Medical Device Adverse Events Research Articles

The application study of harmonization code in medical device adverse event reporting

BackgroundThe reporting of adverse events in medical devices (MD) is a starting point of post-market surveillance and the most common source of initial safety signals. Because MD adverse events (AE) occur globally and involve high-profile international public health crises, international regulators implanted standard codes for MDAE reporting. This study aimed to assess the application of MDAE terminology and codes by providing examples of virtual events.MethodsAn online survey was conducted among participants of the MD Training Program for Regulatory Authorities which provide International Medical Device Regulators Forum (IMDRF) adverse event terminology and codes, and six virtual MDAE cases.ResultsAll 29 of the 72 participants were regulators. In all cases, most participants selected the broad (level 1) codes rather than the detailed (level 2 or level 3) codes. While responders selected a variety of codes for all annexes in case 1, over 50% of responders selected the intended codes in case 6. The codes for cause investigation were chosen more frequently than other annexes for device problem, components, and health effect. No differences were observed in code selection amongst different stakeholders.ConclusionsWe identified the diversification in terminology and code selection for reporting MDAEs.

Awareness Regarding Medical Device Safety among Physicians: A Knowledge, Attitude, and Practice Survey

Abstract Background: With the huge inflow of medical devices into the healthcare market, it is imperative to monitor the device safety throughout its period of usage, with the help of a systematic continual surveillance mechanism. Although the Materiovigilance Program of India has been formally introduced since 2015, there exists a dearth of awareness regarding its existence and functioning among the major stakeholders of patient safety. Addressing this gap, the study probes the awareness regarding materiovigilance among the doctors in eastern India. Methods: A cross-sectional questionnaire-based study was carried out using a 20-item structured survey tool to evaluate the knowledge, attitude, and practice of medical professionals regarding safety surveillance of medical devices. Responses obtained were statistically analyzed and interpreted. Results: Principal elements of medical device adverse event (MDAE) reporting were known to around 40% of respondents. However, the time frame for reporting an event/incident was found to be grossly unclear. Over 30% of respondents were aware of the effect of MDAEs and that its reporting could enhance patient safety. Items related to practice domains revealed that although around 50% of respondents of either category encountered MDAEs in their practice setup, only 10.95% of faculty and 6.41% of residents have reported it. Less than 5% of the respondents were ever trained on how to report MDAEs. The mean domain score for knowledge was on higher mark for the faculty, while that for attitude and practice domains were higher for the residents. Conclusion: There was a gross dearth of awareness regarding materiovigilance among the doctors. Enhanced sensitization regarding medical device safety surveillance in all healthcare levels can definitely help the situation ensuring patient safety.

Monitoring System of Medical Device Adverse Events in the US and Application of MAUDE Database in Medical Device Registration

In order to achieve precise risk control of medical devices, it is necessary to establish a scientific evaluation system throughout the entire life cycle of medical devices that focuses on risk identification and risk control. This study summarizes the medical device adverse event monitoring system of the US on regulatory agencies and regulatory law, adverse events reporting forms and time limits, adverse event database, adverse event report analysis and evaluation, as well as adverse event feedback and control. Furthermore, some examples are provided to illustrate the application of the MAUDE database in risk analysis, physical and mechanical performance research, and clinical evaluation of medical device registration and application materials.

Materiovigilance: An Overview

Pharmacovigilance is a crucial process that aims to guarantee that patients are prescribed safe pharmaceuticals. The World Health Organisation describes it as "the discipline of science and activities relating to the identification, evaluation, comprehension, and avoidance of adverse effects and other drug-related problems." Recent advances in science have led to a major expansion in the role of medical devices in the healthcare delivery system. PV encompasses issues relating to medication therapy as well. To regulate the import, manufacture, sales, and distribution of medical equipment, the Indian government, along with the Drugs Technical Advisory Board, recently established the Medical Equipment Rules, in 2017. Postmarketing surveillance carried out by an Indian regulatory authority (MvPI) is becoming increasingly popular, comparable to that of international regulatory agencies. An essential instrument for protecting users from unforeseen effects and improving their health and safety, the adverse events reporting system (ADERS) allows for the recording of all types of medical device adverse events (MDAEs).

