Posts Tagged 33026

Needlestick Safety And Prevention Act ::: Frequently Asked Questions

Saturday, December 3rd, 2011 | Permalink

What is the Needlestick Safety and Prevention Act? The Needlestick Safety and Prevention Act (the Act) (Pub. L. 106-430) was signed into law on November 6, 2000. Because occupational exposure to bloodborne pathogens from accidental sharps injuries in healthcare and other occupational settings continues to be a serious problem, Congress felt that a modification to OSHA’s Bloodborne Pathogens Standard was appropriate (29 CFR 1910.1030) to set forth in greater detail (and make more specific) OSHA’s requirement for employers to identify, evaluate, and implement safer medical devices. The Act also mandated additional requirements for maintaining a sharps injury log and for the involvement of non-managerial healthcare workers in evaluating and choosing devices. How does the “Needlestick Act” apply to OSHA’s Bloodborne Pathogens Standard? The Act directed OSHA to revise its Bloodborne Pathogens Standard (29 CFR 1910.1030). OSHA published the revised standard in the Federal Register on January 18, 2001; it took effect on April 18, 2001. The agency implemented a 90-day outreach and education effort for both OSHA staff and the regulated public before beginning enforcement of the new requirements. Accordingly, OSHA will not enforce the new provisions of the standard (requiring employers to maintain a sharps injury log and to involve non-managerial employees in selecting safer needle devices) until July 17, 2001. (The requirement to implement the use of engineering controls, which includes safer medical devices, has been in effect since 1992). How does the revision affect states that operate their own federally-approved occupational safety and health programs? States and territories that operate their own OSHA-approved state programs must adopt the revisions to the bloodborne pathogens standard, or adopt a more stringent amendment to their existing standard, by Oct. 18, 2001. (NOTE: The original adoption date for state plan states was July 18, 2001 (or six months from the date the standard was published in the Federal Register). However, an additional three months was added which coincides with the Federal 90-day education campaign). http://www.osha.gov

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Needlestick Safety And Prevention Act ::: Frequently Asked Questions

No more tragedies: an introduction to ISO 80369

Thursday, November 24th, 2011 | Permalink

No more tragedies: an introduction to ISO 80369 by Laura Dowling   A hospital patient should never be injured, or worse, because a hospital employee accidentally connects a small tube carrying medicine or nutrients to the wrong tube outside the patient’s body. That’s what happened to Robin Rogers in 2006. According to the New York Times, a hospital nurse caring for Rogers during her final weeks of pregnancy inadvertently connected a feeding tube with liquid nutrients to an IV in Rogers’ arm. The Times noted, “Putting such food directly into the bloodstream is like pouring concrete down a drain.” She died shortly after. Today, a new industry-wide standard defined as ISO 80369 is under development to help eliminate these heartbreaking tragedies. Once completed in the coming years, the international ISO 80369 standard will provide strict guidelines for manufacturers to produce non-interchangeable connectors that only can be used between devices intended for the same clinical application. As the Times noted, the non-interchangeable connectors will be made incompatible “just as different nozzles at gas stations prevent drivers from using the wrong fuel.” The products at the core of ISO 80369 are small-bore luer connectors (less than 8.5 mm in diameter) that hospital personnel use to link, for example, a medicine bag to an IV. The male and female components of luer connectors join together to create secure, yet detachable, leak-proof connections. Multiple connections between medical devices and tubing are common in patient care. Although tiny, these inexpensive connectors play an extremely critical role in any medical device. ISO 80369 is a package consisting of seven sections of standards. The first section, titled “General Requirements” is the initial governing document that was finalized in April this year. Six additional sections–each meticulously focusing on tube connectors for a specific clinical application and market–must be in place in the coming years.    

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No more tragedies: an introduction to ISO 80369