Materials & Processes for Medical Devices (August 10- 13): Luer Tip Roughness and Texture to Prevent Breakage In Critical Applications

19.2 Luer Tip Roughness and Texture to Prevent Breakage In Critical Applications

Wednesday, August 12, 2009: 11:20 AM
Salon E (Hilton Minneapolis )
Mr. Andrew C. Farinella , BD, Franklin Lakes, NJ
David F. Vincenti , BD, Franklin Lakes, NJ
M Bowen , BD, Franklin Lakes, NJ
During in-patient care, the delivery of medication and nutrition is frequently accomplished using large size (20 mL to 60 mL capacity) Luer-Lok syringes. This is usually part of a system which remains assembled and connected directly to the patient for up to 24 hours. In specific cases, the syringe in this system was shown to experience a tip breakage failure mode. This failure created not only problems for the hospital staff (cost of replacement, loss of time for cleanup and replacement) but additional risk for the patient (an unnecessary clinical intervention). While some clinicians have developed temporary or "work-around" solutions, these require change in technique or the use of additional devices, with corresponding increase in cost and waste volume. A texture and roughness and corresponding method of characterization have been implemented on the conical surface of the luer tip in order to prevent this failure mode under the identified circumstances in normal clinical use. This engineered surface has been shown in laboratory studies and clinical use to reduce the rate of failure to well below clinician expectations, with no required change in user technique, provide effective engagement, and create no adverse impact on any other element of product performance.