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ObjectivesGenerating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding.Design setting and participantsWe invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020.Main outcome measuresConsensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity.ResultsOf 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains.ConclusionsWe have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.

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. [ABSTRACT FROM AUTHOR]

Maryam Mooghali,1,2 Joseph S Ross,1– 4 Kushal T Kadakia,5 Sanket S Dhruva6,7 1Department of Internal Medicine, Yale School of Medicine, New Haven, CT, USA; 2Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT), Yale School of Medicine, New Haven, CT, USA; 3Department of Health Policy and Management, Yale School of Public Health, New Haven, CT, USA; 4Center for Outcomes Research and Evaluation, Yale-New Haven Health System, New Haven, CT, USA; 5Harvard Medical School, Boston, MA, USA; 6Department of Medicine, UCSF School of Medicine, San Francisco, CA, USA; 7San Francisco Veterans Affairs Health Care System, San Francisco, CA, USACorrespondence: Maryam Mooghali, Yale Center for Outcomes Research and Evaluation (CORE), 195 Church Street, New Haven, CT, 06510, USA, Tel +1 203 497-1239, Email maryam.mooghali@yale.eduBackground: 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.Keywords: medical devices recalls, device safety, Food and Drug Administration

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

This observational cohort study examined outcomes after peripheral vascular intervention (PVI) with paclitaxel coated devices (PCD) and non-PCD, and evaluated heterogeneity of treatment effect in populations of interest. The study included patients undergoing percutaneous transluminal angioplasty and or stent placement between 1 October 2015 and 31 December 2018 in the Vascular Quality Initiative Registry linked to Medicare claims. It determined differences in patient mortality and ipsilateral major amputation after PVI with PCD and non-PCD using Kaplan–Meier analyses and Cox regressions with inverse probability weighting in three cohorts: (A) patients treated for femoropopliteal or infrapopliteal occlusive disease with or without any other concurrent treatment (n = 11 452); (B) those treated for isolated superficial femoral or popliteal artery disease (n = 5 519); and (C) patients with inclusion criteria designed to approximate RCT populations (n = 2 278). The mean age of patients was 72.3 (SD = 10.9) years, and 40.6% were female. In cohort A, patients receiving PCD had a lower mortality rate (HR 0.88, 95% CI 0.79 – 0.98) than those receiving non-PCD. There was no significant difference in mortality between groups in cohort B (HR 0.91, 95% CI 0.80 – 1.04) and cohort C (HR 1.10, 95% CI 0.84 – 1.43). Patients receiving PCD did not have a significantly elevated risk of major amputation compared with those receiving non-PCD (cohort A: HR 0.84, 95% CI 0.70 – 1.00; cohort B: HR 0.84, 95% CI 0.67 – 1.06; and cohort C: HR 1.05, 95% CI 0.51 – 2.14). No increased patient mortality or major amputation was found at three years after PVI with PCD vs. non-PCD in this large, linked registry claims study, after accounting for heterogeneity of treatment effect by population. The analysis and results from three cohorts intended to mirror the cohorts of previous studies provide robust and niche real world evidence on PCD safety and help to understand and reconcile previously discrepant findings. [ABSTRACT FROM AUTHOR]

Clear communication around surgical device use is crucial to patient safety. We evaluated the utility of the Device Briefing Tool (DBT) as an adjunct to the Surgical Safety Checklist. A nonrandomized, controlled pilot of the DBT was conducted with surgical teams at an academic referral center. Intervention departments used the DBT in all cases involving a surgical device for 10 wk. Utility, relative advantage, and implementation effectiveness were evaluated via surveys. Trained observers assessed adherence and team performance using the Oxford NOTECHS system. Of 113 individuals surveyed, 91 responded. Most respondents rated the DBT as moderately to extremely useful. Utility was greatest for complex devices (89%) and new devices (88%). Advantages included insight into the team's familiarity with devices (70%) and improved teamwork and communication (68%). Users found it unrealistic to review all device instructional materials (54%). Free text responses suggested that the DBT heightened awareness of deficiencies in device familiarity and training but lacked a clear mechanism to correct them. DBT adherence was 82%. NOTECHS scores in intervention departments improved over the course of the study but did not significantly differ from comparator departments. The DBT was rated highly by both surgeons and nurses. Adherence was high and we found no evidence of "checklist fatigue." Centers interested in implementing the DBT should focus on devices that are complex or new to any surgical team member. Guidance for correcting deficiencies identified by the DBT will be provided in future iterations of the tool. [ABSTRACT FROM AUTHOR]

