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The CMG Voice

Fungus Prompts Closures of ORs at Seattle Children’s Hospital

Posted Wednesday, May 22, 2019 by Tyler Goldberg-Hoss

Aspergillus is a common fungus that is all around us, including the air we breathe. For most of us, it causes no issues. However, it can be problematic, deadly even, if it finds its way into the wrong part of the body, and/or into a patient whose immune system is not strong.

That is what makes the recent discovery of aspergillus in the operating rooms at Seattle Children’s Hospital so worrisome, particularly for the pediatric patients and their families.

Some people, particularly those who may be patients at Seattle Children’s, have depressed immune systems. For those people, even breathing in Aspergillus can cause serious infections.

For others, even if they are not immunocompromised, if they have a surgery and the Aspergillus gets into their surgical site – the knee or brain, for example – that can also cause a serious, sometimes deadly infection.

So for operating rooms such as those at Seattle Children’s, it is vitally important that the air is free from Aspergillus and other things that can get into a patient’s surgical site and cause infections.

Environmental engineers at Seattle Children’s continue to evaluate the airflow in and around the ORs, in hopes of identifying the reason for these increased levels of the fungus.

Meanwhile, surgical patients are either being moved to outside facilities for surgeries, or having their surgeries postponed. For the hospital and its patients, it’s an unfortunate situation to be in. On the one hand, no one wants patients to develop unnecessary surgical site infections. And on the other, some of the patients really need surgery, and sending them to outside hospitals such as Harborview can disrupt the continuity of care for a pediatric surgical patient.

It is a difficult situation, most of all for any patients who develop a serious infection as a result.

You can read more about this here.

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Sleep Aids now Must Carry Warnings of Risky Sleep Behaviors

Posted Tuesday, May 21, 2019 by Carl-Erich Kruse

The FDA this week announced that it is requiring certain sleep aids to prominently feature, on their boxes, warnings of risky sleep behaviors such as sleep walking and sleep driving. The warning is meant to warn patients to stop taking the medication if they are finding they are engaging in activities when they are not fully awake. The FDA warning is targeting popular sleep aids Lunesta, Sonata, and Ambien.

The FDA acknowledges that the Boxed Warning is the agency’s most prominent warning, and the Contraindication is the agency’s strongest warning, to avoid use in patients with prior episodes of complex sleep behavior. These behaviors can lead to injuries and death of either the patient or victim of the half-asleep, unaware patient. The warnings are meant to inform both patients and health care professionals.

The drugs have been on the market to treat insomnia or many years. Injuries from complex sleep behaviors are rare, but can be significant and devastating, hence the warnings. These warnings are in addition to previous ones that the medication can impair driving and activities that require alertness the morning after use. Drowsiness has already been listed as a possible side effect.

You can read the FDA press release here

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FDA Halts Pelvic Mesh Sales

Posted Friday, May 10, 2019 by Carl-Erich Kruse

Citing insufficient evidence that the probable benefits of pelvic mesh outweighed its probable risk, the US Food and Drug Administration this week ordered the two remaining companies still selling pelvic mesh to cease sales.

Surgical pelvic mesh, or transvaginal mesh, has been used for decades to treat pelvic organ prolapse and stress urinary incontinence. For pelvic organ prolapse, the mesh has been used to reinforce the weakened muscles and ligaments that support a woman’s pelvic organs. It has been used for stress urinary incontinence to support the urethra or bladder neck to prevent loss of urine due to physical movement or activity.

The FDA’s significant action comes after pelvic mesh litigation grew into one of the largest mass tort cases in our nation’s history. Claims have arisen out of complications including erosion of the adjacent soft tissues (including organs), pain, infection, failure of the device, infection, urinary problems, and incontinence, to name a few. The FDA began issuing warnings and guidance documents regarding mesh use in 2008, and reclassified pelvic mesh as class III (high risk) medical device in 2016.

Over 100,000 claims related to pelvic mesh have been filed since it hit the market. These claims have led to nearly $8 billion in settlements. In addition, the FDA’s tightening oversight on pelvic mesh has reduced to only two remaining mesh manufacturers at the time of the FDA’s latest action. Undoubtedly many women have had successful treatment with pelvic mesh, but the devices’ failure rate was simply too high for the FDA to continue authorizing its sale or distribution in the United States.

The FDA advised that mesh patients without complications continue with their annual follow-ups and, perhaps, simply hope for the best.

Typically, claims such as these are considered products liability claims, and not claims of medical negligence. However, health care providers, including surgeons implanting mesh, may have done so in a negligent fashion, or failed to timely and appropriately diagnose and/or treat injuries occurring as a result of the mesh.

Read the FDA’s notice here. The FDA’s 2001 Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse can be found here.

