Reporting of Death in US Food and Drug Administration Medical Device Adverse Event Reports in Categories Other Than Death.

Importance: 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. Objective: 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. Design, Setting, and Participants: 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. Exposures: 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. Main Outcomes and Measures: 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. Results: 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%). Conclusions and Relevance: 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.

Field testing the applicability of motorcycle autonomous emergency braking (MAEB) during pre-crash avoidance maneuver.

OBJECTIVE: Autonomous Emergency Braking (AEB) is a promising technology for crash avoidance or pre-crash impact speed reduction through the automatic application of braking force. Implementation of AEB technology on motorcycles (MAEB) is still problematic as its interaction with the rider may compromise the safety. In previous studies, MAEB interventions at low decelerations were shown to be easily manageable by common riders in straight line condition, but they were not previously tested in lateral maneuvers such as lane change and swerving, which are common in pre-crash situations. The objective of this paper is to assess the applicability of MAEB activation during lateral avoidance maneuver and to estimate its benefits in this scenario. METHODS: Field tests were carried out involving common riders as participants, using a test protocol developed on the experience of previous studies. The test vehicle was a sport-touring motorcycle equipped with an automatic braking system that could be activated remotely by researchers to simulate MAEB intervention. The motorcycle was equipped with outriggers to prevent capsizing. The Automatic Braking (AB) interventions using a nominal deceleration of 0.3 g were deployed at pseudo-random times in conditions of straight-line travel and a sharp lane-change maneuver emulating a pre-crash avoidance action. The straight-line trials were used as the reference condition for analysis. RESULTS: Thirty-one participants experienced AB interventions in straight-line and lane-change at an average speed of 44.5 km/h. The automatic braking was deployed in all the key phases of the avoidance maneuver. The system reached a deceleration of 0.3 g for a time of intervention of approximately 1 s. The participants were consistently able to control the vehicle during the automatic braking interventions and were always able to complete the lane-change maneuver. The speed reductions obtained with the AB interventions during lane change were very similar to those obtained in the straight-line conditions. CONCLUSIONS: MAEB interventions with decelerations up to 0.3 g can be easily managed by motorcycle riders not only in straight-line conditions but also during an avoidance maneuver. Further investigations using higher deceleration values are now possible.

Firearm purchasing and storage during the COVID-19 pandemic.

To better understand motivations behind purchase and storage of firearms during the COVID-19 pandemic, we used Amazon Mechanical Turk to conduct an online survey of individuals who did and did not purchase a firearm since 1 January 2020 in response to COVID-19. The survey was fielded between 1 and 5 May 2020. We asked about motivations for purchase, changes in storage practices and concern for themselves or others due to COVID-19. There were 1105 survey respondents. Most people who purchased a firearm did so to protect themselves from people. Among respondents who had purchased a firearm in response to COVID-19 without prior household firearm ownership, 39.7% reported at least one firearm was stored unlocked. Public health efforts to improve firearm-related safety during COVID-19 should consider increasing access to training and framing messages around the concerns motivating new firearm purchase.

Novel manufacturing of simple masks in response to international shortages: Bacterial and particulate filtration efficiency testing.

Many healthcare systems have been forced to outsource simple mask production due to international shortages caused by the COVID-19 pandemic. Providence created simple masks using surgical wrap and submitted samples to an environmental lab for bacterial filtration efficiency testing. Bacterial filtration efficiency rates ranged from 83.0% to 98.1% depending on specific material and ply, and particular filtration efficiency rates ranged from 92.3% to 97.7%. Based on mask configuration, specific surgical wrap selected, and ply, the recommended filtration efficiency for isolation and surgical masks of 95% and 98%, respectively can be achieved. These alternative masks can allow for similar coverage and safety when hospital-grade isolation masks are in short supply.

Incidence of appropriate implantable cardioverter-defibrillator therapy and mortality after implantable cardioverter-defibrillator generator replacement: results from a real-world nationwide cohort.

