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      Stakeholder perspectives on scaling up medical device reprocessing: A qualitative study

      research-article
      1 , 2 , * , , 3 , 4 , 5
      PLOS ONE
      Public Library of Science

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          Abstract

          Background

          The United States health care sector is one of the largest polluting industries, which has significant adverse effects on human health. Medical device reprocessing (MDR) is a sustainability solution that has the potential to decrease hospital waste, cut carbon emissions, reduce spending, and improve supply chain resiliency; however, only a small proportion of FDA-approved devices are actually reprocessed. Thus, we conducted a qualitative study to understand barriers and facilitators of scaling up MDR.

          Methods and findings

          We conducted in-depth interviews with 17 stakeholders (exceeding thematic saturation) at a large academic health system in New England and national MDR organizations. We also collected observations through site visits at the health system. We recruited participants from June 2021 to April 2022 through purposive sampling. Using an analytic approach guided by the Consolidated Framework for Implementation Research, we applied inductive and deductive codes related to key implementation constructs. We then conducted a thematic analysis and identified five overarching themes related to barriers and facilitators of MDR. First, respondents explained that regulatory bodies and original equipment manufacturers determine which devices can be reprocessed. For example, some respondents described that original equipment manufacturers use tactics of forced obsolescence that prevent their devices from being reprocessed. Second, respondents explained that MDR has variable compatibility with hospital priorities; for example, the potential cost savings of MDR is compatible with their priorities, while the perception of decreased functionality of reprocessed medical devices is incompatible. Third, respondents described that physician preferences influence which reprocessed devices get ordered. Fourth, respondents explained that variable staff knowledge and beliefs about MDR influence their motivations to select and collect reprocessable devices. Lastly, respondents emphasized that there was a lack of infrastructure for evaluating and maintaining MDR programs within their health system.

          Conclusions

          Based on our findings, we have outlined a number of recommendations that target these barriers and facilitators so that the environmental and financial benefits of MDR can be realized at this health system and nationally. For example, implementing federal policies that prevent original equipment manufacturers from using tactics of forced obsolescence can facilitate the scale-up of MDR nationally. Additionally, providing life cycle assessments that compare the environmental effects of single-use disposable, reprocessable disposable, and reusable devices could facilitate health systems’ purchasing decisions. Creating and disseminating audit and feedback reports to hospital staff might also facilitate their continued engagement in the program. Lastly, hiring a full-time program manager that leads MDR programs within health systems could improve program sustainability.

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          Most cited references20

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          Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups.

          Qualitative research explores complex phenomena encountered by clinicians, health care providers, policy makers and consumers. Although partial checklists are available, no consolidated reporting framework exists for any type of qualitative design. To develop a checklist for explicit and comprehensive reporting of qualitative studies (in depth interviews and focus groups). We performed a comprehensive search in Cochrane and Campbell Protocols, Medline, CINAHL, systematic reviews of qualitative studies, author or reviewer guidelines of major medical journals and reference lists of relevant publications for existing checklists used to assess qualitative studies. Seventy-six items from 22 checklists were compiled into a comprehensive list. All items were grouped into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. Duplicate items and those that were ambiguous, too broadly defined and impractical to assess were removed. Items most frequently included in the checklists related to sampling method, setting for data collection, method of data collection, respondent validation of findings, method of recording data, description of the derivation of themes and inclusion of supporting quotations. We grouped all items into three domains: (i) research team and reflexivity, (ii) study design and (iii) data analysis and reporting. The criteria included in COREQ, a 32-item checklist, can help researchers to report important aspects of the research team, study methods, context of the study, findings, analysis and interpretations.
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            Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science

