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

Table 6 Several recommendations to prevent patient infections associated with the breaches described in Tables 1 and 2

Olympus MAJ-855 auxiliary water tube:

Clean and high-level disinfect (or steam sterilize) the MAJ-855 auxiliary water tube (in accordance with its manufacturer’s instructions)[9]. Recommendations for reprocessing this MAJ-855 tube and the colonoscope’s auxiliary water tube have been previously published[10]

Improper reprocessing, or the misuse, of the MAJ-855 tube may pose an increased risk of infection warranting patient notification[2]

Colonoscope:

After each clinical case, clean and high-level disinfect (at a minimum) the colonoscope (and all other types of GI endoscopes)[64]. Refer to the colonoscope’s operator’s manual for detailed reprocessing instructions[83]

In addition to its other channels and surfaces, including the suction and air/water valves, reprocess the auxiliary water channel regardless of whether this channel was used or flushed with water during the clinical case[76,77]. Do not use the GI endoscope if assurances that this channel (or any other surface) was properly reprocessed cannot be provided

Soil dripping from a “reprocessed” colonoscope may indicate improper cleaning of the auxiliary water channel. Do not use a visibly soiled or improperly reprocessed GI endoscope rather, reprocess it again before its reuse

Improper reprocessing of the colonoscope and its auxiliary water channel may pose an increased risk of infection warranting patient notification[2]

Prior to its reprocessing, visually inspect (for damage) and leak-test the colonoscope, in accordance with its manufacturer’s instructions. Do not use a colonoscope that has not been leak-tested, has a leak and fails this test, is torn, and/or is otherwise damaged. Return the damaged colonoscope to its manufacturer, in accordance with its operator’s manual

Flexible laryngoscope:

After each clinical case, clean and high-level disinfect (at a minimum) the flexible laryngoscope, including, if featured, its suction channel, suction valve, and biopsy inlet or port[2,78]

A unique set of step-by-step instructions for reprocessing laryngoscopes is provided in reference 78, to which the reader is referred

Prior to its reprocessing, visually inspect (for damage) and leak-test the flexible laryngoscope, in accordance with its manufacturer’s instructions. Do not use a flexible laryngoscope that has not been leak-tested, has a leak and fails this test, is torn, and/or is otherwise damaged. Instead, return the flexible laryngoscope to its manufacturer, in accordance with its operator’s manual

Improper reprocessing of the flexible laryngoscope-for example, failing to use a detergent to clean it; or “cleaning” and “disinfecting” its surfaces by wiping them with a sanitizing cloth or a gauze soaked with a disinfectant, such as 70% alcohol or a quaternary ammonium product-may pose an increased risk of infection warranting patient notification[1,2,6]

Service and maintain the flexible laryngoscope, like all types of flexible endoscopes, including colonoscopes, as recommended by its manufacturer[80]

Transvaginal ultrasound transducer (or probe):

After each clinical case, clean and high-level disinfect (at a minimum) the transvaginal ultrasound transducer regardless of whether this reusable probe was covered with one or two protective sheaths[75,82]. Refer to this transducer’s reprocessing manual for more detailed instructions

Improper reprocessing of this transducer-for example, “cleaning and disinfecting” its surfaces by spraying them with a disinfectant; wiping them with a disposable sanitizing cloth; or using running tap water (without detergent)-may pose an increased risk of infection warranting patient notification[1,12,81]