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More oversight needed on gear and techniques |
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Though even well-intentioned practitioners try to provide patients with careful, thoughtful, and thorough information about prospective procedures they will undergo, at least two major aspects of surgery remain challenging, at best, for regular folks to wrap their minds around — how doctors actually perform operations and the gear they rely on when they do them. It is all too human for surgical techniques and medical apparatus to remain, even in the 21st century, part of doctors’ “secret sauce.” These two elements, history has shown, can make and break practitioners’ reputations — and help determine their compensation. Critics say that state and federal regulators, as well as medical scientists, need to step up and debunk much of the hype — and even patient peril — associated with these components of operations. But surgeons insist they should be less questioned than applauded for how they improve patient outcomes and allow for medical advances. Women, alas, have borne the undue burden of surgeons’ “innovations” in techniques and with gear. It was just a relative blink ago, for example, that surgeons were gung-ho to sell patients — mostly women — on seeing dramatic weight loss through “lap-band” procedures. The laparoscopic operations were widely promoted by some surgeons for their ease, convenience, and reversibility. But they quietly have fallen out of favor only after hard experience showed they were far less effective than other weight-loss operations — and they too often led to serious complications, including multiple, repeat follow-up surgeries. Even as doctors quietly shelved lap-band procedures, other surgeons were forced all too slowly by negative outcomes to abandon what they viewed as promising, minimally invasive procedures to attack cervical cancer. Surgeons advanced the technique, with small slits in the abdomen instead of a large incision, in the belief that it was safe and would help patients recover faster. But research over time showed instead that the minimally invasive approach led to greater cancer recurrence and death. Surgeons largely shut down their use of another minimally invasive approach, along with a much-touted medical device, in procedures involving women’s reproductive organs. Instead of opening patients’ abdomens and cutting out tissues, surgeons relied on “keyhole” procedures and a device called a morcellator to grind up and vacuum them out. As the Wall Street Journal reported, this surgical “innovation” later was suspected of not only leaving microscopic, diseased tissue behind but also dispersing it widely and causing cancer to spread. The New York Times reported this about the absence of oversight on novel surgical techniques: “Surgery is not regulated the way drugs are. Although the Food and Drug Administration must approve new surgical devices, it does not control the way they are used. A tool approved for one purpose can be used for another. Surgeons can try new approaches, and innovations can catch on and spread, as long as hospitals allow it. Some innovations have backfired. “ While the FDA is supposed to oversee medical devices, critics say the agency has bungled its responsibilities. It has allowed a “Wild West” atmosphere to flourish, putting patients at great risk and allowing manufacturers and doctors to profiteer. At least 32 million Americans (1 in 10 of us) have at least one medical device implanted in us, items including artificial joints, cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices, according to one expert estimate. With billions of dollars at stake in such gear, scandals have erupted over surgeons’ use of everything from nuts, bolts, and screws to faulty cardiac pumps to million-dollar robotic assistants. We all pay added health care costs, of course, because surgeons insist on their individual techniques and choices for materials used in procedures. As part of informed consent, patients should insist that their doctors be as clear and persuasive as possible about these vital components of operations. This might include asking if rigorous clinical trials have been conducted to demonstrate the benefits of an approach or device. (Hint: These aren’t often run, and if material is available it may be provided by a device maker, hospital, or other party with financial interests and potential conflicts.) |
Patients’ diligence a must with booming surgery centers
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With hospital costs ever soaring, millions of patients increasingly may find that their surgeries won’t be performed in the big, shiny buildings that cost hundreds of millions to construct on sprawling, distant campuses. Instead, they may find themselves going around the corner to free-standing, specialized facilities for their operations. Caveat emptor, experts say, about so-called ambulatory surgical centers. The USA Today network and the Kaiser Health News service investigated these facilities recently, digging into patients’ nightmares with surgical centers, not only those performing “routine” procedures but also those handling increasingly longer, more complex, and difficult operations. The surgeries, once the province only of big and well-staffed hospitals, put patients at risk, the news organizations reported: “[Our] investigation found that surgery centers operate under such an uneven mix of rules across U.S. states that fatalities or serious injuries can result in no warning to government officials, much less to potential patients. The gaps in oversight enable centers hit with federal regulators’ toughest sanctions to keep operating, according to interviews, a review of hundreds of pages of court filings and government records obtained under open records laws. No rule stops a doctor exiled by a hospital for misconduct from opening a surgery center down the street.” USA Today and Kaiser collected information on deaths and patient harms that have occurred in some of the 5,600 free-standing, specialized surgical centers nationwide. Such centers have burgeoned because they can be nimbler than the hospitals and academic medical centers they now outnumber. The centers can be set up without hospitals’ high overhead costs, including for staff and equipment that may be unnecessary for a specialty practice. The facilities also can be set up closer to patients, theoretically offering them greater access and convenience, with easy navigation and parking. But regulators have been slow to adapt, leaving critical oversight to organizations that are retained by doctors and the centers themselves to certify crucial safety and quality measures. The federal Agency for Healthcare Research and Quality has sought to partner voluntarily with centers across the country to improve patient safety and the quality of care, with an effort to get staff to use evidence-driven procedure checklists and with a program to boost training and standards. The Leapfrog Group — which describes itself as a “national health care nonprofit driven by employers and other purchasers of health care” and which issues hospital ratings — expanded its institutional scrutiny, starting four years ago, to surgical centers. Patients can examine the group’s criteria and ratings for centers that voluntarily report key data to the group (hospitals have criticized the Leapfrog letter grades and its methodology for assessing them). While it is true that many of the surgical centers specialize in one-day procedures with supposedly fewer risks — endoscopy, colonoscopy, and plastic surgery — no operation is risk-free. Patients should know about the credentials and experience of not only their surgeon but also the anesthesiologist and surgical staff (nurses and other surgical assistants). They also should know what contingencies facilities have if complications arise and more expertise and emergency resources are required — for example, how often are patients transferred to a major hospital and is one nearby. Patients also must drill down with their surgeons about the recovery and follow-up processes for them after undergoing an operation in a surgical center. Patients, alas, have become accustomed to, even adept at, researching where they get their health care as increasing attention has focused on hospitals’ safety and quality. The federal government — along with groups like Leapfrog and U.S. News and World Report provides star ratings of hospitals based on more extensive and detailed criteria. |
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