C. A general comment: Neither performing disinfection-effectiveness tests nor including traditional AERs (as required for a true and fair comparison) would not necessarily have precluded ECRI’s evaluation from providing a meaningful discussion about the safe and proper use of AERs. Indeed, its evaluation, in addition to providing some insights into the field of endoscope reprocessing, features a list of some of the STERIS Reliance EPS’s noteworthy “pros” and “cons.”
Remember that this blog is a shorten version of a more complete article, which is the second in a series of two and which can be downloaded and read in its entirety, along with its tables and several box articles, by clicking here. The first article in this series of two can be downloaded by clicking here.
But, this evaluation’s salient omissions (see: Table 1 of the more comprehensive article upon which this blog is based) restrain its capabilities, reach and application. Remembering that ECRI rates a device preferred if it “meets all major performance and safety criteria … and offers significant advantages over other alternatives,”1 * this evaluation’s failure both to have performed any efficacy tests and to have included any traditional AERs presents obvious limitations and inconsistencies that arguably invalidate its conclusions and rating.
Arguably invalidating this evaluation’s design and rating, there remains the possibility that this singularly evaluated STERIS Reliance EPS, rated preferred, could prove to be less safe and perform worse than ASP’s Evotech ECR or any of the disfavored (and excluded) traditional AERs.
D. Accolades: Displayed in Table 2 (which is only available on p. 23 of the more comprehensive article upon which this blog is based), ECRI’s evaluation uses a litany of hyperbolic phrases to laud the presumed advantages of the STERIS Reliance EPS. These unambiguous expressions imply, if not require, that clinical data had been published convincingly demonstrating that this new AER significantly reduces the risk of healthcare-acquired infections (compared with traditional AERs). But, despite this evaluation’s statement that the Reliance EPS “should contribute significantly to patient and staff safety,”1 no such clinical data have been published.
That ECRI’s evaluation uses such expressions: (a) to describe and praise the STERIS Reliance EPS; (b) to claim its technology is a significant advancement; (c) to suggest inferentially that it may reduce the risk of infection—for example, this evaluation states that the Reliance EPS “significantly reduces the risk that an endoscope would be reprocessed incorrectly”;1 and (d) to justify its preferred rating (for compatible endoscopes)—without having either demonstrated that this new AER improves clinical outcomes or performed any tests to evaluate its disinfection effectiveness)—is most confusing and suggests an overstatement of the performance and safety of the STERIS Reliance EPS. (Note: STERIS wrote in 2010 that the FDA advised it that “incremental modifications” to the STERIS Reliance EPS rendered it without a legal clearance to be marketed.)
E. A manufacturer’s claims? Some of this evaluation’s conclusions suggest that it, at times, may have confused a manufacturer’s claim with scientifically-acquired data.
For example, first, ECRI’s evaluation discusses a possible, though implausible, cause of endoscope damage associated with peracetic acid, which is the Reliance EPS’s active ingredient, without clarifying that the explanation it provides is an unsubstantiated claim advanced by the Reliance EPS’s manufacturer itself and is not a finding independently verified by ECRI during this evaluation (see: Box A on p. 24S1 of the more comprehensive article — click here to download a copy — upon which this blog is based).
This blog is to be read along with Dr. Muscarella’s blog entitled “Endoscope Damage: Can it be Caused by Disinfectants used to Prevent Infections?,” which can be read by clicking here.
Second, ECRI’s evaluation lists as a “pro” that the STERIS Reliance EPS “disinfects (the) suction valves”1 of GI endoscopes. But this, too, is the manufacturer’s claim—not an independently determined finding (remember that ECRI’s evaluation did not perform any microbiological tests to assess the effectiveness of this new AER for disinfecting GI endoscopes or their suction valves).1 A distinction with an important difference that would have altogether distinguished the manufacturer’s claim from an evidence-based result, ECRI’s evaluation might have more aptly stated this ostensible “pro” as: “According to its manufacturer, the STERIS Reliance EPS disinfects suction valves.” (ECRI’s evaluation does not discuss whether this new AER can reprocess air/water valves.)
Third, ECRI’s evaluation states that the STERIS Reliance EPS “eliminates personnel exposure to toxic LCG (liquid chemical germicide) agents and fumes.”1 Discussed in Box B of the more comprehensive article upon which this blog is based (click here to download a copy), however—apparently, again, having confused the manufacturer’s claim from a scientifically-determined finding—this evaluation appears not to have performed the air sampling tests necessary to render this definitive conclusion.
Fourth, discussing the STERIS Reliance EPS’s two automated “self-decontamination” cycles (a short and long cycle), ECRI’s evaluation suggests that both are safe and effective. But, although one of its aims (see: Box C in the more comprehensive article upon which this blog is based), this evaluation did not test or evaluate the safety and effectiveness of either cycle. Instead, this evaluation provides the manufacturer’s own specifications for both cycles.30
Remember that this blog’s box articles (Box A- Box D) are only available in the more complete PDF version of this blog, which can be downloaded by clicking here.)
F. Water filter maintenance: And, fifth, ECRI’s evaluation states that the STERIS Reliance EPS “sounds an alarm and displays a maintenance message when filters should be changed,”1 adding that this new AER “measures pressure across the water feed filter during filling, and it tests the integrity of this filter with an air pressure test at the end of each cycle. If the filter does not pass either of these tests, the unit will alarm until the cycle is canceled. Traditional AERs do not have an alarm for this.”1 (It is unclear how this evaluation determined that none of these traditional AERs feature this alarm, having not included or tested any of them.)
Notably, this evaluation’s discussion and listing of this audible alarm and air-pressure integrity test as a “pro” inferentially suggest that the STERIS Reliance EPS monitors the microbial quality of the “filtered” rinse water. But, while this would be a significant advantage, no AER, including the evaluated STERIS Reliance EPS, features such an alarm, or integrity test, to monitor its filtered water for microbial contamination.
In truth, alarms, air-pressure filter integrity tests, and diagnostic cycles can detect a marked reduction in the flow of tap water through a water filter, often indicating that the “feed” filter’s bacterial membrane has become clogged requiring replacement. But, these alarms, tests, and cycles do not detect what is most clinically important—when bacteria and other waterborne microorganisms are leaking through the filter re-contaminating the endoscope during terminal water rinsing, posing an increased risk of infection.
Indeed, terminally rinsing the endoscope with water of a pristine quality is crucial to patient safety.31 But, by (again) not distinguishing between a manufacturer’s claim and an independently-determined result, ECRI’s evaluation missed an opportunity to provide important insight into the capabilities and limitations of these alarms and air-pressure filter integrity tests. To be sure, no verification and validation data have been published demonstrating that the activation of an alarm, the result of an air-pressure integrity test, or having reached a specific pressure differential indicates microbial contamination of the rinse water, due to a breached filter.