As medication regimen adherence become increasingly more important to patient outcomes – the importance of advanced delivery and packaging continues to grow.
The consolidation of the required components into procedure trays or single use injection kits (SUIK’s) has been shown to provide a higher standard of patient safety, as well user convenience and efficiency during parenteral drug preparation and administration.
SUIK’s have been used in common practice within the operating theater for decades, however only now they are becoming extremely popular in other health care practice.
The Asepsis SUIK’s proprietary features uniquely expands on the CDC’s recommendation for Injection Safety Guidelines. The Asepsis SUIK not only provides for a single dose vial and the correct diluent (if required) – but also calibrates and intuitively marks procedural measurement indicia for each of the components within the SUIK on the syringe. This calibration eliminates crucial hands on preparation, calculation and administration procedures which have been statistically identified as leading causes of MAE’s.
Asepsis offers a range of cGMP manufacturing and assembly services for SUIK’s and procedure tray packaging. Our assembly and packaging areas comprise of three ISO class clean rooms in full compliance with ISO Class 7 with additional segregated Class 8 climate control (≥10°C) finished storage areas.
Asepsis provides a multitude of assembly and manufacturing services for custom thermoformed trays and clam shell packaging for injection and procedure kits. Our design staff are experts in designing packaging to ensure product safety and as well as functionality for end-use.
Asepsis’ patented SUIK’s are uniquely configured to provide either a single dose vial (Safe-T-Dose) or a reduced volume single dose vial (Pedia-Dose); both configurations further prevent infection by restricting the reuse of the vial, while in parallel also reducing environmental discharge impact.
More importantly, both SUIK’s comprise a medication specific calibrated syringe (Safe-T-Syringe), that enables a user to prepare, (reconstitute if required), and administer a medication according to its PI to one or more specific patient characteristics while obviating any calculations or correlation procedures. This patient tailored administration also provides for additional calibration of the syringe indicia, enabling lower incremental dosing indicia of the drug dose(s) and patient characteristic(s). This dose optimization of a patient’s physical characteristics provides higher precision dosing and perhaps patient outcome from this enhanced dose accuracy.
Independent Bain surveys in three countries and GfK usability studies conducted in simulated use physical environments (in adherence to ANSI/AAMI HE75:2009 and ANSI/AAMI/IEC 62366:2007 and FDA Draft Guidance for Industry, Applying Usability and Usability Engineering to Optimize Medical Device Design) concluded 100% of registered nurses preferred our CDD kits and syringes over existing industry practiced technology.