Improving safety claims in digital health interventions using the digital health assessment method.

Objective: Establish a relationship between digital health intervention (DHI) and health system challenges (HSCs), as defined by the World Health Organization; within the context of hazard identification (HazID), leading to safety claims. To improve the justification of safety of DHIs and provide a standardised approach to hazard assessment through common terminology, ontology and simplification of safety claims. Articulation of results, to provide guidance for health strategy and regulatory/standards-based compliance. Methods: We categorise and analyse hazards using a qualitative HazID study. This method utilises a synergy between simplicity of DHI intended use and the interaction from a multidisciplinary team (technologists and health informaticians) in the hazard analysis of the subject under assessment as an influencing factor. Although there are other methodologies available for hazard assessment. We examine the hazards identified and associated failures to articulate the improvements in the quality of safety claims. Results: Applying the method provides the hazard assessment and helps generate the assurance case. Justification of safety is made and elicits confidence in safety claim. Controls to hazards contribute to meeting the HSC. Conclusions: This method of hazard assessment, analysis and the use of ontologies (DHI & HSC) improves the justification of safety claim and evidence articulation.

Optimization-Based Stable Balancing Weights Versus Propensity Score Weighting for Samples With High Covariate Imbalance.

PURPOSE: To compare the performance (covariate balance, effective sample size [ESS]) of stable balancing weights (SBW) versus propensity score weighting (PSW). Two applied cases were used to compare performance: (Case 1) extreme imbalance in baseline covariates between groups and (Case 2) substantial discrepancy in sample size between groups. METHODS: Using the Premier Healthcare Database, we selected patients who (Case 1) underwent a surgical procedure with one of two different bipolar forceps between January 2000 and June 2020, or (Case 2) a neurological procedure using one of two different nonabsorbable surgical sutures between January 2000 and March 2020. Average treatment effects on the treated (ATT) weights were generated based on selected covariates. SBW was implemented using two techniques: (1) "grid search" to find weights of minimum variance at the lowest target absolute standardized mean difference (SMD); (2) finding weights of minimum variance at prespecified SMD tolerance. PSW and SBW methods were compared on postweighting SMDs, the number of imbalanced covariates, and ESS of the ATT-weighted control group. RESULTS: In both studies, improved covariate balance was achieved with both SBW techniques. All methods suffered from postweighting ESS that was lower than the unweighted control group's original sample size; however, SBW methods achieved higher ESS for the control groups. Sensitivity analyses using SBW to apply variable-specific SMD thresholds increased ESS, outperforming PSW. CONCLUSIONS: In this applied example, the optimization-based SBW method provided ample flexibility with respect to prespecification of covariate balance goals and resulted in better postweighting covariate balance and larger ESS as compared with PSW.

[Implant anchorage: In vivo and in vitro analyses : Clusters for implant anchorage and safety]. / Implantatverankerung: In-vivo- und In-vitro-Analysen : Cluster Implantatverankerung und -sicherheit.

Aseptic implant loosening is the primary cause of revisions in arthroplasty. Various in vitro and in vivo methods are available for assessing implant fixation and stability. The aim of the Musculoskeletal Biomechanics Research Network (MSB-NET) is to continuously improve or develop these methods. In vitro analyses are often conducted using static and dynamic ISO and ASTM standards, while RSA, DXA, and EBRA analyses are established in vivo methods for evaluating implant fixation. Primary stability analyses, as well as acoustical methods, provide additional opportunities to detect loosening early and precisely evaluate implant stability. The cluster serves as a link between basic research, clinical practice, and end users to promote in vitro and in vivo methods to improve implant safety.

Characterizing the safety profile of vagus nerve stimulation devices for epilepsy from 21,448 manufacturer and user reports.