AI as a Medical Device Adverse Event Reporting in Regulatory Databases: Protocol for a Systematic Review.

The reporting of adverse events (AEs) relating to medical devices is a long-standing area of concern, with suboptimal reporting due to a range of factors including a failure to recognize the association of AEs with medical devices, lack of knowledge of how to report AEs, and a general culture of nonreporting. The introduction of artificial intelligence as a medical device (AIaMD) requires a robust safety monitoring environment that recognizes both generic risks of a medical device and some of the increasingly recognized risks of AIaMD (such as algorithmic bias). There is an urgent need to understand the limitations of current AE reporting systems and explore potential mechanisms for how AEs could be detected, attributed, and reported with a view to improving the early detection of safety signals. The systematic review outlined in this protocol aims to yield insights into the frequency and severity of AEs while characterizing the events using existing regulatory guidance. Publicly accessible AE databases will be searched to identify AE reports for AIaMD. Scoping searches have identified 3 regulatory territories for which public access to AE reports is provided: the United States, the United Kingdom, and Australia. AEs will be included for analysis if an artificial intelligence (AI) medical device is involved. Software as a medical device without AI is not within the scope of this review. Data extraction will be conducted using a data extraction tool designed for this review and will be done independently by AUK and a second reviewer. Descriptive analysis will be conducted to identify the types of AEs being reported, and their frequency, for different types of AIaMD. AEs will be analyzed and characterized according to existing regulatory guidance. Scoping searches are being conducted with screening to begin in April 2024. Data extraction and synthesis will commence in May 2024, with planned completion by August 2024. The review will highlight the types of AEs being reported for different types of AI medical devices and where the gaps are. It is anticipated that there will be particularly low rates of reporting for indirect harms associated with AIaMD. To our knowledge, this will be the first systematic review of 3 different regulatory sources reporting AEs associated with AIaMD. The review will focus on real-world evidence, which brings certain limitations, compounded by the opacity of regulatory databases generally. The review will outline the characteristics and frequency of AEs reported for AIaMD and help regulators and policy makers to continue developing robust safety monitoring processes. PRR1-10.2196/48156.

Health-care Professionals' Perception toward Medical Device Postmarket Surveillance Practices: A Cross-sectional Study in India.

A cross-sectional, web-based survey was conducted to assess the health-care professionals (HCPs)' perception toward existing medical device postmarket surveillance (PMS) practices in India. A total of 1756 responses (medical practitioners [19.8%], nurses [22.5%], pharmacists [21.4%], and biomedical engineers [13.8%]) were recorded and analyzed. About 71.2% of participants were aware about the ongoing PMS program, 87.5% were aware that medical devices are under regulation in India, and 83.3% were aware about who can report medical device adverse event (MDAE). About 56.3% of participants agreed that they take regular feedback from patients after using high-risk medical device. Majority of participants (69.4%) were aware about tools for reporting MDAE and the online reporting form is the most preferable tool among users. About 76.2% of participants were agreeing that reporting of MDAE is their professional/ethical responsibility. This study reveals that Indian HCPs show a good understanding of PMS practices and a positive perception toward MDAE reporting. However, underreporting still remains a challenge in India.

Study on the impact of sensitization on materiovigilance programme among pharmacy and dental postgraduate students

ABSTRACT Background Medical devices play a crucial role in patient care but entail inherent risks, necessitating the presence of materiovigilance to monitor and prevent medical device adverse events (MDAEs). The primary objective of our study is to evaluate the impact of an awareness and sensitization program regarding medical devices among participants. Methods A self-administered, validated knowledge, attitude, and practice (KAP) questionnaire consisting of 15 questions was distributed to study participants, and their responses were collected. The data were analyzed using SPSS software version 18. Results Out of the 182 responses received, 56% were from the Pharmacy, while 44% were from the Dental field. 64.8% of the participants were unaware of the Materiovigilance Programme of India (MvPI). However, an overwhelming 97.5% displayed a positive attitude towards reporting MDAEs. Only 5% of the participants had received training on how to report MDAEs. Furthermore, 85.71% of participants had not seen the MDAE reporting form. Conclusion To improve the reporting of MDAEs, it is essential to implement educational interventions and provide training to Pharmacy and Dental postgraduate students. These measures will increase awareness and promote better understanding and implementation of materiovigilance practices.