            Background Many interventions found to be effective in health services research studies fail to translate into meaningful patient care outcomes across multiple contexts. Health services researchers recognize the need to evaluate not only summative outcomes but also formative outcomes to assess the extent to which implementation is effective in a specific setting, prolongs sustainability, and promotes dissemination into other settings. Many implementation theories have been published to help promote effective implementation. However, they overlap considerably in the constructs included in individual theories, and a comparison of theories reveals that each is missing important constructs included in other theories. In addition, terminology and definitions are not consistent across theories. We describe the Consolidated Framework For Implementation Research (CFIR) that offers an overarching typology to promote implementation theory development and verification about what works where and why across multiple contexts. Methods We used a snowball sampling approach to identify published theories that were evaluated to identify constructs based on strength of conceptual or empirical support for influence on implementation, consistency in definitions, alignment with our own findings, and potential for measurement. We combined constructs across published theories that had different labels but were redundant or overlapping in definition, and we parsed apart constructs that conflated underlying concepts. Results The CFIR is composed of five major domains: intervention characteristics, outer setting, inner setting, characteristics of the individuals involved, and the process of implementation. Eight constructs were identified related to the intervention (e.g., evidence strength and quality), four constructs were identified related to outer setting (e.g., patient needs and resources), 12 constructs were identified related to inner setting (e.g., culture, leadership engagement), five constructs were identified related to individual characteristics, and eight constructs were identified related to process (e.g., plan, evaluate, and reflect). We present explicit definitions for each construct. Conclusion The CFIR provides a pragmatic structure for approaching complex, interacting, multi-level, and transient states of constructs in the real world by embracing, consolidating, and unifying key constructs from published implementation theories. It can be used to guide formative evaluations and build the implementation knowledge base across multiple studies and settings.
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              Purposeful Sampling for Qualitative Data Collection and Analysis in Mixed Method Implementation Research.

              Purposeful sampling is widely used in qualitative research for the identification and selection of information-rich cases related to the phenomenon of interest. Although there are several different purposeful sampling strategies, criterion sampling appears to be used most commonly in implementation research. However, combining sampling strategies may be more appropriate to the aims of implementation research and more consistent with recent developments in quantitative methods. This paper reviews the principles and practice of purposeful sampling in implementation research, summarizes types and categories of purposeful sampling strategies and provides a set of recommendations for use of single strategy or multistage strategy designs, particularly for state implementation research.
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Writing – original draftRole: Writing – review & editing
                Role: Formal analysisRole: Writing – review & editing
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS One
                plos
                PLOS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                30 December 2022
                2022
                : 17
                : 12
                : e0279808
                Affiliations
                [1 ] Department of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, CT, United States of America
                [2 ] Yale School of Medicine, New Haven, CT, United States of America
                [3 ] Department of Social and Behavioral Sciences, Yale School of Public Health, New Haven, CT, United States of America
                [4 ] Department of Anesthesiology, Yale School of Medicine, New Haven, CT, United States of America
                [5 ] Department of Environmental Health Sciences, Yale School of Public Health, New Haven, CT, United States of America
                University of Miami, UNITED STATES
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Author information
                https://orcid.org/0000-0001-6855-0402
                Article
                PONE-D-22-15627
                10.1371/journal.pone.0279808
                9803114
                36584081
                c1f060b6-23f6-48a3-a49c-0d7af7c06cb9
                © 2022 Hennein et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 30 May 2022
                : 15 December 2022
                Page count
                Figures: 1, Tables: 2, Pages: 16
                Funding
                The authors received no specific funding for this work.
                Categories
                Research Article
                Biology and Life Sciences
                Bioengineering
                Biotechnology
                Medical Devices and Equipment
                Engineering and Technology
                Bioengineering
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                Medical Devices and Equipment
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                Medical Devices and Equipment
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                Research and Analysis Methods
                Research Design
                Qualitative Studies
                Engineering and Technology
                Equipment
                Measurement Equipment
                Custom metadata
                Data cannot be shared publicly because of potential loss of confidentiality. Data are available after receiving approval from the Yale IRB. Researchers who would like access to the data can email HRPP@ 123456yale.edu to gain approval to access the confidential data.

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