AIMS: The safety of omitting implantable cardioverter-defibrillator (ICD) generator replacement in patients with no prior appropriate therapy, comorbid conditions, and advanced age is unclear. The aim was to investigate incidence of appropriate ICD therapy after generator replacement. METHODS AND RESULTS: We identified patients implanted with a primary prevention ICD (n = 4630) from 2007 to 2016, who subsequently underwent an elective ICD generator replacement (n = 670) from the Danish Pacemaker and ICD Register. The data were linked to other databases and evaluated the outcomes of appropriate therapy and death. Predictors of ICD therapy were identified using multivariate Cox regression analyses. A total of 670 patients underwent elective ICD generator replacement. Of these, 197 (29.4%) patients had experienced appropriate therapy in their 1st generator period. During follow-up of 2.0 ± 1.6 years, 95 (14.2%) patients experienced appropriate therapy. Predictors of appropriate therapy in 2nd generator period was low initial left ventricular ejection fraction (≤25%) [hazard ratio (HR) 1.87, confidence interval (CI) 1.13-1.95] and appropriate therapy in 1st generator period (HR 3.95, CI 2.57-6.06). For patients with appropriate therapy in 1st generator period, 4-year incidence of appropriate therapy was 50.6% vs. 16.4% in those without (P < 0.001). Among patients >80 years with no prior appropriate therapy 8.8% of patients experienced appropriate therapy after replacement. Comorbidity burden and advanced age were associated with reduced device utilization after replacement and a high competing risk of death without preceding appropriate therapy. CONCLUSION: A significant residual risk of appropriate therapy in the 2nd generator was present even among patients with advanced age and with a full prior generator period without any appropriate ICD events.

Algorithm-based reduction of inappropriate defibrillator shock: Results of the Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination-Implantable Cardioverter Defibrillator Study.

BACKGROUND: Inappropriate shocks (IS) continue to have a major negative impact on patients implanted with defibrillators. OBJECTIVE: The purpose of this study was to assess IS reduction with the PARAD+ discrimination algorithm in a general population implanted for primary or secondary prevention. METHODS: ISIS-ICD (Inappropriate Shock Reduction wIth PARAD+ Rhythm DiScrimination-Implantable Cardioverter Defibrillator) was a 2-year international, interventional study in patients implanted with a dual implantable cardioverter-defibrillator (ICD) or triple-chamber defibrillator (cardiac resynchronization therapy-defibrillator [CRT-D]) featuring PARAD+. IS (shocks not delivered for ventricular tachycardia or fibrillation) were independently adjudicated. The primary endpoint was percentage of IS-free patients at 24 months. Primary and worst-case analyses of annual incidence rates of patients with ≥1 IS, overall and per defibrillator type, were conducted. RESULTS: In total, 1013 patients (80.7% male; age 67.1 ± 11.4 years; 68%/30%/2% primary/secondary/other indication) were enrolled and followed for a median of 552 days (interquartile range 354; 725). Of 993 analyzed patients programmed with PARAD+, 14 had ≥1 IS, corresponding to a percentage free from IS of 98.1% (95% confidence interval [CI] 96.8%- 98.9%). Annual incidence rates (per 100 person-years) of patients with IS were 1.0 (95% CI 0.59-1.69) and 2.1 (95% CI 1.46-3.02) in the primary and worst-case analyses, respectively. In ICD patients, rates were 1.2 (95% CI 0.68-2.23) and 2.3 (95% CI 1.47-3.53), and in CRT-D patients 0.59 (95% CI 0.19-1.83) and 1.8 (95% CI 0.93-3.44) per 100 person-years. CONCLUSION: The annual rate of defibrillator patients with IS using the enhanced PARAD+ discrimination algorithm alone ranged from 1.0 to 2.1 per 100 person-years in a general population implanted for primary or secondary prevention.

Magnetic resonance imaging with cochlear implants and auditory brainstem implants: Are we truly practicing MRI safety?