Pattern of Medical Device Adverse Events in a Tertiary Care Hospital in Northern India: An Ambispective Study.

Knowledge about the pattern of adverse events caused by medical devices (MDs) is limited in India. We aimed to assess the pattern of MD adverse events (MDAEs) in a tertiary hospital in Northern India. This descriptive study was conducted ambispectively at various clinical departments of PGIMER, Chandigarh. We followed the guidelines edged by the Materiovigilance Program of India (MvPI) to conduct this study. The prospective study (PS) was done from January to December 2020, with a concurrent retrospective study (RS) proceeding to 3 years to learn more about the reporting culture, demographics, notification status, risk class of defective devices, and the type of adverse events. We received 224 MDAE in the PS and identified 413 MDAE in the RS. Reporting of adverse events to the national MvPI was negligible in the RS. In the PS, nurses reported the majority of MDAEs (65%), followed by doctors (30%). The occurrence of MDAE was higher in males (PS; 52%, RS; 57%) and age groups between 21 and 30 years (PS; 19.1%, RS; 23.2%) in both studies. MDAEs were frequent in low- to moderate-risk devices (class B: 66%) in the PS, while it was documented only for high-risk devices (class C: 51% and class D: 49%) in the RS. Most of the serious adverse events (SAEs) were reported among moderate to high-risk devices, and an increased frequency of SAE (60.4%) was observed among nonnotified MDs. The overall incidence of near-miss events was 14%. Knowledge of MDAEs and reporting of defective devices to regulatory authorities is essential to prevent further incidence. Adverse events caused by MDs are ubiquitous irrespective of their risk classification, notification status, and patient demographic factors. Accelerated reporting of MDAE by all cadre of healthcare professionals is urgently required to safeguard the health of Indians.

Discussion on Medical Device Adverse Event Surveillance

With the continuous development of medical technology and the wide application of medical devices, the risk of medical device adverse events is gradually increasing. In order to ensure the safety and effectiveness of medical devices, timely detection and treatment of adverse events of medical devices, and to protect the safety and rights of patients, the state continuously strengthens the monitoring of adverse events of medical devices. This paper firstly introduces the domestic and foreign medical device adverse event related regulations, it introduces the form of medical device adverse event monitoring work in China, compares and analyzes the data of medical device adverse events in recent years, and puts forward some problems in medical device adverse event monitoring work, in order to continuously improve the control and management of the risk level of medical devices, and ensure the clinical use of medical devices and patient safety.

Evaluation of Machine Translation Accuracy Focused on the Adverse Event Terminology for Medical Devices.

The purpose of this study was to evaluate the accuracy of deep neural machine translation focused on medical device adverse event terminology. 10 models were obtained, and their English-to-Japanese translation accuracy was evaluated using quantitative and qualitative measures. No significant difference was found in the quantitative index except for a few pairs. In the qualitative evaluation, there was a significant difference and googletrans and GPT-3 were regarded as useful models.

Assessment of knowledge, attitude, and practice of materiovigilance among interns in a tertiary care institute: A cross-sectional study

Background: Medical interns have major role in reporting of medical device adverse events. Various studies have shown inadequate knowledge and understanding of medical device adverse events in health care professionals in foreign countries which impact the reporting of such events. Indian data on knowledge and reporting of such events is lacking. Aim and Objectives: The aim of this study was to evaluate the knowledge, attitude, and practice of materiovigilance among interns in Hassan Institute of Medical Sciences (HIMS), Hassan. Materials and Methods: This was a cross-sectional questionnaire-based study conducted among interns of HIMS. The questionnaire consists of 15 questions pertaining to knowledge, attitude, and practice of materiovigilance. Results: The questionnaire was administered to 100 interns, out of which 83 responded resulting in 83% response rate. The mean knowledge score of interns was 3.21 ± 0.97. The majority of the participants (97.6%) believed that medical device can cause adverse events; however, very few of them (12%) have reported it during their practice. Conclusion: Our research found that there is a lack of knowledge among interns about the reporting of medical device adverse events and the materiovigilance program. Proper educational intervention is necessary to make them aware of the materiovigilance and enhance reporting.

