Trends in software as a medical device (Preprint)

2020 ◽  
Author(s):  
Aaron Ceross ◽  
Jeroen Bergmann
Keyword(s):  
Health Care ◽  
Data Analysis ◽  
High Risk ◽  
Adverse Events ◽  
Medical Device ◽  
Empirical Analysis ◽  
Medical Devices ◽  
Digital Revolution ◽  
The Us ◽  
Software Registration

UNSTRUCTURED Software-as-a-medical-device (SaMD) has gained popularity as a type of medical device. However, to date, empirical analysis of SaMD trends have been lacking. Using databases managed by the US medical device regulator (the Food and Drug Administration), we map the path SaMD takes towards classification and recorded adverse events. The findings show that while SaMD has been identified in literature as an area of development, the data analysis suggests that this growth has been modest. These devices are overwhelming classified as moderate to high risk and they take a very particular path to that classification. The digital revolution in health care is less pronounced when evidence is considered of SaMD. In general, the trend for software registration mimics that of medical devices.

scholarly journals Pattern of Medical Device Adverse Events in a Tertiary Level Hospital in Northern India: An Ambispective Study

2021 ◽  
Author(s):  
Saifuddin PK ◽  
Ajay Prakash ◽  
Ram Samujh ◽  
SK Gupta ◽  
Vanita Suri ◽  
...  
Keyword(s):  
Retrospective Study ◽  
High Risk ◽  
Adverse Events ◽  
Prospective Study ◽  
Medical Device ◽  
Medical Devices ◽  
Tertiary Level ◽  
Risk Class ◽  
Northern India ◽  
Class B

Abstract Background: This is the first study to evaluate the pattern of adverse events related to medical devices in India. We aimed to evaluate medical device adverse events (MDAEs) reported at a tertiary level teaching hospital in northern India.Methods: This descriptive study was conducted ambispectively at PGIMER, Chandigarh. We used the medical device risk classification given by the Indian regulatory authority which was framed in line with the recommendation of the Global Harmonization Task Force. The prospective study (PS) was done from January 2020 to December 2020 with a concurrent retrospective study (RS) proceeding to three years so as to learn more about the reporting culture, demographics, risk class of devices and the type of adverse events.Result. We obtained 224 MDAE in the prospective study and identified 413 MDAE in retrospective study. Reporting culture of retrospective adverse events to the national materiovigilance programme of India (MvPI) was negligible. Marginally increased incidence of MDAE reported among male patients (PS; 52%, RS; 57%) and age group between 21-30 years (PS; 19.1%, RS; 23.2%) in both studies. Fewer number of MDAEs were also reported from infants (7.5%) and the elderly (6.9%) population. Regarding risk class, MDAEs were frequent in low to moderate risk devices (Class B: 66%) in the prospective study, while it was documented only for high-risk devices (Class C: 51% & Class D: 49%) in the retrospective study. However, serious adverse events (SAEs) were equally prevalent among moderate to high-risk devices (Class B: 33%, C: 34% &D: 33%). An increased frequency of SAE was observed among non-notified medical devices (60.4%). Concerning reporting culture, nurses reported the majority of MDAEs (65%). Overall 14% of the incidents were documented as near-miss events.Conclusion: Medical devices elicit adverse events irrespective of their risk class, notification status and patient demographic factors. Escalated reporting of MDAEs by surgeons and biomedical engineers is recommended at India.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

PP096 European Union-Health Technology Assessments For Medical Devices - How To Overcome Reimbursement Divergence

2017 ◽  
Vol 33 (S1) ◽  
pp. 116-117
Author(s):  
Jana Hemmerling ◽  
Karolin Eberle ◽  
Sara Hogger ◽  
Maike Gupta ◽  
Anna Ullraum ◽  
...  
Keyword(s):  
Health Care ◽  
Medical Device ◽  
Medical Devices ◽  
Small Body ◽  
Health Technology ◽  
Surrogate Endpoints ◽  
European Network ◽  
Gemeinsamer Bundesausschuss ◽  
Real World Data ◽  
Clinical Reality

