Drug Administration Manufacturer Research Articles

Unrecognized maternal heart rate artefact in cases of perinatal mortality reported to the United States Food and Drug Administration from 2009 to 2019: a critical patient safety issue

BackgroundMaternal heart rate artefact is a signal processing error whereby the fetal heart rate is masked by the maternal pulse, potentially leading to danger by failure to recognize an abnormal fetal heart rate or a pre-existing fetal death. Maternal heart rate artefact may be exacerbated by autocorrelation algorithms in modern fetal monitors due to smooth transitions between maternal and fetal heart rates rather than breaks in the tracing. In response, manufacturers of cardiotocography monitors recommend verifying fetal life prior to monitoring and have developed safeguards including signal ambiguity detection technologies to simultaneously and continuously monitor the maternal and fetal heart rates. However, these safeguards are not emphasized in current cardiotocography clinical practice guidelines, potentially leading to a patient safety gap.MethodsThe United States Food and Drug Administration Manufacturer and User Facility Device Experience database was reviewed for records with event type “Death” for the time period March 31, 2009 to March 31, 2019, in combination with search terms selected to capture all cases reported involving cardiotocography devices. Records were reviewed to determine whether maternal heart rate artefact was probable and/or whether the report contained a recommendation from the device manufacturer regarding maternal heart rate artefact.ResultsForty-seven cases of perinatal mortality were identified with probable maternal heart rate artefact including 14 with antepartum fetal death prior to initiation of cardiotocography, 14 with intrapartum fetal death or neonatal death after initiation of cardiotocography, and 19 where the temporal relationship between initiation of cardiotocography and death cannot be definitively established from the report. In 29 cases, there was a recommendation from the manufacturer regarding diagnosis and/or management of maternal heart rate artefact.ConclusionsThis case series indicates a recurring problem with undetected maternal heart rate artefact leading to perinatal mortality and, in cases of pre-existing fetal death, healthcare provider confusion. In response, manufacturers frequently recommend safeguards which are found in their device’s instructions for use but not in major intrapartum cardiotocography guidelines. Cardiotocography guidelines should be updated to include the latest safeguards against the risks of maternal heart rate artefact. An additional file summarizing key points for clinicians is included.

Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for Patient- and Circuit-Related Adverse Events Involving Extracorporeal Membrane Oxygenation.

We assessed commonly reported patient- and circuit-related adverse events involving extracorporeal membrane oxygenation (ECMO) devices by analyzing post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. ECMO is a rescue therapy for critically ill patients requiring oxygenation and cardiopulmonary support. Key configurations include veno-venous (VV) ECMO for respiratory support and veno-arterial (VA) ECMO for cardio-respiratory support. Robust data on the most commonly reported complications associated with ECMO therapy are limited. The MAUDE database was queried from January 1, 2009, through March 31, 2019, yielding 93 reports. After excluding duplicate reports, 82 reports were included in the final analysis. Percentages represent the proportion of total submitted MAUDE reports on ECMO. Of the reported cases, 24 were VV-ECMO, 8 were VA-ECMO, and the remainder were unspecified. The most commonly reported patient-related adverse events included hemodynamic decompensation of patients (12.2%), death (12.2%), atrial perforation (7.3%), and bleeding (7.3%). The most commonly reported failure modes were in the following circuit components: mechanical pump (19.5%, mostly due to technical failure or clots), membrane oxygenator (19.5%, mostly due to tear in the membrane or temperature probe), and access cannulae (18.3%, mostly due to structural damage). Analysis of the MAUDE database demonstrates that in real-world practice, ECMO devices are associated with important complications. With broadened global utilization of ECMO devices, standard complication and failure reporting policies may improve patient selection, operator proficiency, and existing device technology. An analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience database demonstrates that in real-world practice, extracorporeal membrane oxygenation devices are associated with serious complications. The most commonly reported patient-related adverse events were hemodynamic decompensation of patients and death, and the most commonly reported failure modes were in the device's mechanical pump and membrane oxygenator.

Thoracic Endovascular Aortic Repair Adverse Events Reported In The Food And Drug Administration Manufacturer And User Facility Device Experience Database.

PurposeThe purpose of this study is to identify adverse events (device- and patient-related) associated with thoracic aortic stent graft systems and their timing post-procedure.Materials and methodsThe Food and Drug Administration’s Manufacturer and User Facility Device Experience (FDA-MAUDE) voluntary database was searched for Thoracic Aortic Endovascular Repair (TEVAR) devices reported over the course of 1 year (January 1, 2014 to December 31, 2014). The data abstracted included the indication for treatment, device used, and adverse events.ResultsDuring 2014, there were 334 original submissions to the FDA-MAUDE database describing 371 adverse events regarding TEVAR devices that met inclusion criteria for this study. All submissions were from manufacturers, and none were from physicians. The most common pathologies treated were thoracic aortic aneurysm (67.6%) and type B aortic dissection (25.1%). The most frequently reported intraoperative, early postoperative (<30 days), and late postoperative (>30 days) events overall were technical device failure, neurologic complications (stroke, paraplegia), and endoleak, respectively. Of note, there were descriptions of retained deployment materials, late graft infections, and aorto-visceral fistula formation up to 3 years postoperatively.ConclusionThe MAUDE database is a valuable repository for complications and device failures that are not otherwise in the published literature and submitted by manufacturers relating to this relatively new technology.

Device-Related Complications Associated with Magec Rod Usage for Distraction-Based Correction of Scoliosis.