Chest compressions and ventilation attempts can generate aerosols during resuscitation. It is important to determine whether different materials suitable for the blanketing of cardiac arrest patients can diminish exposure to aerosols. In this study, three volatile organic compounds, ethanol, acetone, and isoprene, commonly found in human breath in moistened air, acted as substitutes for aerosols. Here, we present information on the adsorption of these volatiles to three blanketing materials: polyvinyl chloride, polyethylene, and aluminum coated polyethylene terephthalate. After exposure to the surfaces of these materials the test volatiles were quantified by the proton transfer reaction-time of flight-mass spectrometry. There was a trend towards a potentially higher reduction for acetone (p = 0.071) and isoprene (p = 0.050) on polyethylene, compared to polyvinyl chloride and aluminum coated polyethylene terephthalate during the rise interval. Adsorption capacity did not differ between the foils and was between 67% and 70%. From our studies, we propose that the aluminum-coated polyethylene terephthalate surface of space blankets prove adequate to diminish exposure to volatiles in moistened air, and hence to aerosols. [ABSTRACT FROM AUTHOR]

Intrasaccular flow disruption is an innovative approach for the endovascular treatment of intracranial aneurysms. As of now, only one device is currently available worldwide: the Woven EndoBridge (WEB) device (MicroVention, Aliso Viejo, CA, USA). After 10 years of clinical use and careful clinical evaluation of the WEB device by multiple prospective, multicenter studies, this article is summarizing the current knowledge regarding this endovascular technique; indications, modalities, safety and efficacy of the WEB procedure are described.

Extreme ocean conditions during typhoons pose significant challenges to the sustainable utilization of ocean renewable energy. This study focuses on analyzing the wind and sea states within typhoon systems and the variations in offshore wind & wave energy flux during typhoons passing over the northern South China Sea (SCS) from 2000 to 2022. The trajectories and intensities of 769 typhoons in the Western Pacific, along with wind & wave energy flux variations during 155 instances of typhoons making landfall in the SCS, are isolated for comprehensive analysis. Specifically, the safety of energy exploitation during severe typhoon Hato (2017) is assessed considering the local met-ocean condition during typhoon passing and the survival ocean conditions of Offshore Wind Turbines (OWTs) and Wave Energy Converters (WECs). The WRF model and FVCOM-SWAVE model are used to provide necessary winds and waves during the passage of Hato with simulations validated against observations for reliable safety assessments. The results show that, over the past 22 years, the regions spanning from northern Guangdong to the Luzon Strait have been subjected to robust winds and formidable waves. The average values of Wind Power Density (WPD) and Wave Power Flux (WPF) during typhoons have exceeded 1500 W/m2 and 20 kW/m, respectively. In the Hato typhoon system, the maximum wind speed surpasses 60 m/s, while the significant wave height is about 10 m. Moreover, the survival capabilities of current OWTs (MySE5.5-155, SWT-6.0-154, SWT-7.0-154, SG 8.0–167 DD and D10000-185) and WECs (Sea Power and CycWEC) are assessed, demonstrating their ability to withstand the entire typhoon lifetime. Therefore, OWTs and WECs exhibit robust survival capabilities through comprehensive assessments based on the validated numerical simulation results, facing extreme typhoon conditions. • The ocean states within typhoon systems and the variations in offshore wind & wave energy during typhoons passing over the northern SCS are analyzed. • A survey of offshore wind and wave energy exploitation safety during typhoon Hato (2017) is performed. • This study identifies survival OWTs and WECs during typhonn Hato. [ABSTRACT FROM AUTHOR]

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., Competing Interests: The authors declared no potential conflicts of interest with respect to the research, authorship and/or publication of this article., (© The Author(s) 2024.)

