Device safety assessment of bronchoscopic microwave ablation of normal swine peripheral lung using robotic-assisted bronchoscopy.

INTRODUCTION: The aim of this study was to assess the safety of bronchoscopic microwave ablation (MWA) of peripheral lung parenchyma using the NEUWAVE™ FLEX Microwave Ablation System, and robotic-assisted bronchoscopy (RAB) using the MONARCH™ Platform in a swine model. METHODS: Computed tomography (CT)-guided RAB MWA was performed in the peripheral lung parenchyma of 17 Yorkshire swine (40-50 kg) and procedural adverse events (AEs) documented. The acute group (day 0, n = 5) received 4 MWAs at 100 W for 1, 3, 5, and 10 min in 4 different lung lobes. Subacute and chronic groups (days 3 and 30, n = 6 each) received one MWA (100 W, 10 min) per animal. RESULTS: The study was completed without major procedural complications. No postprocedural AEs including death, pneumothorax, bronchopleural fistula, hemothorax, or pleural effusions were observed. No gross or histological findings suggestive of thromboembolism were found in any organ. One 3-Day and one 30-Day swine exhibited coughing that required no medication (minor AEs), and one 30-Day animal required antibiotic medication (major AE) for a suspected lower respiratory tract infection that subsided after two weeks. CT-based volumetric estimates of ablation zones in the acute group increased in an ablation time-dependent (1-10 min) manner, whereas macroscopy-based estimates showed an increasing trend in ablation zone size. CONCLUSION: The NEUWAVE FLEX and MONARCH devices were safely used to perform single or multiple RAB MWAs. The preclinical procedural safety profile of RAB MWA supports clinical research of both devices to investigate efficacy in select patients with oligometastatic disease or primary NSCLC.

Use, Safety Assessment, and Implementation of Two Point-of-Care Tests for COVID-19 Testing.

OBJECTIVES: The Abbot ID NOW COVID-19 assay and Quidel Sofia 2 SARS Antigen FIA are point-of-care assays that offer rapid testing for severe acute respiratory syndrome coronavirus 2 viral RNA and nucleocapsid protein, respectively. Given the utility of these devices in the field, we investigated the feasibility and safety of using the ID NOW and Sofia assays in the public health response to the coronavirus disease 2019 pandemic and in future public health emergencies. METHODS: A combination of utilization and contamination testing in addition to a review of instrument workflows was conducted. RESULTS: Utilization testing demonstrated that both tests are intuitive, associated with high user test success (85%) in our study, and could be implemented by staff after minimal training. Contamination tests revealed potential biosafety concerns due to the open design of the ID NOW instrument and the transfer mechanisms with the Sofia. When comparing the workflow of the ID NOW and the Sofia, we found that the ID NOW was more user-friendly and that the transfer technology reduces the chance of contamination. CONCLUSIONS: The ID NOW, Sofia, and other emerging point-of-care tests should be used only after careful consideration of testing workflow, biosafety risk mitigations, and appropriate staff training.

A simple apparatus for safety assessment of magnetically induced torque on active implantable medical devices (AIMDs) under 1.5 T and 3.0 T MRI.

OBJECTIVE: Our goal is to design and validate a simple apparatus for the safety assessments of magnetically induced torques by four active implantable medical devices (AIMDs) in 1.5 T and 3.0 T magnetic resonance imaging (MRI) environments. MATERIALS AND METHODS: A simple apparatus was designed to measure the magnetically induced torque. Before testing the apparatus, its effectiveness was first evaluated with a commercially available weights. The torque values of the four AIMDs, namely implantable cardioverter defibrillator (ICD), pacemaker, bone conduction implant, and cochlear implant, under 1.5 T and 3.0 T MRI environments were measured and compared with established international standard. RESULTS: The ICD, pacemaker, bone conduction implant, and cochlear implant had average torques of 1.405, 0.255, 9.460, and 5.490 N·cm under 1.5 T MRI and 2.950, 0.668, 14.618, and 11.484 N·cm under 3.0 T MRI, respectively. DISCUSSION: The apparatus developed in this study was verified to be feasible for measuring magnetically induced torques, with tests on four types of AIMDs under 1.5 T and 3.0 T MRI environments. Although the designed structure is simple, the apparatus was shown to measure torque values of AIMDs under MRI accurately.

[Comparison Study between the Second and First Editions of ISO/ TS 10974-Assessment of the Safety of Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device].

