patient safety


Vaginal Mesh Study: Complications More Likely With Lower-Volume Surgeons

How do you minimize risk when undergoing surgery, an inherently risky endeavor?

If you happen to be one of the thousands of women facing surgery to treat stress urinary incontinence (SUI) — that uncontrollable leakiness due to weakened pelvic muscles, and yet another injustice of middle-age — there’s one pretty clear path to lower risk: Find a surgeon who performs many, many of these operations.

In a new analysis, Canadian researchers reviewed 10 years of data from nearly 60,000 patients who had vaginal mesh surgically implanted to treat stress urinary incontinence. The study concludes: “Ten years after SUI mesh surgery, 1 of every 30 women may require a second procedure for mesh removal or revision. Patients of lower-volume surgeons have a 37% increased likelihood of having a complication.”

The findings, published in the journal JAMA Surgery, “support the regulatory statements that suggest that patients should be counseled regarding serious complications that can occur with mesh-based procedures for SUI and that surgeons should achieve expertise in their chosen procedure,” the researchers write.

In case you’ve missed it, vaginal mesh implants have been in the news lately — and the news isn’t good. In May, a Delaware jury awarded $100 million to a woman who sued Boston Scientific, one of the manufacturers of vaginal mesh devices, for negligence, breach of warranty and fraud. Many more cases are pending and regulators continue to scrutinize the devices.

Patients and advocacy groups have also raised major concerns about the safety of vaginal mesh, the study authors note, citing complications ranging from chronic pain (and specifically, pain during sex) and fistula to erosion of the mesh into the vagina, which can require multiple followup surgeries and, needless to say, emotional and physical distress. More than 50,000 women have joined class action lawsuits related to vaginal mesh complications after SUI and prolapse procedures, the study says.

In an editorial accompanying the new analysis, Quoc-Dien Trinh, MD, a urologic surgeon at Boston’s Brigham and Women’s Hospital and assistant professor of surgery at Harvard Medical School, writes: “Although the lay press has focused on the judicial aspect and the potential financial fallout for manufacturers, little attention has been paid to understanding the factors associated with adverse events after vaginal mesh-based procedures. ”

In an interview, Trinh, who also studies health outcomes and patient safety, said the relationship between surgical volume and outcome is well established; that is, the more you do. the better you are. But while patients tend to shop around for high-volume surgeons when considering very complex procedures, like for cancer or heart surgery, that scrutiny doesn’t always carry over for simpler surgeries. “It’s something that people often don’t think about,” Trinh said, “but the same relationship [high volume equals better outcomes] applies to the less complex, same day procedures. Though the complications from vaginal mesh surgery may not be life threatening, erosions and fistulas, these things can make your recovery and quality of life miserable.”

Of course, Trinh said, it’s sometimes unrealistic for people to demand the very best, most experienced surgeon for every procedure. Continue reading

Patient Safety Scandal: Senator Steps In, Colleagues Search Souls

(Source: C-SPAN)

(Source: C-SPAN)

Paging Dr. Atul Gawande, paging Dr. Atul Gawande. Please call your assigning editor at The New Yorker to discuss the scandal around the $11 million that the company CareFusion allegedly paid to a leading figure in the patient safety field who pushed the company’s surgical antiseptic.

I confess, that’s just my fantasy, that Dr. Gawande — prominent himself in patient safety as author of “The Checklist Manifesto” — might want to take on this assignment. But this story — which publisher Brian Johnson explained last week here — seems to just keep building. The latest: Propublica reports today that Sen. Charles Grassley — known among other things for digging in to conflicts of interest in medicine —  is demanding to see documents relevant to the case.

That’s the hard news update, but perhaps even more interesting is the public soul-searching among Denham’s colleagues and acquaintances in the patient safety field that you can read online. Consider the opening of this blog post by Dr. Bob Wachter (Which Atul Gawande tweeted was his “disturbing read of the week”):

In retrospect – always in retrospect – it should have been obvious that, when it came to Dr. Charles Denham, something was not quite right. [And a bit later:] The scandal, which broke two weeks ago, involves a $40 million fine levied by the Department of Justice against a company called CareFusion. The company allegedly paid Denham more than $11 million in an effort to influence the deliberations of a “safe practices” committee of the National Quality Forum co-chaired by Denham. While I was shocked to hear this news, in retrospect there were so many unusual things about the career of Chuck Denham that alarm bells could have, okay, should have, gone off – for many people who knew him, including me. But they didn’t.

That post brought responses in the comments from other big names in patient safety, struggling to understand Dr. Denham’s nature: He seemed like a “user,” but he was also warmly supportive of the victims of medical errors and their families. He seems to have been lining his own pockets; he also seems to have done a lot of good.

