Development and validation of a standardized causality assessment tool for adverse events associated with medical devices

PurposeTo assess the utility of the Manufacturer And User Facility Device Experience (MAUDE) database in objectively capturing adverse events for transvaginal mesh in the United States.Materials and MethodsWe reviewed 1,103 individual medical device reports submitted to the MAUDE database that inspired the United States (US) Food and Drug Administration's 2008 Public Health Notification. Entries were compiled into a categorical database that reported manufacturer, brand, reporter type, report source, and type of adverse event.ResultsThere were numerous examples of missing, duplicated, and non-standardized entries. Analysis revealed 64 reports with duplicated information, and six reports representing multiple patients. Forty-seven percent of medical device reports did not identify a reporter source. At least 28% of reported devices are no longer on the US market. There was wide variability in the quality and completeness of submitted reports and true adverse event rates could not be accurately calculated because the number of total cases was unknown.ConclusionsThe MAUDE database was limited in its ability to collect, quantify, and standardize real-life adverse events related to transvaginal mesh. While it functions to collect information related to isolated adverse events, systematic limitations of the MAUDE database, that no doubt extend to other medical devices, necessitate the development of new reporting systems. Alternatives are under development, which may allow regulators to more accurately scrutinize the safety profiles of specific medical devices.

PD57-04 MAJOR COMPLICATIONS AND ADVERSE EVENTS OF SPACEOAR HYDROGEL: AN ANALYSIS OF THE MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE DATABASE

Introduction: Pulsed field ablation (PFA) is an adaptation of direct current ablation first used for catheter ablation in the 1980s. Expectations of a reduced risk profile led to the current resurgence in investment and interest in the technology as a potential alternative energy source for ablations to treat atrial fibrillation (AF). However, reports of adverse events, including new risks, are increasing. Research Question: How many adverse effects are reported with the use of newly available PFA systems? Aims: Quantify and describe the adverse events from PFA reported to date in the Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. Methods: We searched the U.S. FDA’s MAUDE database for all reports filed with the code “QZI”, which is the product code for PFA systems created with the first FDA approvals in February 2024. All reports from inception through April 2024 (a total of 3 months) were included in this review. Per manufacturer presentation in May 2024, approximately 1000 cases utilizing PFA had been captured in a post-market registry of the predominant commercially used technology, but the exact number of cases can not be determined from MAUDE data. Results: A total of 217 adverse events were reported over the first 3 months of US approval, with 91 of these considered patient injuries. These injuries included 10 cases of cardiac tamponade, 7 reports of postoperative arrhythmia, 6 instances of device-related tissue entrapment, 5 cases of hemolysis with impaired renal function, 5 cases of stroke or TIA, including both embolic and hemorrhagic, 3 cases of intraoperative heart block, 2 coronary spasms, and 2 cases of intraoperative ST elevation. (Figure) Of the 91 reported patient safety events, 46 required hospitalization, 13 cases required temporary pacing, 11 required pericardiocentesis, 4 required dialysis, 4 required cardiothoracic surgery, and 2 required cardioversion. Conclusions: A number of adverse events have been reported to the MAUDE database in the first 3 months of FDA approval of PFA. The cardiac electrophysiology community should remain vigilant to ensure that the benefit-risk profile remains acceptable for patient safety.

Introduction: Fractional Flow Reserve (FFR) measurement is commonly used in the cardiac catheterization laboratory to assess functional significance of coronary arterial plaques. Robust real-world data on complications and modes of failure of FFR guidewires are limited. We analyzed the post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to report these endpoints for commonly utilized FFR guidewire. Methods: MAUDE database was queried from January 1, 2010, to April 1, 2020, for 3 commonly used FFR guidewires (PressureWire TM X (Abbott), Comet TM (Boston Scientific) and Verrata TM (Philips)) by searching for following events: “injury”, “malfunction”, “death”, and “other” yielding 544 reports. After excluding incomplete reports and older devices not in current use, 486 reports were analyzed. Results: Figure 1 shows reported modes of failure and patient adverse events. Guidewire tip fracture was the most reported mode of failure in 174 (35.8%) cases. Guidewire kinking (n= 152 (31.3%)), communication failure (n= 141 (29.0%)), and shaft fracture (n= 67 (13.8%)) were also reported. 133 (27.4%) of total device failures resulted in patient adverse events. Most common patient adverse event was retained guidewire tip in 71 (53.4%) cases followed by freshly deployed stent dislodgment (n= 26 (19.6%)) and coronary artery dissection (n=23 (17.3%)) respectively. 6 patient deaths were reported. Conclusions: FFR guidewire failures can occur due to a variety of mechanisms and lead to patient adverse events. MAUDE database serves as an important platform for improved collaboration between clinicians, device manufacturers, and regulatory bodies to improve device performance and optimize patient outcomes. Our analysis provides insights into the mechanism of FFR guidewire failure and associated adverse events but cannot verify causality or provide a comparison among different guidewires.

