Is the FDA validation process for sterilizers, as established in AAMI ST8, current with today's steam sterilization practices?

HPN's most recent Blogline post comes from Thomas K. "Chip" Moore, consultant and owner of the Sterilization-Answer-Man.com. Retired from Getinge in 2007 after a 39-year career in sales and marketing, Moore has more than 20 years experience working on AAMI Committees and is active on selected Working Groups, was a member of the AAMI Sterilization Standards Committee, and is a member of IAHCSMM and the AORN Specialty Assembly for Sterile Processing. He also served as an Ex-Officio Board member for NYSACSP for three years. He was recipient of the 2003 IAHCSMM Award of Honor and was selected by Healthcare Purchasing News as one of the 30 most influential industry people. 

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


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Keeping trains and interoperability on track

Dr. Dick Johannes, Vice President of Clinical Research at CareFusion, discusses trends in operating room procedures and management, at CareFusion’s Online Center for Safety. ___________________________________________________________________

“Recently, on our way to a morning meeting, Dr. Carlos Nunez and I got to talking about model railroads – a mutual interest and hobby. We recounted the history of Digital Command Control [DCC] – a system that utilizes digital computer technology to operate model railroad trains. DCC was first introduced in the 1990s and dramatically changed model railroad technology: For the first time, when running multiple locomotives on the same track, you could move each train in different directions and at different speeds.

Similar to most technological breakthroughs, numerous manufacturers began engineering their own early and highly proprietary versions of Command Control for model railroads. While this brought the technology to the marketplace, it introduced a new problem for users as these early approaches were incompatible with one another. We could now run trains independently on a model railroad, but couldn’t take a locomotive to a friend’s house with a different system and expect it to run.

Enter the National Model Railroad Association (NMRA) who assembled a working group to develop a common standard in model train technology. German firm Lenz Electronics gave – yes gave – their previously proprietary protocol to the NMRA to be adopted as a standard¹. Suddenly, in order to obtain the NMRA imprimatur, all manufacturers had to conform to single technical standard. Not only did the technology succeed but it literally exploded. It now supports amazing lighting effects, an array of advanced automation capabilities and even digital sound. Best of all, the technology is fully interoperable. Some firms chose not to adopt the common standard and eventually disappeared. But most of those who embraced the NMRA DCC standard continue to thrive today.

It was at this point in our discussion that Carlos asked, ‘Where is the NMRA for healthcare?’ Great question! Today, CMS is creating incentives for hospitals to adopt enhanced healthcare information technology (HIT), introducing new concepts and standards like ‘meaningful use.’ But what is the future for widespread interoperability in healthcare and what will that journey require?”

Visit here to read the full article.

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"

Dr.Carlos Nunez, Chief Medical Officer at CareFusion explores trends and issues facing the healthcare industry and in respiratory care practices at CareFusion’s Online Center for Safety. In his most recent post, Dr. Nunez discusses the need for greater cost control in healthcare.

“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.

A decade of “smart” infusion pumps

Dr. Tim Vanderveen, Vice President of the Center for Safety and Clinical Excellence for CareFusion, discusses trends in medication management at CareFusion’s Online Center for Safety. In his most recent post, Dr. Vanderveen, who has authored several patents in infusion technology and was one of the original creators of smart IV pumps – spotlights the 10-year anniversary of smart infusion pumps. He discusses how smart pumps have evolved and provides a glimpse into the future of medication safety.

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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.