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.

Intrasaccular flow disruption is an innovative approach for the endovascular treatment of intracranial aneurysms. As of now, only one device is currently available worldwide: the Woven EndoBridge (WEB) device (MicroVention, Aliso Viejo, CA, USA). After 10 years of clinical use and careful clinical evaluation of the WEB device by multiple prospective, multicenter studies, this article is summarizing the current knowledge regarding this endovascular technique; indications, modalities, safety and efficacy of the WEB procedure are described. [ABSTRACT FROM AUTHOR]

ObjectiveThe objective of this study was to determine magnetic resonance imaging (MRI)-related heating for a low-intensity focused ultrasound pulsation (LIFUP) device used during MRI performed at 3 T/128 MHz.Materials and methodsA special phantom was constructed to mimic the thermal properties of the human brain, and a piece of human temporal bone (skull) was embedded on top. Four fluoroptic thermometry probes, placed above and below the skull, were used to measure temperature changes during MRI (3 T/128 MHz; scanner-reported head average specific absorption rate 1.1-2 W/kg) with and without concurrent LIFUP sonication. LIFUP sonication was applied using a focused ultrasound device (BXPulsar 1001, Brainsonix, Inc., Los Angeles, CA, USA) at a derated spatial-peak temporal-average intensity of 3870 mW/cm(2) .ResultsMRI performed at relatively high specific absorption rate (SAR) caused a slight elevation in temperature (≤0.6°C). Concurrent use of MRI at a medium-strength SAR and LIFUP sonication resulted in maximum temperature rise of 3.1°C after 8 min of continuous use.ConclusionsUnder the specific conditions utilized for this investigation, LIFUP sonication does not appear to present significant heating risks when used concurrently with MRI. This information has important implications for the use of the LIFUP sonication in human subjects undergoing MRI at 3 T/128 MHz.

ObjectiveThe objective of this study was to determine magnetic resonance imaging (MRI)-related heating for a low-intensity focused ultrasound pulsation (LIFUP) device used during MRI performed at 3 T/128 MHz.Materials and methodsA special phantom was constructed to mimic the thermal properties of the human brain, and a piece of human temporal bone (skull) was embedded on top. Four fluoroptic thermometry probes, placed above and below the skull, were used to measure temperature changes during MRI (3 T/128 MHz; scanner-reported head average specific absorption rate 1.1-2 W/kg) with and without concurrent LIFUP sonication. LIFUP sonication was applied using a focused ultrasound device (BXPulsar 1001, Brainsonix, Inc., Los Angeles, CA, USA) at a derated spatial-peak temporal-average intensity of 3870 mW/cm(2) .ResultsMRI performed at relatively high specific absorption rate (SAR) caused a slight elevation in temperature (≤0.6°C). Concurrent use of MRI at a medium-strength SAR and LIFUP sonication resulted in maximum temperature rise of 3.1°C after 8 min of continuous use.ConclusionsUnder the specific conditions utilized for this investigation, LIFUP sonication does not appear to present significant heating risks when used concurrently with MRI. This information has important implications for the use of the LIFUP sonication in human subjects undergoing MRI at 3 T/128 MHz.

