Description of Event or Problem · 1
COMPATIBILITY OF IV ADMINISTRATION SETS WITH CLOSED ENTERAL NUTRITION CONTAINERS: AN EVALUATION OF THE CLOSED SYSTEM OF ENTERAL NUTRITION (LARGE VOLUME OF PREFILLED, READY-TO-HANG, ENTERAL FORMULA/TUBE FEEDING CONTAINERS) WAS CONDUCTED FOR PROPOSED INPATIENT USE IN HOSPS. PT SAFETY, COST ANALYSIS, EASE OF USE, TIME COMPARISON, WASTAGE, CONTAMINATION POTENTIAL AND SAFETY WERE PART OF ANALYSIS. RPTR'S ANALYSIS REVEALED A POTENTIALLY DANGEROUS PT SAFETY ISSUE. CLOSED ENTERAL NUTRITION SYSTEM CONTAINERS ARE DESIGNED SO A SPIKED ENTERAL ADMINISTRATION SET IS USED TO ACCESS THE CONTAINER (ANALOGOUS TO THE SPIKED IV ADMINISTRATION SET USED TO ACCESS AN IV BAG). AFTER SPIKING THE CONTAINER OF FORMULA, THE DISTAL END OF THE ENTERAL NUTRITION SET IS ATTACHED TO THE PT'S FEEDING TUBE. RPTR IDENTIFIED THAT VARIOUS CLOSED ENTERAL NUTRITION CONTAINERS COULD BE SPIKED WITH AN IV INFUSION SET [ALARIS MEDICAL SYSTEMS LATEX-FREE INFUSION SET (#2120)]. FLOW OF ENTERAL NUTRITION FORMULA WAS EVALUATED WITH AND WITHOUT AN IV INFUSION PUMP. FLOW OF ENTERAL NUTRITION FORMULA FROM THE NESTLE ULTRAPAK ENTERAL CLOSED SYSTEM BAG WAS FURTHER TESTED THROUGH AN IV SET CONTAINING IN-LINE IV FILTERS. INTRAVENOUS FILTERS OF 0.2, 1.2 OR 5 MICRON PORE SIZES WERE TESTED BASED ON RECOMMENDATIONS FOR ADMINISTRATION OF 2-IN-1 OR 3-IN-1 PARENTERAL NUTRITION FORMULAS. ALL CLOSED ENTERAL NUTRITION CONTAINERS COULD BE SPIKED AND INFUSED THROUGH AN UNFILTERED IV ADMINISTRATION SET. ENTERAL NUTRITION FORMULA WOULD NOT PRIME BEYOND THE 0.2 MICRON FILTER. FORMULA INITIALLY PRIMED BEYOND THE 1.2 MICRON FILTER BUT WOULD NOT FLOW; AND IT PRIMED WITH 4 ML OF FORMULA FLOW THROUGH THE 5 MICRON FILTER. THUS ENTERAL NUTRITION FORMULA CAN BE INADVERTENTLY DELIVERED INTRAVENOUSLY USING AN UNFILTERED IV INFUSION SET AND MINIMAL FORMULA DELIVERED THROUGH A 5 MICRON FILTER. HISTORICALLY, IT WAS POSSIBLE FOR HEALTHCARE WORKERS TO PREVENT POTENTIAL CONFUSION BY VISUALLY NOTING AND ENSURING THAT ONLY STERILE, CLEAR LIQUIDS WERE SUITABLE FOR INTRAVENOUS ADMINISTRATION. THIS HAS CHANGED WITH THE USE OF OPAQUE INTRAVENOUS FAT EMULSION, 3-IN-1 PARENTERAL NUTRITION FORMULAS, AND DRUG PRODUCTS SUCH AS LIPID-BASED AMPHOTERICIN, DOXORUBICIN AND PROPOFOL. THESE DRUG PRODUCTS MAKE IT IMPORTANT TO RE-EMPHASIZE WHICH TYPE OF FLUIDS CAN AND CANNOT BE INFUSED INTRAVENOUSLY. THE RECENT INTRODUCTION OF THE MODIFIED NESTLE ULTRAPAK