aren't as informed about the meat that's on the menu at your favorite fast food joint.

A collaborative new report ranks the 25 largest US fast food and "fast casual" restaurant chains on their antibiotics policies and practices. For the second year in a row, Panera Bread and Chipotle Mexican Grill take top honors, each receiving an A grade. Sixteen of the 25 chains received a grade of F, though that's actually an improvement over last year's findings.

The report, called Chain Reaction II, is co-authored by six nonprofit activist organizations, including the Natural Resources Defense Council, Consumers Union and Friends of the Earth. It seeks to sound the alarm about the overuse of antibiotics in poultry and livestock, typically "to help them survive and make them grow faster in unsanitary, crowded and stressful conditions."

This year, in the second annual report, twice the number of restaurant chains received a passing grade. The authors say this is in large part due to companies' transition of chicken supplies away from routine use of antibiotics.

SUBWAY jumped from a grade of F all the way up to a B, on account of it being the only restaurant chain to adopt a new antibiotics policy that applies to all types of meat it serves, according to the report.

In August, McDonald's USA (Grade: C+) announced completion of its commitment to only serve chicken not treated with antibiotics important to human medicine nearly a year ahead of schedule.

While they agree that restaurants are making changes for the better, when it comes to healthier, more responsible food sourcing, they add that efforts to date are simply not enough.

Visit CNN for the report.

Deadline reminder for the Jeannie A. Akridge Memorial Scholarship presented by HPN

Each year, Healthcare Purchasing News (HPN) will present an International Association of Healthcare Central Service Materiel Management (IAHCSMM) member a scholarship that will cover his or her tuition to the annual conference, including travel expenses up to $1,000.

Jeannie Akridge served as HPN‘s Managing Editor for more than a decade before she succumbed to breast cancer in November 2014 at age 42. Kristine Russell, HPN Publisher and Executive Editor, and the entire HPN staff, are proud to continue “The Jeannie A. Akridge Memorial Scholarship” as a tribute to her.

Akridge actively demonstrated her passion for her editorial work, for her extensive coverage of CS/SPD topics and for her profound respect for and appreciation of CS/SPD professionals.

HPN chose IAHCSMM for the award because of the long-standing partnership between the two organizations in the area of continuing education and CS/SPD advocacy, which continues monthly in print and daily online.

Next year’s IAHCSMM meeting is May 7-10, 2017, at the Gaylord in Nashville, TN.

HPN currently is accepting submissions for the award, which includes a short essay by the candidate explaining why his or her department’s efforts to clean and sterilize instruments makes a difference in the delivery of high-quality and safe patient care. HPN will announce the winner in early November to commemorate the anniversary of Akridge’s passing.

Submissions must be unique to Healthcare Purchasing News.

Last year’s inaugural winner, Jo M. Wood is currently the Central Processing Department Compliance & Education Supervisor at Boston Medical Center in Boston, MA. View her submission here.

Please send your submissions to krussell@hpnonline.com by October 3, 2016. Candidates must be available to attend the IAHCSMM meeting in May.