Medical device users can take steps to prevent or reduce medical
device risks to patients and healthcare workers. A particular
focus in medical device safety is the attention paid to infusion
pumps.
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).