OBJECTIVE: This study summarizes medical device reports (MDRs) associated with adverse events for vagus nerve stimulation (VNS) devices indicated for epilepsy as reported by the Manufacturer and User Facility Device Experience (MAUDE) database of the US Food and Drug Administration. METHODS: The MAUDE database was surveyed for MDRs from November 2013 to September 2022 regarding VNS devices for epilepsy. Event descriptions, device problems, correlated patient consequences, and device models were grouped and analyzed in Python. Based on event description, revision surgeries and other unique events were identified. Revenue from VNS device sales was used to approximate growth in their use over time. RESULTS: A total of 21,448 MDRs met the inclusion criteria. High VNS impedance, the most prevalent device malfunction overall (17.0% of MDRs), was the most common factor for 18 of the 102 encountered patient problems and led to 1001 revision surgeries (3371 total revisions). Included in those 18 device malfunctions were 3 of the top 6 occurring patient problems: seizure recurrence (9.9% associated with high impedance; encompassed focal, absence, and grand mal subtypes), death (1.3%), and generalized pain (7.9%). The next 4 top cited device malfunctions-lead fracture (13.7% of MDRs), operational issue (6.6%), battery problem holding charge (4.2%), and premature end-of-life indicator (2.9%)-differed widely in their percentage of cases that did not impact patients (77.4%, 57.3%, 48.9%, and 92.2%, respectively), highlighting differing malfunction severities. Seizure recurrence, the most prevalent patient impact, was the outcome most associated with 32 of the 68 encountered device problems, including high impedance (12.8%), lead fracture (12.2%), operational issue (18.4%), battery problem holding charge (31.2%), and premature end-of-life indicator (8.9%), which comprised the top 5 occurring device problems. In general, MDRs spanned a diverse range including device age, hardware, software, and surgeon or manufacturer error. Trends were seen over time with declining annual MDRs coupled with a rise in the use of VNS devices as gauged by revenue growth. Shifting device and patient problem profiles were also seen in successive models, reflecting engineering updates. CONCLUSIONS: This study characterizes the most common and consequential side effects of VNS devices for epilepsy while clarifying likely causes. In addition, the outcomes of 68 distinct device malfunctions were identified, including many not ubiquitously present in literature, lending critical perspective to clinical practice.

Eventos adversos e queixas técnicas de tecnologias para o manejo de estomias de eliminação no Brasil / Adverse Events and Technical Complaints of Technologies for the Management of Elimination Ostomies in Brazil / Eventos adversos y quejas técnicas de tecnologías para el manejo de ostomías de eliminación en Brasil

Objetivo: Describir los eventos adversos y las quejas técnicas relacionadas con tecnologías para el manejo de ostomías de eliminación reportadas en Brasil. Método: Estudio descriptivo y transversal realizado con datos secundarios registrados en Notivisa. Los datos representan eventos adversos y quejas técnicas reportadas desde enero de 2007 hasta agosto de 2023. Se utilizaron recursos de estadística descriptiva para el análisis. Resultados: Se identificaron un total de 2.812 notificaciones, de las cuales 101 (3,6%) fueron eventos adversos y 2.711 (96,4%) quejas técnicas. El estado de São Paulo representó 884 (31,4%) de las notificaciones. Las bolsas recolectoras fueron los productos más reportados, con 2.688 (95,6%) notificaciones, incluyendo 84 (3,1%) eventos adversos y 2.604 (96,9%) quejas técnicas. En cuanto a los resultados, hubo falta de información en 2.718 (96,7%) de las notificaciones, retención urinaria en 19 (0,67%), dermatitis en 13 (0,46%) y lesiones cutáneas en 9 (0,32%). Conclusión: El número de notificaciones ha seguido aumentando en los últimos años, pero la calidad sigue siendo baja, representada por un alto índice de información omitida. Las quejas técnicas sobre las bolsas recolectoras representan el mayor número de notificaciones en Brasil. La descripción de los resultados en el uso de productos para el tratamiento de las ostomías no es clara y puede llevar a un subregistro de eventos adversos importantes, como la dermatitis. (AU)

Objetivo: Descrever os eventos adversos e as queixas técnicas de tecnologias para o manejo de estomias de eliminação notificados no Brasil. Método: Estudo transversal, descritivo, realizado por meio de dados secundários registrados no Notivisa. Os dados representam eventos adversos e queixas técnicas notificados no período de janeiro de 2007 a agosto de 2023. Para análise, utilizaram-se recursos da estatística descritiva. Resultados: Identificaram-se 2.812 notificações, das quais 101 (3,6%) eram eventos adversos e 2.711 (96,4%) queixas técnicas. O estado de São Paulo foi responsável por 884 (31,4%) notificações. As bolsas coletoras foram os produtos mais notificados, apresentando 2.688 (95,6%) notificações, sendo 84 (3,1%) eventos adversos e 2.604 (96,9%) queixas técnicas. Sobre os desfechos, verificou-se a ausência de informações em 2.718 (96,7%) notificações, 19 (0,67%) notificações de retenção urinária, 13 (0,46%) de dermatite e 9 (0,32%) de lesão cutânea. Conclusão: O número de notificações permanece em ascendência nos últimos anos; entretanto, a qualidade ainda é baixa, representada por alta taxa de omissão de informações. As queixas técnicas de bolsas coletoras representam maior número de notificações no Brasil. A descrição dos desfechos na utilização de produtos para manejo de estomias não é clara e pode gerar subnotificação de eventos adversos importantes, como a dermatite. (AU)