Atul, your mission, should you choose to accept it: Dig into Dr. Denham’s case, and use it as a lens to cast light more generally on financial conflicts of interest in medicine. How and why do they happen? Are these good doctors gone bad? Good doctors convinced they’re still good? Bad doctors unmasked? 10,000 words by April would be ideal….

Patient Safety Scandal: Company Paid Doctor $11M In Kickback Case

(Source: C-SPAN)

(Source: C-SPAN)

File this story under, “How can you help but turn cynical when…” To complete the sentence: “…when even the very people charged with protecting patient safety appear to succumb to the corrupting effects of big money?”

Here’s an example of a recent headline, from Reuters: Carefusion to Pay $40 Million In U.S. Kickbacks Lawsuit. And on Influential Patient Safety Board Cut Ties With Doc Before Carefusion Kickbacks Case.

What’s the story? And is it, as it seems, an extraordinarily outrageous case of financial conflict of interest at the highest levels of medicine? I asked Brian Johnson, publisher of, who wrote the safety board story above. Our conversation, edited.

So, Brian, just how outrageous is this case?

Large legal settlements involving kickback payments to doctors tend to happen quite frequently. The Department of Justice is very aggressive in prosecuting companies for kickbacks, off-label promotions, these types of alleged wrongdoings. This case is unique because in essence, it appears to be an attempt to influence an entire health care system by paying a key member of a very influential patient safety organization.

So there’s particular irony in the fact that it’s an organization whose existence is aimed at protecting patients, and yet a member of it allegedly put finances before safety?

Allegedly. In the settlement, CareFusion does not admit any wrongdoing. Here are the outlines of the story: On Jan. 9, the Department of Justice released a statement saying that it had settled a longstanding investigation into the sales and marketing practices of an antiseptic skin wipe made by CareFusion, called ChloraPrep. The company ended up paying out just under $41 million to settle accusations of off-label promotion and kickbacks. The statement says in part:

“The settlement resolves allegations that, under agreements entered into in 2008 by CareFusion’s predecessor, CareFusion paid $11.6 million in kickbacks to Dr. Charles Denham while Denham served as the co-chair of the Safe Practices Committee at the National Quality Forum, a non-profit organization that reviews, endorses and recommends standardized health care performance measures and practices. The government contends that the purpose of those payments was to induce Denham to recommend, promote and arrange for the purchase of ChloraPrep by health care providers.”

What sets this story apart from the usual kickback settlement?

A few things. First, the Department of Justice went out of their way to specifically name a single prominent doctor, Dr. Charles Denham, for having received 11.6 million dollars from the company.

Ullp. That’s a lot of money.

At the time that he received the payments, Denham was co-chair of the Safe Practices Committee of the National Quality Forum. The NQF is one of the most important patient safety organizations in the country. Continue reading

Five Takes On Vaccine Safety And Autism

A new report does little to sway those skeptical of vaccines

By Karen Weintraub and Rachel Zimmerman

On Thursday, the influential Institute of Medicine issued a report on vaccine safety. After analyzing more than 1,000 published studies that looked at vaccine-related adverse events, the IOM concluded that most vaccines are safe, serious side effects are rare and there’s no link between vaccines and autism.

“We have a lot of evidence that vaccines save lives and avert a lot of suffering,” said Dr. Ellen Wright Clayton, a professor of pediatrics and law at Vanderbilt University in Nashville, Tenn. and chairwoman of the panel that wrote the report. She added: “The MMR vaccine does not cause autism…MMR and DTaP do not cause Type 1 diabetes. The flu shot does not cause Bell’s palsy and does not trigger episodes of asthma.”

But the report, by offering no new clinical data, did little to ease the concerns of those skeptical of vaccines. Here then, slightly edited, are five responses to the IOM report, four were solicited by CommonHealth and one came to us by email.

1. Alison MacNeil, a clinical social worker, lives with her husband and two children in Cambridge, Mass. Their six-year-old son Nick has autism and was the focus of the opening segment of the PBS Autism Now series that aired in April, anchored by Alison’s father Robert MacNeil.

The most recent report from the IOM will provide cold comfort for families like mine who have witnessed their children’s regression into Autism and chronic illness following vaccination. Not to mention the families the VICP has awarded settlements finding a causal relationship between their child’s Autism and vaccination. No comfort at all for the 93 girls who have died following the Gardasil vaccine.
I take issue with the IOM’s stance that vaccine adverse events are rare. Since 1999 the VAER’s system has received 11,000 to 12,000 individual reports per year of vaccine adverse events. By 2010 VEARS had received 352,650 adverse reports. It is estimated that only 1-10% of adverse vaccine events are even reported. I also take issue with IOM’s denial of any causal relationship between vaccination and Autism. $2 billion dollars has been paid out for 2,541 vaccine injuries, 1,300 of those were for brain injuries. There are 5,800 cases remaining to be adjudicated. Continue reading

Rep. Jeffrey Sanchez: Make Massachusetts Patients Safer

Rep. Jeffrey Sanchez

This Tuesday, the Massachusetts legislature’s Joint Committee on Public Health is slated to hold a hearing on 33 — count ’em, 33 — proposed bills on patient safety and quality of care. (The agenda is here.) Here, Rep. Jeffrey Sánchez, the joint committee’s House chair, writes a guest post about his own legislative offering, to be heard at the hearing along with the others.

