Medical device postapproval safety monitoring: where does the United States stand?

Reporting standards for adverse events after medical device use in the peripheral vascular system

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.

Adverse Events Associated with New Nitinol Venous-Labeled Stents: A Review of the FDA MAUDE Database

While computer-related failures are known to play a significant role in deaths and injuries involving medical devices reported to the U.S. Food and Drug Administration (FDA), there is no similar reporting system that meaningfully captures security-related failures in medical devices. Medical device software must satisfy system properties, including safety, security, reliability, resilience, and robustness, among others. This column focuses on the challenges to satisfying a security property for medical devices: postmarket surveillance, integrity and availability, and regulation and standards. Medical devices depend on software for patient care ranging from radiation therapy planning to pharmaceutical compounding to automated diagnosis of disease with mobile medical apps. Meanwhile, the medical community has observed an uptick in reported security vulnerabilities in medical device software—raising doubts of cybersecurity preparedness. It should come as little surprise that security risks in medical devices “could lead to patient harm” as recently explained by the chief scientist at the FDA Center for Devices and Radiological Health. Device manufacturers and healthcare providers ought to more carefully and deliberately consider security hazards during the phases from design to use of medical devices. Measuring Medical Device Security: Quantitative or Qualitative? Between years 2006 and 2011, 5,294 recalls and approximately 1.2 million adverse events of medical devices were reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. Almost 23% of these recalls were due to computer-related failures, of which approximately 94% presented medium to high risk of severe health consequences (such as serious injury or death) to patients. For security incidents on medical devices, no systematic national reporting system exists. Yet, individual hospitals know of hundreds of security incidents on medical devices. For instance, the FDA MAUDE does not capture adverse events such as lack of or impaired availability of function when malware infects a medical device’s operating system. FDA’s own disclaimer explains that the MAUDE database is qualitative rather than quantitative. MAUDE is incomplete with underreporting and reporting bias. Imagine the reaction of a clinician using a high-risk pregnancy monitor that begins to perform more slowly because of a Conficker infection. Would the clinician report a malware infection? Likely not. Admitting to playing a role in accidentally infecting a medical device Controlling for Cybersecurity Risks of Medical Device Software

In the US, most postmarket medical device safety data are obtained through adverse event reports that are submitted to the US Food and Drug Administration (FDA)'s Manufacturer and User Facility Device Experience (MAUDE) database. Adverse event reports are classified by the reporter as injury, malfunction, death, or other. If the device may have caused or contributed to a death, or if the cause of death is unknown, the FDA requires that the adverse event be reported as a death. To determine the percentage of medical device adverse event reports submitted to the MAUDE database that were not classified as death even though the patient died. In this study, a natural language processing algorithm was applied to the MAUDE database, followed by manual text review, to identify reports in the injury, malfunction, other or missing categories that included at least 1 term that suggested a patient death, such as patient died or patient expired, from December 31, 1991, to April 30, 2020, for any medical device. Manual review of a random sample of 1000 adverse event reports not classified as death and of selected reports for 62 terms that are associated with deaths but were not classified as death. Percentage of adverse event reports in which the patient was said to have died in the narrative section of the report but the reporter classified the report in a category other than death. The terms in the natural language processing algorithm identified 290 141 reports in which a serious injury or death was reported. Of these, 151 145 (52.1%) were classified by the reporter as death and 47.9% were classified as malfunction, injury, other, or missing. For the overall sample, the percentage of reports with deaths that were not classified as deaths was 23% (95% CI, 20%-25%), suggesting that approximately 31 552 reports in our sample had deaths that were classified in other categories. The overall percentage of missed deaths, defined as the percentage of deaths that were classified in other categories, was 17% (95% CI, 16%-19%). Many of the findings of this study suggest that many medical device adverse event reports in the FDA's MAUDE database that involved a patient death are classified in categories other than death. As the FDA only routinely reviews all adverse events that are reported as patient deaths, improving the accuracy of adverse event reporting may enhance patient safety.