ISO/TS 10974 is a general international technical specification (TS) which concentrates on the safety assessment of magnetic resonance imaging (MRI) for active implantable medical devices. ISO/TS 10974 Ed.2 was published in 2018 with substantial revision to Ed.1. To provide a guideline for adopting this recently revised TS in practice, this paper summarized the major changes and analyzed the technical improvements in Ed.2. Moreover, we also discussed current and emerging challenges to MRI safety evaluation remaining in Ed.2. The study revealed the consistency between these two editions with respect to classification of potential patient hazards and testing strategies, whereas Ed.2 has many methodological improvements over Ed.1 in testing methods for RF-induced heating, gradient-induced malfunction, and combined field testing, etc. However, it is still necessary to expand the scope of applicability and to adopt latest research findings into this TS to keep pace with the rapid developments in industry, making it a better guidance in the future.

A Multicenter Randomized Controlled Trial Comparing Safety, Efficacy, and Cost-effectiveness of the Surgisis Anal Fistula Plug Versus Surgeon's Preference for Transsphincteric Fistula-in-Ano: The FIAT Trial.

OBJECTIVE: To undertake a randomized comparison of the Biodesign Surgisis anal fistula plug against surgeon's preference in treating cryptoglandular transsphincteric fistula-in-ano. SUMMARY BACKGROUND DATA: The efficacy of the Biodesign Surgisis anal fistula plug in healing anal fistulae is uncertain. METHODS: Participants were randomized to the fistula plug with surgeon's preference (advancement flap, cutting seton, fistulotomy, Ligation of the Intersphincteric Fistula Tract procedure). The primary outcome was faecal incontinence quality of life (FIQoL) at 12-months. Secondary outcomes were fistula healing, incontinence rates, and complication and reintervention rates. RESULTS: Between May 2011 and March 2016, 304 participants were randomized to fistula plug or surgeon's preference. No differences were seen in FIQoL between the 2 groups at 12 months. Clinical fistula healing was reported in 66/122 (54%) of the fistula plug and 66/119 (55%) of the surgeon's preference groups at 12 months. Fecal incontinence rates improved marginally in both the groups. Complications and reinterventions were frequent, with significantly more complications in the fistula plug group at 6-weeks (49/142, 35% vs 25/137, 18%; P=0.002). The mean total costs were £2738 (s.d. £1151) for the fistula plug and £2308 (s.d. £1228) for the surgeon's preference group (mean difference +£430, P=0.0174). The average total quality adjusted life years (QALYs) gained was marginally higher in the fistula plug group. The fistula plug was 35% to 45% likely to be cost-effective across a willingness to pay threshold of £20,000 to £30,000 / QALY. CONCLUSIONS: The Biodesign Surgisis anal fistula plug is associated with similar FIQoL and healing rates to surgeon's preference at 12 months. Higher costs and highly uncertain gains in QALYs mean that the fistula plug may not be considered as a cost-effective treatment in the UK NHS.

Reúso de dispositivos médicos de uso único e implicações para a segurança do paciente / Reuse of single use medical devices and implications for patienty safety / Reutilización de dispositivos médicos de uso individual e implicaciones para la seguridad del paciente

Objetivo: Descrever aspectos do reúso dos dispositivos médicos de uso único e as implicações dessa prática para a segurança do paciente. Método: Ensaio acadêmico, utilizando dados de revisão integrativa e expertise da autora. Resultados: O reúso de produtos de uso único é realidade mundial e ocasiona debates regulatórios, técnicos, econômicos, éticos e de segurança do paciente, denotando diversos interesses dos distintos atores envolvidos: Estado, fabricantes, serviços de saúde, academia, profissionais e usuários. Embora haja risco teórico, dados não identificam relação causal entre evento adverso e reúso desses produtos. Existem argumentos a favor e contra que compreendem riscos e benefícios e justiça distributiva e social. O rótulo desses produtos representa nó crítico e elemento fomentador dos dilemas que permeiam essa prática. Conclusão: Há consenso de que o reúso de um produto médico deve ter o mesmo padrão de segurança, independentemente se rotulado como de uso único ou de multiuso. Alguns produtos ditos de uso único podem ser seguramente reusados, mas essa prática requer condições organoestruturais dos serviços de saúde, além de expertise, adoção de protocolos e supervisão dessas atividades.

Objective: to describe aspects of the reuse of single-use medical devices and implications for patient safety. Method: academic essay, using integrative review data and author's expertise. Results: the reuse of single-use products is a worldwide reality and causes regulatory, technical, economic, ethical and patient safety debates, denoting several interests of the different actors involved: State, manufacturers, health services, academia, professionals and users. Although there is a theoretical risk, data do not identify a causal relationship between adverse events and reuse of these products. There are arguments for and against and are involved: risks and benefits, distributive and social justice. The label of these products represents a critical node and fomenting element of the dilemmas that permeate this practice. Conclusion: There is consensus that the reuse of a medical product should have the same safety standard, regardless of whether labeled as single-use or multipurpose. Some so-called single-use products can be safely reused, but this practice requires organo-structural conditions of health services, as well as expertise, adoption of protocols and supervision of these activities.

