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August 28, 2015   Download print version

Could cameras in operating rooms reduce preventable medical deaths?

Universal flu vaccine a step closer as scientists create experimental jabs

Surgeon who wrote of becoming killer is denied bail reduction

No, you do not have to drink 8 glasses of water a day

Rising cost of prescription drugs threatens healthcare gains

White House is pressed to help widen access to Hepatitis C drugs

A new job hazard for doctors is rising with India's economy

Ultrasound-based vasculitis diagnosis may save vision


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Self Study Series:
September 2015

CQI in device decontamination: the role of washer indicators

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Could cameras in operating rooms reduce preventable medical deaths?

Chris Nowakoski’s wife died in Wisconsin during what should have been a routine procedure on her pacemaker. Danny Long’s wife in North Carolina suffered catastrophic neurological injury during a surgery to relieve numbness in her extremities. A doctor perforated the colon and esophagus of Deirdre Gilbert’s daughter in Texas, then operated on her after she was dead.

In each case, the families still don’t know the full story of what happened to their loved ones because of a lack of documentation and an inability to pursue a costly lawsuit. They are relatives of an estimated 400,000 a year people who die in the United States of preventable medical errors, the third-leading cause of death after heart disease and cancer. But the families say they could have known much more if cameras had been installed in the operating rooms, recording the actions and movements of the doctors and staffers involved.

They are enthusiastic supporters of a growing movement that is seeking to require hospitals and surgical suites to have video and audio recording capability. Now, a surgeon in Toronto has built a “black box” that synchronizes a patient’s physical data with video and audio recordings of an operation, enabling doctors to review their work the same way athletes watch video of their performances. And he said he has lined up two U.S. hospital systems to take part in the first testing of the system.

A bill that would require cameras in every operating room in Wisconsin has been introduced in the state legislature, and supporters say that lawmakers in other states are closely watching the bill’s progress. The proposed legislation, known as the “Julie Ayer Rubenzer Law,” is named for a Wisconsin woman who died after she was given excessive amounts of propofol during breast-enhancement surgery.

Rubenzer’s brother, Wade Ayer, founded the National Organization for Medical Malpractice Victims and helped draft the bill, which is supported by patient-advocate groups around the country. Ayer said video and audio recordings can capture the reasons behind “adverse events,” as the medical industry terms them, and deter inept or simply bad behavior by medical personnel — such as the anesthesiologist in suburban Washington who can be heard harshly criticizing her patient in an audio recording made by the patient. The physician was hit with a $500,000 jury verdict.

Currently, re-creating what went wrong in an operating room involves a mixture of memories and whatever notes were taken at the time or shortly afterward, a vague combination that vexes families trying to get to the truth about a failed procedure or a fatal complication. Recording surgeries “offers transparency, truth and accuracy,” Ayer said, “in collecting data for the medical record and testimony. It offers data and insight for medical boards and even prosecutors. It offers oversight and policing.”

But the healthcare industry has flexed its muscle where needed, sometimes driven by concerns about the effects that video recordings could have on medical malpractice lawsuits as well as the cost of installing and maintaining complex recording systems. A bill in Massachusetts that would require hospitals to allow recording by a licensed videographer, at the patient’s expense, has repeatedly failed in recent years in the face of opposition from hospitals, according to news media reports.

Ayer has also begun lobbying members of Congress in order to judge interest in a federal law regarding surgical cameras. He also is pushing for a national database of doctors who have had their licenses taken away after they made medical errors. The license of the doctor whose actions killed Ayer’s sister was revoked in Florida, but he now practices in Pennsylvania, public records show.

Some advocates for operating-room cameras say the devices can only help. They add that tort reform in many states limits damages in malpractice cases, discouraging lawyers from taking on cases without clear-cut evidence — such as video. Visit the Washington Post for the story.

Universal flu vaccine a step closer as scientists create experimental jabs

A universal flu vaccine that protects against multiple strains of the virus is a step closer after scientists created experimental jabs that work in animals.

The vaccines prevented deaths or reduced symptoms in mice, ferrets and monkeys infected with different types of flu, raising hopes for a reliable alternative to the seasonal vaccine.

Doctors hope that a universal flu vaccine would do away with the need for people at risk to have flu jabs every year, and even protect the public from dangerous, potentially pandemic, strains that jump from birds or pigs into humans.

Conventional flu vaccines target the “head” of a molecule called haemagglutinin (HA) that sits on the surface of flu viruses. But because the head of the HA mutates so rapidly, seasonal flu vaccines must be continually re-formulated to ensure they are effective.

During the last flu season, mutations in the HA molecule on one of the most common circulating strains, H3N2, meant that the seasonal flu vaccine offered little protection. Public Health England said in February that the less effective vaccine was likely to have been behind a steep rise in flu deaths.