OBJECTIVE: Our objective is to evaluate the safety in patients with cochlear implants (CIs) and auditory brainstem implants (ABI) undergoing 1.5 Tesla (T) magnetic resonance imaging (MRI). Secondly, we want to raise awareness on CI and MRI safety, and advocate for continued improvement and advancement to minimize morbidity for our CI patients. METHODS: Retrospective case series from 2006 to 2018 at a single tertiary academic center. Data was collected on patients with CI or auditory brainstem implants undergoing MRI. Outcomes collected include demographic data, age at time of MRI, MRI characteristics, complications, CI manufacturer, and image quality. RESULTS: Eighteen patients with CI or ABI collectively underwent a total of 62 MRI scans. Five of 15 (33%) CI patients with magnet had complications: five total of 24 MRI scans (21%). Two patients had magnet removal prior to 29 MRI scans without complications. Four of five MRI-related complications were equipped with a U.S. Food and Drug Administration-approved head wrap. Three of five required a trip to the operating room to explore and reposition the CI magnet; two could not complete MRI secondary to pain. Of the complications, two were Cochlear (Sydney, Australia), two Advanced Bionics (Valencia, CA), and one MED-EL (Innsbruck, Austria). Synchrony model (MED-EL) had 0 of seven complications, with a total of 19 MRI scans, which features a freely rotating and self-aligning magnet. CONCLUSION: Our series offers a diverse number of CI manufacturers and is in accordance with other literature that CI MRI-related adverse events are occurring at an unacceptable frequency. We can promote CI MRI safety through our institutions' MRI CI patient protocols, raise awareness that diagnostic MRI benefits must outweigh CI-related complications, and advocate for continued industry technological innovation. LEVEL OF EVIDENCE: 4 Laryngoscope, 129:482-489, 2019.

Comparison of lead failure manifestation of Biotronik Linox with St. Jude Medical Riata and Medtronic Sprint Fidelis lead.

PURPOSE: To compare lead failure manifestation and lead performance of the Biotronik Linox/Sorin Vigila defibrillator lead (Linox group) with the St. Jude Medical Riata/Riata ST (Riata group) and Medtronic Sprint Fidelis defibrillator leads (Fidelis group). METHODS: We assessed the performance of all aforementioned leads implanted at our center and investigated the manifestation of lead failures. RESULTS: Of 93 Linox, 86 Riata, and 81 Fidelis leads implanted at our center, 11 (12%), 22 (26%), and 25 (31%) leads failed during a median follow-up of 46, 61, and 84 months, respectively. Inappropriate shocks were delivered in 64% (Linox), 5% (Riata), and 32% (Fidelis) of lead failures; a device alert was noted in none (Linox), 5% (Riata), and 52% (Fidelis); and lead failure was a coincidental finding in 36% (Linox), 91% (Riata), and 16% (Fidelis) of cases (p < 0.001). Non-physiological high rate signals were observed in 73% (Linox), 27% (Riata), and 80% (Fidelis) of lead failures (p = 0.001) and damaged lead integrity was found in 36% (Linox), 73% (Riata), and 24% (Fidelis) of cases (p = 0.064). Lead survival at 5 years was 88%, 92%, and 71% for Linox, Riata, and Fidelis group, respectively. CONCLUSIONS: The most frequent clinical manifestation of lead failure was inappropriate shocks for Linox, coincidental finding for Riata and device alert for Fidelis leads. Non-physiological high rate signals were frequently observed in Linox and Fidelis lead failures whereas in Riata lead failures, a damaged lead integrity was the predominant finding.

Straight to the point: considering sharp safety in dentistry.

All members of the clinical dental team face a daily risk of a personal sharp injury. A wide range of sharp instruments are used, some of which are specifically designed to easily pierce the skin and mucosa. The instruments are placed, moved, passed between colleagues, used for treatment, replaced and cleaned, all in relatively confined areas. The clinical dental workplace and the decontamination unit are both therefore sharp-risk environments. There is a clear risk of a sharp injury and the potential consequences of occupational exposure to blood-borne pathogens are at least inconvenient and at worst, career and even life threatening. However, good sharp safety is not universally understood and practised throughout the dental profession. This paper considers the risk of sharp injury in dentistry and discusses some of the methods used to improve sharp safety.

Comparing the application of two theoretical frameworks to describe determinants of adverse medical device event reporting: secondary analysis of qualitative interview data.