Analysis of Adverse Event Reports in FDA’s MAUDE Database

Background and Objective: Medical devices (MDs) play a pivotal role in the modern healthcare environment. Adverse events are an expected part of an MD’s lifecycle. To prevent the recurrence of such events, various vigilance systems have been established worldwide. The Manufacturer and User facility Device Experience (MAUDE) database of the US Food and Drug Administration (FDA) is a publicly accessible database that contains data of medical device reports (MDRs) submitted to FDA since 1991. The aim of this study is to examine the evolution of MD adverse event reports and analyze several characteristic parameters, as they evolved during the last three decades.
 Material and Methods: An analysis of MAUDE data was performed to examine the outcomes and device characteristics of adverse event reports from 1991 up to 11/2022. These outcomes included the event type, remedial action, report source, reporter occupation and device evaluation by manufacturer. Specific MD groups were analyzed separately to examine their effect on the event outcomes. Segregated files of the database that contain different types of information on adverse event reports were combined to investigate the various aspects of these reports.
 Results: Event outcomes are presented as annual histograms. An overall of about 15 million reports have been submitted to MAUDE during the 30 years period examined with more than 2.5 million of them during the first 10 months of the year 2022. This number is growing at an increasing rate. Most of the events (63.5%) have resulted in simple device malfunction, without serious implications to the patient. Depending on the device type however, the health risks may be higher (98.4% injuries from specific dental implants and 3.2% deaths from implantable defibrillators). About 20% of the reports have led to recalls or other corrective actions. Most of the reports (96%) are submitted by manufacturers and over 70% of the devices returned to them are evaluated, following the requirements of FDA 21 CFR, 803. The reporter’s occupation was found to be related to the types of devices associated with the event. Finally, the average device age was found to be 4 years, with an increasing tendency observed over the years, while still most of the events occur during the first year of operation.
 Conclusion: A medical device adverse event reporting system is a critical component of safety in the use of medical technology in modern healthcare. The information available in MAUDE and its use continues to grow at an accelerated rate and allows critical improvements of MDs, especially in terms of risk prevention, as it gives perception about their safety issues. FDA has taken various steps to encourage and facilitate adverse event reporting and make the data available to the public.

Knowledge, attitude and practice of materiovigilance among nurses and healthcare technicians in a tertiary care hospital: A questionnaire-based survey

Materiovigilance is “the coordinated system of identification, collection, reporting, and analysis of any untoward occurrences associated with the use of medical devices. This aims to safeguard the well-being of patients by not only preventing the recurrence of these Medical Device Adverse Events but also by taking necessary actions for safety improvements or recalls of such devices. The increasing importance of evaluating the awareness and reporting practices of Medical Device Adverse Events among Indian Healthcare Professionals, the present study was conducted to assess the Knowledge, Attitude, and Practice of Materiovigilance among nurses employed in a tertiary care hospital. This study is questionnaire-based survey which is designed to evaluate the knowledge, attitude and practice of medical professionals. Our study found that nurses and healthcare technicians in a tertiary care hospital possessed adequate knowledge about different facets of Materiovigilance and maintained a positive attitude towards reporting adverse events associated with medical devices. However, we also noted that the translation of this knowledge and attitude into effective practice of reporting Medical Device Adverse Events was lacking within the participants.

Challenges encountered by healthcare professionals in monitoring adverse events due to medical devices-A review

Medical devices can be hazardous despite their positive benefits. Reporting medical device adverse events are voluntary for all the health care professionals but the number of reporting adverse medical events are less when compared with all the available studies in India. Hence it is important to address the reasons and challenges that are faced by health care professionals in reporting the events so that safety and quality action can be taken in order to prevent them. Understanding the obstacles to and reasons for patient reporting is necessary and may help to increase the safety of medications. This review provides an insight into factors contributing to underreporting of MDAE such as Health care system capacity related, organizational related barriers, and Industry responsiveness. This review might offer helpful data for overcoming barriers in monitoring and support quality and safety management in hospitals.