To examine the adverse events reported in the United States Food and Drug Administration(USFDA)'s Manufacturer and User Facility Device Experience (MAUDE) database for over-the-counter (OTC) or non-prescription hearing aids. A retrospective cross-sectional study was performed using the USFDA's MAUDE database from January 2014 to August 2024. Adverse events were identified using the product codes (QUF, QUG, and QUH) and the keywords ("Hearing Aid, Air-Conduction with Wireless Technology, Over the Counter, Hearing Aid, Air-Conduction, Over the Counter, and Self-Fitting Air-Conduction Hearing Aid, Over the Counter"). Exclusion criteria included reports unrelated to OTC hearing aids and the usage of the device, or those providing insufficient information. The incidence of adverse events was estimated using data from market research reports. A total of 25 adverse events were identified, with 17 reports meeting the inclusion criteria. Medical device reports (MDRs) were available for 2022 (n=1), 2023 (n=9), and 2024 (n=7). Eighteen(60.0%) reports were related to device malfunction, six (20.0%) were regarding poor customer service, three (10.0%) referred to medical adverse events, two (6.7%) were associated withfailure to provide hearing benefits, and one (3.3%) referred to incompatibility with other medical equipment. Nine (30.0%) of the device malfunction reports were due topoor construction or the device falling apart, with eight (88.9%) of those cases resulting in foreign bodies in the ear. The incidence rate of adverse events for OTC hearing aids was calculated as 0.00132%. There is a low reported incidence of adverse events associated with OTC hearing aids. Possible poor construction of the device and its falling apart, resulting in foreign bodies in the ear, and poor customer service were commonly reported as adverse events. This information can aid providers in advising patients and managing expectations. However, more robust studies are needed to monitor adverse events associated with OTC hearing aids.

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. We aimed to understand how the COVID-19 pandemic impacted medical device reporting by analyzing reports in the MAUDE database that mention COVID-19. 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. 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. 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.

IntroductionA review of the medical device adverse events submitted to the United States Food & Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was undertaken to determine the major sources of the information.MethodsThe reporter’s occupation and source of the medical device report were determined for acquisition dates Jan 1, 1997 to Dec 31, 2018. A total of 7,766,737 adverse event records were analyzed.Results96.6% of reports originated with the manufacturer. Patients (patients/family/friend) were the most frequent submitter of reports directly to the FDA, almost five times as often as physicians. Nurses submitted reports directly to the FDA 2.77 times as often as physicians. Only 0.49% of physician reports were submitted directly to the FDA, representing 0.09% of total MAUDE reports.ConclusionIncreasing physician reporting directly to the FDA and MAUDE through the MedWatch reporting system is an imperative. Incorporating information from the perspective of the physician has the potential of increasing the quality of the data and improving the reliability of post-market surveillance.

It is essential for physicians to be fully informed regarding adverse events and malfunctions associated with medical devices that occur in routine practice. There is limited information on this important issue in the medical literature, and it is mostly based on initial studies and case reports. More advanced knowledge regarding device adverse events is necessary to guide physicians towards providing safe treatments. The FDA requires that manufacturers and device users submit medical device reports (MDRs) for suspected injuries from device use or malfunction. The database of MDRs, entitled Manufacturer and User Facility Device Experience (MAUDE) enables the FDA to monitor device performance and identify potential safety issues. We employed the following search strategy to identify reported adverse events. We searched the MAUDE electronic database on the FDA website in December 2013: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm We collected all reported cases between 1991 and December 2013. The search terms utilized included a comprehensive list of device manufacturers, specific product names, and the wavelengths/technology of the devices used in the field of dermatology. Our search yielded 1257 MDRs. Forty-five MDRs were excluded due to insufficient data. The data is broken down into the adverse events observed, such as, but not limited to: blistering, burns, scarring, dyschromia, fat loss, and nerve palsy. The MDRs describe the adverse event and attempt to determine if it was related to device malfunction versus operator error. Radiofrequency devices, diode lasers, and intense pulsed light devices were the most commonly reported devices related to injuries. 1257 MDRs, from a myriad of devices used in dermatology, have been reported to the FDA as of December 2013. Despite the underreporting of adverse events, the MAUDE database is an untapped resource of post-market surveillance of medical devices. The database can offer additional information, which combined with the initial device studies and published case reports from our colleagues, will help raise awareness and improve patient safety.

Lessons Learned from the MAUDE Database on Transvaginal Synthetic Mesh and Sling Reports

BackgroundIn December 2020, the JET7 Xtra Flex reperfusion catheter was voluntarily recalled after reports of injury and death associated with device malfunction. The FDA’s MAUDE (Manufacturer and User Facility Device...

