Renewing the Call for Reforms to Medical Device Safety-The Case of Penumbra.

Importance: Strengthening premarket and postmarket surveillance of medical devices has long been an area of focus for health policy makers. The recent class I recall (the most serious of the US Food and Drug Administration [FDA] recalls) of reperfusion catheters manufactured by Penumbra, a US-based medical device company, illustrates issues of device safety and oversight that mandate attention. Objectives: To review the regulatory history and clinical evidence of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7) and use the device recall as a case study of the challenges associated with clinical evaluation, transparency, and oversight of medical devices in the US. Evidence: Regulatory history and clinical evidence for the Penumbra medical devices were analyzed through a qualitative review of decision letters in the Access FDA database for medical devices and medical device reports in the Manufacturer and User Facility Device Experience database and a review of market data (eg, earnings calls, company communications) and clinical literature. Findings: The JET 7 device was subjected to a class I recall following more than 200 adverse event reports, 14 of which involved patient deaths. Regulatory analysis indicated that each of the Penumbra reperfusion catheters was cleared under the 510(k) pathway (which allows devices to be authorized with limited to no clinical evidence), with limited submission of either new clinical or animal data. Clinical evidence for Penumbra devices was generated from nonrandomized, single-arm trials with small sample sizes. The regulatory issues raised by JET 7 are reflective of broader challenges for medical device regulation. Opportunities for reform include strengthening premarket evidence requirements, requiring safety reporting with unique device identifiers, and mandating active methods of postmarket surveillance. Conclusions and Relevance: The case study of JET 7 highlights the long-standing gaps in medical device oversight and renews the impetus to build on the Institute of Medicine recommendations and reform FDA medical device regulation to protect public health.

Secondary Medication Administration and IV Smart Pump Setup.

ABSTRACT: Secondary infusion by large-volume IV smart pump is used extensively in the acute care setting for one-time or intermittent administration of medications such as antibiotics, electrolyte replacements, and some oncology drugs. Consistent and accurate delivery of secondary medications requires a full understanding of the system and setup requirements. Unfortunately, it is not uncommon for nurses to find a secondary medication only partially administered when their programming should have resulted in a complete infusion. This article discusses the technical requirements that every nurse should know when administering secondary medications using an IV smart pump.

Home Hazard Removal to Reduce Falls Among Community-Dwelling Older Adults: A Randomized Clinical Trial.

Importance: Falls are the leading preventable cause of morbidity, mortality, and premature institutionalization for community-dwelling older adults. Objective: To test the effectiveness of a behavioral intervention on fall risk among older adults receiving services from an Area Agency on Aging. Design, Setting, and Participants: This randomized clinical trial examined a home hazard removal intervention in the community using a race- and sex-stratified randomization design. Older adults receiving services from the Area Agency on Aging in urban St Louis, Missouri, were assigned to a home hazard removal intervention delivered over 2 weeks with a 6-month booster or usual care control. Eligible participants were adults aged 65 years or older who did not have dementia, were at high risk for falling, and resided in the community. Enrollment occurred from January 2015 to September 2016; 12-month follow-up occurred from February 2016 to October 2017. Data were analyzed from February 2019 to July 2021. Interventions: The intervention was a home hazard removal program delivered by an occupational therapist in the home that included a comprehensive clinical assessment and a tailored hazard removal plan. Usual care control consisted of annual assessments and community referral. Main Outcomes and Measures: The primary outcome was the hazard of a fall over 12 months. Prespecified secondary outcomes included the rate of falls over 12 months, daily activity performance, falls self-efficacy, and self-reported quality of life. Results: A total of 310 participants (mean [SD] age, 75 [7.4] years; 229 [74%] women; 161 Black participants [52%]) were randomized, with 155 participants assigned to the intervention and 155 participants assigned to usual care. Retention was 127 participants (82%) in the intervention group and 126 participants (81%) in the control group. There was no difference for our primary outcome of fall hazard (hazard ratio, 0.90; 95% CI, 0.66-1.27). There was a 38% reduction in the rate of falling in the intervention group compared with the control group (relative risk, 0.62; 95% CI, 0.40-0.95; P = .03). At 12 months, the rate of falls per person-year was 1.5 (95% CI, 1.32-1.75) in the intervention group and 2.3 (95% CI, 2.08-2.60) in the control group. There was no difference in daily activity performance (adjusted difference, -0.20; 95% CI, -0.95 to 0.55; P = .60), falls self-efficacy (adjusted difference, -0.12; 95% CI, -1.25 to 1.01; P = .84), or quality of life (adjusted difference, 0.84; 95% CI, -0.95 to 2.64; P = .35). Conclusions and Relevance: This randomized clinical trial found that a brief home hazard removal program did not reduce the hazard of falls among community-dwelling older adults at high risk for falling. The intervention was effective in achieving a reduced rate of falls, a prespecified secondary outcome. This effectiveness study has the potential for delivery through the national aging services network. Trial Registration: ClinicalTrials.gov Identifier: NCT02392013.

