Thursday, June 28, 2012
Supreme Court allows healthcare law to largely stand
Monday, June 11, 2012
Will pay-for-performance work for infection prevention?
The pay-for-performance (P4P) movement in the U.S. healthcare system is not new, but the Patient Protection and Affordable Care Act (PPACA) has the potential to usher in the largest federal expansion of P4P to date. A provision of PPACA mandates pilot testing of P4P for certain Medicare providers, beginning no later than January 1, 2016. Even if legal and political challenges result in the repeal of PPACA, momentum for P4P continues as insurance companies and healthcare systems strive to improve health outcomes and reduce costs.
Pros and Cons
Proponents of P4P focus on the logic behind providing incentives to healthcare organizations and providers to meet measurable process improvements or clinical outcomes, such as better management of chronic diseases or reducing infection rates. At first glance, these P4P objectives seem reasonable and desirable in terms of improving clinical outcomes. But detractors of P4P cite a number of problems, including the assumption that financial incentives (or disincentives tied to poor performance) will affect important clinical outcomes associated with morbidity and mortality. (See “Effect Of Pay For Performance On The Management And Outcomes Of Hypertension In The United Kingdom: Interrupted Time Series Study.”) A study published online in New England Journal of Medicine (March 28, 2012) found that hospitals participating in the Medicare Premier Hospital Quality Incentive Demonstration (HQID) had no decrease in 30-day mortality compared to control hospitals over a six-year period. The authors noted that P4P effects on mortality did not differ significantly among conditions for which outcomes were explicitly linked to incentives (i.e., acute myocardial infarction and CABG) and those not linked to incentives (i.e., congestive heart failure and pneumonia). (See “The Long-Term Effect of Premier Pay for Performance on Patient Outcomes.”) As expected, a quick scan of the medical literature shows an evolution from primarily positive articles in the early and mid-2000s, when P4P was a broad goal yet to be widely implemented, to more recent restrained views of actual P4P program outcomes.
Read the full story.
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Crosby’s work in CareFusion’s Medical Affairs Department represents the perfect culmination of a career that has always focused on combining education with research to improve patient care. From her start working in a bone marrow transplant unit at a university medical center to her recent honorary appointment as a research associate in infectious disease in the Department of Microbiology at Queen Elizabeth Hospital in the UK, Crosby’s primary focus has been the clinical application of infection control products to improve patient health outcomes. But Cindi has also always understood the importance of building networks to share information and solve problems. Her education and background as a microbiologist has helped her assemble effective global partnerships with key thought leaders in infection prevention, and she has built on this further by publishing and speaking to share information with those who care for patients.
If you wish to read more of Dr. Crosby’s blogs, then please visit: http://www.carefusion.com/safety-clinical-excellence/perspectives/infection_prevention.aspx.
Thursday, April 26, 2012
SPD Professionals launch new blog: “Reprocess This!”
Thursday, April 12, 2012
Is the FDA validation process for sterilizers, as established in AAMI ST8, current with today's steam sterilization practices?
In his article, Moore examines the performance and validation standards set forth in Hospital Steam Sterilizer guidance document ANSI/AAMI ST8, and asks whether these test requirements are sufficiently robust, given today's mixed loads.
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“If you happened to manage a company that manufactures sterilizers for use in US healthcare, what steps would you take to sell a steam sterilizer in the United States? The first step is to recognize that sterilizers are used to process reusable medical devices for patient use, and sterilizers are considered as Class II medical devices. Therefore, they are regulated by the Food and Drug Administration (FDA). Before any Class II device can be placed into commercial distribution, the FDA must grant clearance of the labeling claims for the sterilizer. Many of those labeling claims are developed through a process called performance validation. Fortunately, a guidance document exists to help the sterilizer manufacturer develop performance data to base those labeling claims. Once the FDA clears the sterilizer for US commercial distribution, the product is considered safe and effective when the user follows the written instructions for use (IFU).
The guidance document for healthcare sterilizers is a nationally recognized standard, developed through the consensus method at the Association of the Advancement of Medical Instrumentation (AAMI). The document is ANSI/AAMI ST8, the Hospital Steam Sterilizer guidance document. The ST8 committee updates the document every five years. The current ST8 document was published in 2008. Yet, does the performance and validation testing contained in ST8 reflect current healthcare sterilization practices? This article will attempt to review those performance challenges and compare them to practices found today in US healthcare facilities, both large and small.”
To read the entire article, visit
http://www.hpnonline.com/dailyupdates/Moore-SterilizationValidation.pdf
What's your reaction? We want to hear from you. Let us know your thoughts below.
Tuesday, April 10, 2012
Keeping trains and interoperability on track
Friday, March 16, 2012
Senators introduce bipartisan effort to make medical devices safer
Oregon's Senator Jeff Merkley, with Senators Chuck Grassley (R-IA), Michael Bennet (D-CO) and Herb Kohl (D-WI), introduced the bipartisan Ensuring Safe Medical Devices for Patients Act. The bill would give the Food and Drug Administration the tools it needs to improve oversight of medical devices. Defective medical devices have been associated with thousands of deaths in recent years.
