Potential for an Event Related to Patients Receiving Liquid Medications Through an Enteral Route
The industry responded with a new manufacturing standard and devices for medical small tubing connections to prevent tubing misconnections following the Joint Commission Sentinel Event Alerts 36 (Tubing misconnections—a persistent and potentially deadly occurrence) and 53 (Managing risk during transition to new ISO tubing connector standards). ENFit connectors were introduced to prevent inadvertent use of IV tubing as an administration set solving the safety concern and meeting ISO 18250 Standard for reservoir connectors.
The Joint Commission presented on the standards in December 2014 webinar. Enteral-specific syringes are included in FDA guidance recommendations and could be fast-tracked through FDA processes. Products are expected on the market at any time.
Potential harm to the patient
Children receiving small dose, high alert medications with the transition to the new ENFit syringes could experience 0.15 mL to 0.2 mL variability in dosing.
Actions to mitigate risk at your hospital
Review the ISMP Medication Safety Alert, which addresses dosing variability using ENFit syringes.
Nursing, medical and clinical leaders, pharmacy and pharmacy purchasing leaders, quality and patient safety leaders, legal and risk management, clinical educators, cause analysis staff, organizational leaders (e.g., NICU, accreditation and regulatory, ambulatory, clinical nutrition, ER, OR, home care, supply chain).
The Child Health Patient Safety Organization® identified the potential for an event related to patients receiving liquid medications through an enteral route. Some challenges were identified in the April 9, 2015, ISMP Medication Safety Alert related to measurement and administration issues that have the potential to cause dosing errors in the pediatric population.
Small dosing errors could cause serious harm in children and proposed solutions to date are not fail safe. Vendors are currently aware of the situation and working on solutions. Most products are not yet available for further testing and for providers to begin in-service training; however, all caregivers administering small dose, high alert medications should be aware that practice changes are coming with the use of ENFit enteral feeding device products and heightened awareness to prevent harm will be necessary. This is of particular concern for the broader pediatric community. More information is expected from Global Enteral Devise Suppliers Association (GEDSA) and ISMP.
For additional resources, contributors and sources, download the PDF.