Objetivo: Describir aspectos de la reutilización de dispositivos médicos de un solo uso e implicaciones para la seguridad del paciente. Método: ensayo académico, utilizando datos de revisión integradores y la experiencia del autor. Resultados: La reutilización de productos de un solo uso es una realidad mundial y provoca debates regulatorios, técnicos, económicos, éticos y de seguridad del paciente, que denotan diversos intereses de los diferentes actores involucrados: Estado, fabricantes, servicios de salud, academia, profesionales y usuarios. Aunque existe un riesgo teórico, los datos no identifican una relación causal entre el evento adverso y la reutilización de estos productos. Hay argumentos a favor y en contra y están involucrados: riesgos y beneficios, justicia distributiva y social. La etiqueta de estos productos representa un nodo crítico y un elemento que fomenta los dilemas que impregnan esta práctica. Conclusión: Existe un consenso de que la reutilización de un producto médico debe tener el mismo estándar de seguridad, independientemente de si está etiquetado como de uso único o multipropósito. Algunos de los llamados productos de un solo uso pueden reutilizarse de manera segura, pero esta práctica requiere condiciones organoestructurales para los servicios de salud, además de experiencia, adopción de protocolos y supervisión de estas actividades.

Assessment of Data Sources That Support US Food and Drug Administration Medical Devices Safety Communications.

Importance: Medical Device Safety Communications (MDSCs) are used by the US Food and Drug Administration (FDA) to convey important new safety information to patients and health care professionals. The sources of initial safety signals that trigger MDSCs have not been described previously. Objective: To assess the sources of initial safety signals that trigger publication of MDSCs and the potential associations among MDSC data source, type of safety issue, and subsequent FDA action. Design, Setting, and Participants: In this cross-sectional study, all MDSCs published on the FDA website between January 1, 2011, and December 31, 2019, were assessed. The MDSC characteristics, sources of initiating safety signals, regulatory approval or clearance pathways of the related medical devices, and subsequent FDA actions were collected from the FDA website. Main Outcomes and Measures: The main outcome was the distribution of sources of initial safety signals that led to publication of MDSCs. Secondary aims included exploration of potential associations among safety signal sources (direct reporting vs other), type of safety issue (death vs other), and FDA action (withdrawal vs other). Results: A total of 93 MDSCs were evaluated. Median time from device approval to MDSC posting was 10 years (interquartile range, 6-16 years). The most common data sources that triggered MDSCs were direct reports to the FDA through the Medical Device Reporting (MDR) program (44 of 93 [47%]) followed by regulator-initiated assessments (32 [34%]). Common safety issues included patient injury (25 [27%]), potential wrong diagnoses (19 [20%]), and death (18 [19%]). Frequent FDA action after MDSC posting included recommendation for increased vigilance and caution (47 [51%]), complete device withdrawal (12 [13%]), and warnings of specific lots or clinics (12 [13%]). There was a statistically significant correlation between direct reports of adverse events to the FDA through the MDR program and risk of death as a safety issue (14 of 44 [32%] for direct reporting vs 4 of 49 [8%] for any other data sources, P = .007). Conclusions and Relevance: In this cross-sectional study, the most common source of initial safety signals that triggered MDSCs was direct reports of real-world adverse events to the FDA through the MDR program. The delayed detection of postmarketing adverse events highlights the importance of proactive identification of emerging device-related safety issues.

From Concept to Counter: A Review of Bringing an Orthopaedic Implant to Market.

Physicians offer unique contributions to the orthopaedic implant design process by providing creative ideas and insightful clinical expertise. This article provides a brief overview of the pertinent considerations of transforming a concept into an orthopaedic implant and bringing it to the market. Implant concept choice should consider medical or surgical necessity, regional variability, market characteristics, cost of goods sold, and average selling price. Implant development requires adherence to regulatory requirements and device classification. Implant production incorporates design specifications, mechanical testing, sterilization, packaging, and marketing and sales. Orthopaedic implant company agreements determine physician compensation through royalties and/or the purchase of intellectual property. After rollout, physicians participate in monitoring for device safety. Bringing an orthopaedic implant from a concept to the market can be lengthy and complicated, but innovation is essential for advancing patient care and well-being.

Impact of Design on Medical Device Safety.