To review the evidence on the application of tools for dengue outbreak prediction/detection and trend monitoring in passive and active disease surveillance systems in order to develop recommendations for endemic countries and identify research needs. Systematic review of literature in the Cochrane Database of Systematic Reviews, PubMed, EMBASE, Lilacs, WHO library database, manual reference search and grey literature. Two reviewers independently applied pre-defined inclusion and exclusion criteria and assessed the level of evidence. Studies describing the outcome of dengue disease surveillance with respect to trend monitoring and outbreak prediction/detection based on empirical data were included. Twenty-four studies (of 1804 references) met the eligibility criteria. Different indicators and their respective threshold values were identified as potential triggers for outbreak alerts through retrospective analysis of data from passive and/or active surveillance systems. Some indicators are potentially useful for predicting imminent outbreaks in the low transmission season and others for detecting outbreaks at an early stage. However, the information collected is mainly retrospective and often site-specific and appropriate levels of sensitivity and specificity of the outbreak indicators/triggers could not be determined. Retrospective and prospective virus surveillance studies were not conclusive regarding the question of whether a newly introduced serotype is an outbreak predictor, but contributed additional indicators for outbreak prediction/detection. Under-reporting was a major concern. Taking cost and feasibility issues into account, it remains an open question whether dengue surveillance should be passive (based on routine reporting) or active (based on more costly sentinel or other active population based surveillance systems). Adding active surveillance elements to a well-functioning passive surveillance system improves sensitivity; adding laboratory elements to the system improves specificity. In view of the lack of evidence about the most feasible and sustainable surveillance system in a country context, countries could use a stepwise approach to locally adapt their passive routine surveillance system into an improved combined active/passive surveillance approach. Prospective studies are needed to better define the most appropriate dengue surveillance system and trigger for dengue emergency response.

Off-Label Does Not Mean Off-Base

Introduction The CardioMEMS (Abbott) is an implantable pulmonary artery pressure monitor for heart failure patients approved by the United States Food and Drug Administration (FDA) based on the CHAMPION trial reporting a reduction in the composite outcome of heart failure hospitalizations (HFH) and all-cause mortality. The result was driven by reduction in HFH; there was no benefit on mortality. While CardioMEMS was approved by the FDA in May 2014 and received Conformitè Europënne (CE) Mark approval in December 2014, the FDA review found preferential attention towards patients in the treatment arm that may have biased results. The FDA-mandated industry-sponsored post-marketing study identified 5 device-related complications in a 1,200-patient cohort from September 2014 to October 2017. A separate review of adverse events reported to the FDA during a similar timeframe from May 2014 to May 2017 identified 155 instances of injury or death. As worldwide implantation rates of CardioMEMS have increased since 2017 to roughly 20,000, we updated device-related events reported to the FDA to aid in understanding its current real-world safety profile. Methods The FDA mandates reporting of all medical device-related events to the Manufacturer and User Facility Device Experience (MAUDE) database, a passive surveillance system. We queried all available reports from May 28, 2014 to November 28, 2020 using the unique product code for CardioMEMS (“MOM”). Almost all reports (96%) contained a narrative description, which was used to enumerate adverse events. Results A total of 2,861 MAUDE reports have been filed for CardioMEMS in the reporting period, increasing from an average of 38 reports per 6-month period from May 2014 to May 2017 to an average of 149 reports per 6-month period afterwards (Figure 1). The majority reported inaccurate measurements, which required replacement of the external unit, repeat non-invasive testing, or repeat catheterization to resolve (Table). There were 169 (5.9%) patient deaths reported; most commonly reported non-fatal safety events included hemoptysis, heart failure exacerbation, and significant bleeding at the groin site (Table 1). Conclusion We found an increased number of adverse events associated with CardioMEMS in the last 3 years compared to the first 3 years, partially coinciding with increased use. Safety of CardioMEMS should be considered along with the lack of evidence of benefit on all-cause mortality from clinical trials. MAUDE has the known limitation of incomplete adverse event reporting, thus actual adverse event rates are certainly higher. Another limitation is lack of an exact denominator as number of implantations annually is not publicly available. Our analysis demonstrates risks associated with CardioMEMS implantation that are increasing in number. These data can more accurately inform discussions regarding risks and benefits between patients, physicians, and policymakers when considering CardioMEMS. Funding Acknowledgement Type of funding sources: None. FigureTable

Adverse events associated with Vibrant Soundbridge: A MAUDE study