Adverse events of the single-operator cholangioscopy system: a Manufacturer and User Facility Device Experience database analysis

Analysis of Adverse Events With Essure Hysteroscopic Sterilization Reported to the Manufacturer and User Facility Device Experience Database

How Often Does Technology Fail in Robotic-Assisted Arthroplasty? A Comprehensive Analysis of a United States Food and Drug Administration Database

Pharmacovigilance involves detecting, assessing, understanding, and preventing adverse drug reactions (ADRs). Causality assessment, crucial in this process, determines the likelihood of a drug causing an adverse event (AE), influencing clinical decisions. The WHO-UMC system is the most widely used causality assessment tool. Automated methods enhance efficiency and accuracy but require high-quality data and expert validation. The objectives of the study were to develop and validate an automated ADR causality assessment algorithm and improve pharmacovigilance by reducing manual workload and enhancing data accuracy. In 2024, web-based software was developed to automate ADR causality assessment using the WHO-UMC system. It recorded patient data, temporal relationships, and dechallenge/rechallenge outcomes. The database included user roles, ADR assessments, and acknowledgment tracking to enhance pharmacovigilance training. Pharmacists, the largest participant group, played a key role in ADR assessment due to their pharmacological expertise. Nurses, as frontline caregivers, provided insights into real-time usability, while doctors, though fewer, evaluated clinical relevance. The tool received positive feedback for its intuitive interface, with a mean System Usability Scale (SUS). It achieved 90% concordance with expert assessments, demonstrating high validity. Sensitivity (92%), specificity (88%), and Positive Predictive Value (91%) confirmed accuracy. Automation significantly reduced assessment time from 11 to 3 minutes. The automated ADR assessment tool showed strong usability, validity, and time-saving benefits.

Is fluoride varnish safe?: Validating the safety of fluoride varnish

Background: The World Health Organization declared COVID-19 “a pandemic” on March 11, 2020. An essential preventive and screening strategy adopted was temperature screening at various public places such as airports and hospitals with devices like handheld, noncontact infrared thermometers. Before this pandemic, the industrial thermometers have never been used in health-care settings. The study was conducted to compare temperature readings of these industrial-grade infrared noncontact handheld thermometers with a digital thermometer. Materials and Methods: Three Testo® industrial-grade infrared noncontact thermometer (IGNCT) and Dr. Trust digital thermometer were used on 117 individuals for recording temperature. The average of three readings was taken for each instrument by a single investigator. Results: Out of 117 individuals, 14 (11.9%) were febrile. The Pearson correlation values between the digital thermometers varied from 0.3 to 0.42. The reliability, as measured by the intraclass correlation, was poor (0.16-“0.4). The area under the curve for IGNCT devices varied from 76% to 84%. Conclusion: Industrial-grade infrared noncontact temperature (IGNCT) recording devices with its no-touch technique to measure temperature while maintaining distance may be useful in a pandemic situation. However, the higher the area under the curve, the better it is. In a large cohort, 20% will be misclassified, and in absolute terms, they may be translated into large numbers. Hence, there is a case for better devices having an area under the curve of nearly 100% for the screening of population. The role of IGNCT devices for the screening of individuals to identify cases of febrile illness is limited owing to its poor reliability and unacceptable area under the curve for screening large populations.