The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre- and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the design of MDs interacts with their safety profile and how this dipole of intended performance and safety may be supported by Human Factors Engineering (HFE) throughout the Total Product Life-Cycle (TPLC) of an MD in order to capitalize on medical technologies without exposing users and patients to unnecessary risks.

Improving Medical Risk Management Using Automotive Standards.

This paper provides a strategy for assessing systems through pulling on some of the techniques introduced in the ISO 26262: 2018[1] automotive functional safety standard. This will help improve and simplify the risk assessment and development activities of safety relevant medical devices. The approach is systems focussed and relates to medical devices that would come under the remit of IEC 60601-1[2], hence are defined as ME EQUIPMENT or ME SYSTEMS (medical electrical equipment that transfers energy to or measuring energy from the patient). The approach described demonstrates the great advantage of cross-sectoral learning and the efficiencies that can be created from doing so.

Generating comparative evidence on new drugs and devices after approval.

Certain limitations of evidence available on drugs and devices at the time of market approval often persist in the post-marketing period. Often, post-marketing research landscape is fragmented. When regulatory agencies require pharmaceutical and device manufacturers to conduct studies in the post-marketing period, these studies might remain incomplete many years after approval. Even when completed, many post-marketing studies lack meaningful active comparators, have observational designs, and might not collect patient-relevant outcomes. Regulators, in collaboration with the industry and patients, ought to ensure that the key questions unanswered at the time of drug and device approval are resolved in a timely fashion during the post-marketing phase. We propose a set of seven key guiding principles that we believe will provide the necessary incentives for pharmaceutical and device manufacturers to generate comparative data in the post-marketing period. First, regulators (for drugs and devices), notified bodies (for devices in Europe), health technology assessment organisations, and payers should develop customised evidence generation plans, ensuring that future post-approval studies address any limitations of the data available at the time of market entry impacting the benefit-risk profiles of drugs and devices. Second, post-marketing studies should be designed hierarchically: priority should be given to efforts aimed at evaluating a product's net clinical benefit in randomised trials compared with current known effective therapy, whenever possible, to address common decisional dilemmas. Third, post-marketing studies should incorporate active comparators as appropriate. Fourth, use of non-randomised studies for the evaluation of clinical benefit in the post-marketing period should be limited to instances when the magnitude of effect is deemed to be large or when it is possible to reasonably infer the comparative benefits or risks in settings, in which doing a randomised trial is not feasible. Fifth, efficiency of randomised trials should be improved by streamlining patient recruitment and data collection through innovative design elements. Sixth, governments should directly support and facilitate the production of comparative post-marketing data by investing in the development of collaborative research networks and data systems that reduce the complexity, cost, and waste of rigorous post-marketing research efforts. Last, financial incentives and penalties should be developed or more actively reinforced.

Integrated Security, Safety, and Privacy Risk Assessment Framework for Medical Devices.

The substantial improvements and innovations in communication networks and bio-medical technologies have led to the adoption of networked medical devices due to which the attack surface has increased profoundly. Numerous devices in practice were designed and developed years ago without security measures. In such a scenario, the role of regulatory bodies has become evident. The Food and Drug Administration (FDA) validates and approves devices before commercialization. In contrast, the European Union (EU) follows a decentralized approach and Notified Bodies (NB) for assuring high standards, safety and quality of medical devices being marketed in Europe. Once the device has gone through stringent regulations including good manufacturing practices, Quality Management System (QMS), labeling, clinical tests, performance standards, adequate storage and packaging practices, a declaration of conformity will be granted, which is a legal binding document stating that the device is conformant with applicable European requirements and can be marketed in Europe. However, such regulations lack a systematic methodology to determine unified security, safety and privacy risk that eventually influence the health of patients. To cover these gaps, this research proposes Integrated Safety, Security, and Privacy (ISSP) Risk Assessment Framework to determine the risk level of the device and required security controls. It is, then applied to a case scenario of an infusion pump and further evaluated by comparing it with current standards and practices. The comparison shows that the framework provides a unified approach to consider different types of risks associated with devices.

Swedish national survey on MR safety compared with CT: a false sense of security?