Objective: To describe adverse events and technical complaints involving technologies for the management of elimination ostomies reported in Brazil. Method: This cross­sectional descriptive study used secondary data recorded in the Notivisa system. The data encompass adverse events and technical complaints reported from January 2007 to August 2023. Descriptive statistical tools were used for the analysis. Results: A total of 2,812 notifications were identified, of which 101 (3.6%) were adverse events, and 2,711 (96.4%) were technical complaints. The state of São Paulo accounted for 884 (31.4%) notifications. Collection bags were the most frequently reported products, with 2,688 (95.6%) notifications, including 84 (3.1%) adverse events and 2,604 (96.9%) technical complaints. Regarding outcomes, 2,718 (96.7%) notifications lacked information, 19 (0.67%) reported urinary retention, 13 (0.46%) reported dermatitis, and 9 (0.32%) reported skin injury. Conclusion: The number of notifications has continued to rise in recent years; however, the quality remains low, as evidenced by the high rate of omitted information. Technical complaints about collection bags represent the largest number of notifications in Brazil. The description of outcomes in the use of products for ostomy management is unclear and may lead to the underreporting of significant adverse events such as dermatitis. (AU)

Severe Insulin Pump-Related Adverse Events: Potential Root Causes and Impact of the COVID-19 Pandemic.

OBJECTIVE: To explore insulin pump-associated severe adverse events (SAEs) involving intensive care unit (ICU) admissions and deaths and examine the impact of the COVID-19 pandemic on these SAEs. METHODS: Qualitative template analysis of narrative data in reported insulin pump-associated SAEs occurring between May 1, 2019, and January 31, 2021, involving MiniMed 670G, MiniMed 630G, Omnipod, Omnipod DASH, and t:slim X2 insulin pumps. RESULTS: Over the 21-month measurement period, 460 SAEs involving an ICU admission and 288 SAEs involving a death were reported to the Food and Drug Administration. Problems with the pump or pod reservoir/cartridge were among the most frequently cited potential root causes in SAEs involving ICU admissions and deaths overall. However, problems with the infusion set or site and the pump battery or power emerged in the top three potential root causes of SAEs involving an ICU admission, whereas the patient sleeping at the time of the event and the tasks of changing the pod/infusion set, including reservoir/cartridge and programming the pump emerged in the top three for SAEs involving a death. The median monthly number of reported SAEs involving ICU admissions and deaths decreased during the pandemic, but their potential root causes were unchanged. CONCLUSIONS: Although insulin pumps are generally safe, SAEs related to their components and external factors can and do occur. By learning from the potential root causes of insulin pump-associated SAEs, providers and patients can implement corrective actions to prevent future events, thereby reducing harm.

Themes, Rates, and Risk of Adverse Events of the Artificial Pancreas in the United States Using MAUDE.

Three manufacturers sell artificial pancreas systems in the United States for management of Type 1 Diabetes. Given the life-saving task required of an artificial pancreas there needs to be a high level of trust and safety in the devices. This evaluation sought to find the adjusted safety event reporting rate and themes along with device-associated risk in events reported utilizing the MAUDE database. We searched device names in the MAUDE database over the period from 2016 until August 2023 (the date of retrieval). Thematic analysis was performed using dual-reviewer examination with a 96% concurrence. Relative risk (RR) was calculated for injury, malfunction, and overall, for each manufacturer, as well as adjusted event rate per manufacturer. Most events reported related to defects in the manufacturing of the casing materials which resulted in non-delivery of therapy. Tandem Diabetes Care, Inc. had an adjusted event rate of 50 per 100,000 units and RR of 0.0225. Insulet had an adjusted event rate of 300 per 100,000 units and RR of 0.1684. Medtronic has an adjusted event rate of 2771.43 per 100,000 units and RR of 20.7857. The newer Medtronic devices show improvements in likely event rate. While the artificial pancreas is still in its infancy, these event rates are not at an acceptable level for a device which can precipitate death from malfunctions. Further exploration into safety events and much more research and development is needed for devices to reduce the event rates. Improved manufacturing practices, especially the casing materials, are highly recommended. The artificial pancreas holds promise for millions but must be improved before it becomes a true life-saving device that it has the potential to become.