BACKGROUND: Post-market surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Few studies have examined factors that influence whether and how physicians report AMDEs, an essential step in the development of behaviour change interventions. This study was a secondary analysis comparing application of the Theoretical Domains Framework (TDF) and the Tailored Implementation for Chronic Diseases (TICD) framework to identify potential behaviour change interventions that correspond to determinants of AMDE reporting. METHODS: A previous study involving qualitative interviews with Canadian physicians that implant medical devices identified themes reflecting AMDE reporting determinants. In this secondary analysis, themes that emerged from the primary analysis were independently mapped to the TDF and TICD. Determinants and corresponding intervention options arising from both frameworks (and both mappers) were compared. RESULTS: Both theoretical frameworks were useful for identifying interventions corresponding to behavioural determinants of AMDE reporting. Information or education strategies that provide evidence about AMDEs, and audit and feedback of AMDE data were identified as interventions to target the theme of physician beliefs; improving information systems, and reminder cues, prompts and awards were identified as interventions to address determinants arising from the organization or systems themes; and modifying financial/non-financial incentives and sharing data on outcomes associated with AMDEs were identified as interventions to target device market themes. Numerous operational challenges were encountered in the application of both frameworks including a lack of clarity about how directly relevant to themes the domains/determinants should be, how many domains/determinants to select, if and how to resolve discrepancies across multiple mappers, and how to choose interventions from among the large number associated with selected domains/determinants. CONCLUSIONS: Given discrepancies in mapping themes to determinants/domains and the resulting interventions offered by the two frameworks, uncertainty remains about how to choose interventions that best match behavioural determinants in a given context. Further research is needed to provide more nuanced guidance on the application of TDF and TICD for a broader audience, which is likely to increase the utility and uptake of these frameworks in practice.

Hygiene of venepuncture tourniquets in Denmark.

Tourniquets are widely used to make the vein more visible prior to blood collection. Venepuncture tourniquets are however a non-sterile and potentially reusable equipment. Several studies have shown that they are colonised by a variety of pathogenic bacteria and consecutively use of the same tourniquet on multiple patients will increase the risk of a nosocomial infection. This matter is however only scarcely studied. The objective of this study was to investigate the nationwide use of disposable and non-disposable venepuncture tourniquets and the standardised procedures for cleaning the tourniquets. A questionnaire concerning use and cleaning of tourniquets was therefore sent to all major Danish clinical biochemistry laboratories (n = 12). All but one laboratory had a local procedure for usage and handling of tourniquets, including structured procedures for cleaning. Despite this, only 75% of laboratories had a guideline for cleaning the tourniquets and only 50% had a specified cleaning program. At the hospitals using non-disposable tourniquets the handling differed considerably and at two hospitals the tourniquets were only cleaned once a week, while one laboratory did not clean the tourniquet before it was visibly stained. Of note, five of the eight hospitals using disposable tourniquets only disposed the tourniquets on a daily basis. In conclusion, there is a lack of guidelines for handling tourniquets in 25-33% of the hospitals and a number of hospitals used both types (disposable and non-disposable), which could confuse the handling of the tourniquets. A national guideline for usage and cleaning of venepuncture tourniquets is therefore strongly recommended.

The regulatory ancestral network of surgical meshes.

BACKGROUND: All surgical meshes entering the U.S. market have been cleared for clinical use by the 510(k) process of the Food and Drug Administration (FDA), in which devices simply require proof of "substantial equivalence" to predicate devices, without the need for clinical trials. However, recalled meshes associated with adverse effects may, indirectly, continue to serve as predicates for new devices raising concerns over the safety of the 510(k) route. METHODOLOGY: Here we assess the potential magnitude of this problem by determining the ancestral network of equivalence claims linking recently cleared surgical meshes. Using the FDA website we identified all surgical meshes cleared by the 510(k) route between January 2013 and December 2015 along with all listed predicates for these devices. Using a network approach, we trace the ancestry of predicates across multiple generations of equivalence claims and identify those meshes connected to devices that have since recalled from the market along with the reason for their recall. CONCLUSIONS: We find that the 77 surgical meshes cleared between 2013 and 2015 are based on 771 interconnected predicate claims of equivalence from 400 other devices. The vast majority of these devices (97%) are descended from only six surgical meshes that were present on the market prior to 1976. One of these ancestral meshes alone, provided the basis of 183 subsequent devices. Furthermore, we show that 16% of recently cleared devices are connected through equivalence claims to the 3 predicate meshes that have been recalled for design and material related flaws causing serious adverse events. Taken together, our results show that surgical meshes are connected through a tangled web of equivalency claims and many meshes recently cleared by the FDA have connections through chains of equivalency to devices which have been recalled from the market due to concerns over clinical safety. These findings raise concerns over the efficacy of the 510(k) route in ensuring patient safety.

An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration's Reclassification of transvaginal mesh.

Purpose: To 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 Methods: We 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. Results: There 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. Conclusions: The 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.

The nature, magnitude, and reporting compliance of device-related events for intravenous patient-controlled analgesia in the FDA Manufacturer and User Facility Device Experience (MAUDE) database.