Background: Chest physiotherapy (CPT) is a non‐pharmacological therapy to facilitate airway secretion removal. There have been concerns about potential electromagnetic interference (EMI) and lead integrity problems during the use of vibrating CPT devices in patients with cardiac implantable electronic devices (CIEDs). Hypothesis: Two CPT devices can be used safely in patients with CIED. Methods: Volunteer patients with CIED underwent device interrogation to check lead integrity and device function before and after application of CPT devices. Mechanical lung vibrator and high‐frequency chest wall oscillation (HFCWO) vests were used while monitoring surface electrocardiograms and intra‐cardiac electrograms. Results: We prospectively enrolled 46 patients with CIEDs (25 pacemakers, 15 implantable cardioverter‐defibrillators, and six cardiac resynchronization therapy‐defibrillators). There was no noise detection or EMI during CPT in any patient. None of the patients showed clinically significant changes in lead integrity parameters. HFCWO inappropriately accelerated the pacing rate up to the maximal programmed value in five patients with pacemakers and two with cardiac resynchronization therapy‐defibrillators. Conclusion: CPT may be safely applied to patients with CIED without compromising lead integrity or device function, except for unwanted increase in pacing rate caused by misdetection of chest wall vibration as patients' activity while using HFCWO. Deactivation of the accelerometer‐based activity sensor may be needed when HFCWO is planned for CPT. [ABSTRACT FROM AUTHOR]

Background: The Odon Device™ is a new device for assisted vaginal birth that employs an air cuff around the fetal head for traction. Assisted vaginal birth (AVB) is a vital health intervention that can result in better outcomes for mothers and their babies when complications arise in the second stage of labour. Unfortunately, instruments for AVB (forceps and ventouse) are often not used in settings where there is most clinical need often due to lack of training and resources, resulting in maternal and neonatal morbidity and mortality which could have been prevented. This is often due to a lack of trained operators as well as difficulties in the sterilisation and maintenance of AVB devices. This novel, single use device has the potential to mitigate these difficulties as it is single use and is potentially simpler to use than forceps and ventouse. All the studies of the Odon Device to date (pre-clinical, preliminary developmental and clinical) suggest that the Odon Device does not present a higher risk to mothers or babies compared to current standard care, and recruitment to intrapartum research exploring the device is feasible and acceptable to women. The first study in which the Odon Device was used in clinically indicated conditions (the ASSIST Study) reported a lower efficacy than those reported with established devices. The reasons need to be explored, specifically focussing on learning curve, the technique of the doctors using this new device and potential modifications to device design. A follow-on clinical study to further investigate the efficacy and safety of the Odon Device in its indicated use, the ASSIST II Study, is therefore being undertaken. Methods: The primary feasibility outcome is study feasibility (recruitment and retention rates) whilst the primary clinical outcome successful vaginal birth completed with the Odon Device. Key secondary feasibility outcomes include participant withdrawal, compliance in data collection and acceptability of the device to women and operators. Secondary clinical outcomes include maternal, neonatal and device outcomes. Safety data will be reviewed following every birth exploring maternal, neonatal and device risks. Using A'Hern approach for sample size calculation, we aim to recruit 104 women requiring an assisted vaginal birth for a recognised clinical indication. Assuming an AVB success rate of 65% or more, a one-sided alpha risk of 5% and power of 90%. Discussion: The data from the ASSIST II Study will provide the information required regarding acceptability, recruitment, outcome data collection, device design, technique of device use and operator learning curve in order to design a future randomised controlled trial of the Odon Device versus current modes of assisted vaginal birth. Trial registration: ISRCTN registration: 38829082 (prospectively registered July 26, 2019) [ABSTRACT FROM AUTHOR]