Targeting bacterial growth in biofilm conditions: rational design of novel inhibitors to mitigate clinical and food contamination using QSAR.

Antimicrobial resistance (AMR) is a pressing global issue exacerbated by the abuse of antibiotics and the formation of bacterial biofilms, which cause up to 80% of human bacterial infections. This study presents a computational strategy to address AMR by developing three novel quantitative structure-activity relationship (QSAR) models based on molecular topology to identify potential anti-biofilm and antibacterial agents. The models aim to determine the chemo-topological pattern of Gram (+) antibacterial, Gram (-) antibacterial, and biofilm formation inhibition activity. The models were applied to the virtual screening of a commercial chemical database, resulting in the selection of 58 compounds. Subsequent in vitro assays showed that three of these compounds exhibited the most promising antibacterial activity, with potential applications in enhancing food and medical device safety.

How AI should be used in radiology: assessing ambiguity and completeness of intended use statements of commercial AI products.

BACKGROUND: Intended use statements (IUSs) are mandatory to obtain regulatory clearance for artificial intelligence (AI)-based medical devices in the European Union. In order to guide the safe use of AI-based medical devices, IUSs need to contain comprehensive and understandable information. This study analyzes the IUSs of CE-marked AI products listed on AIforRadiology.com for ambiguity and completeness. METHODS: We retrieved 157 IUSs of CE-marked AI products listed on AIforRadiology.com in September 2022. Duplicate products (n = 1), discontinued products (n = 3), and duplicate statements (n = 14) were excluded. The resulting IUSs were assessed for the presence of 6 items: medical indication, part of the body, patient population, user profile, use environment, and operating principle. Disclaimers, defined as contra-indications or warnings in the IUS, were identified and compared with claims. RESULTS: Of 139 AI products, the majority (n = 78) of IUSs mentioned 3 or less items. IUSs of only 7 products mentioned all 6 items. The intended body part (n = 115) and the operating principle (n = 116) were the most frequently mentioned components, while the intended use environment (n = 24) and intended patient population (n = 29) were mentioned less frequently. Fifty-six statements contained disclaimers that conflicted with the claims in 13 cases. CONCLUSION: The majority of IUSs of CE-marked AI-based medical devices lack substantial information and, in few cases, contradict the claims of the product. CRITICAL RELEVANCE STATEMENT: To ensure correct usage and to avoid off-label use or foreseeable misuse of AI-based medical devices in radiology, manufacturers are encouraged to provide more comprehensive and less ambiguous intended use statements. KEY POINTS: • Radiologists must know AI products' intended use to avoid off-label use or misuse. • Ninety-five percent (n = 132/139) of the intended use statements analyzed were incomplete. • Nine percent (n = 13) of the intended use statements held disclaimers contradicting the claim of the AI product. • Manufacturers and regulatory bodies must ensure that intended use statements are comprehensive.

Improved safety and quality in intravascular brachytherapy: A multi-institutional study using failure modes and effects analysis.

PURPOSE: Highlight safety considerations in intravascular brachytherapy (IVBT) programs, provide relevant quality assurance (QA) and safety measures, and establish their effectiveness. METHODS AND MATERIALS: Radiation oncologists, medical physicists, and cardiologists from three institutions performed a failure modes and effects analysis (FMEA) on the radiation delivery portion of IVBT. We identified 40 failure modes and rated the severity, occurrence, and detectability before and after consideration of safety practices. Risk priority numbers (RPN) and relative risk rankings were determined, and a sample QA safety checklist was developed. RESULTS: We developed a process map based on multi-institutional consensus. Highest-RPN failure modes were due to incorrect source train length, incorrect vessel diameter, and missing prior radiation history. Based on these, we proposed QA and safety measures: ten of which were not previously recommended. These measures improved occurrence and detectability: reducing the average RPN from 116 to 58 and median from 84 to 40. Importantly, the average RPN of the top 10% of failure modes reduced from 311 to 172. With QA considered, the highest risk failure modes were from contamination and incorrect source train length. CONCLUSIONS: We identified several high-risk failure modes in IVBT procedures and practical safety and QA measures to address them.

