BACKGROUND: This blog by Lawrence F Muscarella, PhD, discusses his comprehensive review of a published evaluation of the STERIS Reliance Endoscope Processing System (“EPS”; Steris Corp., Mentor, OH), which is a currently-marketed automated endoscope reprocessor, or AER, labeled to wash and high-level disinfect gastrointestinal (GI) endoscopes.1
The blog, which is the second in a series of two, complements and is to be read in conjunction with the first blog in this series—“Let Sleeping Dogs Lie?”—which can be read by clicking here.2
Discussing a topic similar to the one recently addressed in a front-page newspaper article about “watchdog” firms and their working relationships with the companies whose products these firms evaluate and rate,3 this blog encourages non-profit healthcare institutes and organizations (in the field of infection control) to manage more rigorously potential conflicts of interest.
This blog acknowledges, however, that not every conflict can necessarily be eliminated. In these instances, these institutes and organizations are encouraged to disclose in the text of their product evaluations or infection-control guidelines, respectively, the details of any working relationships4 and financial associations, or interactions, they may have with manufacturers.5-13
Examples of such interactions that would warrant full disclosure include these healthcare institutes and organizations receiving money from manufacturers through educational research grants, advertising, honoraria, gifts, and/or free product samples.6,7
INTRODUCTION: The first blog in this series of two provide a shortened review of the “Up Close” column published in the September, 2008, issue of Healthcare Purchasing News (HPN).2,14 This column in HPN provides insight into the workings of the ECRI Institute (“ECRI”; Plymouth Meeting, PA), a non-profit healthcare institute that advertises itself to be modeled after, to have adopted the strict and uncompromising conflict-of-interest policies of, and to employ for its evaluations of medical products a rating scheme similar to that developed and used by Consumers Union (Yonkers, N.Y).2,14-21
Click here to read about having Dr. Muscarella improve the quality and safety of your GI endoscopy department through his expert confidential audits and reviews.
To avoid the conflicts of interest that working relationships with manufacturers can pose, Consumers Union, among other practices, anonymously purchases “off the shelf” all of the products it evaluates. The results of its evaluations are published in its monthly magazine Consumer Reports.2,3,6-12 To maintain its independence and objectivity and to ensure “no agenda other than the interests of consumers,” Consumers Union neither accepts free samples nor borrows from manufacturers the products it evaluates and rates.2 Its assertion that it models itself after Consumers Union notwithstanding,2 ECRI acknowledges having “working relationships”4 with manufacturers, which typically include borrowing from these manufacturers the medical devices it evaluates and rates (rather than purchasing these devices anonymously, or independently testing them in the clinical setting).
AIM: In January, 2007, the ECRI Institute published the results of its evaluation of the STERIS Reliance EPS.1 Because interactions and working relationships with manufacturers reportedly can introduce bias and result in the overstatement of a product’s performance,2,5-11,22 ECRI’s evaluation of the STERIS Reliance EPS was reviewed, to assess this evaluation’s clarity, validity and objectivity.
This blog does not evaluate the performance of the STERIS Reliance EPS; rather it reviews ECRI’s evaluation of this device. Moreover, this blog is a shorten version of a more complete article, which can be read in its entirety, along with its several box articles, by clicking here.
Click here to download in its entirety the more complete PDF version of this blog, including Table 1 and Table 2 along with several box articles.
RESULTS: The Rating of an AER: ECRI’s evaluation provides a dual, if nuanced, rating for the STERIS Reliance EPS—the first of which is “preferred” for most healthcare facilities.1 ECRI’s evaluation provides a second rating, however, of “not recommended” (which is one of this institute’s three “acceptable” ratings) for healthcare facilities that use GI endoscopes marketed by Pentax (Montvale, NJ). (Pentax is one of the three primary manufacturers of GI endoscopes sold in the U.S. The other two are Olympus [Center Valley, PA] and Fujinon [Wayne, NJ].)
According to ECRI, this second, less enthusiastic rating is warranted because of “compatibility concerns” and the potential for the STERIS Reliance EPS to cause endoscope damage that might void Pentax’s warranty.1
DISCUSSION: ECRI’s evaluation rates the presumed performance and safety of the STERIS Reliance EPS.1 Whether this new model may prove in time to be the most effective and safest AER on the market, surpassing all others, remains to be determined. But ECRI’s evaluation is, at times, confusing, if not inconsistent, and its rating and conclusions are challenging to reconcile and understand. Table 1 lists several of this evaluation’s salient shortcomings, oversights and omissions—two of which, in particular, not only compromise this evaluation’s published aims, but also call into question its validity and objectivity.
