CHPSO patient safety alert—Enteral lines and luer misconnections July 13, 2010
In the May edition of CHPSO Patient Safety News we discussed the
risks posed by using the same connector for differing purposes,
such as breathing gases, enteral feeding and neuraxial access.
Two recent publications highlight the seriousness of
misconnections involving enteral tubes.
By 2013, California will require mutually incompatible connectors
for intravenous and enteral feeding lines and by 2014 mutually
incompatible connectors for epidural lines as well.Mutually
incompatible connectors do not guarantee that misconnections
never occur but provide a mechanical barrier that should greatly
reduce the risk.
California also requires hospitals to have, in their patient
safety plan, measures to prevent adverse events associated with
misconnecting intravenous, enteral feeding, and epidural lines.
This requirement sunsets once the 2013 and 2014 deadlines for
mutually incompatible connectors have passed.
Hospitals are encouraged to review their current patient safety
plan in light of the FDA letter and its recommendations below.
Since standards for non-compatible connectors do not yet exist,
mechanical means of preventing misconnection require adopting
proprietary connectors, and the proprietary nature of those
connectors could present patient care difficulties. Some
manufacturers have other means of calling attention to enteral
lines, such as by color or label.
Adoption of a proprietary connector, color or label poses its own
risks. Since providers may assume they will see incompatible
connectors or an identifying color or label, such
incompatibilities or markings should be consistent. Patients
receive these lines from many different providers and it is
unlikely that all patients treated in your facility will have
lines meeting your specifications. For patients with different
lines, additional steps may be needed.
“In the fluoroscopy suite, approximately 3 mL of barium sulfate
was injected into the patient’s central venous line (CVL), which
was misidentified as her gastrostomy tube. The error was
recognized when the first video fluoroscopic image revealed
barium in the patient’s right atrium, and 10 mL of blood
containing a thick, chalky, whitish-pink suspension was
immediately aspirated from the CVL.” The child survived. —
Soghoian S, Hoffman RS, Nelson L. Unintentional i.v. injection of
barium sulfate in a child. American journal of health-system
pharmacy. 2010;67(9):734-6. Available at: http://www.ncbi.nlm.nih.gov/pubmed/20410548.
The gastrostomy tube had a slip fitting compatible with luer-tip
syringes, and a luer slip syringe was used to draw up the barium
sulfate. The CVL had a luer lock fitting.
The only difference between luer lock and luer slip is that luer
lock fittings have extensions around the outside of the fitting
for locking the male and female fittings together. Luer lock and
luer slip both have the same internal fitting dimension and
taper, and each can be connected to the other. Using luer lock
for intravascular access and luer slip for other access fails to
protect against misconnection.
On July 9, the FDA published a letter to manufacturers of enteral
feeding tubes, healthcare professionals, and hospital purchasing
departments regarding luer misconnections —
“These misconnections can be dangerous and result in injuries.
Luer connectors easily interconnect many medical components,
accessories, and delivery systems across multiple medical
applications. Because of the nature of the connector design,
human factors, and the clinical environment, healthcare
professionals may mistakenly connect the wrong devices and
deliver substances through the wrong route…. In particular,
misconnections with enteral feeding tubes and solutions have been
associated with death and serious injury.”
The FDA’s recommendations for health care professionals and
purchasing departments are:
Do not modify or adapt devices since that may defeat the
Trace lines back to its origins when reconnecting devices;
Route tubes and catheters that have different purposes in
unique and standardized directions; and
Consider the safety of various systems and connections when
purchasing new inventory.
California Health and Safety Code §1279.6, effective January 1,
2010, contains the patient safety plan requirements and the 2013
and 2014 deadlines for mutually incompatible connectors.