Safety reporting of Essure medical device: a qualitative and quantitative assessment on the FDA manufacturer and user facility device experience database in 2018.

Background: There have been numerous cases of adverse events since the introduction of Essure medical devices for sterilization in 2002. This study analyzed the safety event reports of the Essure reported in the Manufacturer and User Facility Device Experience (MAUDE). Methods: A retrospective analysis examined the MAUDE reports between Jan-1, 2018, and Oct-31, 2018 and focused on safety reports related to the Essure device. Safety reports were categorized and analyzed by their event type, device problem, patients' symptoms and the level of harm. Of this study cohort, 10% of samples were randomly selected for quantitative analyses. Thematic analysis was conducted for reports included death cases. Results: A total of 4,994 eligible reports were analyzed. There were ten reports associated with individuals' deaths, and the main themes of safety reports from qualitative analysis were pains, bleeding, surgery, migraine, and infection. Quantitative analysis of 500 randomly selected samples showed that 98% of adverse event reports were associated with different injuries such as surgery, pain, bleeding, hysterectomy, and menorrhagia. Additionally, more than 90% of reports were submitted by the manufacturer. Conclusion: These findings indicated several safety issues of Essure. More meaningful pre- and post-marketing surveillance and regulation are warranted in the medical device market to ensure safety and effectiveness, including investigating complaints, promptly sharing relevant information with regulators and users, and implementing corrective actions.

Predicting partitioning from low density polyethylene to blood and adipose tissue by linear solvation energy relationship models.

The variety of polymers utilized in medical devices demands for testing of extractables and leachables according to ISO 10993-18:2020 in combination with ISO 10993-1:2018. The extraction of the materials involves the use of organic solvents as well as aqueous buffers to cover a wide range of polarity and pH-values, respectively. To estimate patient exposure to chemicals leaching from a polymer in direct body contact, simulating solvents are applied to best mimic the solubilization and partitioning behavior of the related tissue or body fluid. Here we apply linear solvation energy relationship (LSER) models to predict blood/water and adipose tissue/water partition coefficients. We suggest this predictive approach to project levels of potential leachables, design extraction experiments, and to identify the optimal composition of simulating extraction solvents. We compare our predictions to LSER predictions for commonly applied surrogates like ethanol/water mixtures, butanol, and octanol as well as olive oil, butanone, 1,4-dioxane for blood and adipose tissue, respectively. We therefore selected a set of 26 experimentally determined blood/water partition coefficients and 33 adipose tissue/water partition coefficients, where we demonstrate that based on the root mean squared error rmse the LSER approach performs better than surrogates like octanol or butanol and equally well as 60:40 ethanol/water for blood. For adipose tissue/water partitioning, the experimentally determined octanol/water partition coefficient performs best but the rmse is at the same range as our LSER approach based on experimentally determined descriptors. Further, we applied our approach for 248 extractables where we calculated blood/low density polyethylene (LDPE) and adipose tissue/LDPE partition coefficients. By this approach, we successfully identified chemicals of potential interest to a toxicological evaluation based on the total risk score.

Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study.

