Although performing a root cause analysis (RCA) after an adverse
event has become standard practice in many health care
organizations, there is little evidence to support that this
process has improved patient safety.1 Organizational
culture plays a large part in the success of an RCA; there are
fundamental issues in the structure of the RCA process to address
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.
80369-2 connectors: breathing and driving gas applications
80369-5 connectors: limb-cuff inflation systems
The January 2016 California deadline applies to IV applications,
enteral feeding, and epidural uses. The first three of the above
standards are relevant to this deadline.
The Luer connector standards will tighten current specifications,
so that fewer connector problems (e.g., leaking junctions) will
be encountered in IV applications. Otherwise, the Luer standard
has not significantly changed, and end-users should not notice
In my last column, I discussed the critical role of leaders in
shaping organizational culture. Here we take the next step
and look at the requirements for achieving high reliability.
Given high rates of adverse events, process failures and patient
harm, the idea of achieving high reliability in healthcare may
seem absurd. Even so, many well-respected healthcare leaders have
sounded the clarion call to make this the primary goal.