BACKGROUND: The aim of this study is to determine the characteristics, magnitude, and the quality of reporting of mandated events involving intravenous patient-controlled analgesia (IV-PCA) devices in the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database; a postmarket surveillance system. METHODS: We utilized a mixed-methods approach to systematically characterize structured data and text narratives associated with IV-PCA events submitted to MAUDE between 1 January 2011 and 12 September 2016. RESULTS: Of 1,430 IV-PCA events reported during the study period, 6.4% were adverse events (AEs) as identified via structured data fields in the MEDWATCH forms. Upon qualitative review of the narrative texts, 11.0% of events were associated with an unfavorable clinical outcome, which was 71% higher than the incidence of the adverse outcomes reported using the structured data fields. Device-related issues, which were mostly preventable, accounted for 86.9% of events. Of 65 reportable events submitted by manufacturers, 18.5% did not comply with reporting requirements as mandated by law. CONCLUSION: Patients on IV-PCA continue to experience serious complications as a result of preventable errors. Multi-modal interventions including educational training and the development and adoption of PCA devices with improved safety features are needed to improve safety.

Overview of high-risk medical device recalls in obstetrics and gynecology from 2002 through 2016: implications for device safety.

The field of women's health has endured numerous recent controversies involving medical devices such as pelvic meshes, laparoscopic morcellators, and a hysteroscopic sterilization device. With the recent passage of the 21st Century Cures Act, new legislation will change how the Food and Drug Administration regulates medical devices. Given these controversies and new changes, we investigated high-risk, class I recalls in women's health from 2002 through 2016. Class I recalls for medical devices are defined by the Food and Drug Administration as the most serious recall events and are designated for situations when there is a reasonable probability of serious adverse health consequences or death. We defined a recall event as a group of unique Food and Drug Administration recalls that share a similar reason for recall and occurred within a 1-month time frame. In total, 7 class I recall events were identified encompassing 83 unique recalls affecting >88,000 medical devices in distribution. Recalls involved a broad range of devices used in women's health including diagnostic assays for chlamydia and gonorrhea, a laparoscopic tissue morcellator, and obstetrical/gynecological surgical kits. Four of 7 (57%) recall events were due to postmarketing problems such as improper packaging and labeling while the remaining 3 (43%) recalls were due to premarketing problems (eg, software issues). Additionally, 3 of 7 (43%) recall events were cleared via the 510(k) pathway, while the remaining were essentially exempt from any form of premarket approval. Two recall events involved sterility concerns of 71 surgical kits used in obstetrics and gynecological surgeries representing the majority of affected devices (78,423) in distribution. Class I medical device recalls are rare but serious events. Most recalled devices in women's health had minimal preapproval regulation and were recalled due to both premarketing and postmarketing reasons. Future regulatory efforts to improve postmarketing surveillance may mitigate the potential impact and frequency of class I recalls, but do not replace the need for a higher burden of proof for both safety and efficacy prior to medical device approval.

Premature Trigger of ERI in Medtronic EnRhythm Devices.

BACKGROUND: Medical technology has made significant advances over the last few decades with smaller and more dynamic pacemakers. However, technical failures leading to premature replacement is a cause of concern. We present a series of Medtronic EnRhythm devices that reached premature elective replacement indicator (ERI). METHODS: The database of Centre of Heart Rhythm Disorders was searched for EnRhythm device implantation from 2006 to 2011. Battery depletion <8.5 years was considered premature considering the projected average longevity to be 8.5-10.5 years. An unexpected premature ERI was defined when it was reached within 3 months of last normal check. Device follow-up was conducted every 3 months after advisory. RESULTS: A total of 88 EnRhythm pacemakers were implanted. Over a median follow-up of 6.2 years (range: 0.3-9.2), 39 (44.3%) EnRhythm devices reached premature ERI. In 11 (28%), ERI was not recognized and patients were being investigated for other causes of unsteadiness or dyspnea prior to device check. Notably, three (7%) patients had premature ERI < 3.5 years. Ten (25.6%) had sudden and unexpected premature ERI. While asynchronous pacing was observed, there were no cases of absence of pacing. CONCLUSIONS: The rate of premature ERI for EnRhythm devices was 44.3%, significantly higher than reported by the manufacturer. Of concern, a sizeable proportion occurred unexpectedly, warranting more frequent reviews and empirical replacement in some patients. With the experience of the EnRhythm, appropriate monitoring strategies are recommended for future advisories.