The Need for Greater Reporting of Medical Device Incidents

Craig, Amanda M.; O’Meley, Patrick; Carter, Pamela

doi:10.33590/emjinnov/10312553

Cited by 9 publications

(6 citation statements)

References 23 publications

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“…Adding to this, in cases of human error, underreporting is expected to be even more prevalent. 24,25 Other issues may be the symptoms of underutilizing the MDR system's potential. For example, although more than one remedial action code can be assigned to an adverse event, in practice reports in MAUDE, use a single code.…”

Section: Discussionmentioning

confidence: 99%

Analysis of Adverse Event Reports in FDA’s MAUDE Database

Zisimopoulos,

Pallikarakis

2023

GlobalCE

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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.

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Section: Discussionmentioning

confidence: 99%

Analysis of Adverse Event Reports in FDA’s MAUDE Database

Zisimopoulos,

Pallikarakis

2023

GlobalCE

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“…Moreover, it is also essential to evaluate the impact of these training sessions by periodical analysis on the quality of the reports received at the MDAE monitoring centers. [ 22 ]…”

Section: Discussionmentioning

confidence: 99%

Knowledge, Attitude, and Practice of Materiovigilance Among Nurses at a Tertiary Care Hospital in South India

Sivagourounadin

Rajendran

Ravichandran

2022

Journal of Pharmacy and Bioallied Sciences

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Background and Objective: Inadequate knowledge and underreporting of medical device-associated adverse events (MDAEs) were observed among health-care professionals (HCPs) in studies carried out in other countries. In India, HCP's knowledge, attitude, and practice (KAP) regarding materiovigilance have not been explored extensively. Hence, the present study was carried out to assess KAP of materiovigilance among nurses working in a tertiary care teaching hospital in South India. Materials and Methods: This is a descriptive, cross-sectional study conducted among nurses. A self-administered, validated questionnaire was distributed to 420 nurses. Data were analyzed using the Statistical Package for the Social Sciences software version 21.0. Kruskal–Wallis test was used to compare KAP score of materiovigilance among the study participants. Results: A total of 400 (95.2%) responses were received. About 65.7% ( n = 263) of nurses were having adequate knowledge about the various aspects of materiovigilance and 80.5% ( n = 322) of nurses had a positive attitude toward MDAE reporting. However, only 18 (4.5%) of nurses have reported about MDAEs. Further, factors such as uncertainty on how to report a MDAE and concerns about their legal issues significantly led to underreporting of MDAEs. Conclusion: The transition of adequate knowledge and positive attitude to good practice of MDAE reporting was lacking among the study participants. Hence, with due consideration of these deficits and the various factors influencing MDAE reporting, it is necessary to conduct periodical workshops and training sessions for HCPs to enhance their spontaneous reporting of MDAEs.

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“…3 Due to a lack of knowledge on ADR reporting, adverse events are underreported globally. 4 In the diagnosis, surveillance, and treatment of diseases, medical devices are extremely important. Medical equipment, like drugs, can potentially have negative side effects when used 6 .…”

Section: Assessment Of Practicementioning

confidence: 99%

“…Incorrect diagnostic outcomes, injury to the patient's physical and mental health, and occasionally deadly adverse events are only a few of the horrible outcomes caused by several medical devices. 3,4 These incidents produced notifiable morbidity and mortality as a result of unfavorable medical device events. Due to malfunctions, some medical equipment is taken back off the market.…”

mentioning

confidence: 99%

A study assessing the knowledge, attitude, and practice of materiovigilance among medical professionals in the states of Tamil Nadu and Andhra Pradesh, India

K.,

2024

Int J Basic Clin Pharmacol

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Background: Medical devices are vital for healthcare diagnosis and treatment but pose inherent risks. Physicians and healthcare professionals play a crucial role in reporting adverse events associated with these devices. Despite this, there is a notable scarcity of literature addressing the knowledge, attitudes, and practices surrounding India's Materiovigilance (Mv) Program. This study aimed to evaluate the knowledge, attitudes, and practices of doctors and postgraduate residents in Andhra Pradesh and Tamil Nadu regarding the Materiovigilance program of India (MvPI). Methods: It was conducted as an observational, cross-sectional study, a structured self-administered Google Form survey was distributed among medical professionals and citizens of Andhra Pradesh and Tamil Nadu. The survey, comprising 22 questions on knowledge, attitudes, and Mv practices, was disseminated via various social networking sites. Results: Out of 700 doctors and postgraduate residents surveyed, 496 responded, yielding a response rate of 70.8%. The majority (96.8%) acknowledged the potential for adverse events from medical devices, with 91.1% agreeing on healthcare professionals' responsibility to report such events. Despite experiencing medical device-related adverse events in practice (63.3% of respondents), only a small fraction (12.1%) reported them, although 93.5% expressed willingness to report. Conclusions: The study underscores a knowledge gap among physicians and residents regarding MvPI in India, highlighting the necessity for educational interventions. To address this gap, MvPI coordinators should organize conferences and seminars aimed at enhancing awareness and reporting practices among healthcare professionals.

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The Need for Greater Reporting of Medical Device Incidents

Cited by 9 publications

References 23 publications

Analysis of Adverse Event Reports in FDA’s MAUDE Database

Analysis of Adverse Event Reports in FDA’s MAUDE Database

Knowledge, Attitude, and Practice of Materiovigilance Among Nurses at a Tertiary Care Hospital in South India

A study assessing the knowledge, attitude, and practice of materiovigilance among medical professionals in the states of Tamil Nadu and Andhra Pradesh, India

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