Open AccessStopper fragments in parenteral preparations: a potential problem
Author(s) -
Janayna Gomes Pucciarelli,
Evandro Watanabe,
Simone de Godoy,
Rachel Maciel Monteiro,
Pedro Castania Amadio Domingues,
Leila Maria Marchi-Alves
Publication year - 2022
Publication title -
revista prevenção de infecção e saúde
Language(s) - English
Resource type - Journals
ISSN - 2446-7901
DOI - 10.26694/repis.v8i.2219
Subject(s) - bevel , perforation , vial , bottle , significant difference , surgery , materials science , chromatography , medicine , biomedical engineering , composite material , chemistry , structural engineering , engineering , punching
The presence of extrinsic particles in injectable solutions is a medicationerror of usual occurrence that may has important clinical significance. This study aimedto evaluate the presence of stopper fragments in solution derived from bottle-vial afterthe preparation of drugs using different sorts of needles. Outline: experimental study,wherein 50 bottles-vials were used, divided into groups. Group 1: stopper perforatedwith three-bevel tip needle; Group 2: stopper perforated with blunt tip needle; Group3: without perforation of the stopper. The figure and the size of the particles weredetermined through optic microscopy. The data were analyzed by means of descriptivestatistics and the differences among the groups were analyzed through Fischer’s ExactTest. Results: it was verified the presence of six stopper fragments in the solutionderived from five bottles which had the stoppers perforated by three-bevel tip needle(29.4%) and the two fragments in two bottles which had the stoppers perforated withblunt tip needle (11.8%), with significant difference (p=0.044) in the comparison amongthe groups. The three-bevel tip needle produces larger particles (0.36 mm2) than thenblunt tip needle (0.12mm²). Implications: risk evaluations must enable the limitation,the detection, and the rejection of atypical unities at the time of the drugs’preparations, preserving patient safety