scholarly journals The Impact of COVID-19 on Medical Device Reporting and Investigation

2021 ◽  
pp. 28-35
Author(s):  
Zoe Pruitt ◽  
Christian Boxley ◽  
Seth Krevat ◽  
Srijan Sengupta ◽  
Raj Ratwani ◽  
...  
Keyword(s):  
Patient Safety ◽  
Medical Device ◽  
Medical Devices ◽  
Current Time ◽  
Safety Issues ◽  
User Facility ◽  
Future Harm ◽  
Clinically Significant ◽  
The Impact ◽  
The U.S

Introduction The Manufacturer and User Facility Device Experience (MAUDE) database houses medical device reports submitted to the U.S. Food and Drug Administration (FDA). In May 2020, the FDA released guidance about medical device reporting during a pandemic, anticipating delays in reporting and investigating events involving medical devices. Methods We aimed to understand how the COVID-19 pandemic impacted medical device reporting by analyzing reports in the MAUDE database that mention COVID-19. Results From the 816,470 reports submitted between January 1 and July 31, 2020, 3,500 (0.43%) included phrases related to COVID-19. Of these reports, 4.8% (167/3,500) described adverse events during COVID-19 patients’ treatment, and 90.3% (3,161 /3,500) described barriers manufacturers faced investigating malfunctioning devices during the pandemic. 4.9% (172/3,500) of reports were not related to COVID-19. Malfunctions were clinically significant in 85.8% (3,004/3,500) of reports. Discussion Reports indicate challenges some manufacturers had when investigating medical devices during the pandemic. The pandemic made investigating implants uniquely difficult, as restrictions to person-to-person contact limited the type of care patients could receive. Because full-scale investigations into malfunctioning devices may be difficult to perform during the pandemic, safety issues may go unaddressed and result in future harm to patients. Conclusion The COVID-19 pandemic and the myriad of healthcare, travel, and shipping challenges it created impacted how manufacturers reported and investigated medical devices. At the current time, it is unclear how manufacturers will address delayed clinical management of implant devices and other uninvestigated malfunctions after the pandemic and how this will impact patient safety.

scholarly journals Nighthawk: Making Night Float Education and Patient Safety Soar

2017 ◽  
Vol 9 (6) ◽  
pp. 755-758 ◽  
Author(s):  
Brett W. Sadowski ◽  
Hector A. Medina ◽  
Joshua D. Hartzell ◽  
William T. Shimeall
Keyword(s):  
Patient Safety ◽  
Online Education ◽  
Senior Resident ◽  
Resident Satisfaction ◽  
Educational Materials ◽  
Team Members ◽  
Safety Issues ◽  
Night Float ◽  
Satisfaction With Supervision ◽  
The Impact

ABSTRACT Background  Some residency programs responded to duty hour restrictions by implementing night rotations. Night supervision models can vary, resulting in potential patient safety issues and educational voids for residents. Objective  We evaluated the impact of multiple evidence-based interventions on resident satisfaction with supervision, perception of the education value of night rotations, and residents' use of online educational materials. Methods  The night team was augmented with an intern to assist with admissions and a senior resident (the “nighthawk”) to supervise inpatient care and deliver a night medicine curriculum. We instituted a “must-call” list, with specific clinical events requiring mandatory attending notification, and reduced conflict in the role of the night float team. We studied patient contact, online curriculum use, residents' perceptions of nighthawk involvement, exposure to educational materials, and satisfaction with supervision. Results  During the first half of academic year 2016–2017, 51% (64 of 126) of trainees were on the night medicine rotation. The nighthawk reviewed 1007 intern plans (15 per night; range, 6–36) and supervised 215 hands-on evaluations, including codes and rapid responses (3 per night; range, 0–12). The number of users of the online education materials increased by 85% (13 to 24), and instances of use increased 35% (85 to 115). The majority of residents (79%, 27 of 34) favored the new system. Conclusions  A nighthawk rotation, a must-call list, and reducing conflict in night team members' roles improved resident satisfaction with supervision and the night medicine rotation, resulting in increased communication.

Advancing Medical Technology Using FPGAs

2010 ◽  
Author(s):  
Zach Olson
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
High Performance ◽  
Heart Surgery ◽  
Open Heart Surgery ◽  
Good Alternative ◽  
Real Time Processing ◽  
Precise Control ◽  
Glucose Levels ◽  
The Impact

Field Programmable Gate Arrays (FPGAs) have dramatically changed the design of medical devices in the past decade. FPGAs offer the flexibility of writing software on a standard microprocessor and the reliability and performance of dedicated hardware. In the design of medical devices that previously required the rigorous design of custom circuits or ASIC design, FPGAs are providing a good alternative at a much lower cost for low to mid-volume medical device design. In this session, we will explore how FPGAs relate to medical device technology including real-time processing of data, high performance image processing, precise control, and code reuse from prototype to deployed device. We will explore how this technology was applied to two devices that improve the success of high-risk surgeries. In the first, FPGA technology is used to monitor blood glucose levels in patients during open-heart surgery. The second example is a device that simulates electrical signals from the human nervous system to train neurophysiologists for events that may happen during surgery. We will explore the impact FPGAs have on design cycles, briefly explore the design process, and compare different programming methodologies including C, VHDL, and LabVIEW. Finally, we will discuss the impact of FPGAs with respect to the 510k process.