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Fungal Superbug now “Serious Global Health Threat”

Posted Monday, May 6, 2019 by Carl-Erich Kruse

Recent appearances of a “superbug” strain of fungus have appeared in hospitals worldwide, keeping researchers and epidemiologists on their toes. The fungus, candida auris, was first reported only in 2009 in the ear of an elderly woman in Japan. Similar strains appeared in India and Pakistan around the same time. Three years later, the fungus appeared again during testing of infections of eighteen people in India. It shortly appeared in South Africa, Venezuela, Europe, and the United States. It has continued to spread with new cases in new areas reported every month. The US Center for Disease Control calls the fungus a “serious global health threat.”

Hospitals and researchers are finding the fungus extremely difficult to eradicate: the several strains of the fungal species have each exhibited imperviousness to major antifungal medications. This is troubling, as the fungus is particularly lethal for patients with immune systems already compromised by illness or age. The 90 day reported mortality rate is between 30 and 60 percent. An outbreak in Spain colonized in 372 people; caused infections in 85; and 35 (41%) died within thirty days.

The outbreak has led to public health officials scrambling to release information for health care providers, but also working to manage outbreaks quietly. Though the CDC operates a site with information for providers and consumers, and tracking the numbers of reported cases around the country, the CDC is not allowed to disclose locations of outbreaks. The US is not alone though, in that similar cloaks of secrecy exist in the UK and Spain, for example. Officials at Royal Brompton Hospital in London deemed there was “no need” to tell the public of a single appearance of the fungus despite its tenacious response to cleaning efforts. The interest here seems more interested in protecting hospital reputations than public health. One year after the initial outbreak at Royal Brompton Hospital, the hospital had fifty more patients struck. The hospital shut down its ICU for eleven days, and still made no announcement.

The rise of the superbug has started to create its own field of research. While there exists widespread awareness of antibiotic resistant bacteria, fungicidal resistant germs are not widely known. Suspicions have settled on the rise of bugs like candida auris related to overuse of antifungals in agriculture, similar to the rise of bacterial strains from overuse of antibiotics in livestock. Candida auris may itself be thousands of years old, and largely benign for much of its existence, but recent adaptations have caused it to proliferate aggressively.

The CDC reports that, as of the time of this writing, clinical cases have appeared in twelve states. We can expect further spread of the fungus. How hospitals and the CDC respond to the evolving threat waits to be seen. Research continues into the most effective ways to prevent, treat, and eradicate the fungus.

Read the New York Times article here. You can find the CDC website for the fungus here.

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Doctors who pay the most claims are those who have paid claims in the past

Posted Wednesday, May 1, 2019 by Tyler Goldberg-Hoss

A little while ago the New England Journal of Medicine published the results of a study that looked at thousands of paid claims over a 10 year period. The purpose of the study was to attempt to identify characteristics of the claims and the doctors who pay them in the hopes that those doctors could be reliably identified early on and provided resources to improve in ways that may avoid claims being made in the future.

The biggest takeaway, in my view, was this: “Approximately 1% of all physicians accounted for 32% of paid claims.”

Of course, this seems somewhat intuitive. But it is certainly not as simple as that. For example, risks of having to pay a claim go up or down depending on the type of doctor – all things being equal, neurosurgeons can expect to pay more claims than psychiatrists.

But the fact remains – there are some doctors who pay lots of claims. And the corresponding problem also remains – what to do about it? Is it possible to identify those doctors, provide them with tools to change, and avoid future claims?

I don’t pretend to have the answer to that question, but the report does consider at least one idea that can change and does have the probability of improving the odds of identifying those particular doctors, changing behavior, and improving patient safety (and consequently the number of paid claims).

And that is transparency.

This article notes that the current system (filing legal claims, settling or trying cases in court) is meant to improve the system by acting as a deterrent to future bad care, then states that, in that regard, it “performs poorly”.

I think one of the same reasons you can’t identify these doctors, and also why this system appears to “perform poorly”, is because of a lack of transparency.

Institutions and insurers of physicians who are paying claims take considerable effort to avoid anyone knowing who paid the claim or how much it was.

In settling claims, every single entity providing medical care in Washington State, including insurers of those physicians, with whom I have resolved a claim on behalf of my client, routinely pressures them into signing confidentiality agreements.

Similarly, institutions are loathe to report doctors to the National Practitioner Data Bank (NPDB). The NPDB was set up as a confidential database to improve healthcare quality. Institutions and insurers are mandated to report any claims paid above a certain amount. The purpose is to have a database available so that, if one physician has a number of claims paid, leaves the area and tries to go to some other city or state to find employment, hospitals considering hiring him or her will have access to this database and the knowledge of the doctor’s history of paying claims.

Doctors, understandably, don’t like this. And their institutions take great efforts to shield their doctors, finding ways to describe the payment as being made not because of the bad actions of the doctor, but about a systemic error, or an error made by another, often low level, provider.

This contributes to a national lack of transparency, which itself inhibits the ability of researchers such as those involved in this study from coming to meaningful conclusions that may result in increased patient safety.

There are not easy questions, for sure. But improving transparency is at least a meaningful start.

Read her for the full report:

Prevalence and Characteristics of Physicians Prone to Malpractice Claims

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