Review of an Evaluation of the STERIS Reliance EPS Reprocessor

Overlooked in ECRI’s evaluation, microorganisms can leak through the bacterial membrane of any AER’s (or “sterilizing” system’s) water filter without activating an audible, visual, or diagnostic alarm and despite the water filter passing an air-pressure (or comparable) integrity test (known as a “false-negative” result). By not detecting microorganisms in filtered rinse water claimed to be “sterile” or “bacteria-free,” these alarms and filter tests are limited in function and can provide a false sense of security and a misleading result that paradoxically may pose an increased risk of infection.^31-33

G. Other details and considerations: ECRI’s evaluation provides a second rating for the STERIS Reliance EPS—not recommended for reprocessing Pentax endoscopes—which, oddly, is one of ECRI’s three “acceptable” ratings (the other two are preferred and acceptable, in descending order).  Understanding that ECRI’s evaluation states that Pentax contraindicates the use of the STERIS Reliance EPS for reprocessing any of its endoscopes, it is most confounding that this evaluation did not instead rate the STERIS Reliance EPS  unacceptable for reprocessing Pentax’s flexible endoscopes.

Similarly, ECRI’s evaluation notably diminishes the significance of some of the STERIS Reliance EPS’s other acknowledged disadvantages—for example, as discussed in Box D of the more comprehensive article upon which this blog is based, that both the initial and associated operating costs of the STERIS Reliance EPS are significantly higher than the disfavored traditional AERs (though, likely, not ASP’s EvoTech EPS);  or, that the STERIS Reliance EPS does not facilitate endoscope drying after each completed cycle (see: Table 1 of the more comprehensive article upon which this blog is based), a shortcoming that this evaluation mentions but does not list as a specific disadvantage. Indeed, ECRI’s evaluation does not emphasize the importance of endoscope drying—a measure as crucial to the prevention of healthcare-acquired infections as manual cleaning of the endoscope.³¹

ECRI’s evaluation also arguably downplays the potential significance of the STERIS Reliance EPS’s inability “to detect two significant user errors” that “an advanced reprocessor should be able to prevent” (this new AER’s preferred rating notwithstanding).¹According to ECRI’s evaluation, one of these two errors (which is not listed as a disadvantage) is the STERIS Reliance EPS’s failure to notify the user when a channel connector has become disconnected from the colonoscope’s auxiliary water channel—one of the specific concerns with traditional AERs that this evaluation suggests can result in ineffective disinfection and an increased risk of disease transmission.

The other error (which this evaluation does acknowledge as a disadvantage) is the STERIS Reliance EPS’s failure to detect inadequate fluid flows through the internal channels of a second endoscope, if the operator (inadvertently) presses this AER’s “one-endoscope cycle” button when simultaneously reprocessing two GI endoscopes.

CONCLUSION: The omissions, oversights, and shortcomings that this review identifies herein (see: Table 1 of the more comprehensive article upon which this blog is based) raise fair questions about the validity and objectivity of ECRI’s evaluation of the STERIS Reliance EPS. As Consumers Union   understands well,² the establishment of working relationships with manufacturers to evaluate and rate their products—whether a drug, medical device, or a consumer item—may pose conflicts of interests that, unless rigorously and transparently managed, can compromise objectivity.^5-11,22,34 Studies suggest that interactions with manufacturers can introduce bias and the publication of only favorable data about a product.^2,3,5-11,22Whether ECRI’s acknowledged working relationships⁴ with manufacturers may have influenced its conclusions and rating of the STERIS Reliance EPS is debatable.