(CommonHealth welcomes guest posts on health care topics of broad public interest. To inquire about submitting one, please click on the “Get in Touch” button below.)

In Massachusetts, we’re surrounded by some of the best health care institutions and practitioners in the world and don’t typically think patient safety is an area that needs to be addressed. But unfortunately, accidents happen.

Back in 1999, the Institute of Medicine released an eye-opening study, “To Err is Human,” which found that nearly 100,000 people die every year in the United States due to medical errors. As the report’s title suggests, these errors aren’t malicious or intentional; they are often a result of systems or a culture that make it too easy for mistakes to occur. We need to encourage systems that make it difficult, if not impossible, to make an error.

Another area that must be addressed in order to improve patient safety is the rate of health-care-associated infections. Each year in the Commonwealth, there are about 34,000 such infections. In addition to delaying recoveries and affecting quality of life, these infections have a significant financial impact, costing the Commonwealth between $200 and $400 million annually.

There are shining examples right here in Massachusetts of the type of systemic changes that are necessary to address these patient safety issues. Dr. Atul Gawande, a surgeon at Brigham and Women’s Hospital, was part of a team that developed a simple two-minute checklist for use in surgery that has seen a drop in deaths and complications of an astounding 36%. New England Baptist Hospital instituted a program to screen and treat patients for MRSA (methicillin-resistant staph) and ended up reducing all surgical site infections by almost 60%. The Massachusetts Hospital Association and the Massachusetts Coalition for the Prevention of Medical Errors are also working together to reduce the number of central line-associated blood stream infections.

These types of initiatives should be implemented across the Commonwealth. To do so, I have filed House Bill 1519, An Act reducing medical errors and improving patient safety. This bill, which is among those to be heard on Tuesday, includes: Continue reading

Has Your Hospital Taken The ‘Partnership For Patients’ Pledge?

It hit the national news last week, the new billion-dollar initiative by the federal Department of Health & Human Services to create a public-private partnership aimed at preventing patient injuries and complications. The partnership aims to save 60,000 lives and prevent millions of injuries over the next three years.

News takes a little while to reach the provinces out here, though, so it wasn’t until today that we had our official roll-out of the “Partnership for Patients: Better Care, Lower Costs” initiative. The Worcester event featured our regional HHS director, Christie Hager, and other prominent figures in health care.

Of course, we’d like to think that Massachusetts is so far ahead in areas like patient safety and health care quality that we don’t need a federal push in the right direction. And indeed, many of the state’s hospitals and other providers have already signed on to the federal pledge to protect patients better, which is here. (Wondering if your organization has taken the pledge? Go here and search by state. )

But speaking by phone after the event, Christie Hager of HHS said the partnership offered “the opportunity to really connect the dots.”

“There have been pockets of institution-based, provider-network-based initiatives and efforts to improve patient safety,” she said. “This represents, regionally as well as nationally, an opportunity to create a really cohesive and collective approach to improving systems of care. So it’s an opportunity to connect the dots between efforts that have been ongoing and really systematize those with the support of the investment that the U.S. Department of Health & Human Services is making now to support future work.”

The initiative aims to save lives and also to lower costs, she noted. HHS estimates the partnership could save $50 billion over ten years. “It’s a lot more expensive to do things the wrong way than the right way,” she said.

Nurses Say Staff Reductions Put Tufts Medical Center Patients At Risk; Hospital Denies Charges

The Massachusetts Nurses Association says recent staff reductions and reorganizations at Tufts Medical Center are putting patients at risk, and they cite more than 520 reports of “incidents that jeopardized patient care in the last year.”

Care is being dangerously compromised, they say, due to: “delays in nursing assessment, delays in the administration of medications and tests, nurses missing significant changes in patients’ health status…patients falling due to lack of assistance with getting up and moving around and patients being left in soiled beds for hours at a time.”

Officials at the medical center deny the charges and say the statements are a “union tactic” for contract negotiations.

The 1,200 RNs at Tufts are currently negotiating a new contract, and seeking “safe staffing levels, and prohibitions against forced overtime and the inappropriate floating of nurses.” Today they are holding a candlelight vigil to protest the staffing levels.

