Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Wednesday, December 30, 2015

Harvard public health expert: Patient Safety Needs Federal Regulation

Like aviation, patient safety needs federal regulation

A new federal agency should be established to oversee patient safety at healthcare facilities to reduce medical errors, Lucian Leape, adjunct professor of health policy at Harvard T.H. Chan School of Public Health, said December 10, 2015 at a National Academy of Medicine symposium on advances and challenges in patient safety and healthcare quality.

“We really ought to have a federal patient safety agency like the Federal Aviation Administration (FAA)” that exists for airplane safety, Leape said in his remarks, according to a December 11, 2015 MedPage Today article. “That’s what we need and we should have said that [in the report], and I’ll say it right now,” said Leape, a member of the committee that created the report. “The thing the FAA does is that it sets standards, enforces standards, and works with industry and makes sure the standards are the right ones and that people are all on board.”
Now, he said, “The only people who pay for medical mistakes are patients. There have to be consequences for the failure to do what we know is the right thing to do. We’ve spent 15 years relying on goodwill and persuasion, but there needs to be an element of discipline.”
http://www.medpagetoday.com/PublicHealthPolicy/HealthPolicy/55192
http://www.hsph.harvard.edu/news/hsph-in-the-news/like-aviation-patient-safety-needs-federal-regulation/?utm_source=Twitter&utm_medium=Social&utm_campaign=Chan-Twitter-General
Expert: More Oversight Needed for Health Facility Safety
Lucian Leape, MD, calls for an 'FAA-like' federal agency
by Joyce Frieden  News Editor, MedPage Today 
WASHINGTON -- The federal government should create a new agency to oversee basic practices at healthcare facilities and cut down on the rate of medical errors, according to Lucian Leape, MD, adjunct professor of health policy emeritus at Harvard School of Public Health, in Boston.
"We really ought to have a federal patient safety agency like the Federal Aviation Administration (FAA)" exists for airplane safety, Leape said Thursday at an event here commemorating the 1999 release of the National Academy of Medicine's landmark report on medical errors, "To Err is Human."

"That's what we need and we should have said that [in the report], and I'll say it right now," said Leape, who served on the committee that developed the report.
"The thing the FAA does is that it sets standards, enforces standards, and works with industry and makes sure the standards are the right ones and that people are all on board," he told MedPage Today.
Leape acknowledged that human beings are more complicated than airplanes, but he added that right now, "The only people who pay for medical mistakes are patients. There have to be consequences for the failure to do what we know is the right thing to do." Examples of the types of standards the agency would enforce include 100% handwashing, flu vaccines for all employees, and no central line infections, Leape said, adding that this would not involve questioning a physician's judgment regarding a specific patient.
Although "carrots," or positive incentives, would be the preferred way to get health facilities to do the right thing, Leape acknowledged that "sticks" might be needed too. "We've spent 15 years relying on goodwill and persuasion, but there needs to be an element of discipline," he said.
Other speakers at the event, which also celebrated the 2001 release of "Crossing the Quality Chasm: A New Health System for the 21st Century," included Dan Ariely, PhD, a professor of psychology and behavioral economics at Duke University in Durham, N.C. Ariely discussed ways to help patients comply more easily with their treatment regimens.

The basic idea, Ariely explained, is that people are more interested in the short term than in the long term, so providers can use that knowledge to motivate people in the short term to do something that will be good for them in the long term. For example, Ariely said, when he was diagnosed with hepatitis C and had to give himself a shot of interferon three times a week as part of a clinical trial, he dreaded doing it because the side effects were extremely unpleasant.
However, he knew that taking the interferon could cure the disease and prevent the need for a liver transplant down the road, so he rewarded himself immediately after each shot with watching a video that he was really looking forward to. "A year and a half later, I was free of hepatitis C. My physician told me I was the only patient in the protocol that took the medication on time," he said.
Another strategy to help with compliance involves "loss aversion" -- the idea that people hate to lose money or something else they value more than they enjoy gaining something, Ariely continued.
In one experiment, "We gave people $3 a day to take their medication on time. What happened? Absolutely nothing," he said. "What if we took away $3 every time they didn't take their medications on time? The [institutional review board] wouldn't let us do that ... but what they allowed us to do is pre-pay people as if they took the medication for 3 months in advance ... and then take the money back, and that worked better."
During a question-and-answer session, Ariely was asked how motivational techniques could be used to help physicians and other providers comply with rules like handwashing. "I don't think it's about small punishments or rewards. These things we need to treat very differently ... they need to be either habitual or ritualistic," he said.

For instance, "Very few physicians don't wash their hands when they go to the OR. But the OR has a tremendous ritualistic element -- the surgeons stand there, people dress them -- there's a whole ceremony around it that's incredibly addictive."
As with the rituals surrounding religion, "It's not just about the action, but providing a higher-order meaning," he said. "A lot of things in medicine should look like that, but if you have 12-minute appointments and lots of paperwork to fill out, it's a little harder to feel a connection to a higher-order meaning."
Audience members also heard from experts in other industries whose structures might also apply to healthcare. For instance, Conrad Grant, head of the air and missile defense department at Johns Hopkins University Applied Physics, Laboratory, in Laurel, Md., compared hospital intensive care units (ICUs) to defensive weapons systems.
"In the ICU [unlike a weapons system], many systems have been designed for individual purposes, and have not been integrated into a coordinated set of systems," he said. "In certain situations, [these systems] may even be working at cross purposes if they are not correctly configured. There are so many straightforward improvements we could make today with an immediate reduction in preventable harm."
Grant gave one example in response to a question about "alarm fatigue" ICU nurses get from having device alarms -- many of them false -- constantly going off. "In weapons systems we also have alarms ... that go off with threats that present themselves or when the conditions of the ship aren't what we want them to be."

"We have carefully tried to engineer that so they're not so repetitive and constant that they become overwhelming," he said. "Part of the way to eliminate alarms is to cross-correlate systems that trigger the alarm ... if you couple it with second sensors that would recognize the same set of conditions and look to see if both of them are showing that same condition before you trigger the alarm, you have some verification."

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