Evaluation of three methodologies for testing disposable ENT endoscope sheaths as viral barriers

Citation
Cd. Lytle et al., Evaluation of three methodologies for testing disposable ENT endoscope sheaths as viral barriers, J TEST EVAL, 26(6), 1998, pp. 587-593
Citations number
18
Categorie Soggetti
Material Science & Engineering
Journal title
JOURNAL OF TESTING AND EVALUATION
ISSN journal
00903973 → ACNP
Volume
26
Issue
6
Year of publication
1998
Pages
587 - 593
Database
ISI
SICI code
0090-3973(199811)26:6<587:EOTMFT>2.0.ZU;2-J
Abstract
Three methods to determine the barrier function of ENT endoscope sheaths we re evaluated: (1) the air deflation test, a candidate quality assurance tes t, compared differences in pressure between a test sheath and an intact one ; (2) a virus barrier test challenged with bacteriophage phi X174 outside t he sheath, with barrier penetration determined by rinsing inside and assayi ng for penetrated virus; (3) another virus barrier test challenged from ins ide, with virus penetration determined by assaying a collection/submersion solution. Sheaths with laser-drilled holes or tears generated by acupunctur e needles were tested. Five-mu m holes and larger were detected by air defl ation or inside virus challenge. Outside virus challenge could reliably det ect only 30-mu m holes. Tears of 35-mu m length were detected by inside vir us challenge, while all three tests detected 85-mu m tears. In addition, ai r bubbles during submersion detected and located 5-mu m holes and larger, s uggesting another quality assurance test.