INTRODUCTION:National Health Technology Assessments (HTAs) for medical devices are crucial to regulate the quality and costs of healthcare systems. However, there is diversity in several aspects among European countries. Consequently, controversial results might arise, generating contrary reimbursement decisions. The European Network for Health Technology Assessment (EUnetHTA) is an interface platform for the harmonization of HTA information across Europe. The European Commission expects national uptake of a European HTA. Thus, European HTAs might overcome the diversity of national HTA requirements.METHODS:We aimed to compare German and European HTAs for medical devices regarding processes, methods, timelines, and involvement of medical device companies. Therefore we analyzed guidelines, requirements, and output of EUnetHTA and compared those aspects with the German G-BA (Federal Joint Committee, Gemeinsamer Bundesausschuss) standard and IQWiG (Institute for Quality and Efficiency in Health Care, Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen) methods.RESULTS:We found differences between the European and German HTAs for medical devices regarding timelines, involvement of medical device companies, body of evidence, use of surrogate endpoints, and methodology. European HTAs for medical devices reflect the clinical reality by integrating the existing evidence (including real world data) and by using comprehensive statistical methods for medical devices. In contrast, German HTAs for medical device-based technologies are long lasting and are often restricted to a small body of evidence.CONCLUSIONS:As a conclusion, similar to pharmaceuticals, the European HTA framework might also become a worldwide platform for HTAs of medical device-based technologies with the potential to harmonize reimbursement decisions and patients health care across countries on the basis of clinical reality.

scholarly journals An Analysis of FDA Adverse Event Reporting Data for Trends in Medical Device Use Error

2020 ◽  
Vol 9 (1) ◽  
pp. 130-134
Author(s):  
Benjamin M. Knisely ◽  
Camille Levine ◽  
Kush C. Kharod ◽  
Monifa Vaughn-Cooke
Keyword(s):  
Adverse Event ◽  
Adverse Events ◽  
Medical Device ◽  
Medical Devices ◽  
Product Life Cycle ◽  
Risk Mitigation ◽  
Adverse Event Reporting ◽  
Mitigation Strategies ◽  
Event Reporting ◽  
Device Use

Humans can contribute to error at all stages of the medical device product life-cycle. Use error associated with medical devices can result in catastrophic consequences for end users and inefficient use of healthcare system resources. Industry-wide statistics about medical device use error has the potential to aid in identifying opportunities for human factors intervention, however publicly available statistics are sparse. The Food and Drug Administration (FDA) requires medical device manufactures, importers, and device user facilities to track and report adverse events for post-market surveillance through medical device reports (MDRs). This data is available in an online database: Manufacturer and User Facility Experience (MAUDE). This study provides a comprehensive evaluation of use error adverse events in MAUDE (2010-2018) based on device class, device operator, and event outcome, to address the lack of industry-wide statistics on medical device use error. Results indicate that use error is significantly represented in adverse event reporting, constituting 28.1% of reports labeled with device problem codes. Events associated with patient device operators were predominately associated with diabetes-related medical devices, while provider operators were associated with a wider array of devices. Additionally, it was found that most use error reports were attributed to issues with device output; using the device in accordance with manufacturer expectations; and physically activating, positioning, or separating device components. This work demonstrates the viability of using MAUDE to attain industry wide statistics on medical device use error for later integration in industry-wide or device-specific risk mitigation strategies.

scholarly journals Approval of High-Risk Medical Devices in the US: Implications for Clinical Cardiology

2014 ◽  
Vol 16 (6) ◽  
Author(s):  
Benjamin N. Rome ◽  
Daniel B. Kramer ◽  
Aaron S. Kesselheim
Keyword(s):  
High Risk ◽  
Medical Devices ◽  
Clinical Cardiology ◽  
The Us

scholarly journals Marketing authorization of medical devices in China

2016 ◽  
Vol 22 (1) ◽  
Author(s):  
Weifan Zhang ◽  
Rebecca Liu ◽  
Chris Chatwin
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Marketing Authorization ◽  
Regulatory Environment ◽  
Doing Business ◽  
The Us ◽  
Research Gap ◽  
Business In China ◽  
China’S Economy

Medical device regulations across the globe have significant variations. The Chinese medical device market, like China’s economy, is developing rapidly. This article reviews the medical device regulations in China and illustrates the major changes that have been recently implemented according to the new medical device regulations that came into force on the 1st June, 2014. Most regulatory research has focused on the US and EU medical device regulations with little written about the Chinese medical device regulations. The purpose of this article is to bridge the research gap and to introduce the Chinese medical devices regulatory environment to investors or companies who are engaged in the medical device market or doing business in China

scholarly journals Treatment Patterns, Adverse Events, and Economic Burden in a Privately Insured Population of Newly Diagnosed Patients with Chronic Lymphocytic Leukemia in the United States