The U.S. Food and Drug Administration's role in improving radiation dose management for medical X-ray imaging devices.

The U.S. Food and Drug Administration (FDA) has been concerned with minimizing the unnecessary radiation exposure of people for half a century. Manufacturers of medical X-ray imaging devices are important partners in this effort. Medical X-ray imaging devices are regulated by FDA under both its electronic product regulations andits medical device regulations. FDA also publishes guidance documents that represent FDA's current thinking on a topic and provide a suggested or recommended approach to meet the requirements of a regulation or statute. FDA encourages manufacturers to develop medical devices that conform to voluntary consensus standards. Use of these standards is a central element of FDA's system to ensure that all medical devices marketed in the U.S. meet safety and effectiveness requirements. FDA staff participate actively in the development and maintenance of these standards, often advancing or introducing new safety and dose management requirements. Use of voluntary consensus standards reduces the amount of time necessary to evaluate a premarket submission and reduces the burden on manufacturers. FDA interacts with industry and other stakeholders through meetings with industry groups, public meetings, public communications, and through the development of voluntary consensus standards. In these interactions, FDA staff introduce new concepts for improving the safety of these devices and provide support for similar initiatives from professional organizations. FDA works with all stakeholders to achieve its mission of protecting and promoting the public health.

Cybersecurity: The need for data and patient safety with cardiac implantable electronic devices.

Remote monitoring of cardiac implantable electronic devices (CIEDs) has become routine practice as a result of the advances in biomedical engineering, the advent of interconnectivity between the devices through the Internet, and the demonstrated improvement in patient outcomes, survival, and hospitalizations. However, this increased dependency on the Internet of Things comes with risks in the form of cybersecurity lapses and possible attacks. Although no cyberattack leading to patient harm has been reported to date, the threat is real and has been demonstrated in research laboratory scenarios and echoed in patient concerns. The CIED universe comprises a complex interplay of devices, connectivity protocols, and sensitive information flow between the devices and the central cloud server. Various manufacturers use proprietary software and black-box connectivity protocols that are susceptible to hacking. Here we discuss the fundamentals of the CIED ecosystem, the potential security vulnerabilities, a historical overview of such vulnerabilities reported in the literature, and recommendations for improving the security of the CIED ecosystem and patient safety.

[How did the private labs fit onto COVID-19 crisis?] / Comment les laboratoires de biologie médicale privés français se sont adaptés à la crise de la COVID-19 ?

Confronted with the COVID-19 crisis, healthcare professionals have had to tackle an epidemic crisis of a huge magnitude for which they were not prepared. Medical laboratories have been on the front line, from collecting samples to performing the analysis required to diagnose this new pathology. Responding to the needs and to the urgency of the situation, the authorities relied on the network of private laboratories. In France, private laboratory medicine represents 70% of overall activity, and with a network of more than 4,000 local laboratories, private laboratory medicine has been the cornerstone of the « screen-trace-isolate ¼ strategy. This article gives feedback from private laboratory medicine professionals, directly involved in the reorganization carried out at the pre-analytical, analytical and post-analytical stages, during the crisis from March to October 2020.

Accuracy of fluid delivery devices for the neonate: Are the measures assured?

