Enhanced visual inspection of medical devices

Author: Stephen Kovach1, Weston Balch2, Mary Ann Drosnock1
1 Healthmark Industries, Fraser, MI, U.S.A.
2 University Hospital, San Antonio, Texas, U.S.A

Background: Recent incidents of infections received from contaminated arthroscopic shavers and flexible endoscopes have led to changes in how sterile processing professionals visually inspect these medical devices. Certain shaver manufacturers have updated their Instructions for Use (IFU) to require the use of additional tools to inspect their medical devices.
Materials and methods: This three-phase study explores the development and implementation of new technologies in the area of enhanced visual inspection of medical devices. Phase 1 examines the results of surveys taken on the process of visual inspection of orthopedic shavers. Phase 2 outlines results of a small-scale inspection of orthopedic shavers in healthcare facilities. Phase 3 details the implementation and inspection results of a borescopic examination step added into the processing procedures for a large health care facility.

Results: Responses collected during Phase 1 showed that 80% of healthcare facilities were not inspecting their shavers even though some IFUs required that this process be performed.
Upon inspection of shavers from three sterile processing departments in Phase 2, 57% of shavers presumed clean were visually soiled.
Of the total of 28 devices inspected during Phase 3, 32% were dirty on initial inspection with the borescope. Adding a required inspection-step to the instrument management software program for all shaver count sheets was not seen by staff as an interruption of assembly, but as a critical part of ensuring that they were assembling a visually clean instrument.
Conclusion: Our borescope data for arthroscopic shavers showing that 32% of cleaned devices were actually inadequately cleaned supports the need for better integration of borescope examination into facilities that reprocess such devices. These advanced visual inspection tools are cutting-edge technology that progressive sterile processing departments are utilizing to deliver safe and ready to use medical devices to the next patient.

Read more in Steri-World Issue 03/18.

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