Letting sleeping dogs lie is usually prudent. But, awakening these dogs from a lazy afternoon nap and having them stand on all four legs is sometimes warranted and apt, in the idealistic view that important issues worth barking for are at hand.

Introduction

More and more often, infection-control guidelines disclose existing financial associations between the authors and manufacturers of infection-control and related products.

Examples of such financial associations with manufacturers include the receipt of funding through educational research grants, honoraria, conference travel, gifts, and product samples.[1-5]  An infection-control guideline’s publication of these financial associations suggests that the importance of such disclosure is no longer being undervalued or under-appreciated.

“Up Close”

The president and CEO of a non-profit healthcare institute (ECRI Institute) discusses the importance of strict conflict-of-interest policies in an article published in the “Up Close” column of the September, 2008, issue of the trade magazine Healthcare Purchasing News (HPN).[6]

This column also discusses this institute’s advertised mission to improve patient care by, among a number of other services, evaluating and rating the safety and effectiveness of medical devices, including those in the field of infection control.

For its evaluations of medical devices (which it publishes in its own a monthly journal), this healthcare institute emphasizes that it has modeled itself after, adopted the strict and uncompromising conflict-of-interest policies of, and employed for its healthcare product evaluations a paradigm, style, and rating scheme similar to those developed and used by, Consumers Union (Yonkers, N.Y)[6-11]—the publisher of the popular monthly consumer magazine Consumer Reports.

Click here to read Dr. Muscarella’s review of one of ECRI Institute’s medical device evaluations.

The president of the this healthcare institute states in this column in HPN that “hundreds of hospitals, health insurers, and Ministries of Health get evidence-based guidance and vital insight on the ever-changing healthcare landscape” from this institute’s evaluations of medical devices and other services.[6]

In addition to discussing this  institute’s ability to “marry practical experience and uncompromising independence with the thoroughness and objectivity of evidence-based research,”[6] this president asserts that “accurate, reliable research does not live in environments where conflicts of interest are present. Period.”[6,7]

This observation is both singular and exceptional, and this institute’s advertised commitment to both the “discipline of science”[6,12] and the “integrity of independence”[11,12] is outstanding and invites respect, support, and praise. Few endeavors to improve patient care would be as noble and worthwhile.

Integral to its advertised repudiation of conflicts of interest and mission to ascribe in lockstep to the unrivaled standard of objectivity established by Consumers Union, this healthcare institute claims to be “completely independent”[6] of and to have no financial associations with medical device manufacturers.[6-13]

The integrity and scientific merit of this institute’s published evaluations and ratings of the safety and effectiveness of medical devices, including automated endoscope reprocessors (or, AERs),[14] are based on the verity, or genuineness, of this advertised ethos.

In addition to noting its claimed approbation of Consumers Union’s revered model of uncompromising independence for its evaluations of medical devices.[6-11] the president of this healthcare institute details in this “Up Close” column in HPN this institute’s existential journeys and the self-actualization of its “DNA.”[6]

The expression of this institute’s genotype would appear at times responsible for the impressive impact of some of its published research.  Remnants of the devil can, at times, be entangled in the details,[15] however, and one’s definition of a “conflict of interest” and “uncompromising independence”[6,7,11,12] may differ from another’s (see: Box A, below).

“Working relationship”?

Notwithstanding its claim to “avoid conflicts of interest like, well, the plague,”7 to be “completely independent,”[6] and to have adopted Consumers Union’s model for its product evaluations,[6-11] ECRI Institute acknowledges (arguably, confusingly) having “working relationships”[13] with manufacturers (albeit “at financial arm’s length”[13]).

Whether an institute that has working relationships[13] with manufacturers can be “completely independent”[6] of their influence is a matter of debate.

Some may argue that having working relationships[13] with manufacturers is all but required of a non-profit institute that evaluates and rates the safety and effectiveness of competing medical devices, to ensure the publication of accurate data.

At first glance, such an institute’s policy would appear reasonable and pragmatic, if not cost-effective.  But, it is the execution of this policy, not its written words, that holds the truth and, if their fine details are opaque, cryptic or inadequately disclosed, working relationships[13] with manufacturers can present conflicts and introduce bias that belie trust and understanding.[1-5,16-20]

Consumers Union: To buy or not to buy?  

Recognizing that interactions (e.g., working relationships) with manufacturers can present challenges, Consumers Union does not accept revenue from advertising.[21,22]

Nor does it accept from competing manufacturers gifts or free samples of products for an evaluation, claiming to prohibit these activities to ensure having “no agenda other than the interests of consumers.”[21,22]

To “remain unbiased from commercial influence” and maintain its “independence and impartiality,” Consumers Union instead anonymously purchases “off the shelf” all of the products it evaluates and rates for publication in its monthly magazine Consumer Reports.[21-23]

The president of this healthcare institute (ECRI Institute) similarly states that its “monthly journal accepts no advertising from any source.”[6] (But, in fairness, is revenue from advertising the only “currency” of influence?)

This institute’s policy vis-à-vis advertising is part and parcel to its aforementioned and frequent claim to employ Consumers Union’s model of objectivity, excellence, and independence (ECRI Institute’s “working relationships”13with manufacturers notwithstanding).[6-13]

Nevertheless, despite claiming to have adopted the model established by Consumers Union[6-11]—which, as previously mentioned, prohibits accepting gifts or free samples from competing manufacturers for a product evaluation[21-23]—the ECRI Institute typically borrows from each respective manufacturer the medical devices it ordinarily tests and rates for an evaluation.[24]  (That this institute does not purchase the medical devices it evaluates is not easily identifiable and is not disclosed in the text of its product evaluations.[14])

Although some medical devices can admittedly be expensive to purchase and the costs associated with an evaluation of their safety and effectiveness all but prohibitive, published studies suggest that the acceptance of gifts or free product samples from manufacturers can be “ethically challenging”[16] and pose conflicts of interest potentially at odds with objectivity and “dispassionate”4 critical analysis.[5,18-20,25]

(Whether any of the medical devices submitted for an evaluation might have been modified by its manufacturer to enhance artificially and unfairly its performance and obtain an unfair advantage, potentially skewing the evaluation’s ratings and results, is plausible and cannot typically be determined or ruled out.)