INTRODUCTION: Delivery of accurate volumes of fluid in surgical neonates and children is crucial for the good outcome of treatment. But how accurate are the calibrations on the fluid delivery devices? AIMS: This study seeks to verify the accuracy of these devices in common use in our practice. MATERIALS AND METHODS: This is a cross-sectional experimental study carried out in our center; a tertiary health facility in Southern Nigeria in May 2019. Fluid delivery devices (FDDs) used in the course of treatment of our pediatric patients were randomly included in the study. The number of drops per ml of each device was obtained by counting while the fluid dropped until a 1 ml volume was delivered. The data was then collated and analyzed. RESULTS: A total of 215 FDDs were included in this study. They comprised infusion giving set, Soluset (Burette) giving set, and blood giving set. The rate of delivery was 20 drops/ml (infusion giving sets), 60 drops/min (Burette/Soluset), and 15 drops/ml (Blood giving set). They were all in keeping with the labeled/assumed calibration in each of the types of FDDs P < 0.05. Therefore, the mean, median, and mode were the same. CONCLUSION: This study has demonstrated that the FDDs used our center are accurately calibrated and safe as they deliver volumes of fluid as labeled. The findings in this study reassure us of the dependability and accuracy of delivery of the FDDs we use in children in our center.

Protección del equipo para la realización de ecografías en paciente con COVID-19 / Equipment cover-up for ultrasound use in COVID-19 patients

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Regulatory Science, and How Device Regulation Will Shape Our Future.

Pediatric medical device approvals lag behind adult approvals. Historically, medical devices have rarely been designed specifically for children, but use in children has most often borrowed from adult or general use applications. While a variety of social, economic, and clinical factors have contributed to this phenomenon, the regulatory process remains a fundamental aspect of pediatric device development and commercialization. FDA's Center for Devices and Radiological Health (CDRH) has established programmatic and technological areas of advancement to support innovation that serves the public health needs of children and special populations. We highlight four regulatory areas that have the potential to shape the future of pediatric cardiology: the CDRH Early Feasibility Study Program, advancements in 3D printing or additive manufacturing, computational modeling and simulation, and the use of real-world evidence for regulatory applications. These programs have the potential to impact all stages of device development, from early conception, design, and prototyping to clinical evidence generation, regulatory review, and finally commercialization. The success of these programs relies on a collaborative community of stakeholders, including government, regulators, device manufacturers, patients, payers, and the academic and professional community societies.

Key factors for successful implementation of the National Rollover Protection Structure Rebate Program: A correlation analysis using the consolidated framework for implementation research.

Objectives On US farms, tractor overturns are the leading cause of death; however, these fatalities are preventable with the use of a rollover protection structure (ROPS). A ROPS rebate program was established in New York in 2006 to address these fatalities. Due to its success, the program expanded to six additional states before being implemented as the National ROPS Rebate Program (NRRP) in 2017. The aim of this study was to evaluate the success of the NRRP implementation using short- and long-term ROPS outcome measures and identify which components of the consolidated framework for implementation research (CFIR) correlate with these outcomes. Methods Stakeholders involved in the NRRP implementation were surveyed at four time points, beginning at the time of the NRRP launch and then every six months. These surveys measured 14 relevant CFIR constructs. Correlations between CFIR survey items (representing constructs) and three outcome measures (intakes, funding progress, and retrofits) were used to identify CFIR survey items that are predictive of the outcomes. Results Eight CFIR survey items were highly correlated (rho ≥0.50) with at least one of the three outcome measures. These eight CFIR survey items included four constructs: access to knowledge and information, leadership engagement, engaging (in fundraising and funding requests), and reflecting and evaluating. Conclusions The results of this study provide important guidance for continuing the implementation of the NRRP. Similarly, these findings can inform the evaluation of other similarly structured implementation efforts and the application of CFIR in a variety of settings.

External Orthopaedic Implants in the Magnetic Resonance Environment: Current Concepts and Controversies.

MRI provides diagnostic three-dimensional imaging and remains extremely important in the diagnosis and management of spinal trauma as well as other acute traumatic injuries, including those of the extremities. The American Society for Testing and Materials has created standards against which all implantable medical devices are tested to ensure safety in an MR environment. Most implantable passive orthopaedic devices can undergo MRI without consequence to the patient. However, the American Society for Testing and Materials has recently updated its terminology resulting in confusion among providers and institutions. Primary safety concerns are radiofrequency-induced heating and magnetically induced torque or displacement. These safety concerns have emerged as a recent source of debate, particularly regarding the imaging of patients with external fixation and cervical immobilization devices in place. Surveys have shown a lack of consensus among radiologists regarding this issue. Having an institutional protocol in place for the imaging of these patients streamlines the diagnosis and early stabilization of certain polytraumatized patients. The purpose of this review is to summarize the pertinent literature as well as the current industry recommendations regarding the safety of commonly used external fixation, cervical immobilization, and traction devices in the MR environment.

