This appeared a little while ago.
ECRI Cautions Hospitals About Tech Hype
Cheryl Clark, for HealthLeaders Media , February 12, 2014
Independent research from the non-profit ECRI Institute aims to distinguish between must-have hospital technologies and manufacturer hype.
A device that allows untrained nurses to sedate colonoscopy patients without an anesthesiologist, hospital gowns woven with infection-fighting copper, and oral drugs embedded with sensors are among the emerging technologies senior executives may be pressured to bring into their hospitals and healthcare systems.
But the 2014 edition of the ECRI Institute's annual "Top 10 Hospital C-Suite Watch List" aims to distinguish between must-have technologies and hype.
The Pennsylvania-based non-profit group conducts independent research to verify manufacturers' claims, regulatory compliance, and any emerging safety or efficacy issues associated with emerging technologies, especially those that cost a lot of money.
"These technologies are worthwhile to look at, but hospitals need to think about how they [would have to] make necessary changes to implement them," says Robert Maliff, ECRI's director of applied solutions.
1. Sedasys Computer-Assisted Sedation System
Approved by the U.S. Food and Drug Administration in 2013, the Sedasys system from Ethicon Endo-Surgery, Inc. purports to allow "non-anesthesiologist clinicians" to replace more expensive nurse anesthetists and anesthesiologists in administering sedation, specifically propofol, for millions of endoscopic procedures such as colonoscopy.
Approved by the U.S. Food and Drug Administration in 2013, the Sedasys system from Ethicon Endo-Surgery, Inc. purports to allow "non-anesthesiologist clinicians" to replace more expensive nurse anesthetists and anesthesiologists in administering sedation, specifically propofol, for millions of endoscopic procedures such as colonoscopy.
This could save the healthcare system $160 million in 2015, the manufacturer says.
Evidence of efficacy, however, is based on a single manufacturer-sponsored trial of 1,000 patients during routine procedures, which showed that many patients were deeply sedated, which "may elevate the risk of cardiopulmonary complications such as interrupted breathing."
"Concerns remain about procedure risks," the ECRI report says.
2. Symplicity Catheter-based Renal Denervation Device for Hypertension
In use only in Europe, but expected in the U.S. next year, Medtronic, Inc.'s device called Symplicity would treat hypertension and sleep apnea, which are associated with high morbidity and mortality.
In use only in Europe, but expected in the U.S. next year, Medtronic, Inc.'s device called Symplicity would treat hypertension and sleep apnea, which are associated with high morbidity and mortality.
ECRI recently updated its report to note Medtronic's announcement that an efficacy endpoint was not reached in a "pivotal trial" of the device, a major snag in its approval process.
Some 48% of hypertensive patients whose conditions are inadequately controlled through medication would be a candidates for treatment with Symplicity. It involves the use of a catheter to disrupt a signaling pathway from the kidneys to the central nervous system that contribute to hypertension.
ECRI recently updated its report to note Medtronic's announcement that an efficacy endpoint was not reached in a "pivotal trial" of the device, a major snag in the approval process. The company plans to continue trials of its product for other non-hypertension clinical indications.
Read about another 8 in the article found here:
All I can say is that all these are a testament to inventiveness but maybe not such a good advertisement for applied common sense.
Read through and see which you would be keen on.
David.
1 comment:
ECRI also did the Deep Dive study of health IT risk and found that in 36 member PSO hospitals, in 9 weeks, there were 171 IT-related mishaps capable of causing harms; 8 known harms, some serious, and 3 possible deaths. Thses were voluntary reports (http://hcrenewal.blogspot.com/2013/02/peering-underneath-icebergs-water-level.html)
The medical malpractice company for the Harvard medical community also just released concerning numbers. CRICO recently analyzed a year’s worth of medical malpractice claims from 2012 in its comparative database and found 147 cases in which EHRs were a contributing factor. Computer systems that don’t “talk” to each other, test results that aren’t routed properly, and mistakes caused by faulty data entry or copying and pasting were among the EHR-related problems found in the claims, which represented U.S. $61 million in direct payments and legal expenses.
That figure, from just one of Massachusetts' insurers, represents a significant # of the total medical malpractice suits filed in the state in one year, which in turn due to the economics of the activity in turn reflect a small % of actual situations of malpractice. (http://hcrenewal.blogspot.com/2014/02/patient-safety-quality-healthcare.html)
These numbers and their extrapolations should raise some alarm bells.
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