80369-7 “Luer” connectors: IV and hypodermic applications
The January 2016 California deadline applies to IV applications, enteral feeding and epidural uses. The -3, -6 and -7 standards are relevant to this deadline. CHPSO is a US clinical representative on the ISO committee workgroups and is heavily involved in industry and distributor planning for the roll-out of these new safer connectors.
With nearly 100,000 health related apps available at the fingertips of smartphone or tablet users, consumers can capture their vitals without having to step into a hospital. Mobile health, or mHealth, involves using these smartphones or tablets for a medical purpose. Software applications, or apps, can provide diabetes management, track sleeping habits, and screen for depression.
Eight-month old Maddie Sims was ejected from a car and transported by EMS to the hospital. She was cyanotic on arrival. A team of Children’s Hospital Los Angeles (CHLA) techs, nurses and physicians packed around Maddie’s bedside.
In an era dependent on technology to make our lives easier, patients continue to suffer from severe complications with medical devices. While the FDA monitors problems associated with medical devices, some devices require thoughtful design and sufficient research before the devices are rushed to market. As part of the research, such devices require a close look at how they work within a system. Some devices receive the proper research1 after it is made publicly available, when end-users unintentionally go through a trial-and-error phase.
California law requires hospitals to report certain events to the Department of Public Health, which may issue administrative penalties in certain cases. The California Hospital Association maintains a database of those reports that elicited a penalty. CHA members can access the database at www.calhospital.org/ij-catalog/reports.
The Institute of Medicine (IOM) released a study of the 510(k) clearance process for medical devices.Their answer to the question: “Does the 510(k) clearance process provide a reasonable assurance of safety and effectiveness?” was: “The 510(k) clearance process is not intended to evaluate the safety and effectiveness of medical devices with some exceptions.The 510(k) process cannot be transformed into a premarket evaluation of safety and effectiveness as long as the standard for clearance is substantial equivalence to any previously cleared device.” As one of the committee members at the IO
The April 2010 CHPSO Patient Safety News discussed the risks of using standard Luer fittings for non-intravenous uses. Inappropriate connections can occur, such as intrathecal injection of an intravenous medication (e.g., vincristine). Developing non-interoperable connectors, so that connectors for fundamentally different uses cannot connect with each other, will prevent most of these incidents.
FDA monitors reports of adverse events and other problems with medical devices and alerts health professionals and the public when needed to ensure proper use of devices and the health and safety of patients. Recent medical device recalls and other FDA safety communications can be found on the Medical Device Safety section of the FDA website.
Luer connectors were invented in the late 1890s to provide leak-free connections between glass hypodermic syringes and needles, while allowing easy fitting and removal by pushing together and pulling apart (“Luer slip”). Several years later, a variant was made with threads so that the connectors would be screwed together and secured (“Luer-lock”).
Initial reports suggest that, as medical devices become more complex, the risk of infection and intra-operative problems rise. Preliminary reports from member hospitals raise the possibility of increased infection risk with the use of complex medical equipment (e.g., robotic surgery devices).