In two studies reported on Monday, separate research teams describe how they created novel flu vaccines that target the “stem” of the HA molecule instead of the head. The stem of the HA molecule is similar across different flu strains and mutates far less often.

One of the teams, led by Barney Graham at the National Institutes of Health in Maryland, created their vaccine by attaching part of a flu virus’s HA stem to tiny balls of protein. These protein nanoparticles kept the stem intact and made it easy for the immune system to spot once it was injected.

In lab tests, one version of the vaccine completely protected mice and partially protected ferrets from injections of H5N1 bird flu virus, which was fatal in unvaccinated animals. The H5N1 flu strain has killed more than 400 people since 2003, most of whom caught the virus from infected poultry.

A second team, led by Antonietta Impagliazzo at the Crucell Vaccine Institute in Leiden, created their own experimental flu vaccine by removing the head of the HA molecule, and tweaking the stem to make it bind to antibodies more effectively. Visit the Guardian for the report

Surgeon who wrote of becoming killer is denied bail reduction

Long before he faced lawsuits and criminal charges, a North Texas neurosurgeon emailed one of his employees.

“I am ready to leave the love and kindness and goodness and patience that I mix with everything else that I am and become a cold blooded killer,” Christopher Duntsch wrote.

To authorities, the chilling Dec. 11, 2011, email points to Duntsch’s mind-set in the months before he “intentionally, knowingly and recklessly” botched spinal surgeries, severely injuring four people and killing one woman, Floella Brown, who died in July 2012.

The email was among new evidence Dallas County prosecutors presented against Duntsch at a hearing Friday in which Criminal District Judge Carter Thompson refused to reduce Duntsch’s $600,000 bail.

Duntsch, 44, was arrested July 21 on five counts of aggravated assault causing serious bodily injury and a count of injuring an elderly person. He performed those procedures at Dallas Medical Center, South Hampton Community Hospital and University General Hospital.

Dallas police said in a search warrant affidavit that he is also under investigation in the botching of at least 10 other patients’ surgeries in Plano and Dallas that occurred from November 2011 through June 2013. Duntsch “knowingly takes actions that place the patients’ lives at risk,” police said, such as causing extreme blood loss by cutting a major vein and then not taking proper steps to correct it.

In one case, Duntsch left a surgical sponge inside a man's body. During that same surgery, another doctor forced him to stop operating because of his “unacceptable surgical technique,” the affidavit said.

Duntsch’s medical license was revoked in December 2013 after the Texas Medical Board found he had a pattern of failing to follow proper procedures before operations or respond to complications that caused at least two deaths. Visit the Dallas News for the story.

No, you do not have to drink 8 glasses of water a day

If there is one health myth that will not die, it is this: You should drink eight glasses of water a day. It’s just not true. There is no science behind it. And yet every summer we are inundated with news media reports warning that dehydration is dangerous and also ubiquitous.

These reports work up a fear that otherwise healthy adults and children are walking around dehydrated, even that dehydration has reached epidemic proportions.

Let’s put these claims under scrutiny. Water is present in fruits and vegetables. It’s in juice, it’s in beer, it’s even in tea and coffee, and no coffee isn’t going to dehydrate you, research shows that’s not true either.

The human body is finely tuned to signal you to drink long before you are actually dehydrated. Contrary to many stories you may hear, there’s no real scientific proof that, for otherwise healthy people, drinking extra water has any health benefits. For instance, reviews have failed to find that there’s any evidence that drinking more water keeps skin hydrated and makes it look healthier or wrinkle free.

It is true that some retrospective cohort studies have found increased water to be associated with better outcomes, but these are subject to the usual epidemiologic problems, such as an inability to prove causation. Moreover, they defined “high” water consumption at far fewer than eight glasses.

Prospective studies fail to find benefits in kidney function or all-cause mortality when healthy people increase their fluid intake. Randomized controlled trials fail to find benefits as well, with the exception of specific cases — for example, preventing the recurrence of some kinds of kidney stones. Real dehydration, when your body has lost a significant amount of water because of illness, excessive exercise or sweating, or an inability to drink, is a serious issue. But people with clinical dehydration almost always have symptoms of some sort.

There is no formal recommendation for a daily amount of water people need. That amount obviously differs by what people eat, where they live, how big they are and what they are doing. But as people in this country live longer than ever before, and have arguably freer access to beverages than at almost any time in human history. Visit the New York Times for the article.

Rising cost of prescription drugs threatens healthcare gains

According to a recent report from the Centers for Disease Control and Prevention's National Center for Health Statistics, an unprecedented 90.8% of Americans now have health insurance.