Adopting Identification Standards in the Medical Device Supply Chain

2020 ◽  
Vol 13 (1) ◽  
pp. 1-14 ◽  
Author(s):  
Yousef Abdulsalam ◽  
Dari Alhuwail ◽  
Eugene S. Schneller
Keyword(s):  
Supply Chain ◽  
Medical Device ◽  
Medical Devices ◽  
Business Intelligence ◽  
Return On Investment ◽  
Survey Methods ◽  
Device Identification ◽  
Medical Device Manufacturers ◽  
High Level ◽  
The U.S

The U.S. Food and Drug Administration has recently mandated that medical device manufacturers adopt Unique Device Identification (UDI) standards on their medical devices. The benefits that UDI brings to hospitals and patients is relatively obvious, including inventory transparency, product safety, product equivalency, business intelligence. However, adoption by manufacturers, who face the mandate, has been slow in part because the benefit to them is not as readily perceived. This study focuses on the incentives, barriers, and benefits that medical device manufacturers perceive in UDI adoption. This study seeks to understand which adoption pressures are driving manufacturers to act, and attempts to gauge the benefits to manufacturers from UDI adoption. Through survey methods, the evidence suggests that medical device manufacturers implement UDI largely as a response to the coercive and normative pressures they face. There continues to be a high level of uncertainty regarding the return on investment for the medical device manufacturers, particularly from the late adopters.

Software-as-a-Medical Device: demystifying Connected Health regulations

2016 ◽  
Vol 18 (2) ◽  
pp. 186-215 ◽  
Author(s):  
Noel Carroll ◽  
Ita Richardson
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Healthcare Service ◽  
Healthcare Sector ◽  
Future Research ◽  
Extensive Literature ◽  
Comprehensive Overview ◽  
Content Type ◽  
Connected Health ◽  
The Impact

Purpose Connected Health is an emerging and rapidly developing field never before witnessed across the healthcare sector. It has the potential to transform healthcare service systems by increasing its safety, quality and overall efficiency. However, as healthcare technologies or medical devices continuously rely more on software development, one of the core challenges is examining how Connected Health is regulated – often impacting Connected Health innovation. The purpose of this paper is to present an understanding of how Connected Health is regulated. Many of these regulatory developments fall under “medical devices”, giving rise to Software-as-a-Medical Device (SaaMD). Design/methodology/approach Through an extensive literature review, this paper demystifies Connected Health regulation. It presents the outcome of expert discussions which explore the key regulatory developments in the context of Connected Health to provide a practical guide to understanding how regulation can potentially shape healthcare innovation. Findings Several key issues are identified, and the authors present a comprehensive overview of regulatory developments relating to Connected Health with a view to support the continued growth of IT-enabled healthcare service models. The authors also identify the key challenges in Connected Health and identify areas for future research. Originality/value A key outcome of this research is a clearer understanding of the opportunities and challenges that regulation and standards present to Connected Health. Furthermore, this research is of critical importance in a first attempt towards recognising the impact of regulation and standards compliance in Connected Health.

scholarly journals The impact of calibration on medical devices performance and patient safety

2018 ◽  
Vol 29 (12) ◽  
Author(s):  
Altayyar Saleh S ◽  
Mousa MA ◽  
Alfaifi AM ◽  
Negm AE ◽  
Ali MO
Keyword(s):  
Patient Safety ◽  
Medical Devices ◽  
The Impact

Premarket Review of Medical Devices in the United States

2000 ◽  
Vol 7 (3) ◽  
pp. 293-326
Author(s):  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Regulatory System ◽  
The United States ◽  
The Public ◽  
The World ◽  
Contemporary Perspective ◽  
Premarket Approval ◽  
The U.S ◽  
Medical Device Regulation

