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

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.

Understanding Preferences for Visualized New and Future HIV Prevention Products Among Gay, Bisexual and Other Men Who Have Sex with Men in the Southern United States: A Mixed-Methods Study.

Men who have sex with men (MSM) are vulnerable to HIV infection. Although daily oral pre-exposure prophylaxis (PrEP) prevents HIV among MSM, its usage remains low. We conducted virtual in-depth interviews (IDIs) and focus groups (FGs) with Black, Hispanic/Latino, and White MSM consisting of current PrEP users and those aware of but not currently using PrEP. We delved into their preferences regarding six emerging PrEP products: a weekly oral pill, event-driven oral pills, anal douche/enema, anal suppository, long-acting injection, and a skin implant. Our mixed methods analysis involved inductive content analysis of transcripts for thematic identification and calculations of preferences. Among the sample (n = 98), the weekly oral pill emerged as the favored option among both PrEP Users and PrEP Aware IDI participants. Ranking exercises during FGs also corroborated this preference, with the weekly oral pill being most preferred. However, PrEP Users in FGs leaned toward the long-acting injectable. Conversely, the anal suppository and douche/enema were the least preferred products. Overall, participants were open to emerging PrEP products and valued flexibility but expressed concerns about limited protection for products designed solely for receptive sex. Public health practitioners should tailor recommendations based on individuals' current sexual behaviors and long-term vulnerability to infection.

Overcoming Challenges to HIV Medical Care-seeking and Treatment Among Data-to-Care Program Clients in Baton Rouge and New Orleans, Louisiana.

ABSTRACT: Data to Care (D2C) uses US public health surveillance data to identify persons with diagnosed HIV who are not receiving adequate medical care. These persons are linked to care and ancillary social services through personalized outreach. We conducted semistructured interviews with 36 adults with HIV in Louisiana who were engaged for the first time or reengaged back into HIV care through D2C efforts. Before D2C program staff contact, nearly 40% were not contemplating HIV care. Program clients cited barriers to HIV care, including difficulties with appointment scheduling and transportation, health care service and drug costs, low motivation, and competing non-HIV health needs. Thirty-four of the 36 clients said that D2C staff helped them overcome these barriers. Clients also described psychosocial support from D2C staff. After receiving D2C program assistance, more than 90% of clients reported consistently receiving HIV medical care and taking medications. Our findings suggest that D2C staff successfully identified client needs and provided tailored assistance.

Utilization of HIV Prevention, Care, and Treatment Services Among Young Men Who Have Sex With Men and Transgender Persons of Color in the U.S. South: A Qualitative Analysis.

To better understand utilization of HIV prevention, care, and treatment services by young men who have sex with men (YMSM) and young transgender persons (YTG), of Black race or Hispanic/Latino/Latina ethnicity in the U.S. South, we conducted semi-structured interviews with 127 clients at one of four community based organizations (CBOs) in Miami, Atlanta, New Orleans/Baton Rouge, or Columbia, South Carolina. Across sites, the service that most commonly drew respondents into the CBO was HIV and STD testing. Other services commonly used included HIV/STI treatment, counseling services/support groups, and PrEP services. Social/organizational/structural facilitators of service utilization include the welcoming climate/culture of the CBOs, ease of access to the services, and transportation services to reach the CBOs. Suggested service enhancements include broader range of comprehensive, navigational-type services beyond HIV testing and service co-location. Research on how to reduce stigma in the surrounding communities may help reduce health disparities experienced by these populations.