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October 2012 Archives

Pharmacy in meningitis outbreak sent customers glowing report while internal tests showed widespread contaminants

Shortly before a national fungal meningitis outbreak was linked to New England Compounding Center, the Framingham company sent customers a "Quality Assurance Report Card" trumpeting the cleanliness of its labs, even as internal tests showed widespread contamination.

Investigators Visit Company Tied to Meningitis Cases

Criminal investigators from the Food and Drug Administration were at the New England Compounding Center in Framingham, Mass., on Tuesday, officials said, in the first public indication that the federal government was preparing a case against the company linked to a deadly meningitis outbreak.

Meningitis outbreak: Health officials expand warnings of possibly tainted drugs

As the fungal-meningitis outbreak in Florida grew by two more cases Tuesday, officials announced they are expanding warnings to include patients who received any type of injectable drug from New England Compounding Center, whose contaminated steroids led to the outbreak.

FDA Finds Contamination During Fungal Meningitis Investigation

A series of inspections conducted in October at the New England Compounding Center – the facility at the heart of the investigation into a recent fungal meningitis outbreak – found nonsterile conditions and contaminated vials of the steroid methylprednisolone acetate.

Ameridose Issues Recall of All Products

FOR IMMEDIATE RELEASE – October 31, 2012 – Ameridose today announced it will commence a voluntary recall of any unexpired products remaining in circulation. This action is voluntary, and represents an expansion of our cooperation with the U.S.Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy.

Universityof Michigan's New Insight on Managing Fungal Meningitis Outbreak

As the number of fungal meningitis cases continues to rise, physicians across the country are faced with how best to provide the early treatment that can save lives. A University of Michigan Health System infectious disease expert is the lead author of a New England Journal of Medicine report detailing how the outbreak evolved and the complexities of providing anti-fungal treatments.

Lansing-based Sparrow hospital received products from maker of steroids linked to meningitis outbreak, say patients not believed to be at risk

LANSING, MI - Sparrow patients may have been given a product made by the company whose steroidal medication is believed to be the cause of a deadly fungal meningitis outbreak, officials with the health system said in a press release.

Medtronic Helped Write, Edit Positive 'Infuse' Spine Studies

Highly positive studies published in peer-reviewed medical journals depicted Medtronic's spine fusion product as a major breakthrough in back surgery, but those studies were drafted and edited with direct input from company employees, while the doctors listed as authors were paid millions, according to a U.S. Senate investigation.

Settlement Eases Rules for Some Medicare Patients

WASHINGTON -- Tens of thousands of people with chronic conditions and disabilities may find it easier to qualify for Medicare coverage of potentially costly home health care, skilled nursing home stays and outpatient therapy under policy changes planned by the Obama administration.

Soap, Swabs Slash Infection Rates by 44%

A study  conducted at 43 HCA-affiliated community hospitals saw bloodstream infections,  including methicillin-resistant Staphylococcus  aureus (MRSA), drop by  44% when all ICU patients were subjected to daily "universal decolonization"  using antimicrobial soap and nasal swabs.
"The magnitude of this trial is  such that it will create a standard of care for most ICUs in the U.S.,"  study coauthor Ed Septimus, MD, told HealthLeaders Media. "Obviously once  this study results are well known we do expect a rapid adoption across most  hospitals in the United States."
The study, Randomized  Evaluation of Decolonization Versus Universal Clearance to Eliminate MRSA, was conducted with investigators from  Harvard and other academic institutions, the Agency for Healthcare Research and  Quality and the Centers for Disease Control and Prevention.
Nearly 75,000 patients and more than 280,000 patient days in 74 adult ICUs in  16 states were involved. Investigators compared three infection control approaches  in ICUs:

Preventable Error Reporting Hindered by Fear of Reprisal

Hospitals and  other healthcare organizations have done a good job in the last 20 years  building mechanisms to monitor and report preventable errors. However, those  efforts are hobbled by clinicians' reluctance to report colleagues' mistakes for  fear of retaliation, according to a new report from the National Association  for Healthcare Quality.
"In fact, as attention to creating a culture of safety in  healthcare organizations has increased, so have concomitant reports of  retaliation and intimidation targeting staff who voice concern about safety and  quality deficiencies," according to the report, Call  to Action: Safeguarding the Integrity of Healthcare Quality and Safety Systems.
Peter Angood, MD, CEO of the  American College of Physician Executives, which helped compile the report, says  the fear of retaliation is "very distinct and quite palpable in many organizations  to the point that there is even a fear of making comment" about the existence  of the threat.
"It is multi-factorial," Angood tells HealthLeaders  Media. "Some of it comes from historical orientation of hospitals and  healthcare systems towards the physicians and making sure they are happy and as  long as they are happy there is good patient flow and everybody wins.
As we transition off of that entire focus toward physicians and more towards  patients there are the lingering cultural habits of not wanting to cross the  physician's path if things aren't going right."

Medical Harm Complaint System Could be Quality Data Goldmine

A first-of-its kind federal pilot project designed  to make it easier for patients to directly complain about medical errors,  safety issues, and harm may prompt some doctors and hospitals to blanch.
Might it unleash a gripefest about relatively unimportant aspects of care, like  the yucky taste of hospital food, the lack of parking, or meandering laments  that one got sick in the first place? A rage against the night?
Are most patients even sophisticated enough about the healthcare system to know  a medical error or an unsafe condition when they see one, or how to distinguish  it from the natural course of their disease?
With the Office of Inspector General's estimate that one in four Medicare patients  suffers harm at the hands of healthcare providers, could this new information  really give providers any more information than by now, they must already know?
We may soon find out.
The pilot project proposed by the federal Agency for Healthcare Research and  Quality (AHRQ) intends to give such a harm complaint system a trial run  sometime next year, probably in the mid-Atlantic region near Philadelphia. Many  say the information it will produce will be a goldmine for quality improvement.

Steroid Shot Near Spine Gives Illness an Opening

One of the many troubling aspects of the national meningitis outbreak caused by a tainted steroid drug is that so many people are at risk: 14,000 are thought to have been exposed, mostly through injections near the spine for back or neck problems. The drug was contaminated with a fungus that causes a severe form of meningitis that can result in stroke.

1 in 3 Healthcare Workers Skip Flu Shots

Healthy People 2020, the U.S. Department of Health and Human Services' most  recent 10-year agenda for improving the nation's health, set a target that 90%  of healthcare personnel (HCP) be vaccinated against influenza by the year 2020.  Its interim goal is targeting that by 2015, 70% of HCP get the flu vaccine.

Attorneys reach $123M settlement in class-action lawsuit in pedophile pediatrician's abuse

DOVER, Del. -- Attorneys for the state medical society and a southern Delaware hospital have settled a class-action lawsuit filed on behalf of victims of former pediatrician Earl Bradley, who sexually abused scores of his young patients over more than a decade.

Dealing With the Financial Burden of Autism

WHEN Jeff Sell's twin sons were found to have autism 13 years ago, he, like so many other parents in the same situation, found himself with a million questions: Will my children be able to function? What are the best treatments and where do I find them? How will this affect the rest of my family?

UV Device Erases Superbugs from Hospital Rooms

Nasty microorganisms lurking on bed rails, tables, doorknobs and other surfaces in hospitals are causing a more than $30-billion problem for the U.S. healthcare system. Now, a new device is one of many trying to hunt down these microorganisms in an effort to reduce healthcare-associated infections such as methicillin-resistant Staphylococcus aureus (MRSA) and Clostridium difficile.

Meningitis Cases Are Linked to Steroid Injections in Spine

Dr. April Pettit, an infectious diseases specialist at Vanderbilt University, was worried about her patient. He had been ill with meningitis for two weeks, he was not getting better, and she could not figure out why. Antibiotics, the usual treatment, were not helping. Bacteria, the usual suspects, could not be found.

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