Inadvertent C-arm Movements: Potential Cause of Patient and Staff Injury

6518 Background: RECIST and NCI's Common Terminology Criteria are accepted systems that have standardized the reporting of oncology clinical trial outcomes. A standard system for attributing causality to Serious Adverse Events (SAEs) is lacking which can impact drug development and patient safety. The objectives of this study were to: 1) understand the clinical reasoning behind causality assessment during phase I/II oncology clinical trials; and, 2) use this information to develop a causality assessment tool for oncology. Methods: In-depth interviews were conducted with oncologists and trial coordinators at 6 Canadian academic cancer centres. Five main conceptual categories were explored: clinical reasoning; information resources; tools; challenges and concerns; and education. Interviews were recorded and transcribed verbatim. Individual interview content analysis was followed by thematic analysis across the interview set. A new causality assessment tool was developed based upon the qualitative findings and an analysis of existing generic tools. Results: Thirty-two interviews were conducted between May and August 2006 (65% participation). Half of participants were female, 66% were oncologists and 42% had more than 10 years of clinical trial experience. Data showed that participants use a common strategy to assess causality: they gather information, eliminate alternative explanations, and consider the study drug as the cause of the SAE. Over half cited the quality of information resources as a major factor contributing to uncertainty when assessing causality. Participants expressed the need for a standardized approach to causality assessment in oncology clinical trials. The tool developed in this study guides users to consider 5 statements related to potential alternative etiologies and 4 related to other factors that support a drug-SAE connection. The user is asked for their overall impression using a continuous probability rating scale. Conclusions: Attributing causality to SAEs is complex and uncertain. Clinicians describe using a logical system of reasoning, but have encountered barriers which must be addressed. We have developed and are validating a new tool to assist cancer clinicians in providing higher quality safety data about new cancer drugs early in development. [Table: see text]

Background: There is paucity of knowledge regarding the spectrum of neurothrombectomy(NT) device-related complications. Objective: To report the characteristics and proportions of reported adverse-events(AE) related to NT devices used in endovascular treatment of acute ischemic stroke (AIS). Methods: We identified NT device-related AE reported by voluntary sources, user facility reports, and distributor and manufacturer reports to the Manufacturer and User Facility Device Experience Database(MAUDE) from the year 2004 through 2012 to identify patients. Frequency of specific reported AE and associated factors were extracted from the “event description” on the three NT devices currently in use for AIS treatment -Merci Retriever, Penumbra System, and Solitaire-FR stentriever. Results: A total of 706 reported NT device-related AEs were identified with a continual increase in reporting rate since 2004. Of the 706, device malfunction (kink, twist, difficult advancing, fracture, or retention) was the most common reported complication(56%), followed by hemorrhages(23%), dissection(6.8%), vasospasm(6.2%), and distal embolism(2.7%). Intra-arterial(IA) thrombolytic was used in 70%(111/159), intravenous(IV) thrombolytic in 16%, and both IA and IV in 13% of the reported cases. Middle cerebral artery(MCA) was involved in 56%(220/392), internal carotid artery(ICA) in 16 %, and both MCA and ICA in about 21% of cases where the occluded vessel was reported. Multiple devices were used in majority(71%) of reported cases(n=564). The first “pass”(recanalization-attempt) was associated with 34% of reported adverse event per-device(n= 119), 2-passes(29%), and 3-passes(28%). Recanalization was complete in 52 %(266/513) reported cases, and partial in 14%(71/513). Patients’ condition was unchanged in 63%(220/349), worsened in 29%(101/349), and improved in 8%(28/349) of reported cases. Twenty three percent(77/342) mortality was reported among those patients whose final outcome was known and reported. Conclusions: Reports of NT device-related AE have significantly increased over the last 8 years. Proportionally higher-rates of reported device malfunction do not necessarily represent adverse patient outcomes.

BACKGROUND: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.OBJECTIVE:The objective of the study is to analyze the pattern of adverse events due to medical devices used in the department of radiation oncology.METHODS: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.RESULTS: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%).CONCLUSION: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.

Use error is a type of error in a system wherein a user’s actions—or lack of actions— result in a different outcome than intended, possibly resulting in an adverse event. Use error in medicine is especially important, as adverse events can result in life-critical situations. Studies investigating use error have been conducted using databases of medical adverse events (e.g., the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database of adverse events related to device usage). However, these studies are limited by being specific to a context of use (e.g., drug delivery pumps in anesthesia). Therefore, this study investigated use error for medical devices across all contexts of use through a systematic search of the MAUDE database. We found that use error 1) is reported across many sub-fields and contexts of medicine; 2) is associated with many steps in the device usage process; 3) occurs during device operation by both lay users and health professionals; 4) has varying underlying causes; 5) cooccurs in adverse events; and 6) results in a wide array of outcomes, including death. This analysis provides valuable insights into characteristics and context of use errors that can guide design to minimize such errors.