Objective: Percutaneous breast and axillary core biopsy followed by marker placement are integral parts of a breast imager's practice benefiting both patients and clinicians. Marker placement is the standard to facilitate future care. The purpose of this study is to characterize the safety and performance of MammoMARK, CorMARK, and HydroMARK biopsy markers by evaluating device-related adverse events, device deficiencies, and long-term safety. Methods: A retrospective review of three radiology practices identified patients who underwent image-guided breast or axillary biopsies followed by marker placement between 1 January 2012 and 1 January 2017. Medical records were reviewed with adverse events related to marker placement and use recorded. Results: 768 markers were placed with three (0.4%) events recorded. Two device deficiencies and one non-serious adverse event occurred in three patients. Device deficiency events involved user errors deploying the markers, one to inability to locate the marker on post-biopsy imaging, and the second to misplacement relative to biopsy target. One non-serious adverse event involved inability to locate/retain the marker in a surgically resected specimen. No serious adverse events were reported. Conclusion: Placement of breast biopsy markers is safe with minimal associated risks. Issues related to device malfunction, durability, reliability, safety, or performance were not reported. [ABSTRACT FROM AUTHOR]

In this article, an ultralow-frequency electric field probe capable of measuring time-varying gradient coil induced electric fields in a tissue-mimicking material was constructed, calibrated, and validated. This probe consisted of a 2 cm short dipole antenna followed by an instrumentation amplifier. The designed amplifier had a gain of 100 and a cutoff frequency of 31 kHz. The probe was fabricated on a four-layer printed circuit board (PCB), FR4 of thickness 1.57 mm and a copper thickness of $35~\mu \text{m}$. A waterproofed 3-D probe holder was used to cover the electronics and expose the dipole tip to the saline solution. To calibrate this probe in a known environment, a parallel-plate conductor was used. The calibrated probe was validated by measuring the electric field in a saline-filled cylindrical phantom placed within a cylindrically symmetric test coil. In order to do the validation, simulations were performed using an in-house tool developed in MATLAB and a validated tool in Sim4Life. [ABSTRACT FROM AUTHOR]

Background Wearable technology is increasingly used to diagnose, monitor and manage neurological disorders such as Parkinson's Disease (PD). This study aims to gain information about the views and needs of people with Parkinson's (PwP's) regarding wearable technology for monitoring the disease and assisting its management. Methods The study employed a mixed methods parallel design, wherein focus-groups and questionnaires were concurrently conducted with people with PwP's in Munster. Questionnaires and topic guides were developed with significant input from PwP's. The participants for focus-groups were purposively sampled for variation in PD stage, age (all >50 years) and sex. Questionnaire and focus-group results were analysed together, using a pragmatic triangulation protocol. Results Thirty-two questionnaires were completed by PwP's. Four semi-structured focus-groups were held (n=24 participants). Participants were overall positive about wearable technology in PD, and perceived benefits in wearable technology for improved management of symptoms. Wearables should be user-friendly, have an appealing design, and demonstrate clinical usefulness. Comfort and discrete design were emphasised for greater usability. The value of sharing information between PwP's and health professionals for improved outcomes was highlighted. PwP's perceived that increased patient data in the form of reliable information from a wearable device may allow for more accurate management of PD. Participants also felt that a device could help increase physical activity, and potentially track compliance with medication. There was little focus on device safety and privacy/ownership of data. While participants anticipated that there may be challenges for some in wearing a device, they believed overall potential benefits would outweigh these. Conclusion Engagement of PwP's in the design of wearable technology is vital for the development of devices that improve the management of PD. This study will directly inform a multi-country feasibility study of wearable devices for older people, with a particular focus on the needs of PwP's. [ABSTRACT FROM AUTHOR]

Objectives Radiofrequency interference (RFI) is a known medical device safety issue, but there are no documented cases of interference resulting in erroneous laboratory results. Methods We investigated unexpected failure of a hematology analyzer resulting in erroneous WBC counts. Hardware failure was initially suspected, but temporal association with increased power output from a nearby antenna prompted investigation for RFI. Results Power output from an antenna located approximately 4 feet from the analyzer was increased to ensure sufficient signal for emergency communications in the building. Interference from the antenna resulted in aberrant side scatter and abnormal WBC counts. Powering down the antenna returned the instrument to normal working conditions. Conclusions We have shown RFI as the root cause of erroneous WBC counts in a hematology analyzer. We propose that RFI should be on the list of potential interfering mechanisms when clinical laboratory instruments generate inconsistent or unreliable results. [ABSTRACT FROM AUTHOR]