"As the Senate Special Committee on Aging heard first-hand last year, faulty medical devices, especially those implanted in the body, can have a disastrous impact on the health of those who use them," Kohl said. "Innovative technology has provided valuable, life-saving medical devices that have prolonged life and reduced suffering, but the drive toward getting new technologies to market shouldn't be done at the risk of patient safety. This legislation will help achieve that needed and delicate balance between safety and innovation."
Safety problems and recalls of certain medical devices, including metal-on-metal hips, surgical mesh, and implantable programmable infusion pumps have called into question whether the FDA and its Center for Devices and Radiologic Health (CDRH) have the tools needed to protect patients and keep harmful devices off the market. An average of 700 different medical devices has been recalled every year since 2005. Harmful or defective devices were associated with the death of almost 5,000 Americans in 2009 alone.
The legislation builds on two important, bipartisan initiatives to improve the oversight of medical devices:
- Requires FDA to issue a final Unique Device Identifier (UDI) rule by the end of 2012, requiring implantable devices to carry a unique numerical identifier so products can be tracked through the distribution chain and once they are being used with patients. The UDI program was created nearly five years ago but FDA has not implemented it.
- Adds medical devices to the Sentinel post-marketing surveillance initiative, launched in 2008. Sentinel is a national, integrated, electronic system which currently monitors prescription drug safety after FDA approval, once the drugs are being marketed to patients.
The bill has been endorsed by Consumers Union, National Women's Health Network, National Research Center for Women and Families, Health Care Supply Chain Association, the Premier Healthcare Alliance, Association of American Medical Colleges, Alliance for Advancing Nonprofit Health Care, National Association For Continence, MedicAlert Foundation, Public Citizen, and Union of Concerned Scientists. Visit the Senator Kohl’s newsroom for the article.
"Show me the money"
“A curious thing is happening. As the healthcare conversation moved front and center over the last several years, a correlation developed linking cost and quality. Politicians and providers,payors and patients have embraced these complementary themes as the “one-two punch” that will win the fight to keep our healthcare system safe, solvent and sustainable. As far as punches go, it sounds almost painless: Make the system better and safer, and the savings will follow. Who would argue with that logic?
Now it seems that some prominent voices have started to pivot the conversation toward the need for greater cost control, suggesting that quality and safety efforts alone may not deliver the necessary savings. Recently, three opinion pieces appeared in the New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA) that call into question some basic assumptions about the economics of our health care system. Another article, published in Healthcare Finance News, added a new sense of urgency to this pivot in opinion.”
Visit here to read the blog.
Tuesday, February 28, 2012
A decade of “smart” infusion pumps
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In February, we recognized the 10-year anniversary of “smart” infusion pumps – infusion devices with Dose Error Reduction Software (DERS).
I have often been asked why it took so long for manufactures to add “guardrails” into infusion pumps. The short answer is that until it was possible for hospitals to create in their pumps custom drug libraries and best practice drug limits, the idea of adding safety alerts was only a dream. Each time we heard about a death or injury due to an incorrectly programmed pump, we could only hope that caregivers would be more careful in the future. This was of little comfort knowing how easy it was to make a mistake and how vulnerable nurses were without a safety net.
The technological breakthrough was the flash EPROM – basically, a chip that could be programmed with a hospital-specific drug library. Because drugs may be used off-label and IV practices are often not standardized, infusion pump manufacturers began to market “dumb” pumps that hospitals could make “smart.” Thinking back to the first Alaris® smart pumps, it’s amazing that even the initially limited capabilities had such a game-changing impact on our industry. Suddenly, we were in the software business and working feverishly to expand pump safety features to meet the demands of early adopters. We helped hospitals interpret data collected from the near misses and good catches, and we worked with customers and thought leaders to reduce practice and library variation, fine tune drug limits and interpret what Dr. David Bates called the new “treasure trove” of infusion data that was stored in each pump.
Studies have shown the typical adoption cycle for new technology in hospitals averages 20-years and could be even longer in some cases. The adoption of smart IV pumps, however, is almost 70% after only 10 years. One fact that has accelerated smart pump adoption is analogous to air bags in automobiles –the safety features now come standard. And, the “good catches” that pump logs document are evidence that pumps with DERS have prevented many potentially serious and possibly fatal errors.
Over the past 10 years, we have made tremendous progress in creating a safety net for drug administration. Looking ahead, the focus will be on making infusion pumps part of a much larger medication ecosystem, where pumps inherently administer accurate doses, expanding guardrails to patient – not drug – specific capabilities.
Find out more at CareFusion’s Online Center for Safety.
Monday, February 20, 2012
From Trash to Technology: A better way to document supplies at the point of care
Later today, I will climb on the plane and fly to Las Vegas to join 20 to 30 thousand of my colleagues in healthcare IT for the 2012 HIMSS Annual Conference and Exhibition. Sadly, once again this year, the role of the supply chain in meeting some of our most critical clinical and financial challenges in healthcare reform is absent from the agenda - with one notable exception. An impressive group of experts – from medicine and technology (including EMRs, clinical documentation, RFID, and system integration) will meet Wednesday afternoon at HIMSS to discuss the problems associated with inaccurate and incomplete clinical supply documentation at the point of use.
Research has shown that manual, duplicative and disjointed processes in the OR and other procedural suites result in more than $5 billion in waste each year in the US alone. To illustrate the point – while most likely the exception – a colleague recently told me about an OR where supply documentation consists of throwing packaging from supplies...
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