Background: Medical device recalls are initiated in response to safety concerns. Class I (highest severity) recalls imply a reasonable likelihood of serious adverse events or death associated with device use. Recalled devices must be identified, assessed, and corrected or removed, upon which a recall can be terminated. Objective: To characterize Class I medical device recalls and corresponding recalled devices. Methods: This was a cross-sectional study of Class I recalls posted on the Food and Drug Administration's annual log from January 1, 2018 to June 30, 2022 for moderate-risk and high-risk medical devices. Devices were categorized by therapeutic use, need for implantation, and life-sustaining designation; recalls were categorized by reason, status, and time elapsed. Results: There were 189 unique Class I medical device recalls, including 151 (79.9%) for moderate-risk and 34 (18.0%) for high-risk devices. Sixty-five (34.4%) recalls were for cardiovascular devices, 36 (19.0%) for implanted devices, and 37 (19.6%) for life-sustaining devices. The median number of device units recalled in the US per recall notice was 4620 (interquartile range [IQR], 578-42,591), with 11 (5.8%) recalls associated with more than 1 million device units. Overall, 125 (66.1%) devices had multiple recalls, with a median of 4 (IQR, 3-11) recalls issued per recalled device. As of September 15, 2022, 50 (26.5%) recalls were terminated, with a median of 24 (IQR, 17.3-30.8) months elapsed between recall initiation and termination. Recalls were terminated more commonly among devices recalled once compared to those recalled multiple times (36.2% vs 19.2%; p=0.02) and for recalls that recommended discontinuing further use of affected devices compared to those that recommended device assessment and/or education of affected population (31.8% vs 18.2%; p=0.04). Conclusion: High-severity medical device recalls are common and affect millions of device units annually in the US. Recall termination takes a significant amount of time, putting patients at risk for serious safety concerns.

Pathway map development for medical device event reporting in operating theatres: a human factors approach to improving the existing system.

Objectives: This study aimed to develop the actual pathway to reporting and information transfer in operating theatres in relation to medical technology malfunction/failure. This with the aim of understanding the differences with the pathway published by NHS Improvement and identification of points for improvement. Design: This is a qualitative study involving stakeholder interviews with doctors, nurses, manufacturers, medical device safety officer and Medicines and Healthcare products Regulatory Agency. Setting: Data were collected on reporting pathway used in operating theatres. Clinical staff who took part worked in different trusts throughout UK while manufacturers provided devices in UK and EU/USA. Participants: Semistructured interviews were completed with 15 clinicians and 13 manufacturers. Surveys were completed by 38 clinicians and 5 manufacturers. Recognised methods of pathway development were used. The Lean Six Sigma principles adapted to healthcare were used to develop suggestions for improvement. Main outcome measures: To identify the differences between the set pathway to reporting and information transfer to what is occurring on a day-to-day basis as reported by staff. Identify points in the pathway where improvements could be applied. Results: The developed pathway demonstrated great complexity of the current reporting system for medical devices. It identified numerous areas that give rise to problems and multiple biases in decision making. This highlighted the core issues leading to under-reporting and lack of knowledge on device performance and patient risk. Suggestions for improvement were deduced based on end user requirements and identified problems. Conclusions: This study has provided a detailed understanding of the key problem areas that exist within the current reporting system for medical devices and technology. The developed pathway sets to address the key problems to improve reporting outcomes. The identification of pathway differences between 'work as done' and 'work as imagined' can lead to development of quality improvements that could be systematically applied.

Insulin Pump-Associated Adverse Events: A Qualitative Descriptive Study of Clinical Consequences and Potential Root Causes.

Objective: To explore the clinical consequences and potential root causes of insulin pump-associated adverse events (AEs) reported in the Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database. Research Design and Methods: Qualitative template analysis of narrative data in a 20% stratified random sample (n = 2429) of reported AEs that occurred during the first 6 months of 2020 involving five insulin pump models marketed at that time: (1) MiniMed™ 670G, (2) MiniMed™ 630G, (3) Omnipod®, (4) Omnipod DASH®, and (5) t:slim X2™. Results: Of the 2429 AEs, 92% included a clinical consequence in the narrative description, with critical hyperglycemia (i.e., blood glucose [BG] >400 mg/dL; 47%) and critical hypoglycemia (i.e., BG <54 mg/dL; 24%) being the most common consequence cited. Only 50% of the AE narratives included information to support the identification of a root cause. The most cited root cause informing remarks were issues with the pump or pod reservoir/cartridge (9%), the occurrence of an obstruction of flow alarm (8%), and problems with the infusion set or site (8%). Some clinical consequences and root cause informing remarks were cited more frequently in AE narratives involving specific insulin pump models, but manufacturer variability in the amount and type of information reported may have affected these findings. Conclusions: Our findings show general themes found in insulin pump-associated AE that providers can use to raise patient awareness of potential risks associated with insulin pump use and develop strategies to prevent future AEs. Improvements in AE investigation and reporting processes are still necessary.

"Assisted vaginal birth using the Paily obstetric forceps vs Ventouse - A randomized clinical trial".