Studies suggest that interactions with manufacturers can introduce bias and the publication of only favorable data about a product.^2,3,5-11,22

Interactions and working relationships with manufacturers can cause researchers to aggrandize a product’s benefits; to overlook its flaws and shortcomings; and to develop positive attitudes,⁷ preferences, deference, and irrational behavior^5,7toward, and to feel dependent on or indebted or obligated^3,5,8 to, a manufacturer or its products (see: Table 2 of the more comprehensive article upon which this blog is based).^3,5-11,22 

Another aspect of ECRI’s evaluation that raises additional questions about whether working relationships with manufacturers can introduce bias^5-11,22is its discussion of peracetic acid, the active ingredient used by the STERIS Reliance EPS at the same concentration and temperature as the STERIS System 1 (see: Box A of the more comprehensive article upon which this blog is based — download a copy by clicking here).³⁵ Rather than addressing arguably more important patient-safety concerns—such as: the proneness of bacterial water filters to breakage;³¹ the false sense of security an AER’s air-pressure integrity test can provide about the microbial quality of filtered rinse water; or, the lack of verification and validation data demonstrating that the STERIS System 1’s (or any automated reprocessor’s) 0.2 micron bacterial water filter reliably and consistently produces “sterile” rinse water from a hospital’s tap^31-33—ECRI’s evaluation instead dubiously and without independent corroboration advances the manufacturer’s assertion³⁵ that peracetic acid is not the cause of damage that has been linked to endoscopes reprocessed by the STERIS System 1 (and, possibly, the STERIS Reliance EPS).¹

Worse, ECRI’s evaluation does not reference specific studies that challenge the manufacturer’s claim that, not peracetic acid, but rather 2% glutaraldehyde may be responsible for the noted endoscope damage (see: Box A of the more comprehensive article upon which this blog is based — download a copy by clicking here).²⁹ 

This topic of “endoscope damage” linked to peracetic acid is discussed in detail in an article that can be read by clicking here.

ECRI Institute discloses in its evaluation of the STERIS Reliance EPS that it will address in an upcoming report “issues related to sterilization versus HLD (high-level disinfection).” Publication of this report is most welcomed, as, too, is a re-evaluation of the STERIS Reliance EPS. Ideally, this re-evaluation would address the shortcomings cited herein (see: Table 1 of the more comprehensive article upon which this blog is based); include traditional AERs; and would both compare and contrast the STERIS Reliance EPS’s effectiveness and safety to these traditional AERs, which would include ASP’s EvoTech ECR and the STERIS System 1.

This re-evaluation would also discuss the manufacturer’s rationale for marketing the STERIS Reliance EPS, thereby abandoning its long-standing (though unsubstantiated) claim that high-level disinfection of GI endoscopes, compared to “sterilization” using the STERIS System 1, poses an increased infection risk.^36-39 This re-evaluation would therefore provide insight into why the Reliance EPS—despite using a 0.2 micron bacterial retentive filter and the same concentration and temperature of peracetic acid as the STERIS System 1—is marketed and labeled as a washer-disinfector—not as a washer-sterilizer, which is the more coveted label claim.

Last, ECRI is encouraged to provide guidance in this upcoming report about the FDA’s warning letter, dated May 15, 2008, stating that the STERIS System 1 and its chemical agent are “adulterated” and “misbranded.”^40,41 In truth, few discussions about infection control, endoscope reprocessing, and the safety of AERs would be of greater importance to public health and to the prevention of infections, both in the flexible endoscopic (e.g., GI, urology, pulmonary) and operating room settings, than such timely guidance.⁴⁰

FINAL WORD:  The findings of this review suggest that ECRI’s evaluation lacks balance and objectivity, overstating the STERIS Reliance EPS’s safety and effectiveness. The shortcomings and accolades identified in Tables 1 and 2 (which are available by clicking here),  respectively, were unexpected in part because ECRI Institute’s advertised mission, which is impressive and intriguing—see: ECRI’s recently published list of “hospital hazards,”⁴²—would appear to be well-suited to satisfying the public’s ardency for independent¹⁴ and objective evaluations of infection-control products. Greater transparency and more rigorous management of conflicts of interest are recommended, to improve the quality, validity and objectivity of all types of product evaluations and healthcare guidelines.

This blog’s references are available here.

Blog by: Lawrence F Muscarella PhD posted on 12-18-2012; updated 9/25/2013