PO-02-227 ADVERSE EVENTS ASSOCIATED WITH AUTOMATIC EXTERNAL DEFIBRILLATOR - LIFEPAK: A STUDY FROM FOOD AND DRUG ADMINISTRATION MAUDE DATABASE

Automatic External defibrillator (AED) can analyze heart rhythms and allows operators to deliver treatment in patients with tachyarrhythmias or cardiac arrest with a shockable rhythm. The incidence of adverse events (AE) between different ED models is not well known. We sought to assess the type of AE associated with the AED – Lifepak series (Stryker, Kalamazoo, MI) using the FDA Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database is a repository of industry and patient/physician-reported medical device adverse events. A MAUDE database search was conducted on November 10, 2022, for reports received between January 1992 to October 2022 to capture all AE. A total of 32,557 AE were reported from 1992 to 2022. An increase in trends of AE was observed from 1992 to 2022 (0.1% to 7.3%), respectively. Among the 7 Lifepak models, Lifepak CR Plus (5.5%, 1177 events), Lifepak CR2 (5.7%, 1230 events), and Lifepak 20e (5.85%, 1260 events) had the three lowest reported AE while the Lifepak 15 (28.2%, 6073 events), Lifepak 20 (21.2%, 4561 events) and Lifepak 12 (23.6%, 5085 events) had the three highest reported AE (21,503 events). The most commonly reported AE was product malfunction (95.9%, 31,209 events) resulting in patient injury (0.9%, 289 events) and patient death (2.9%, 950 events). Correct utilization of AED is crucial during advanced cardiac life support. Appropriate selection of AED models with clinical situations and operators’ experience is essential.

MP-453087-5 ADVERSE EVENTS ASSOCIATED WITH AVEIRTMVR LEADLESS PACEMAKER: A FOOD AND DRUG ADMINISTRATION MAUDE DATABASE STUDY

Since the first pacemaker implantation, much of the effort has been focused on battery longevity and device miniaturization. Leadless pacemaker offers an innovative approach to the treatment of bradyarrhythmias, thus avoiding long-term lead-related complications. Recently, the Aveir (screw-in type leadless pacemaker) (Abbott) has been approved by the Food and Drug Administration (FDA). We queried the FDA Manufacturer And User Facility Device Experience (MAUDE) database to study the safety profile and assess the types of complications with this relatively novel device technology. The MAUDE database is a repository of industry and patient/physician-reported medical device adverse events. A MAUDE database search was conducted on November 10, 2022, for reports received post-FDA approval to capture all adverse events. A total of 42 events (after removing duplicate entries or programmer or introducer sheath-related issues n=13) were reported for Aveir leadless pacemaker post-FDA approval. The most frequently reported issue was a device malfunction-related event (n=36, 85.7%). The most commonly encountered problem was the capture issue (28.6%, 12 events), followed by the sensing issue (19%, 8 events), high impedance (19%, 8 events), stretched helix (19%, 8 events), device dislodgement (14.3%, 6 events), device separation failure (14.3%, 6 events), premature separation (4.8%, 2 events), material twist (4.8%, 2 events), and broken helix (2.4%, 1 event). As such, this resulted in pericardial effusion requiring pericardiocentesis (9.5%, 4 events), cardiac perforation (9.5%, 4 events), and arrhythmia (2.4%, 1 event). This resulted in one death. Aveir leadless pacemaker implantation may be complicated by myocardial perforations and tears that result in cardiac tamponade and death. Our study is limited by heterogeneity in reporting, and lack of assessment of the total number of cases performed per year; thus, warranting better transparency and monitoring mechanisms.

A cross sectional analysis of medical device associated adverse events with radiotherapy devices - A materiovigilance study.