But because Obamacare is officially called the Patient Protection and Affordable Care Act, the soaring cost of prescription drugs is well on its way to making healthcare unaffordable again.

Prescription drug costs are rising dramatically in the United States. Based on a recent survey by Consumer Reports, 33% of Americans were paying an average of $39 more out of pocket for their regular prescription medications, and 10% were paying as much as an extra $100. Among the drugs that saw the highest increases were medications for asthma, high blood pressure and diabetes, which went up by more than 10% last year.

For low-income and many fixed-income Americans, paying the rising cost of prescription drugs means cutting back on daily expenses. And while it's one thing to cut back on entertainment and restaurants, it's a whole 'nother thing to cut back on groceries or rent payments.

According to the survey, one out of four people whose prescription drug costs went up said they were unable to pay their medical or medication bills. Seven percent said they missed a mortgage payment. One out of four stopped getting their prescriptions filled, and one out of five skipped scheduled doses. That is hardly a prescription for good health.

But the impact of these price increases goes far beyond the people who need prescription drugs. The cost increases affect employers and insurers, who are transferring some of these costs to consumers, requiring them to pay a larger share through their monthly premiums and rising copays.

They also affect state Medicaid programs for the poor and Medicare programs for people with fixed incomes.

So what can be done to rein in the cost?

1. Consumers, employers and insurance companies require much more transparency on how much prescription drugs actually cost. The negotiated rates between drug manufacturers and distributors are a well kept secret, and if you don't know what a drug should cost, you can't tell if you're overpaying.

2. Use generic drugs and get them through mail order, because even if your employer is providing you with health insurance, your copays and deductibles may be rising to the point where you can't afford to buy the brand-name drug at the corner drugstore.

3. There is a need for more competition. The unfortunate fact is that three major pharmacy benefits managers -- CVS Caremark, Express Scripts Inc. and Prime -- negotiate rates between the manufacturers and pharmacies. And now the major insurance companies are starting to merge, leaving even less choice for consumers.

4. Drug manufacturers attribute their rising drug costs to massive investments in research and development, but many critics say that's an excuse for price-gouging. Gilead Sciences' Harvoni, a new medication to treat Hepatitis C, costs $1,350 per pill -- $113,400 for a 12-week treatment. Its predecessor, Solvaldi, cost "only" $1,000 per pill -- $84,000 for a 12-week treatment. Manufacturers are certainly entitled to cover the costs of research and development, but releasing new drugs into the market at a faster pace, depending on how quickly the FDA can accelerate its approval processes, would increase competition and lower the cost of R&D.

5. Long-standing patents on medications often create barriers to developing new ones, and they also delay access to generics. Shortening the expiration of those patents would lower overall costs and might create an environment that encourages more options for consumers.

6. Restrictions on purchasing prescription drugs in other countries and bringing them to the United States -- both through travel and on the Internet -- must be relaxed. This would drive up competition and encourage the companies to lower their prices.

7. This is the big one: The largest purchaser of healthcare services in the country is Medicare, but the law forbids Medicare officials -- unlike Medicaid and Department of Veterans Affairs officials -- from negotiating prices with pharmaceutical companies. That makes no sense whatsoever. Changing this law has the potential to change everything. Visit CNN for the story.

White House is pressed to help widen access to Hepatitis C drugs

The Centers for Medicare & Medicaid Services has issued 2014 quality and financial performance results showing that Medicare Accountable Care Organizations (ACOs) continue to improve the quality of care for Medicare beneficiaries, while generating financial savings. As the number of Medicare beneficiaries served by ACOs continues to grow, these results suggest that ACOs are delivering higher quality care to more and more Medicare beneficiaries each year.

The results demonstrate significant improvements in the quality of care ACOs are offering to Medicare beneficiaries. ACOs are judged on their performance on an array of meaningful metrics that assess the care they provide – including how highly patients rated their doctor, how well clinicians communicated, whether they screened for high blood pressure and tobacco use and cessation, and their use of Electronic Health Records. In the third performance year, Pioneer ACOs showed improvements in 28 of 33 quality measures and experienced average improvements of 3.6% across all quality measures. Shared Savings Program ACOs that reported quality measures in 2013 and 2014 improved on 27 of 33 quality measures.

When an ACO demonstrates that it has achieved high-quality care and effectively reducing spending of health care dollars above specified thresholds, it is able to share in the savings generated for Medicare. In 2014, 20 Pioneer and 333 Shared Savings Program ACOs generated more than $411 million in savings, which includes all ACOs savings and losses. The results show that ACOs with more experience in the program tend to perform better over time. Of the 333 Shared Savings Program ACOs, 119 are in their first performance year in Track 1, which involves standing up the program without the financial risk associated with later tracks.