Remember that Table 1 is only available in the more complete version of this blog, which can be downloaded by clicking here.
A. A singularly evaluated AER: For example, one of this evaluation’s primary aims was to assess the STERIS Reliance EPS’s “advantages and disadvantages compared with other (HLD) AER units” and to determine whether the Reliance EPS both “offers meaningful advantages” compared to other marketed AER models and “is any more or less likely than ‘traditional AERs’* to be used correctly.”1
Per this comparison and stated aim, ECRI rates the STERIS Reliance EPS preferred (for compatible endoscopes)—its highest rating awarded only to a product that “meets all major performance and safety criteria(,) has no serious shortcomings(,) and offers significant advantages over other alternatives.”1 *
*<Footnote:> This evaluation uniquely refers to these other marketed AER models as “traditional AERs” primarily because they use “multiple endoscope-specific connectors” to flush the endoscope’s channels with disinfectant.1 The Reliance EPS uses some of these connectors, but it also uses a “boot” to enclose the GI endoscope’s control head and flush the suction and air/water channels with disinfectant.1 This footnote applies to wherever the text is associated with a supra-scripted asterisk.)
The STERIS Reliance EPS uses endoscope-specific connectors as well as a “boot” (that encloses the GI endoscope’s control head) to flush the suction and air/water channels with disinfectant.1
Despite rating the Reliance EPS preferred (for compatible endoscopes) “based on a comparison with”1 these traditional AERs,* this evaluation confusingly fails to include any of these other marketed AER models, or “alternatives”* , sold in the U.S. by Olympus, Medivators (Minneapolis, MN), and Advanced Sterilization Products (Irvine, CA), among others. (The author of this review article is employed by another manufacturer of a traditional AER, one that is labeled to clean and high-level disinfect GI endoscopes and that also was not included in this evaluation.)
Explaining its exclusion of these traditional AERs,* ECRI’s evaluation states that “most of the models that are available function similarly to one another” and “AER technology has changed little in recent years.”1 But, the technologies employed by some of these traditional AERs, indeed, have markedly changed in recent years (which might have been revealed had ECRI’s evaluation included them and tested their performance).
The EvoTech Endoscope Cleaner and Reprocessor (“ECR”; Advanced Sterilization Products), for example, which was cleared by the FDA the same year as the Reliance EPS (2006), is uniquely labeled to automate the pre-cleaning of GI endoscopes.23 To be sure, the EvoTech ECR uses several endoscope-specific channel connectors, not a boot,* to flush the endoscope’s internal channels with disinfectant—a specific characteristic that this evaluation uses to classify a model as a disfavored traditional AER.1 * One of this evaluation’s most confusing qualities is its rating of the STERIS Reliance EPS preferred (for compatible endoscopes) in comparison with the EvoTech ECR and these other traditional AERs—none of which were evaluated and tested.
B. No microbiological tests performed: The Food and Drug Administration (FDA) requires that simulated in-use microbiological (and some clinical in-use) tests be performed to evaluate the performance and safety of an AER.24-28 Conducted under worst-case conditions using complex (GI) flexible endoscopes artificially contaminated with soil containing resistant microorganisms, these tests (designed to simulate the clinical setting) yield microbial log reductions that are the standard for evaluating the effectiveness of an AER’s disinfection cycle.24-28 This federal requirement notwithstanding, ECRI’s evaluation of the STERIS Reliance EPS, unlike other published evaluations of this same AER,24,25 did not perform these microbiological tests.1 In fact, this evaluation did not perform any performance tests, not even pressure-flow tests.
To be sure, the failure of ECRI’s evaluation to conduct these most important microbiological tests would certainly seem to belie its rating of the STERIS Reliance EPS preferred, compared to the presumed performance and safety of these other traditional AERs.* (For example, ECRI’s evaluation concludes that the STERIS Reliance EPS “offers compelling staff patient and staff safety advantages over traditional automated endoscope reprocessors”1and, too, “includes some unique features that distinguish it from”1 the traditional AERs.*)
But, this evaluation’s failure to perform any microbiological or performance tests—and, most certainly, its confusing exclusion of traditional AERs* (to which the STERIS Reliance EPS is somehow directly compared)—all the more moots the instruction in ECRI’s evaluation “strongly” recommending that healthcare facilities “purchase the Reliance EPS rather than a traditional AER”1 (see: Table 2).
Like Table 1, Table 2 is only available in the more complete version of this blog, which can be downloaded by clicking here.