Materiovigilance is a method for tracking, documenting, and analyzing the causal factors of adverse outcomes or complications associated with the use of medical devices. In addition, it recommends that the Indian regulatory authority takes necessary steps with the aim of enhancing patient safety. The present study was taken up as there are hardly any studies available in the public domain on adverse events due to radiotherapy. The objective of the study is to analyze the pattern of adverse events due to medical devices used in the department of radiation oncology. It was a cross-sectional study carried out from June to September, 2022. The patients who were treated with the medical devices in radiation oncology at Victoria Hospital affiliated with Bangalore Medical College and Research Institute, Bengaluru, were included. The medical device used on the patients causes adverse events. The data were collected from the patient's health records available in the department of radiotherapy. Total 40 adverse events collected as per inclusion and exclusion criteria were analyzed. All the adverse events associated with medical devices were filled in the medical device adverse event reporting form and submitted to materiovigilance program, which also included the causality assessment. All the adverse events were caused due to external beam radiotherapy/teletherapy device. Dermatitis was the most common adverse event found in the reported cases (n = 20, 50%). Materiovigilance program is in budding stage. It was observed that the adverse events in patients were due to medical devices used in radiation oncology. Medical devices with skin-sparing effect (radiation is converged onto tumor) should be promoted and more research and engineering are required in designing of advanced medical devices for the treatment of cancer across the globe.

E-sisters and the case of the Essure coil: power, representation, and voice in women’s public docket accounts to the FDA of medical device adverse events

ABSTRACT One in ten U.S. patients has an internally implanted medical device. Yet, lax regulation by the U.S. Food and Drug Administration (FDA) has resulted in the approval of medical devices disproportionately harming women, including Bayer Pharmaceutical’s Essure, a permanent female sterilization device. Victims of Essure often suffer adverse events, including serious injuries, device malfunctions, and death. Guided by critical feminist theorizing, this case study examines 500 public docket comments written to the FDA by female patients recounting their experiences of adverse events with Essure. Reflexive thematic analysis revealed how women: (a) voiced their experiences to contest meanings of ‘safety,’ expressed identification with their ‘E-Sisters,’ and protected future women from harm; (b) identified forces of greed, deception, and gender bias as creating the conditions for harm to befall them; and (c) enacted resistance and called for a change in the status quo by the FDA and Bayer. Theoretical and practical implications for health communication researchers, medical practitioners and educators, and regulatory agencies are offered.

Benefits of Healthcare Technology Management Input in Medical Product Safety Network Reports

Healthcare technology management professionals play an important role in reporting medical device adverse events to the Food and Drug Administration by helping to identify and report device concerns, providing critical context to medical device reports, and mitigating safety concerns. The expert opinions and insights shared by healthcare technology management professionals are beneficial to the Food and Drug Administration and help the agency mitigate device-related problems and improve patient safety. This article is a case study that discusses how a medical device report involving infusion pump controllers was submitted to the Food and Drug Administration's Medical Product Safety Network reporting program and contributed to a voluntary class I recall affecting more than 800,000 devices nationwide. The details and context provided in the medical device report by the reporting team helped inform the investigation into, and resolution of, a device safety concern.

Analysis of Polyethylene-Related Revisions After Total Ankle Replacements Reported in US Food and Drug Administration Medical Device Adverse Event Database.

There are 2 general types of total ankle replacement (TAR) designs with respect to the polyethylene insert, mobile-bearing (MB) and fixed-bearing (FB) TARs. The aim of this study is to compare polyethylene-related adverse events (AEs), particularly revisions, reported for MB TARs and FB TARs using the US Food and Drug Administration's (FDA's) Manufacturer and User Facility Device Experience (MAUDE) database. A text mining method was applied to the medical device reporting (MDR) in the MAUDE database from 1991 to 2020, followed by manual reviews to identify, characterize, and describe all polyethylene-related AEs, including revisions, reported for MB and FB TARs. We found 1841 MDRs for MB (STAR Ankle only) and 1273 MDRs for 40+ FB TARs approved/cleared by the FDA. For the MB design, 33% (606/1841) of the AEs reported related to the polyethylene component, compared to 24% (291/1273) of the AEs reported for FB designs. Polyethylene fractures were reported in 11.3% (208/1841) for the MB designs compared to 0.2% (2/1273) for the FB designs. Half of the polyethylene-related revisions occurred within an average of 4.1 years after implantation for the MB design compared within an average of 5.2 years for FB designs. Analysis of this database revealed a higher proportion of reported polyethylene fractures and greater need for earlier revisions for polyethylene-related issues with use of the primary MB design in the database as compared with FB TAR designs. Further study of device-related complications with more recent designs for both MB and FB ankle replacement components are needed to improve the outcomes of total ankle replacement. Level III, retrospective comparative study.