Assessing organizational readiness for the Clean Cuts and Sharp Minds Collective: a barbershop health promotion network.

BACKGROUND: Black men have among the lowest life expectancy in the United States. Alarmingly, these men are underrepresented in health promotion efforts. There are well-documented barriers to recruiting and retaining Black men in health promotion efforts, such as exclusionary research practices - many researchers may be hesitant to reach Black men in culturally unique spaces, such as barbershops. Despite these practices, qualitative research among Black men unanimously find that Black men are interested in health promotion efforts. The Clean Cuts and Sharp Minds Collective (CCSMC) was designed to bridge this gap. The objectives of the CCSMC are to train barbers to be lay advocates for their clients, train barbers to be research partners, and serve as a nexus between barbers interested in health promotion at their shops and researchers interested in implementing such efforts. The present study sought to assess the organizational readiness of barbershops in South Carolina (SC) to participate in the CCSMC. METHODS: Barbers in SC were invited to complete a modified version of the Readiness Thinking Tool to assess organizational readiness to participate in the CCSMC. RESULTS: Thirty-six (36; mean age = 41.12; 94.4% identified as Black; 91.7% identified as male) barbers completed the organizational readiness assessment. Results indicated that there was a high level of motivation, innovation-specific capacity, and general capacity within barbershops to participate in the CCSMC. Additionally, many barbers indicated that there would be widespread support to join the CCSMC. CONCLUSIONS: The results from the present study highlight exciting opportunities and future directions for barbershop-academic partnerships. Such partnerships have the potential to promote health equity among, and in partnership with, Black men.

Lessons Learned From a Community-Based Men's Health Fair.

INTRODUCTION: Strategies are needed to promote the uptake of preventive health services among Black, Hispanic, and rural men because these men underutilize health services. Previous research indicates that men prefer community-based health promotion programming, such as health fairs; however, specific guidance on how to tailor health fairs for Black, Hispanic, and rural men are lacking. The present seeks to study provides that guidance. METHODS: A multisectoral team developed, implemented, and evaluated a men's health fair in a county of South Carolina with a sizeable Black, Hispanic, and rural-dwelling population. Although the health fair was open to all men in the county, specific outreach campaigns were implemented to attract Black and Hispanic men. The health fair occurred on Father's Day weekend in 2023 and consisted of health screenings, health information, and other resources (eg, condoms, research studies). Participants who attended the health fair were asked to complete a check-in survey (N = 103) that assessed demographic information and how they heard about the health fair, followed by a survey (N = 58) that assessed facilitators/barriers to participation in a men's health fair. RESULTS: Results were stratified by the gender of respondent. The results highlight the facilitators/barriers experienced by men to attending health fairs and also highlight important differences in facilitators/barriers for men to attend a health fair as perceived by men and women. CONCLUSIONS: These findings have implications for the design and implementation of future men's health fairs to promote preventive health service use among Black, Hispanic, and rural men.

US regulatory considerations for low field magnetic resonance imaging systems.

Although there has been a resurgence of interest in low field magnetic resonance imaging (MRI) systems in recent years, low field MRI is not a new concept. FDA has a long history of evaluating the safety and effectiveness of MRI systems encompassing a wide range of field strengths. Many systems seeking marketing authorization today include new technological features (such as artificial intelligence), but this does not fundamentally change the regulatory paradigm for MR systems. In this review, we discuss some of the US regulatory considerations for low field magnetic resonance imaging (MRI) systems, including applicability of existing laws and regulations and how the U.S. Food and Drug Administration (FDA) evaluates low field MRI systems for market authorization. We also discuss regulatory considerations in the review of low field MRI systems incorporating novel AI technology. We foresee that MRI systems of all field strengths intended for general diagnostic use will continue to be evaluated for marketing clearance by the metric of substantial equivalence set forth in the premarket notification pathway.

Evaluation of Apparatus Used to Test Liquid through Protective Materials: Comparison of a Modified Dot-Blot Apparatus to the ASTM Penetration Cell.

