دورية أكاديمية
أعرض في EDS

Communicating medical device recalls: A rapid review of the literature.

التفاصيل البيبلوغرافية
العنوان: Communicating medical device recalls: A rapid review of the literature.
المؤلفون: Tennant BL; Public Health Practice, Westat, Rockville, MD, USA. Electronic address: BethanyTennant@westat.com., Tesfaye CL; Public Health Practice, Westat, Rockville, MD, USA., Chansky MC; Public Health Practice, Westat, Rockville, MD, USA., Lappin B; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA., Weinberg J; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA., Ritchey ME; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA., MacLennan L; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA., Tarver ME; Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, USA.
المصدر: Patient education and counseling [Patient Educ Couns] 2024 Jun; Vol. 123, pp. 108244. Date of Electronic Publication: 2024 Mar 06.
نوع المنشور: Journal Article; Review
اللغة: English
بيانات الدورية: Publisher: Elsevier Country of Publication: Ireland NLM ID: 8406280 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-5134 (Electronic) Linking ISSN: 07383991 NLM ISO Abbreviation: Patient Educ Couns
أسماء مطبوعة: Publication: Limerick : Elsevier
Original Publication: Princeton, N.J. : Excerpta Medica, c1983-
مواضيع طبية MeSH: Medical Device Recalls* , Patient Participation*, United States ; Humans ; United States Food and Drug Administration ; Consensus
مستخلص: Objectives: The U.S. Food and Drug Administration (FDA) currently regulates more than 190,000 different medical devices. Like all products, these devices may be subject to manufacturing problems, flawed designs, or new and unexpected risks, which in some cases require devices to be recalled. In 2021, the FDA's Patient Engagement Advisory Committee (PEAC) recommended that the FDA consider changes to the communication approach used for medical device recalls to make them more patient-focused, timely, and action-oriented.
Methods: To support this recommendation, we conducted a rapid review of literature published from 2008-2022 to capture and examine information on risk communication approaches, methods, and best practices for recall-related communications about medical products.
Results: We identified 23 articles to include in our review.
Conclusion: Our review found a lack of research-based studies as well as gaps in understanding about consumer perspectives, comprehension, and communication preferences related to recalls. Despite these limitations, we identified current communication approaches, numerous challenges, and recommendations for communicating medical products recall information to consumers.
Practice Implications: Further research is needed to assess consumer attitudes, understanding, and preferences and to reach consensus on best practices for effectively communicating recall information to consumers of medical products.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 Elsevier B.V. All rights reserved.)
فهرسة مساهمة: Keywords: Drugs; Medical device; Recalls; Risk communication
تواريخ الأحداث: Date Created: 20240314 Date Completed: 20240408 Latest Revision: 20240408
رمز التحديث: 20240408
DOI: 10.1016/j.pec.2024.108244
PMID: 38484598
قاعدة البيانات: MEDLINE
الوصف
تدمد:1873-5134
DOI:10.1016/j.pec.2024.108244