ENTERAL CLOSED SYSTEM BAG COMPLICATES THIS SITUATION. THE ULTRAPAK ENTERAL CLOSED SYSTEM BAG HAS THE VISUAL APPEARANCE OF A 3-IN-1 PARENTERAL NUTRITION BAG (CREAMY FLUID IN A BAG RESEMBLING AN IV BAG). EVEN THOUGH ALL CLOSED ENTERAL NUTRITION CONTAINERS DO CONTAIN SOME LEVEL OF AUXILIARY LABELING WARNING OF IV ADMINISTRATION, THIS MAY NOT BE SUFFICIENT TO ELIMINATE THE RISK OF INADVERTENT ADMINISTRATION. TABLE 2 LISTS THE AUXILIARY LABELING ON EACH CONTAINER. CURRENT STANDARDS PERTAIN TO THE COMPATIBILITY OF ENTERAL VS PARENTERAL ADMINISTRATION SYSTEMS. HOWEVER, THEY FOCUS ON THE DISTAL ENDS OF THE ADMINISTRATION SETS. THE OBJECTIVE OF THE ANSI/AAMI ID54-1996 STANDARD ON "ENTERAL FEEDING SET CONNECTORS AND ADAPTERS" IS TO "MINIMIZE THE POSSIBILITY OF POTENTIALLY HARMFUL CONNECTIONS OCCURRING BETWEEN ENTERAL FEEDING SETS AND RIGID FEMALE LUER CONNECTORS OR OTHER INTRAVENOUS SETS". A RECENT SAFETY BRIEF BY THE INSTITUTE FOR SAFE MEDICATION PRACTICES (ISMP) NOTED THAT "THE EUROPEAN COMMITTEE FOR STANDARDIZATION ISSUED A REPORT ABOUT THE DANGERS OF INCORRECT CONNECTIONS BETWEEN DEVICES USED FOR THE VASCULAR, ENTERAL, RESPIRATORY, AND OTHER BODY SYSTEMS. THE REPORT RECOMMENDS THAT INTERNATIONAL STANDARDS BE DEVELOPED IN COOPERATION WITH THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO) TO ASSURE THAT SUCH DEVICE CONNECTORS ARE INCOMPATIBLE WITH ONE ANOTHER. AN ASTM (AMERICAN SOCIETY FOR TESTING AND MATERIALS) COMMITTEE WILL JOIN THE EFFORT. ALTHOUGH THE LUER CONNECTION WAS ORIGINALLY DESIGNED TO CONNECT A HYPODERMIC NEEDLE WITH A SYRINGE, THE CONNECTION WAS SO WELL ACCEPTED BY HEALTHCARE WORKERS THAT IT EVENTUALLY WAS INCORPORATED INTO OTHER DEVICES SUCH AS VASCULAR CATHETERS, ENTERAL FEEDING SETS, EPIDURAL CATHETERS, AND RESPIRATORY DEVICES. HOWEVER, LUER COMPATIBILITY HAS ALSO ALLOWED TRAGIC ACCIDENTS WHERE, FOR EXAMPLE, AN ENTERAL FEEDING CATHETER IS ACCIDENTALLY CONNECTED TO A CENTRAL LINE IV CATHETER OR AN IV INFUSION LINE TO AN EPIDURAL LINE." THE CURRENT DESIGN OF CLOSED ENTERAL NUTRITION SYSTEMS PERMITS THE INADVERTENT SPIKING BY AN IV ADMINISTRATION SET AND INFUSION OF ENTERAL NUTRITION FORMULA INTO AN INTRAVENOUS CATHETER. THIS COULD RESULT IN SERIOUS MEDICAL COMPLICATIONS. RPTR RECOMMENDS THAT STANDARDS BE DEVELOPED FOR INTRAVENOUS AND ENTERAL ADMINISTRATION SETS THAT WOULD PREVENT CONNECTIONS AT THEIR PROXIMAL (SPIKE) ENDS WITH CONTAINERS OF THE OPPOSITE DELIVERY SYSTEM.