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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Sunday, May 27, 2012

Apologies must include Patient Harm/Transparency


 LINK

Investigating Untold Health Stories
By William Heisel  Reporting on Health
At its heart, the debate comes down to this: Should a doctor be able to say sorry to a patient who has been harmed and then avoid the repercussions of the error?
Doug Wojcieszak, the founder of the Sorry Works! program, makes a strong case for changing state and federal laws to encourage apologies and discourage protracted malpractice lawsuits.
A group of patient safety advocates led by Lisa McGiffert from Consumers Union's Safe Patient Project and Robert Oshel, the designer of the National Practitioner Data Bank's Public Use File, argue that the Sorry Works! plan would allow doctors to hide dangerous histories of medical errors and negligent behavior. They have presented a compelling counterargument.
On both sides of the discussion, there are basic assumptions that could be the basis for short-term or long-term projects. Here is the first – and perhaps biggest – question that could yield a fascinating answer. I'll look at more in my next post.
How many patients are harmed every year by medical errors? The patient advocates say:
Authoritative estimates of the number of malpractice deaths in the U.S. range from 100,000 to over 200,000 per year – the rough equivalent of a commercial airliner crashing every day. And the number of malpractice deaths is dwarfed by the number of people who are merely injured but not killed. Three respected studies in the past two years found that at least one in four hospital patients are harmed – that is almost nine million Americans each year.
As you might imagine, no federal government agency tracks deaths or injuries due to malpractice or medical error. (I make the distinction because the former has a legal weight and implies negligence.) The numbers above are estimates, and the range is wide.
That's one of the reasons so many reporters continue to cite the 1999 Institute of Medicine report "To Err Is Human," which said that "at least 44,000 people, and perhaps as many as 98,000 people, die in hospitals each year as a result of medical errors that could have been prevented, according to estimates from two major studies." Even if we take the lowest estimate and adjust roughly for population growth since 1999, that's a massive percentage of the annual number of deaths in the U.S. Consumers Union provided an update to the IOM report in 2009 with "To Err is Human –  To Delay is Deadly."
McGiffert wrote to me citing three studies, all done independently, that she says offer better estimates for the number of patients harmed by the health care system. Each report looked at all harm - not just serious harm and not just what sometimes is termed "preventable harm."
               The Office of Inspector General of the Department of Health and Human Services, also using IHI's global trigger tool, found that 27% of Medicare hospital patients had been harmed by medical error.
               Researchers using the Institute for Healthcare Improvement's "global trigger tool" found that 1 in 3 hospital patients had been harmed.
               And a New England Journal of Medicine study in just one state, North Carolina, which has been looked to as a model in prevention of medical errors, found that 1 in 4 patients had been harmed.
McGiffert wrote:
No one is refuting these studies - they are solid. Also, I have a beef with only talking about deaths when so many millions more are harmed.  We KNOW the IOM is wrong because the deaths from hospital acquired infections ALONE are close to 100,000. So, I think it is time to stop repeating those tired and worn out estimates.
I agree. So let's try to add to the evidence base and find out the true number of patients both killed and harmed. 

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