Personal protective equipment (PPE), such as gowns used in the latest Ebola outbreak in Western Africa, are critical in preventing the spread of deadly diseases. Appropriate test systems and test soils are needed to adequately evaluate PPE. ASTM F903, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Liquid, has been used for decades to test fabrics' resistance to liquid penetration. However, this test apparatus requires at least 60 mL of test solutions, is labor intensive, and has problems with leakage around the gaskets. We compared the F903 test apparatus to a modified dot-blot apparatus to evaluate the visual penetration of a blood test soil. A series of commercially available gowns and drapes were tested in each apparatus. Using blood test soil at 2 psi, there was no statistically significant difference between the two methods except for in one gown. By comparing this gown in the ASTM test apparatus with and without a screen, the particular screen selected did not account for the difference between the dot-blot and F903 apparatuses; however, it is conceivable that a particular screen/fabric combination could account for this difference. The modified dot-blot apparatus was evaluated using three different test solutions: blood, vomit, and a labeled protein (goat anti-rabbit immunoglobulin G-horseradish peroxidase [GaR IgG-HRP]) in a blood test soil solution. This testing revealed significant difference in penetration for some of the PPE garments. The modified dot-blot had several large advantages over the ASTM apparatus-over six times less specimen volume and no edge or gasket leakage. In addition, nitrocellulose can be easily incorporated into the modified dot-blot apparatus, enabling the trapping of viruses and proteins that penetrate PPE-thus permitting the use of antibodies to quickly and sensitively detect penetration.

Surface orientation effects on bending properties of surgical mesh are independent of tensile properties.

INTRODUCTION: Current mechanical testing of surgical mesh focuses primarily on tensile properties even though implanted devices are not subjected to pure tensile loads. Our objective was to determine the flexural (bending) properties of surgical mesh and determine if they correlate with mesh tensile properties. METHODS: The flexural rigidity values of 11 different surgical mesh designs were determined along three textile directions (machine, cross-machine, and 45° to machine; n = 5 for each) using ASTM D1388-14 while tracking surface orientation. Tensile testing was also performed on the same specimens using ASTM D882-12. Linear regressions were performed to compare mesh flexural rigidity to mesh thickness, areal mass density, filament diameter, ultimate tensile strength, and maximum extension. RESULTS: Of 33 mesh specimen groups, 30 had significant differences in flexural rigidity values when comparing surface orientations (top and bottom). Flexural rigidity and mesh tensile properties also varied with textile direction (machine and cross-machine). There was no strong correlation between the flexural and tensile properties, with mesh thickness having the best overall correlation with flexural rigidity. CONCLUSIONS: Currently, surface orientation is not indicated on marketed surgical mesh, and a single mesh may behave differently depending on the direction of loading. The lack of correlation between flexural stiffness and tensile properties indicates the need to examine mesh bending stiffness to provide a more comprehensive understanding of surgical mesh mechanical behaviors. Further investigation is needed to determine if these flexural properties result in the surgical mesh behaving mechanically different depending on implantation direction. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 106B: 854-862, 2018.

Response to Standardized MR Terminology and Reporting of Implants and Devices as Recommended by the American College of Radiology Subcommittee on MR Safety.

The U.S. Food and Drug Administration (FDA) continually works toward the goal of safety. For patients with magnetic resonance (MR) Conditional devices, safety is achieved when MR Conditional labeling is clear and accessible and can be unambiguously interpreted and applied. The FDA supports the three facets of standardization listed by the American College of Radiology (ACR) Subcommittee on MR Safety in their special report: (a) standardization in terminology and reporting of spatial gradient magnetic fields associated with MR systems; (b) standardization in reporting of ferromagnetic testing results for implants and devices; and (c) standardization, consistency, and clarity in radiofrequency power deposition guidelines and terminology. While the FDA is in agreement with the ACR Subcommittee on MR Safety that patient safety is of primary concern, the authors disagree with the Subcommittee on several important points and offer a point-by-point response to the Subcommittee's four recommendations. (©) RSNA, 2015.

ACR guidance document on MR safe practices: 2013.

Because there are many potential risks in the MR environment and reports of adverse incidents involving patients, equipment and personnel, the need for a guidance document on MR safe practices emerged. Initially published in 2002, the ACR MR Safe Practices Guidelines established de facto industry standards for safe and responsible practices in clinical and research MR environments. As the MR industry changes the document is reviewed, modified and updated. The most recent version will reflect these changes.

