Patient safety may be compromised if study conclusions are generalized to products that make similar claims but have no equivalent research evidence

Amit Gefen, Nick Santamaria, Sue Creehan, Joyce Black

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

Abstract

This paper addresses a fundamentally important issue in health care, namely how to make informed decisions on product selection when two products, from different manufacturers, appear to be similar and have medical claims that sound comparable. In such cases, manufacturers of competing products often use each other’s evidence. They argue that the published evidence is generally applicable even if the original bioengineering tests and clinical trials were performed on a specific product, and no equivalence was obtained for their product that has similar medical claims. In this work, we use prophylactic dressings for pressure injury prevention as a good demonstrative example on how patient safety may be compromised if study conclusions are generally projected to such unstudied products. The medical device industry is regulated differently than the pharmaceutical industry, and consequently, voids in current medical device regulation are sometimes used to promote commercial interests. This paper analyzes gaps and potential pitfalls that occur where guiding documentations (e.g. guidelines, standards) do not cope well with medical technology. We explain how that can eventually lead to potential compromises to the well-being of patients, primarily if nurses are unaware of the aforementioned pitfalls. We conclude that currently, there is no alternative to rigorousness: Clinicians and decision-makers need to scrutinize up-to-date literature, decide which products have the best portfolio of bioengineering and clinical research to support the claims made, and which products have the best cost–benefit models. This is fundamentally different from simply buying the least expensive product because of appealing sale arguments.

Original languageEnglish (US)
Pages (from-to)37-45
Number of pages9
JournalJournal of Patient Safety and Risk Management
Volume24
Issue number1
DOIs
StatePublished - Feb 1 2019

Keywords

  • Guidelines
  • bioequivalence
  • medical devices
  • pharmaceuticals
  • pressure ulcers
  • prophylactic dressings

ASJC Scopus subject areas

  • Leadership and Management
  • Health(social science)
  • Health Policy

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