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An innovative surgical suture and needle evaluation and selection program
Robin R Szarmach1, Jean Livingston, George T Rodeheaver
1Consorta, Inc., Catholic Resource Partners, Rolling Meadows, Illinois 60008, USA. rszarmach@consorta.com
Journal of Long-Term Effects of Medical Implants
|March 12, 2003
Summary
Surgical sutures and needles from United States Surgical/Davis & Geck were found clinically acceptable in 98.1% of evaluations. This study assessed performance in nearly 3,500 procedures across 19 hospitals.
Area of Science:
- Surgical biomaterials and device evaluation.
- Clinical performance assessment in surgical procedures.
Background:
- Healthcare resource management organizations and surgical manufacturers collaborate on product evaluation.
- Consorta, Inc. and United States Surgical/Davis & Geck (USS/D&G) partnered to assess surgical biomaterials.
Purpose of the Study:
- To evaluate the clinical performance of surgical needles and sutures manufactured by USS/D&G.
- To gather surgeon feedback on key performance characteristics of surgical sutures and needles.
Main Methods:
- A nonexperimental observational study involving 699 surgeons across 19 hospitals.
- Evaluation of 3,407 surgical procedures assessing packaging, needle sharpness, tissue drag, knot security, and tensile strength.
- Data collection on clinical acceptability of sutures (POLYSORB*, SOFSILK*, monofilament nylon) and needles over 30-day periods.
Main Results:
- Surgical needles and sutures achieved an overall clinical acceptability rating of 98.1%.
- POLYSORB* braided synthetic sutures were rated 98.4% acceptable, SOFSILK* at 98.7%, and monofilament nylon at 96.3%.
- USS/D&G surgical needles demonstrated a 97.9% clinical acceptability rating.
Conclusions:
- The evaluated USS/D&G surgical needles and sutures demonstrate high clinical acceptability.
- The collaborative evaluation program provides valuable data on the performance of surgical biomaterials in diverse surgical settings.