ISSN: 1945-7553
CODEN: JTEVAB
Page Count: 7

Evaluation of Three Methodologies for Testing Disposable ENT Endoscope Sheaths as Viral Barriers

Lytle, CD
FDA Center for Devices and Radiological Health, Rockville, MD

Clavet, CR
FDA Winchester Engineering and Analytical Center, Winchester, MA

Chaput, MP
FDA Winchester Engineering and Analytical Center, Winchester, MA

Varney, GW
FDA Winchester Engineering and Analytical Center, Winchester, MA

To, TM
FDA Winchester Engineering and Analytical Center, Winchester, MA

Carey, RF
FDA Center for Devices and Radiological Health, Rockville, MD


Baker, KH
FDA Center for Devices and Radiological Health, Rockville, MD

(Received 19 January 1998; accepted 2 July 1998)

Abstract

Three methods to determine the barrier function of ENT endoscope sheaths were evaluated: (1) the air deflation test, a candidate quality assurance test, compared differences in pressure between a test sheath and an intact one; (2) a virus barrier test challenged with bacteriophage ΦX174 outside the sheath, with barrier penetration determined by rinsing inside and assaying for penetrated virus; (3) another virus barrier test challenged from inside, with virus penetration determined by assaying a collection/submersion solution. Sheaths with laser-drilled holes or tears generated by acupuncture needles were tested. Five-µm holes and larger were detected by air deflation or inside virus challenge. Outside virus challenge could reliably detect only 30-µm holes. Tears of 35-µm length were detected by inside virus challenge, while all three tests detected 85-µm tears. In addition, air bubbles during submersion detected and located 5-µm holes and larger, suggesting another quality assurance test.

Keywords:
endoscope sheath, air deflation test, viral barrier tests, air bubble test, quality assurance

Paper ID: JTE12117J
DOI: 10.1520/JTE12117J
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