Barbara Tiller, a nurse at Tufts Medical Center for 21 years, said that due to several factors — including the center’s new care delivery model and cost-savings plan, and the fact that the nursing ranks have dwindled — patient care has suffered. “The upshot is fewer nurses caring for more patients,” Tiller said in an interview. “Patients are laying in their beds hoping someone will care for them and there are fewer and fewer of us to do that. Medications are late, tubes don’t get changed, people are laying in wet beds.”

In a letter last May to the medical center’s Board of Trustees, nurses cited several examples of unsafe practices that led to bad patient care. The medical center says these allegations have been investigated and are all “baseless.”

The reduced nursing staff and other changes means that providers are caring for more patients and that the hospital has gone from “being one of the best staffed hospitals in Boston to the worst staffed hospital in the city,” according to a press release put out by the state nurses association. “To compensate for chronic understaffing, TMC is using mandatory overtime, and is forcing nurses to “float” from one area of the hospital to another where they might not be competent to provide appropriate care.”

Pass Protection For Patients

Pediatrician Carolyn Roy-Bornstein worries about critical patient info getting lost between shifts

Dr. Carolyn Roy-Bornstein is a Haverhill-based pediatrician who writes about health care. Here, she considers the hazards of the “patient pass-off” — when patients are handed from one resident to another at the end of a shift, and critical medical information can fall through the cracks:

For anyone who has followed the New England Patriots and their beloved quarterback Tom Brady all these years, the disastrous 28-21 trouncing by the New York Jets in the recent play-off game was a real stab in the heart. The Jets managed to sack our QB five times last Sunday, despite the Patriots’ history of pitch-perfect pass protection.

While drowning my sorrows in a bucket of Buffalo chicken wings and ruminating on this concept of “pass protection,” I started thinking about another kind of “pass-off.” That is: the “patient pass-off,” also called sign-out. Patient sign-out occurs in teaching hospitals when one resident’s shift ends and another begins. Interns try to convey crucial information about a patient’s care: what is happening with the patient, what needs to be followed up on. When I was a resident sign-out happened just once a day: when the end of one 24-hour-on resident’s shift collided with next’s. But with recent changes in residency duty hours, information sign-out between residents has become more frequent.

In 2003, the Accreditation Council for Graduate Medical Education restricted residents’ working hours in response to concerns about resident sleep deprivation and its effect on patient safety. In 2008 the Institution of Medicine curtailed resident work hours even further. With this restriction, the number of patient hand-offs increased. Continue reading

Judge’s Surgery Screwup Turns Him Into An Activist

A sponge left behind after surgery triggered a judge's transformation into a patient safety advocate

There’s nothing like a personal brush with illness to radicalize a patient, or turn a passive observer into an political activist. (Think of Nancy Reagan pleading for embryonic stem cell research.)

So here’s a Florida judge, Nelson Bailey, who had a sponge left inside him after surgery, and is now a newfound convert for patient safety.

The Palm Beach Post reports:

After abdominal surgery at Good Samaritan Medical Center for diverticulitis, the pain in the judge’s belly only got worse. Repeatedly, he says, he returned to his primary doctor and complained. Repeatedly, he was sent for CT scans. And repeatedly, the metal marker on the sponge appearing in the scans was misidentified.

For five months, the surgical sponge festered near Bailey’s intestines. The pus- and bile-stained mass measured more than a foot long and a foot wide when finally removed and unwound in March.

Now that Judge Bailey has recovered (or at least partially recovered — part of his intestine rotted and had to be removed, so he can no longer engage in his favorite activity, horseback trail riding) he has a few demands. He wants equipment available in the OR that beeps when a sponge or other medical equipment is left inside a patient. And he wants to eliminate all caps on damages in medical malpractice lawsuits.

Daily Rounds: Lyme On The Rise; Why We Cry; Tubes Misused

Summer’s nearly over, you’re back from the Cape vacation and you probably thought your nightly ritual of full-body tick examinations could stop. Think again. The Boston Globe’s Stephen Smith reports that Lyme disease is on the rise — in non-beachy places like Framingham and Natick, communities that rarely had to contend with the tick-born disease.

NPR analyzes the evolutionary underpinnings of crying and reports that natural selection likely favored babies who wailed loudest — an efficient way to get what you want. (The piece also explores the related concept of ‘theory of mind,’ understanding another person’s emotional state. For more on this, see the work of of MIT’s Rebecca Saxe, who has done groundbreaking research on the part of the brain that governs this phenomenon.)

And if you missed it, read Gardiner Harris’ hard-hitting story in The New York Times on mixed-up medical tubes inadvertently killing or hurting patients — all due to lax federal oversight and resistance from the medical device industry.