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3557-3557 ◽  
Author(s):  
Shaum Kabadi ◽  
Ravi K Goyal ◽  
Saurabh P Nagar ◽  
James A Kaye ◽  
Keith L Davis ◽  
...  
Keyword(s):  
Health Care ◽  
Adverse Events ◽  
Systemic Therapy ◽  
Research Funding ◽  
The United States ◽  
Treatment Patterns ◽  
Newly Diagnosed ◽  
The Us ◽  
Privately Insured

Abstract Introduction: Contemporary data describing treatment patterns, adverse events (AEs) and outcomes in CLL patients in clinical practice is lacking. We conducted a retrospective cohort study and assessed treatment patterns, AEs, health care resource use (HCRU), and costs in patients with newly diagnosed CLL. Methods: Using a nationally representative population of privately insured patients in the US, adult patients with CLL were selected if they had continuous health plan enrollment for ≥12 months before the first CLL diagnosis without any evidence of any CLL-directed treatment. Treatment patterns up to 4 lines of therapy (LOT) and occurrence of AEs during CLL therapies were assessed. Mean per-patient monthly HCRU and costs were assessed overall and by number of unique AEs. Results: Of all patients meeting the selection criteria (n=7,639; median age, 66 years), 18% (n=1,379) received a systemic therapy during study follow-up. The most common systemic therapy regimens, regardless of therapy line, were bendamustine/rituximab (BR) (32%), rituximab monotherapy (24% [including maintenance]), ibrutinib monotherapy (15%), and fludarabine/cyclophosphamide/ rituximab (FCR) (14%). Of these, BR was the most common LOT-1 regimen (28.1%), while ibrutinib was the most common regimen in LOT-2 (20.8%) and in LOT-3 (25.5%). Use of idelalisib was limited to 1.6% of all patients receiving systemic therapy; however, an increasing trend was observed as patients moved from first to fourth LOT (<1% in LOT-1, 3.1% in LOT-2, 4.7% in LOT-3, and 8.6% in LOT-4). AEs identified during the most common treatments for CLL are presented by treatment regimen in Table 1. The mean monthly all-cause and CLL-related costs, among patients treated with a systemic therapy, were $7,943 (SD=$15,757) and $5,185 (SD=$9,935), respectively. Figure 1 depicts mean monthly costs by care setting and number of AEs, among all patients. Mean (SD) monthly all-cause costs during the post-index date follow-up were $905 ($1,865) among those with no AEs, $1,655 ($5,364) among those with 1-2 AEs, $2,883 ($8,483) among those with 3-5 AEs, and $6,032 ($13,290) among those with ≥6 AEs. Conclusions: This population-based study yielded recent real-world evidence on treatment patterns, AEs, HCRU, and costs in patients enrolled in health plans in the US. Immunochemotherapy, particularly BR, remained the preferred frontline therapy for CLL, whereas ibrutinib was the preferred therapy in LOT-2 and LOT-3, during the study period. This study demonstrates that the AE burden associated with current treatment alternatives for CLL is substantial, and the management of AEs occurring during treatments may have a significant impact on the overall health care costs. Disclosures Kabadi: AstraZeneca: Employment. Goyal:RTI Health Solutions: Employment, Research Funding. Nagar:RTI Health Solutions: Employment, Research Funding. Kaye:RTI Health Solutions: Employment, Research Funding. Davis:RTI Health Solutions: Employment, Research Funding. Mato:Celgene: Consultancy; AstraZeneca: Consultancy; Pharmacyclics: Consultancy, Honoraria, Research Funding; Abbvie: Consultancy; Sunesis: Honoraria, Research Funding; TG Therapeutics: Research Funding; Janssen: Consultancy, Honoraria; Acerta: Research Funding; Prime Oncology: Speakers Bureau; Regeneron: Research Funding.

scholarly journals Adverse Events ‒ One of the Most Important Health Care Quality Indicators: A Case Study

2017 ◽  
Vol 13 (12) ◽  
pp. 288 ◽  
Author(s):  
Vinsas Janusonis
Keyword(s):  
Health Care ◽  
High Risk ◽  
Adverse Events ◽  
Care Quality ◽  
Individual Characteristics ◽  
Team Work ◽  
Registration System ◽  
Causal Factors ◽  
Medium Risk ◽  
The Individual