Competing Interests: Competing interests: MM reported receiving research support through Yale University from Arnold Ventures outside the submitted work. VKR reported having been employed by F-Prime Capital outside the submitted work. KTK reported being previously employed at the Cleveland Clinic London and the US Food and Drug Administration (FDA) and receiving consulting fees from the National Academy of Medicine, all unrelated to this manuscript. JSR reported receiving grants from the FDA, Johnson and Johnson, the Medical Devices Innovation Consortium, AHRQ, NIH, and Arnold Ventures and serving as an expert witness at the request of Relator’s attorneys, the Greene Law Firm, in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen Inc. that was settled in Sep 2022. SSD reported receiving research funding from the Medical Device Innovation Consortium, Arnold Ventures and Department of Veterans Affairs.

Aims: To evaluate the value of magnetic stimulation (MS) in patients with pelvic floor dysfunction (PFD). Methods: The Preferred Reporting Items for Systematic Review and Meta‐analysis (PRISMA) statement was followed. We searched five databases for articles published until November 2017. Included studies investigated the effects of MS on PFD. Meta‐analysis of RCTs was performed using a random effects model, and narrative analysis was undertaken where meta‐analysis was not possible. Results: A total of 20 studies including 1019 patients were eligible for inclusion whose level of evidence for the included studies was low. Meta‐analysis of four trials comparing MS with sham intervention showed that MS was not associated with significant improvement in ICIQ‐SF score (−0.52, 95%CI −1.05, 0.01; P = 0.06, I2 = 16%), QOL score (−0.27, 95%CI −0.57, 0.04; P = 0.09, I2 = 0%), number of leakages (−0.16, 95%CI −0.62, 0.29; P = 0.48, I2 = 52%), and pad test (−1.36, 95%CI −2.64, −0.08; P = 0.04, I2 = 94%). Narrative review showed that there were no convincing evidences that MS was effective for chronic pelvic floor pain, detrusor overactivity, overactive bladder, and the included RCTs had controversial results. MS may have some benefits for nocturnal enuresis and erectile dysfunction according to the trials. Conclusions: There is no convinced evidence to support the benefits of using MS in the management of PFD. The applicability of MS in the treatment of PFD remains uncertain, so larger, well‐designed trials with longer follow‐up periods adopted relevant and comparable outcomes are needed to be further explored to provide a definitive conclusion. [ABSTRACT FROM AUTHOR]

BACKGROUND: The objective of this work was to describe the use of negative-pressure ventilation (NPV) in a heterogeneous critically ill, pediatric population. METHODS: A retrospective chart review was conducted of all patients admitted to a pediatric ICU with acute respiratory failure supported with NPV from January 1, 2012 to May 15, 2015. RESULTS: Two hundred thirty-three subjects at a median age of 15.5 months were supported with NPV for various etiologies, most commonly bronchiolitis (70%). Median (interquartile range) duration of support was 18.7 (8.7-34.3) h. The majority were NPV responders (70%), defined as not needing escalation to any form of positive-pressure ventilation. In non-responders, escalation occurred at a median (interquartile range) of 6.9 (3.3-16.6) h. More NPV non-responders had upper-airway obstruction (P = .02), and fewer had bronchiolitis (P = .008) compared with responders. A bedside scoring system developed on these data was 98% specific in predicting NPV failure by 4 h after NPV start (area under the curve 0.759, 95% CI 0.675-0.843, P < .001). Complications from NPV were rare (3%); however, delayed enteral nutrition (33%) and continuous intravenous sedation use (51%) in children while receiving NPV were more frequent. The annual percentage of pediatric ICU admissions requiring intubation declined by 28% in the 3 y after NPV introduction, compared with the 3 y prior. CONCLUSIONS: NPV is a noninvasive respiratory support for pediatric acute respiratory failure from all causes with few complications and a 70% response rate. Children receiving NPV often required intravenous sedation for comfort, and one third received delayed enteral nutrition. Those who required escalation from NPV worsened within 6 h; this may be predictable with a bedside scoring system. [ABSTRACT FROM AUTHOR]