OBJECTIVE: Instruments used in assisted vaginal birth have seen little innovation for decades. Due to the risk of trauma and technical difficulty incurred during forceps delivery, instrumental deliveries are on a decline, and the global rate of primary cesarean birth is rising. The novel Paily Obstetric Forceps (POF) features a compact, lighter design with thinner blades, designed to increase operator comfort and minimize maternal and neonatal injuries. We aim to determine the feasibility and safety of POF in achieving vaginal birth compared to a ventouse device with a 50 mm silastic cup. STUDY DESIGN: We conducted a single-blinded, parallel arm, randomized clinical trial of the novel POF vs a ventouse device, in patients undergoing indicated assisted vaginal birth, at a tertiary care obstetric unit. We randomized 100 patients to be allocated on a 1:1 ratio to both intervention arms. Primary outcome was the proportion of successful instrumental deliveries. Secondary outcomes were the number of pulls required during traction and any maternal or neonatal adverse events. RESULTS: The POF was significantly more successful in achieving vaginal birth than the ventouse device (n = 50/50, 100 % vs n = 42/50, 84 %, p = 0.006). Operators reported requiring significantly fewer pulls during POF traction than ventouse. POF demonstrated a higher risk for maternal trauma (RR = 3.2, 95 % CI = 1.5 to 6.9, NNH = 2.7) but a lower risk for neonatal injury (RR = 0.6, 95 % CI = 0.3 to 1, NNH = 5.7). Maternal and neonatal recovery durations were comparable. There were no incidences of maternal or neonatal mortality. CONCLUSION: The POF can be used in indicated assisted vaginal birth with superior success rates and better neonatal outcomes than ventouse. Other obstetric forceps must be standardized to conduct larger superiority trials of forceps designs.

The impact of continuous wireless monitoring on adverse device effects in medical and surgical wards: a review of current evidence.

Novel technologies allow continuous wireless monitoring systems (CWMS) to measure vital signs and these systems might be favorable compared to intermittent monitoring regarding improving outcomes. However, device safety needs to be validated because uncertain evidence challenges the clinical implementation of CWMS. This review investigates the frequency of device-related adverse events in patients monitored with CWMS in general hospital wards. Systematic literature searches were conducted in PubMed and Embase. We included trials of adult patients in general hospital wards monitored with CWMS. Our primary outcome was the frequency of unanticipated serious adverse device effects (USADEs). Secondary outcomes were adverse device effects (ADEs) and serious adverse device effects (SADE). Data were extracted from eligible studies and descriptive statistics were applied to analyze the data. Seven studies were eligible for inclusion with a total of 1485 patients monitored by CWMS. Of these patients, 54 patients experienced ADEs (3.6%, 95% CI 2.8-4.7%) and no USADEs or SADEs were reported (0%, 95% CI 0-0.31%). The studies of the SensiumVitals® patch, the iThermonitor, and the ViSi Mobile® device reported 28 (9%), 25 (5%), and 1 (3%) ADEs, respectively. No ADEs were reported using the HealthPatch, WARD 24/7 system, or Coviden Alarm Management. Current evidence suggests that CWMS are safe to use but systematic reporting of all adverse device effects is warranted.

Totally endoscopic cartilage tympanoplasty: a hierarchical task analysis.

BACKGROUND: Totally endoscopic ear surgery is a novel method of conducting otological surgery. Hierarchical task analysis and the systematic human error reduction and prediction approach ('SHERPA') are valuable tools that can effectively deconstruct the technical and non-technical skills required to successfully complete a surgical procedure. METHODS: Twenty-five endoscopic tragal cartilage tympanoplasties were observed, to identify the tasks and subtasks required for completion of totally endoscopic tragal cartilage tympanoplasty. The systematic human error reduction and prediction approach was used to identify the potential risks and methods, to reduce or remediate these risks. RESULTS: A hierarchical task analysis was performed, identifying 8 tasks and 50 subtasks for a safe approach to completing totally endoscopic tragal cartilage tympanoplasty. A risk score for each subtask was calculated to produce a systematic human error reduction and prediction approach and to highlight potential errors. CONCLUSION: This hierarchical task analysis allowed for quick reference to a correct method of endoscopic tympanoplasty. The systematic human error reduction and prediction approach was employed to reduce the risks associated with undergoing endoscopic tympanoplasty, to improve patient safety.