Medical errors, infection-control breaches and the use of adulterated and misbranded medical devices

Table 1 Several of the infection-control breaches identified at three Veterans Affairs Medical Centers in Murfreesboro (TN), Augusta (GA) and Miami (FL)

Breach	Details of breach	Guidelines, manufacturers’ instructions	Infection risk
Improper reprocessing of irrigation tubing used during colonoscopy (Murfreesboro, TN)[1,2]	For as many as 5 yr, the VAMC in Murfreesboro (TN) had been using the Olympus MAJ-855 auxiliary water tube that was: (1) fitted with an improper “two-way” connector; and (2) reprocessed once at the end of the day, not after each patient procedure, as required[2]. Further, the short “irrigation tube” that connects the MAJ-855 tube to a flushing pump was not discarded at the end of the day, also as required[2,8]	According to its manufacturer: (1) the MAJ-855 tube is to be used only with the “one-way” valve with which it is manufactured and shipped (the removal of this valve and its replacement with the two-way connector used by the Olympus MH-974 “washing tube” is contraindicated); (2) the MAJ-855 tube is to be reprocessed after each procedure; and (3) the short irrigation tube is to be discarded at the end of each day[2,9]	Use of the MAJ-855 tube fitted with the MH-974’s two-way connector (instead of the correct one-way valve) can result in: the auxiliary water tube’s malfunction, its contamination due to the “back-flow” of potentially infectious debris from the patient’s colon, and patient-to-patient disease transmission[2]. Further, failure to clean and high-level disinfect (or sterilize) the MAJ-855 tube after each patient procedure, or to discard the short irrigation tube at the end of each day, also poses an increased risk of infection[2,9]
Improper reprocessing of colonoscopes (Miami, FL)[1,2]	For as many as 5 yr, the VAMC in Miami (FL): (1) failed to reprocess the MAJ-855 tube after each procedure, instead merely flushing or rinsing it with (sterile) water; (2) often connected the MAJ-855 tube to the colonoscope while the procedure was already in progress; and (3) did not discard the short irrigation tube (that connects the MAJ-855 tube to a flushing pump) at the end of the day[2]. In addition, “debris” had been identified in the auxiliary water channel of “reprocessed” colonoscopes[2]	According to its manufacturer: (1) the MAJ-855 tube is to be cleaned and high-level disinfected (or sterilized) after each procedure; (2) the MAJ-855 tube is to be connected to the colonoscope, with the auxiliary water system primed, prior to the procedure; and (3) the short irrigation tube is to be discarded at the end of the day[2,9]. The use of an endoscope whose channels are soiled with patient debris is contraindicated[1,2,63,74-77]	Indeed, (1) The failure to clean and high-level disinfect the colonoscope, including its auxiliary water channel, or to discard the short irrigation tube at the end of each day; or, (2) the practice of neither cleaning and high-level disinfecting (or sterilizing) the MAJ-855 tube after each patient procedure nor connecting the MAJ-855 tube to the colonoscope, with the auxiliary water system primed, prior to the procedure, poses an increased risk of disease transmission[2]
Improper cleaning and high-level disinfection of flexible laryngoscopes (Augusta, GA)[1,2]	For almost a year, the VAMC in Augusta (GA) had been improperly reprocessing flexible laryngoscopes after each procedure, namely, by merely wiping them down with a disposable “sanitizing” cloth[2]	Guidelines and manufacturers’ instructions require cleaning and high-level disinfection (or sterilization) of flexible endoscopes and other semi-critical items after each use[49,61,75,78]. The use of an improperly cleaned or disinfected flexible laryngoscope is contraindicated[1-3,75,78]	The improper cleaning and/or high-level disinfection of flexible endoscopes have been causally associated with disease transmission[61,74-80]

The Veterans Health Administration (VHA) concluded that each of these infection-control breaches posed an increased risk of infection[2]. Consequently, in accordance with the VHA’s relevant directives[14], patients were notified of these breaches and of their potential for infection. Several recommendations to prevent infections associated with each of these breaches are provided in Table 6. VAMC: Veterans Affairs Medical Center.