The aim of study: to evaluate inpatients, experienced adverse events (AE) in Klaipeda university hospital (KUH) contingent, healthcare profiles, location and causal factors, the degree of risk, possibility to avoide its, and to compare assessment of doctors and experts, and estimate their changes in different analyzed periods. Material and methods. The study carried out by analyzing the AE reporting forms in KUH at 2000-2014time period. Exploring and comparing 1690 patients, experienced AE data by age, gender, health care profile, the reasons. Results. The survey showed that AE was 0.3 % of hospitalized patients, most of them (54.9 %) ‒ associated with surgery. The largest group of AE ‒ repeated operations (44.8 %), related to childbirth AE (26.2 %) and related to infection ‒ (13.1 %). Almost half (43.2 %) AE were medium risk, one-third (33.8 %) ‒ minimal and one-fifth (21.6 %) ‒ high risk. Doctors (nurses) and experts opinions on the major causative factors of AE ‒ the individual characteristics of the patients (88.5 % and 90.3 %) basically was similar. However, due to the individual characteristics of doctors (nurses) ‒ experts often (14.2 %) could see them as causal factor than doctors or nurses (9.8 %). Due possibility of AE avoidance ‒ doctors (nurses) and experts opinion that almost half of them (44.7 % and 48.8 %) were avoidable was the same, but stood for full possibility of avoidance (11.2 % doctors (nurses) and 16.9 % experts) and complete inevitability (44.1 % doctor (nurses) and 34.3 % experts) of AE. Conclusions: Long-term operating adverse events reporting and registration system and analysis showed that adverse events in KUH is much less than in comparable large multiprofile hospitals of other countries. The structure of AE have advantages with structure in other countries ‒ the most adverse events related to surgery, infections, nursing, but there are significant differences ‒ reported little adverse events related to drugs, diagnostics, and a small number of falls compared with many births related AE. The majority ‒ almost four fifths of the AE was minimal or medium risk, one-fifths ‒ high-risk. The AE related with deaths were few. The main causal factors of AE ‒ individual characteristics of the patients and the doctors, and team work failure. A twothirds of AE could be fully or partially prevented.

scholarly journals Cost-effectiveness Analysis of Sequential Treatment of Abaloparatide Followed by Alendronate Versus Teriparatide Followed by Alendronate in Postmenopausal Women With Osteoporosis in the United States

2018 ◽  
Vol 53 (2) ◽  
pp. 134-143 ◽  
Author(s):  
Quang A. Le ◽  
Joel W. Hay ◽  
Russell Becker ◽  
Yamei Wang
Keyword(s):  
United States ◽  
Health Care ◽  
Cost Effectiveness ◽  
High Risk ◽  
The United States ◽  
Clinical Event ◽  
Risk Of Fracture ◽  
Life Years ◽  
The Us ◽  
Des Model

Background: The US Food and Drug Administration has recently approved abaloparatide (ABL) for treatment of women with postmenopausal osteoporosis (PMO) at high risk of fracture. With increasing health care spending and drug prices, it is important to quantify the value of newly available treatment options for PMO. Objective: To determine cost-effectiveness of ABL compared with teriparatide (TPTD) for treatment of women with PMO in the United States. Methods: A discrete-event simulation (DES) model was developed to assess cost-effectiveness of ABL from the US health care perspective. The model included three 18-month treatment strategies with either placebo (PBO), TPTD, or ABL, all followed by additional 5-year treatment with alendronate (ALN). High-risk patients were defined as women with PMO ⩾65 years old with a prior vertebral fracture. Baseline clinical event rates, risk reductions, and patient characteristics were based on the Abaloparatide Comparator Trial in Vertebral Endpoints (ACTIVE) trial. Results: Over a 10-year period, the DES model yielded average total discounted per-patient costs of $10 212, $46 783, and $26 837 and quality-adjusted life-years (QALYs) of 6.742, 6.781, and 6.792 for PBO/ALN, TPTD/ALN, and ABL/ALN, respectively. Compared with TPTD/ALN, ABL/ALN accrued higher QALYs at lower cost and produced an incremental cost-effectiveness ratio (ICER) of $333 266/QALY relative to PBO/ALN. In high-risk women, ABL/ALN also had more QALYs and less cost over TPTD/ALN and yielded an ICER of $188 891/QALY relative to PBO/ALN. Conclusion and Relevance: ABL is a dominant treatment strategy over TPTD. In women with PMO at high risk of fracture, ABL is an alternative cost-effective treatment.

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