Comprehension of Safety Pictograms Affixed to Agricultural Machinery among Pakistani Migrant Farmworkers in Italy.

Objectives: Safety pictograms are important graphic elements that are useful for rapidly conveying messages in workplaces. The purpose of this study was to investigate the comprehension of safety pictograms affixed to agricultural machinery among a group of Pakistani migrant farmworkers employed in Italy. Methods: Interviews about the meanings attributed to four standardized safety pictograms affixed to agricultural machinery depicting the most frequent causes of farm accidents were administered to 29 Pakistani migrant farmworkers employed on Italian farms. Results: There was high variability in pictogram comprehension. None of the participants interpreted all the pictograms in accordance with the definitions provided by the international standards. Higher comprehension rates were reported for pictograms related to the risks of tractor rollover and foot injury, while pictograms referring to the need to consult a technical manual and the risk of entanglement yielded lower comprehension scores. Previous farming experience in the country of origin and the number of years of education were significantly associated with comprehension scores. Conclusion: A discussion of pictogram features that may be critical for comprehension is provided, and (re)design suggestions are given to improve the cross-cultural comprehension of these safety signs.

Are safe guards at trampoline parks safe enough?: A case report on a complete spinal cord injury after diving into a trampoline park foam pit.

RATIONALE: Recently, commercial indoor trampoline parks have been opened around the globe, and both the number of venues and the park users are increasing. Academic literatures have largely focused on home trampoline related injuries, and less is known about the injuries associated with trampoline parks due to the limited number of studies or cases reported. In this report, we present a complete spinal cord injury sustained at a commercial indoor trampoline park. PATIENT CONCERNS: A 26-year old male developed tetraplegia after plainly jumping on the trampolines and diving into one of the foam pits head first. DIAGNOSIS: C-spine CT revealed bilateral interfacetal dislocation on C6-7, and his C-spine MRI showed anterior translational injury at C6-7 with severe cord encroachment and complete discoligamentous complex disruption. He was diagnosed with complete spinal cord injury. INTERVENTIONS: The patient underwent 30 minutes each of physical therapy and occupational therapy twice a day for a total of 25 days of in-patient rehabilitation. Interventions included tilt table, passive range of motion exercises, functional electrical stimulation, sitting balance training, upper extremity strengthening exercise, and hand manipulation exercises. OUTCOME: Despite intensive rehabilitation and the patient's good spirit, there was no functional change in all physical examinations between evaluations at initial and at discharge. LESSONS: In conclusion, we aim to alert the risks associated with improper use of trampolines, promote safer entertainment environment, and aid in developing mandatory safety measures. We hope to alert the risks associated with improper use of trampolines, promote safer entertainment environment, and aid in developing mandatory safety measures.

Heuristic evaluation and simulated use testing of infusion pumps to inform pump selection.

BACKGROUND: Poorly designed infusion pumps can lead to user errors and adverse incidents. Therefore, assessments of their usability and performance that can inform managerial decisions about the selection of appropriate medical devices are essential. OBJECTIVE: This study aimed to identify design deficiencies and evaluate the usability and performance of four infusion pump models and thus inform decisions about infusion pump selection. METHODS: Four evaluators evaluated the interface designs of the pumps according to a series of design principles in a heuristic evaluation in order to identify pump design deficiencies. Additionally, 60 registered nurses participated in simulated use testing to perform a series of tasks using the pumps in order to examine the pump performances. Outcome measures included task completion time, frequency of deviations, frequency of requests for assistance, and nurses' perceptions. RESULTS: Design issues identified included system status visibility, information access, and error prevention. The results of simulated use testing favored some pumps over others, depending on which outcome measures were considered. CONCLUSIONS: Heuristic evaluations and simulated use testing can provide information about the basic usability of medical devices and related operational issues. However, practitioners should select appropriate evaluation principles, testing tasks, and outcome measures based on the tested medical devices and contexts.