Specifically, these published studies suggest that interactions with manufacturers including receiving from them gifts or product samples can (but, again, do not necessarily) introduce biases that may cause the benefits of a product to be “overstated.”[4] 

Indeed, interactions with manufacturers can affect behavior and outcomes, and if not rigorously managed and disclosed, these interactions can result in improper commercial influence and a loss of objectivity.[4,5,16,18-20]

… But, let’s get back to the sleeping dogs.

Disclosure and Perspective

As some of you may know, Dr. Muscarella, the author of this article, was employed in the early 1990s by the ECRI Institute discussed in this “Up Close” column in HPN,[6] believing in this institute’s advertised mission to improve patient care by doing what is right through a commitment to objectivity and fairness.

But, reasonable differences in his respective definition of a conflict of interest, the execution of “uncompromising independence” (see: Box A, below) and the appropriateness of capitulation and showing deference to a manufacturer during the evaluation of its medical device soon became apparent,[26]

In Dr. Muscarella’s view, the name Consumers Union is synonymous with objectivity, a sobriquet for fairness, a moniker for independence. Its name and mission connote an inflexible code of ethics and policies intended to engender an uncompromising passion and commitment to the interests of the public.

Therefore, healthcare institutes that evaluate infection-control products have, in Dr. Muscarella’s opinion, a fiduciary responsibility, once they claim to employ Consumers Union’s model, to have no working relationships[13] or financial associations with manufacturers of infection-control products, except, possibly, those that are infeasible to eliminate and, to be sure, explicitly and forthrightly disclosed.

(An example of such a disclosure might be to publish in its text as a footnote that the published evaluation of medical devices was developed and performed working and in collaboration with manufacturers, who provided their devices as free samples due to their high price.)

Further, because working relationships[13] or financial associations with manufacturers are not universally defined terms (see: Box A, below), healthcare institutes with them can cause confusion and misunderstanding.

Recommendations and Conclusions 

The efforts of institutes, organizations and consultants entrusted to provide independent recommendations and evaluations of the safety and effectiveness of medical devices and infection-control products are to be enthusiastically respected and supported. (On the topic of full disclosure, Dr. Muscarella is an infection-control consultant and evaluator of medical products. Click here to view a list of his quality services.)

To enhance the deliverance of their stated missions, however, it is recommended that these institutes, organizations, and consultants, among other considerations, adopt strict conflict-of-interest policies.[25]

The endorsement or mere mention of a product in an evaluation or infection-control guideline can be a powerful marketing tool. Openness and transparency about any associations between these institutes, organizations, and consultants and manufacturers of infection-control products are recommended.[4,17,18]

To be sure, some manufacturers employ healthcare experts whose knowledge is indispensable and whose contributions to the safety of medical devices are undeniable, if not also potentially unrivaled. To preclude these experts from participating in a device’s evaluation or the writing of a guideline would be myopic and a public-health disservice.

Indeed, financial associations and working relationships with manufacturers do not preclude the advancement of knowledge and scientific integrity, provided such interactions—for example, institutes accepting free samples of medical devices from several competing manufacturers for an evaluation—are rigorously managed and fully disclosed.[16,25]

Finally, to avoid confusion and misunderstanding, healthcare institutes, infection-control organizations and consultants are encouraged to clarify and publish their respective definitions of a conflict of interest, explaining which specific practices are expressly permitted and prohibited (see: Box A). These are important times. The public is counting on our commitment to fairness, objectivity, and doing what is right.

This article’s references are available here.

Article by: Lawrence F Muscarella PhD posted on 12-17-2012; updated 7-29-2015, Rev A.



Box A. A conflict of interest?

A “conflict of interest” can be simply defined as a person or an organization, institute, or agency in a position of trust and authority having two conflicting duties. (An example would be an attorney representing both the plaintiff and the defendant.) The integrity, objectivity, and usefulness of a healthcare guideline, or the evaluation and rating of a medical device, depend on the sponsoring organization or testing institute, respectively, having in place strict policies to manage and control any conflicts of interest that may arise.

Conflicts that are fully acknowledged and disclosed can be appropriately managed and mitigated, if not eliminated. Those that are overlooked, ignored, and not disclosed, however, in addition to betraying the public’s trust and expectations, are inconsistent with objective scientific research and would raise doubts about the organization’s or testing institute’s mission.[4,5,16,18]

Different interests may define a “conflict of interest”[6,7] differently, however, clouding waters that are already (unnecessarily) muddy. One perspective may deem its definition, like that of “uncompromising independence,”[6] to be inexorably fixed, literal, and not subject to compromise or qualification,[4] viewing a conflict of interest as an emergent contagion of objectivity. (Refer to the main article, above.)

An opposing perspective, however, may interpret the definition of a conflict of interest in more of a contextual and conditional light, permitting sculpturing and compromise to fit inconstant circumstances. This latter perspective may view a conflict of interest instead as a means to an end, a potential opportunity for personal gain that does not require disclosure.

These two dichotomic perspectives bring into focus the importance of infection-control organizations, healthcare institutes, and consultants that evaluate medical devices clearly defining and publishing their respective definition of a conflict of interest, to avoid confusion and misunderstanding.

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