A crossover study, also referred to as a crossover trial, is a form of longitudinal study. Subjects are randomly assigned to different arms of the study and receive different treatments sequentially. While there are many frequentist methods to analyze data from a crossover study, random effects models for longitudinal data are perhaps most naturally modeled within a Bayesian framework. In this article, we introduce a Bayesian adaptive approach to crossover studies for both efficacy and safety endpoints using Gibbs sampling. Using simulation, we find our approach can detect a true difference between two treatments with a specific false-positive rate that we can readily control via the standard equal-tail posterior credible interval. We then illustrate our Bayesian approaches using real data from Johnson & Johnson Vision Care, Inc. contact lens studies. We then design a variety of Bayesian adaptive predictive probability crossover studies for single and multiple continuous efficacy endpoints, indicate their extension to binary safety endpoints, and investigate their frequentist operating characteristics via simulation. The Bayesian adaptive approach emerges as a crossover trials tool that is useful yet surprisingly overlooked to date, particularly in contact lens development. [ABSTRACT FROM AUTHOR]

We present a standardized test methodology and results for our evaluation of the Carefusion Alaris PC infusion pump, comprising the model 8015 PC Unit and the model 8100 Large Volume Pump (LVP) module. The evaluation consisted of basic suitability testing, internal component inspection, surface temperature measurement of selected internal components, and critical performance testing (infusion rate accuracy and occlusion alarm pressure) during conditions of typical hyperbaric oxygen (HBO2) treatment in our facility's class A multiplace chamber. We have found that the pumps pose no enhanced risk as an ignition source, and that the pumps operate within manufacturer's specifications for flow rate and occlusion alarms at all stages of HBO2 treatments, up to 4.0 ATA and pressurization and depressurization rates up to 180 kPa/minute. The pumps do not require purging with air or nitrogen and can be used unmodified, subject to the following conditions: • pumps are undamaged, clean, fully charged, and absent from alcohol cleaning residue; • pumps are powered from the internal NiMH battery only; • maximum pressure exposure 4.0 ATA; • maximum pressurization and depressurization rate of 180 kPa/minute; • LVP modules locked in place with retaining screws. [ABSTRACT FROM AUTHOR]

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., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2023 Zou, Davis, Wigle, Hincapie and Guo.)

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., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Aims To review whether patients with urinary incontinence (UI) treated with magnetic stimulation (MS) have a higher continence rate compared to sham. Methods Computerized search of electronic databases was performed using the keywords magnetic stimulation therapy and urinary incontinence. Inclusion criteria were randomized, blinded and sham-controlled. Results Eight studies involving 494 patients were included (285 patients received active MS and 209 patients received sham MS). Sample size ranged from 20 to 151 participants. Three studies were on stress UI, two studies on urgency UI, two studies on mixed UI and one study on overactive bladder. The primary outcome (cure) was not reported since only one study reported this outcome. Meta-analysis of the secondary outcome (improvement) showed patients who received active treatment were 2.3 times more likely to experience improved continence compared to sham treatment (95% confidence interval: 1.60-3.29; P < 0.001), but was subject to bias due to varying inclusion criteria, poor reporting and variable time points. There were conflicting results in the treatment effect on quality of life (QOL). Twenty out of 494 patients (5%) experienced mild side effects. The longest follow up period was six months. Conclusions There is no firm evidence to support the benefits of using MS in the management of UI, although short-term outcomes suggests that MS improves UI symptoms in women. The applicability of MS as a treatment option for UI remains uncertain until larger, high-quality trials with longer follow-up periods using comparable and relevant outcomes are conducted. Neurourol. Urodynam. 34:713-722, 2015. © 2014 Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]