AbstractIt has been sixty years since the Congress first authorized FDA to regulate medical devices. During this period, countless studies, reports, and investigations have been targeted at medical devices. The law has been significantly modified several times, and the regulations revised on numerous occasions. As for any other scheme of administration or management, revisions are necessary as demand arises for legislative attention to societal risks, the economy fluctuates, and when businesses expand and globalize. Studying the U.S. system of medical device regulation merely from a contemporary perspective fails to take into account the significance of decades of effort in maintaining the quality and integrity of the system in an ever-changing field of medical device regulation.The three-pronged medical device regulatory system that entails inspection of manufacturing facilities, premarket approval, and postmarket recall and reporting enables the public to benefit from medical devices without the fear of unreasonable risk with their use (Appendix 1). President Clinton proudly pronounced the following in a 1995 speech:Today, Americans don't have to worry about safety or effectiveness when they buy [drugs and medical devices] - from cough syrups to the latest antibiotics or pacemakers. The Food and Drug Administration has made American drugs and medical devices the envy of the world and in demand all over the world. And we are going to stick with the standards we have - the highest in the world.…^218

scholarly journals Plastics and cardiovascular health: phthalates may disrupt heart rate variability and cardiovascular reactivity

2017 ◽  
Vol 313 (5) ◽  
pp. H1044-H1053 ◽  
Author(s):  
Rafael Jaimes ◽  
Adam Swiercz ◽  
Meredith Sherman ◽  
Narine Muselimyan ◽  
Paul J. Marvar ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Heart Rate ◽  
Heart Rate Variability ◽  
Medical Device ◽  
Cardiovascular Reactivity ◽  
Medical Devices ◽  
Autonomic Regulation ◽  
Phthalate Exposure ◽  
The Impact ◽  
Ethylhexyl Phthalate

Plastics have revolutionized medical device technology, transformed hematological care, and facilitated modern cardiology procedures. Despite these advances, studies have shown that phthalate chemicals migrate out of plastic products and that these chemicals are bioactive. Recent epidemiological and research studies have suggested that phthalate exposure adversely affects cardiovascular function. Our objective was to assess the safety and biocompatibility of phthalate chemicals and resolve the impact on cardiovascular and autonomic physiology. Adult mice were implanted with radiofrequency transmitters to monitor heart rate variability, blood pressure, and autonomic regulation in response to di-2-ethylhexyl-phthalate (DEHP) exposure. DEHP-treated animals displayed a decrease in heart rate variability (−17% SD of normal beat-to-beat intervals and −36% high-frequency power) and an exaggerated mean arterial pressure response to ganglionic blockade (31.5% via chlorisondamine). In response to a conditioned stressor, DEHP-treated animals displayed enhanced cardiovascular reactivity (−56% SD major axis Poincarè plot) and prolonged blood pressure recovery. Alterations in cardiac gene expression of endothelin-1, angiotensin-converting enzyme, and nitric oxide synthase may partly explain these cardiovascular alterations. This is the first study to show an association between phthalate chemicals that are used in medical devices with alterations in autonomic regulation, heart rate variability, and cardiovascular reactivity. Because changes in autonomic balance often precede clinical manifestations of hypertension, atherosclerosis, and conduction abnormalities, future studies are warranted to assess the downstream impact of plastic chemical exposure on end-organ function in sensitive patient populations. This study also highlights the importance of adopting safer biomaterials, chemicals, and/or surface coatings for use in medical devices.NEW & NOTEWORTHY Phthalates are widely used in the manufacturing of consumer and medical products. In the present study, di-2-ethylhexyl-phthalate exposure was associated with alterations in heart rate variability and cardiovascular reactivity. This highlights the importance of investigating the impact of phthalates on health and identifying suitable alternatives for medical device manufacturing.

scholarly journals A Descriptive Analysis of Capsule Endoscopy Events in the FDA Manufacturer and User Facility Device Experience (MAUDE) Database

2021 ◽  
Vol 12 (02) ◽  
pp. 071-077
Author(s):  
Hangyu Ji ◽  
Shaoli Wang ◽  
Yang Gong
Keyword(s):  
Patient Safety ◽  
Medical Device ◽  
Capsule Endoscopy ◽  
Descriptive Analysis ◽  
Brand Names ◽  
Capsule Endoscope ◽  
Narrative Texts ◽  
Search Terms ◽  
Patency Capsule ◽  
User Facility