The number of beneficiaries served by ACOs is likely to continue to grow. Since the advent of the programs, the number of Medicare beneficiaries served by ACOs has consistently grown from year to year, and early indications suggest the number may grow again next year. The Shared Savings Program continues to receive strong interest from both new applicants seeking to join the program as well as from existing ACOs seeking to continue in the program for a second agreement period starting in 2016. Since passage of the Affordable Care Act, more than 420 Medicare ACOs have been established, serving more than 7.8 million Americans with Original Medicare as of January 1, 2015. For more detailed quality and financial results, visit CMS.

A new job hazard for doctors is rising with India's economy

When an ailing 75-year-old woman succumbed to heart failure after two weeks in intensive care, it fell to a young physician to break the news to her sons. They did not take it well. One marched out of the suburban Mumbai hospital and he soon returned with relatives, who attacked the doctor outside the intensive care ward, leaving him with fractures in his nose and foot as two dozen hospital staffers looked on helplessly.

The incident in April was one of a string of attacks on Indian doctors and medical staff members, most of them by angry friends and relatives of patients. The threats have become so serious that one doctors’ organization this month enlisted an on-call private security company, whose website features testimonials from Bollywood stars and political figures, to protect 4,000 of its members.

There is an increasing expectation from patients that with modern medicine and technology, a doctor should be able to guarantee a good outcome.

Unlike their counterparts in the United States, where physical attacks on medical professionals are rare, doctors in India appear to be at growing risk. The Indian Medical Assn. found in a recent survey that more than three-quarters of doctors had faced violence or verbal abuse at work.

The problem stems from a lack of trust between patients' families and doctors, industry groups say. As India's economy booms, the quality of healthcare available to the aspiring middle class has increased, along with its cost. That has made it more difficult for people to accept when patients don't get better.

At the same time, tales of corruption and carelessness at medical colleges and among practicing doctors have spread through the country, prompting growing skepticism among Indians of a profession that has long been revered here.

Healthcare advocacy groups complain that Indian medical schools don't teach communication skills, producing graduates who can't explain procedures in plain language. Worse, some doctors have been found trying to pad their earnings by performing unnecessary procedures or ordering excessive tests. Since the vast majority of Indians pay out of pocket for healthcare, they wind up footing the inflated bill.

Doctors, especially in government hospitals, counter that they are overworked and underpaid. Shoddy medical infrastructure, including a dearth of well-equipped emergency vehicles, means that many patients reach hospitals too late to be saved.

Doctors say a 2010 law mandating punishment for attacks on medical workers in the western state of Maharashtra, which includes Mumbai, has not been enforced. They also complain about entitled attitudes of patients, particularly in places such as Panvel, a onetime agricultural area that is now a boomtown suburb, bursting with giant apartment blocks. As land prices soar, farming families have become urbanites almost overnight, often harboring what doctors say are unrealistic expectations. Visit the Los Angeles Times for the story.

Ultrasound-based vasculitis diagnosis may save vision

The implementation of a "fast-track" clinic with rapid ultrasound assessment for patients with suspected giant cell arteritis led to a dramatic decrease in permanent visual impairment, a Norwegian study found.

Among 32 patients evaluated conventionally using biopsy of the temporal artery and 43 assessed with the fast-track ultrasound approach, 18 patients -- nine patients in each group -- experienced visual disturbances typical of giant cell arteritis, such as diplopia, blurred vision, and amaurosis fugax, according to Andreas P. Diamantopoulos, MD, PhD, of the Hospital of Southern Norway Trust in Kristiansand, and colleagues.

Yet six patients in the conventional group (21.5%) experienced permanent visual loss compared with only one assessed with the fast track ultrasound approach (2.4%), with what was an 88% lower rate, the researchers reported online in Rheumatology.

Giant cell arteritis is the most common of the primary vasculitides, most often affecting individuals older than 50. One in five patients are thought to experience irreversible vision loss, and high-dose steroids are the treatment of choice.

The gold standard for diagnosing the condition has been biopsy of the temporal artery, with confirmation being provided by a positive response to corticosteroid therapy. However, the inflammation of the artery typically is segmental and so can be missed if the biopsy needle is inserted in areas unaffected by the vasculitic process.

In addition, delay in obtaining the biopsy is common and clinicians may hesitate to prescribe corticosteroids in high doses to older patients, yet speed is of the utmost importance as vision loss can occur rapidly.

"The fast-track approach has been introduced in several fields in medicine with remarkable success in reducing mortality, morbidity, and inpatient days of care. Rapid initiation of treatment improves outcomes in rheumatoid arthritis through the utilization of the window of opportunity," the researchers noted. Visit MedPage Today for the study.