3415 In-vivo evaluation of reusable biopsy forceps: chapter 2.

Abstract

Disposable biopsy (bx) forceps are marketed as more efficacious and safer than reusable ones, but there are few data to support these claims. We report the continuation of a prospective study begun in1998 to evaluate invivo efficacy of a reusable bx forceps (Olympus America, Inc., Melville, NY). Methods: Prospectively, over a 14-month period (9/98-11/99), 15 new bx forceps were assessed. Data collected included pt demographics, procedure and date, bx site, adequacy of bx specimen, and problems at sample collection. Results: 1273 biopsy sessions were undertaken in 1124 procedures (623 EGD, 452 colonoscopies, 24 flexible sigmoidoscopies, 21 EUS, and 4 ileoscopies). Bx sites were esophagus 235, stomach 408 (CLO 178), small bowel 156, large bowel 444, and surgical anastmoses 30 (ileo-colonic 18, eso-gastric 2, gastro-enteric 3, pyloroplasty 1, rectal stump 1, soft palate 1, ileal pouch 2, ileo-rectal 1, and pharynx 1). Forceps were reported as new or like new 1066/1124 (94.8%), some loss of function, but usable 52/1124 (4.7%); and 6/1124 inadequate function to use clinically (0.5%). Histologically, 1269 were adequate (99.7%) and mean specimen size was 2.71 ± 0.07 mm (0.9mm-10mm), with four specimens greater than 1 cm. No forceps problems were encountered in 1210/1273 (95%) of sessions. Mechanical problems were noted in (30/1273, 2.4%) and included: inadequate cusp closure 7, sticky forceps 7, failure to open or open slowly 8, caught in scope channel 1, kink 5, bent needle 1, and difficulty removing the specimen 1. Endoscopists expressed a concern of specimen adequacy in 28 cases (2%), only 2 of the 28 (7%) were determined to be pathologically inadequate. Mean number of uses of forceps to date is 81 ± 8 (19-103). 12 bx forceps are still in use, whereas 3 of the 15 broke after 19, 63, and 64 procedures respectively. Conclusions: 1) To date, this reusable forceps maintained its function for a mean of 81 uses, and 12 of 15 remain in service. 2) Operational problems with the forceps were reported in 30/1273 (2.4%). 3) Endoscopists were satisfied with bx specimen size in 1245/1273 (98%) sessions whereas pathologists reported specimen adequacy in 1269/1273 (99.7%). 4) Prospective in-vivo evaluation to include cost data continues.