Abstract Introduction The malfunction of capsule endoscopy (CE) devices is a significant reason for the failure of CE procedures, which could hinder and prevent diagnosis. Unfortunately, malfunction-related adverse events (AEs) caused by CE devices are rarely reported in publications. Although most malfunction-related AEs could not lead to physical harm, they could reduce the efficiency of medical care and increase medical costs. The manufacturer and user facility device experience (MAUDE) database, a publicly accessible resource for patient safety, contains not only the common complications of CE but also valuable malfunction-related AEs, which have been underutilized. Therefore, the study aims to discover and analyze the possible AEs associated with CE and demonstrate the utility of the MAUDE reports to promote patient safety. Materials and Methods We acquired MAUDE reports of CE systems from January 01, 2008, to July 31, 2020, through a systematic search strategy. We utilized the manufacturers, brand names, and product codes as search terms from which medical device reports including structured data and narrative texts were extracted, followed by a manual review of the narrative texts, reporter occupation, device involved, event type and the phase of the event; finally, patient outcomes were recorded and analyzed as per CE categories and characteristics. Results A total of 377 CEs medical device reports were retrieved, and 342 reports were included after reviewing. There were 327 mandatory reports (96%) and 15 voluntary reports (4%). These reports referred to capsule endoscope (n = 213), sensing system (n = 66), patency capsule (n = 38), and capsule delivery device (n = 26). A total of 349 CE-related AEs were identified, including complications (n = 228), malfunction-related AEs (n = 109), and other events (n = 12). The composition of AEs was not the same for the CE devices. Complications were major AEs of capsule endoscope and patency capsule, but malfunction-related AEs were the most common in AEs of sensing systems and capsule delivery devices. Conclusion MAUDE serves as an invaluable data source for investigating malfunction-related AEs. In addition to common complications, malfunction of CE devices could threaten patient safety in CE procedures. Improving awareness of the malfunction of CE devices and raising adequate training for staff working in gastrointestinal (GI) endoscopic units could be critical and beneficial in preventing malfunction-related AEs.

scholarly journals Using the monocyte activation test as a stand-alone release test for medical devices

ALTEX ◽  
2021 ◽  
pp. 151-156
Author(s):  
Jeffrey Brown
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Safety Assessment ◽  
National Institutes Of Health ◽  
Monocyte Activation ◽  
Device Development ◽  
Medical Device Manufacturers ◽  
Regulatory Evaluation ◽  
Limulus Amebocyte Lysate Test ◽  
The U.S

Monocyte activation tests (MAT) are widely available but rarely used in place of animal-based pyrogen tests for safety assessment of medical devices. To address this issue, the National Toxicology Program Interagency Center for the Eval­uation of Alternative Toxicological Methods and the PETA International Science Consortium Ltd. convened a workshop at the National Institutes of Health on September 18-19, 2018. Participants included representatives from MAT testing laboratories, medical device manufacturers, the U.S. Food and Drug Administration’s Center for Devices and Radio­logic Health (CDRH), the U.S. Pharmacopeia, the International Organization for Standardization, and experts in the development of MAT protocols. Discussions covered industry experiences with the MAT, remaining challenges, and how CDRH’s Medical Device Development Tools (MDDT) Program, which qualifies tools for use in evaluating medical devices to streamline device development and regulatory evaluation, could be a pathway to qualify the use of MAT in place of the rabbit pyrogen test and the limulus amebocyte lysate test for medical device testing. Workshop outcomes and fol­low-up activities are discussed.

A Process for Design, Verification, Validation, and Manufacture of Medical Devices Using Immersive VR Environments

2010 ◽  
Vol 4 (4) ◽  
Author(s):  
Daniel F. Keefe ◽  
Fotis Sotiropoulos ◽  
Victoria Interrante ◽  
H. Birali Runesha ◽  
Dane Coffey ◽  
...  
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
System Level ◽  
Design Verification ◽  
Device Design ◽  
Product Cycles ◽  
Medical Device Design ◽  
Simulation Based ◽  
Device Engineering ◽  
The Impact

This paper presents a framework and detailed vision for using immersive virtual reality (VR) environments to improve the design, verification, validation, and manufacture of medical devices. Major advances in medical device design and manufacture currently require extensive and expensive product cycles that include animal and clinical trials. The current design process limits opportunities to thoroughly understand and refine current designs and to explore new high-risk, high-payoff designs. For the past 4 years, our interdisciplinary research group has been working toward developing strategies to dramatically increase the role of simulation in medical device engineering, including linking simulations with visualization and interactive design. Although this vision aligns nicely with the stated goals of the FDA and the increasingly important role that simulation plays in engineering, manufacturing, and science today, the interdisciplinary expertise needed to realize a simulation-based visual design environment for real-world medical device design problems makes implementing (and even generating a system-level design for) such a system extremely challenging. In this paper, we present our vision for a new process of simulation-based medical device engineering and the impact it can have within the field. We also present our experiences developing the initial components of a framework to realize this vision and applying them to improve the design of replacement mechanical heart valves. Relative to commercial software packages and other systems used in engineering research, the vision and framework described are unique in the combined emphasis on 3D user interfaces, ensemble visualization, and incorporating state-of-the-art custom computational fluid dynamics codes. We believe that this holistic conception of simulation-based engineering, including abilities to not just simulate with unprecedented accuracy but also to visualize and interact with simulation results, is critical to making simulation-based engineering practical as a tool for major innovation in medical devices. Beyond the medical device arena, the framework and strategies described may well generalize to simulation-based engineering processes in other domains that also involve simulating, visualizing, and interacting with data that describe spatially complex time-varying phenomena.

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