OBJECTIVES: The objectives were to survey MR safety incidents in Sweden during a 12-month period, to assess severity scores, and to evaluate the confidence of MR personnel in incident-reporting mechanisms. METHOD: Data were collected within a web-based questionnaire on safety in clinical MR environments with CT for comparison. Data reported MR and CT safety incidents (human injury, material damage, and close calls), incident severity, and confidence of participants in incident-reporting systems. RESULTS: The study population consisted of 529 eligible participants. Participants reported 200 MR and 156 CT safety incidents. Among MR incidents, 16% were given the highest potential severity score. More MR workers (73%) than CT workers (50%) were confident in being aware of any incident occurring at their workplace. However, 69% MR workers (83% for CT) were not aware of reported incidents at their hospitals. CONCLUSION: Safety incidents resulting in human injury, material damage, and close calls in clinical MR environments do occur. According to national risk assessment recommendations, risk level is high. Results indicated that MR personnel tend to a false sense of security, as a high proportion of staff members were sure that they would have been aware of any incident occurring in their own department, while in reality, incidents did occur without their knowledge. We conclude that false sense of security exists for MR. KEY POINTS: • Safety incidents in clinical MR environments still result in human injury and material damage. • Severity level of MR incidents-assessed using Swedish national risk assessment recommendations-is high. • Confidence of MR personnel in incident-reporting mechanisms is high, but reflects a false sense of security, as a high proportion of staff is unaware of reported incidents in the same workplace.

Clinical Trial Assessment Principles of National Class III Medical Devices in China.

Class III medical devices are defined as those which are implanted inside the human body and applied to maintain normal life and retain original tissue or organic functions. Because these devices are associated with high risk, their effectiveness and safety should be strictly monitored and clinically investigated. The aim of clinical investigation of these medical devices is to ensure the acceptability of their effectiveness and safety levels. On designing the clinical trial, the investigator should determine the indices to assess the effectiveness and safety of medical devices, select reasonable data-analyzing methods, and pay attention to several other issues. Although some guidelines on specific class III medical devices have illustrated those aspects in detail, there is still no comprehensive report that details all those principles and methodologies. This article aims to summarize the common features among the instruction principles and provide technological support for the clinical study of class III medical devices.

Does exposure to bentonite dust during tunnel hyperbaric interventions increase health risks for compressed air workers? A prospective qualitative and quantitative safety assessment.

INTRODUCTION: The mining and tunneling industries are historically associated with hazardous exposures that result in significant occupational health concerns. Occupational respiratory exposures causing pneumoconiosis and silicosis are of great concern, silicosis being non-curable. This work demonstrates that compressed-air workers (CAWs) performing tunnel hyperbaric interventions (HIs) may be at risk for hazards related to bentonite exposure, increasing the likelihood of developing harmful illnesses including cancer. Bentonite dust inhalation may result in respiratory levels of silica exceeding acceptable industrial hygiene standards. METHODS: A qualitative observational exposure assessment was conducted on CAWs while they were performing their HI duties. This was followed by quantitative data collection using personal and area air sample techniques. The results were analyzed and interpreted using standard industrial hygiene principles and guidelines from NIOSH and OSHA. RESULTS: Our work suggests bentonite dust exposure may be an emerging particulate matter concern among CAWs in the tunneling industry. Aerosolized bentonite particles may have potential deleterious effects that include pneumoconiosis and silicosis. Silicosis can result in the development of pulmonary carcinoma. CONCLUSIONS: The modern tunneling industry and required hyperbaric interventional tasks represent a potential public health and occupational concern for CAWs. This paper introduces the modern tunneling industry and the duties of CAWs, the hazardous environment in which they perform their duties, and describes the risks and potential harmful health effects associated with these hazardous exposures.

An exploration of rollover protective structures (ROPS) rebate program media coverage: strategies for implementation and sustainment.

BACKGROUND: Media advocacy plays an important role in public health initiatives, as it can provide vital information to target populations, policy makers, or other relevant stakeholders. Unfortunately, little is currently known about the use of media advocacy to promote occupational safety and health programs. This study explores media coverage related to the Rollover Protection Structure (ROPS) Rebate Programs, which were designed to encourage the use of rollover protection on agricultural tractors, thus reducing the risk of tractor overturn fatalities. The Program's portrayal in the media, as well as the role that the media has played in implementing and sustaining these Programs. METHODS: Media articles pertaining to any of the state-based or National ROPS Rebate Programs and published between November 1, 2006 and October 31, 2018 were included for review. Discourse analysis was used to understand the messages portrayed by the media and how those messages shaped the outcomes of the ROPS Rebate Programs. RESULTS: During the study period, 212 unique articles were published about the ROPS Rebate Programs. While these articles all portrayed the ROPS Rebate Programs in a largely positive light, they were used at different stages, from pre-implementation through sustainment of the ROPS Rebate Programs, and to different extents. CONCLUSIONS: Media articles have played an important role in implementing and sustaining the ROPS Rebate Programs. Based on the results of this study, more robust and continuous media coverage are important for the longevity and success of public health programs.