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 — http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM218631.pdf. “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 safety system;
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.