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

    Volume 26, Issue 6 (November 1998)

    ISSN: 0090-3973

    CODEN: JTEOAD

    Page Count: 7


    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.


    Paper ID: JTE12117J

    DOI: 10.1520/JTE12117J

    ASTM International is a member of CrossRef.

    Author
    Title Evaluation of Three Methodologies for Testing Disposable ENT Endoscope Sheaths as Viral Barriers
    Symposium , 0000-00-00
    Committee F04