Endoscope Damage: A Review of the Medical Literature

Initial comments: This blog, written by Lawrence F Muscarella, PhD, discusses whether 2% glutaraldehyde formulations and peracetic acid solutions, either of which may be used to achieve high-level disinfection, might cause damage of immersed flexible endoscopes. In addition, this blog is based on a more comprehensive article that may be read by clicking here. Recommendations are provided herein.

BACKGROUND: Entitled “Endoscope Damage, Part 1,” the first blog in this series of two focuses on the potential for endoscope damage associated with the use of peracetic acid and other types of liquid chemical disinfectants.1-7 Peracetic acid and aldehyde-based disinfectants, such as 2% glutaraldehyde (e.g., Cidex) and ortho-phthalaldehyde (e.g., Metricide OPA Plus), are commonly used to reprocess flexible endoscopes after each use, in accordance with Standard Precautions, to prevent the transmission of infectious agents. This blog herein completes this discussion about endoscope damage. A more detailed article upon which this blog is based may be read by clicking here.

INTRODUCTION: A liquid oxidizing agent that is chemically distinct from aldehyde-based disinfectants, peracetic acid is the active ingredient used by both the Steris System 1 and the Steris Reliance Endoscope Processing System (EPS), at the same concentration (0.2%) and elevated immersion temperature (50—56o C) (but at slightly different immersion times).2,6 Whether endoscope damage acknowledged to be associated with the System 1 may, therefore, also be associated with the Reliance EPS is unclear, although the possibility is discussed in an evaluation of the Reliance EPS authored by the ECRI Institute (“ECRI”).2

Whereas the Reliance EPS is labeled to supplement manual cleaning and both to wash and high-level disinfect gastrointestinal (GI) endoscopes, the Steris System 1 is labeled to “sterilize” several different types of instruments, including GI endoscopes.2 Having been declared last May (2008) to be “adulterated and misbranded” since 1988, the sale of the Steris System 1 in January (2009) became restricted.8,9 (Note: The author of this blog is currently employed by a manufacturer of an automated endoscope reprocessor that is labeled to wash and high-level disinfect GI endoscopes.)

The misbranding of the Steris System 1, its countenanced use in the U.S. despite its discontinuation, and the lack of published position statements by infection-control organizations contraindicating the use of adulterated and misbranded devices in the healthcare setting will be discussed in a future issue of this newsletter. (The author of this article about endoscope damage is employed by the manufacturer of an automated endoscope reprocessor that, like the Reliance EPS, is labeled to wash and disinfect GI endoscopes.)