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

Table 2 Several of the infection-control breaches identified within the VA Caribbean Healthcare System, in Puerto Rico

Breach	Details of breach	Guidelines, manufacturers’ instructions	FDA regulations	Infection risk
Improper high-level disinfection of transvaginal ultrasound transducers[1,3,12]	For approximately 2 yr, the VAMC (in San Juan) and an outpatient clinic (in Mayaguez) did not high-level disinfect transvaginal ultrasound transducers after each use[3]. Instead, staff sprayed these instruments with an ineffective disinfectant (and then, at least at this clinic in Mayaguez, covered them with two latex sheaths before use). Whether these transducers were properly cleaned prior to being sprayed is unclear	Transvaginal ultrasound transducers are semi-critical devices for which high-level disinfection (or sterilization) is recommended after each use[75,81], whether or not these transducers are covered with a protective sheath[1,75,82]		Failure to clean and/or to high-level disinfect these semi-critical devices poses an increased risk of patient infection[75,81]. Further, improperly reprocessed transvaginal ultrasound transducers, even when covered with a protective sheath during the procedure, may pose an increased risk of transmission of infectious agents, including HPV[75,82]
Failure to leak-test colonoscopes[1,3,12]	Colonoscopes used in this VAMC’s operating room were not leak-tested for (at least) 9 mo[3]	Leak testing of the colonoscope is required after each procedure, just prior to cleaning[3,79,83]. This test detects leaks that can permit fluids to invade and damage the endoscope’s internal structures[3]. Manufacturers’ instructions contraindicate the use of a colonoscope (or flexible laryngoscope) that fails this crucial test[83]		Leak testing of the colonoscope is also critical to infection control[3]. Reports causally associate use of a torn or damaged flexible endoscope, with a leak, to disease transmission[3,75,79]
Failure to leak-test flexible laryngoscopes; and the use of a damaged laryngoscope[1,3,12]	Having not leak-tested these instruments for 9 mo, this VAMC (namely, its radiotherapy department) routinely used a damaged flexible laryngoscope, with a leak. Similarly, an outpatient clinic (in Ponce) did not leak-test its flexible laryngoscopes for 3 yr[3]	Leak testing of the laryngoscope is required after each procedure, just prior to cleaning[3,78]. Manufacturers’ instructions contraindicate the use of a laryngoscope that is damaged and/or fails the leak test[3,83]		Both the use of damaged flexible endoscopes and the failure to leak test them have been causally associated with disease transmission[79,80]
Improper cleaning (and high-level disinfection) of flexible laryngoscopes[1,3,12]	For possibly as many as 9 mo, this VAMC (namely, its radiotherapy department) was not properly cleaning a flexible laryngoscope after each procedure using a detergent[3]. Instead, it was rinsed with running water (followed by drying with a clean gauze pad). Further, for 3 yr an outpatient clinic (in Ponce) was not properly cleaning (nor leak testing; see above) its flexible laryngoscope after each use, and this clinic, too, may not have been properly high-level disinfecting the laryngoscope[3]	Guidelines and manufacturers’ instructions require the cleaning (using a detergent) and high-level disinfection of flexible endoscopes after each use[2,3,63,74-78]. The use of an improperly cleaned or high-level disinfected laryngoscope is contraindicated[2,3,75]		Because the laryngoscope was not properly cleaned, this VAOIG report acknowledges that “adequate (high-level) disinfection cannot be ensured”[3]. The improper cleaning and/or high-level disinfection of flexible endoscopes have been causally associated with disease transmission[64,74,76,77,79]
Use of a misbranded flexible laryngoscope[1,3,12]	For possibly as many as 3 yr, an outpatient clinic (in Ponce) used a misbranded flexible laryngoscope[3]		A misbranded device lacks the necessary clearance to be legally marketed in the US[17,43,56]. The use of a misbranded (or adulterated) device is expressly prohibited by the Food, Drug and Cosmetic Act, unless the “unapproved” device has received, for example, an approved “investigational device exemption” (or, IDE), which, among other considerations, requires for its use informed patient consent[17,56]	The safety and effectiveness of a misbranded medical device cannot be assured, and its use could pose an increased risk of patient harm including infection[41,42,45]

The Veterans Health Administration (VHA) concluded that each of these five listed breaches posed a “negligible” risk of infection[1,3,10]. Consequently, patients were not notified of the potential for their exposure to infectious agents, including HIV and other blood-borne pathogens[12]. Several recommendations to prevent infections associated with each of these breaches are provided in Table 6. VAMC: Veterans Affairs Medical Center.