Standards for medical devices in MRI: present and future.

The purpose of this review is to define the current standards addressing safety of medical devices in MRI and to describe ongoing standards development efforts. The American Society for Testing and Materials (ASTM International) began developing standard test methods for determining the MR safety of medical devices in MRI in 1997. To date, five ASTM standards addressing testing and marking medical devices and other items for use in the MR environment have been published. International Standards Organization (ISO) 14630, the general requirements standard for nonactive surgical implants, is currently being revised to include information about MR safety of passive implants and to reference the ASTM standards. To address the unique safety issues of active implants, and in particular, active implants with leads, like pacemakers and neurostimulators, a joint working group between ISO TC150/SC6 on active implants and International Electrotechnical Commission (IEC) SC 62B MT40 on magnetic resonance equipment for medical diagnosis is working to develop a technical specification for active implantable medical devices (AIMDs) in MRI. While much progress has been made, work still needs to continue to develop a complete body of test methods to allow the evaluation of the safety of medical devices in the MR environment.

Effects on instruments of the World Health Organization--recommended protocols for decontamination after possible exposure to transmissible spongiform encephalopathy-contaminated tissue.

It has been recommended by the World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) that rigorous decontamination protocols be used on surgical instruments that have been exposed to tissue possibly contaminated with Creutzfeldt-Jakob disease (CJD). This study was designed to examine the effects of these protocols on various types of surgical instruments. The most important conclusions are: (1) autoclaving in 1N NaOH will cause darkening of some instruments; (2) soaking in 1N NaOH at room temperature damages carbon steel but not stainless steel or titanium; (3) soaking in chlorine bleach will badly corrode gold-plated instruments and will damage some, but not all, stainless-steel instruments, especially welded and soldered joints. Damage became apparent after the first exposure and therefore long tests are not necessary to establish which instruments will be damaged.

Residual ethylene oxide in medical devices and device material.

Ethylene oxide (EO) gas is commonly used to sterilize medical devices. The amount of residual EO remaining in a device depends partly on the type and size of polymeric material. A major concern is the amount of residue that may be available in the body. With the use of the method described by AAMI for headspace analysis of EO residues, different polymers and medical devices subjected to different numbers of sterilization cycles were examined. Next, the effect of various extraction conditions and extraction solutions on these polymers and medical devices was evaluated. The results showed different polymers desorb EO differently. One polyurethane (PU 75D) had much higher EO residue than a different polyurethane (PU 80A). Repeated extraction of the PU 75D was necessary to quantify total EO residue levels. Different extraction solutions influence the amount and reproducibility of EO detected, whereas multiple resterilizations showed no difference in amount of residual EO. Bioavailability of EO was estimated by extracting the devices and polymers in water. Comparison of total EO residues to EO that was bioavailable showed no difference for some polymers and devices, while others had an almost eightfold difference. Some standard biocompatibility tests were run on extracts and devices, but no significant effects were observed.

Effects of different disinfection and sterilization methods on tensile strength of materials used for single-use devices.

Driven by economic and time constraints, some medical centers and third parties are resterilizing single-use devices (SUDs) for reuse. The steam autoclave is quick, but most plastics used in SUDs cannot survive the temperature. Thus, a number of new methods of cleaning, disinfecting, and sterilizing these complex devices are being introduced on the market. The present study investigated the effects of a range of methods on the tensile strength of latex rubber, silicone elastomer, 2 different formulations of polyurethane, nylon, and high-density polyethylene (HDPE) specimens. The methods used were sodium hypochlorite bleach (Clorox), peracetic acid + hydrogen peroxide (Steris), formaldehyde gas (Chemiclave), low-temperature peracetic acid and gas plasma (Plazlyte), and low-temperature hydrogen peroxide gas plasma (Sterrad). The results showed that silicone elastomer was minimally affected, whereas the strengths of nylon, polyethylene, and latex were reduced by some of the methods. Depending on the formulation, the strength of polyurethane either increased or decreased. The data demonstrated that disinfection and sterilization can affect the tensile strength of certain materials used in medical devices.