Introduction Recent literature identifies similar failure rates such as anchor pull-out and rod breakage, but a higher unplanned revision surgery with MAGEC rods than with traditional growth rods. Besides known failure modes such as rod fracture, infection, etc., failure to noninvasively distract the rods was cited as the main cause of such unplanned surgeries. The source of these data ranges from multicenter cohort studies to singular case series. These studies included explanted implants that had undergone failure in distraction mechanism, rod fracture, or infection, or had reached their maximum length. Nevertheless, in addition to identifying the overall mode of failure, it is equally important to identify the large-scale incidence of exclusive failures in comparison with standard instrumentation failure modes in spine surgery. Methods The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) databases were searched for reports on MAGEC rods, and on standard instrumentation used for spinal fusion. The adverse events were recorded, tabulated, and analyzed. Results A search of the US FDA MAUDE database yielded reports of 163 device-related adverse events. These included distraction mechanism failure (n=129), rod fracture (n=24), and minor voluntary reports of infection and tissue discoloration (n=10). For standard instrumentation usage in spine surgery, pedicle screw breakage post surgery (n=336), set screw damage during surgery (n=257), rod breakage post surgery (n=175), interbody cage breakage during surgery (n=118), and pedicle screw breakage during surgery (n=75) were identified as the top 5 failure modes. Conclusions The study identified the distraction mechanism failure as the most common and growing complication associated with MAGEC rod usage in children with scoliosis, leading to unplanned invasive revision surgeries.

Complications involving the subcutaneous implantable cardioverter-defibrillator: Lessons learned from MAUDE

Reports on the subcutaneous implantable cardioverter-defibrillator (S-ICD) cumulatively demonstrate a low rate of complications, but clinical experience with this technology is limited compared with transvenous devices. The purpose of this study was to describe and analyze S-ICD complications reported to the Food and Drug Administration's Manufacturer and User Facility Device Experience database. We reviewed all S-ICD events reported to the Manufacturer and User Facility Device Experience submitted over 24 months (from February 2016 through February 2018) through a prospective and standardized approach at a time when an estimated 15,000 S-ICDs were in service. After removing duplicate entries and nonclinical events (n = 493), 1604 events remained. A total of 542 instances of infection were reported with system removal in 414/542 (77.5%). Inappropriate shocks occurred in 550 patients, and 382 (69%) were attributed to oversensing; in response, 254 (56%), 147 (33%), and 80 (18%) patients underwent system reprogramming, removal, or revision, respectively. There were 15 deaths, and causes included defibrillation failure during follow-up (n = 2), ventricular fibrillation induced by the device (n = 4), device-device interaction resulting in undersensing (n = 1), procedure-related complications (n = 4), and uncertain etiology (n = 4). There were 137 reports of system migration, and in 57 (42%) of these, there were associated inappropriate shocks. System migration events were managed with a combination of system revision (69 [51%]), reprogramming (25[18%]), and system removal (44 [32%]). Several S-ICD complications have been reported that appear to be related to the ICD's design and function over time. Abetter understanding of these complications may help inform patient selection, implant technique, and postimplantation management.

Valuing innovative endoscopic techniques: endoscopic suturing to prevent stent migration for benign esophageal disease

Reimbursement often presents a significant barrier to widespread adoption of innovative endoscopic devices. We aimed to determine the value (defined as cost savings to a payer) of endoscopic suturing devices in preventing the migration of esophageal stents placed for benign esophageal diseases. A decision-analytic model was constructed from a payer perspective evaluating fully covered metal stent placement for benign esophageal diseases (fistula, leak, perforation, or stricture) in a hospital outpatient setting. The model compared 2 strategies: endoscopic suturing to anchor the stent or no suture. Health care outcomes and costs were derived from published systematic reviews and national databases (U.S. Food and Drug Administration Manufacturer and User Facility Device Experience [MAUDE] for safety data; 2018 Medicare Physician Fee Schedule and Provider Utilization and Payment Data databases for reimbursement data). From a payer perspective, reimbursement for care increased by US$1487.98 without endoscopic suturing per patient, compared with US$621.06 with endoscopic suturing, to cover the risk of stent migration in addition to usual professional and facility reimbursement for stent placement. Thus, an average cost saving of US$866.92 per patient was achieved with endoscopic suturing to reduce stent migration risks. Cost savings associated with suturing ranged from US$147.48 to US$1586.36 per patient, based on the indication for the procedure in sensitivity analysis. Cost savings increased with higher rates of technical success in suture placement. Creating a defined reimbursement pathway for endoscopic suture fixation of a stent for the treatment of benign esophageal diseases appears to be justified from a payer perspective.

Complications and Litigation Associated With Injectable Facial Fillers: A Cross-Sectional Study

Soft-tissue injectable fillers are a popular treatment option for patients seeking minimally invasive facial rejuvenation. The use of soft-tissue fillers has increased significantly in the past 10years. In 2017 alone, clinicians administered nearly 2.7 million soft-tissue fillers, up from 1.3 million in 2007. Although injectable fillers have a relatively high safety profile compared with more invasive rejuvenation procedures, serious adverse events, including intra-arterial injections, necrosis, and visual symptoms such as blindness, have been documented. Complications from injectable fillers have also been a source of litigation, which has been shown to be associated with a perceived lack of informed consent. We sought to document the reported complication rates associated with injectable facial fillers from a national database and to report on the available cases of malpractice litigation. The US Food and Drug Administration's Manufacturer and User Facility Device Experience database was used to collect the reported complications from 2013 to 2017 for the following injectable fillers: Artefill, Bellafill, Belotero, Juvederm, Radiesse, Restylane, Sculptra, and Kybella. Complications were organized by filler type, injection location, and complication type. The Thomson Reuters Westlaw Edge database was used to collect the reported jury verdicts and settlements from 2008 to 2017 for injectable facial fillers. A total of 2813 adverse events were analyzed. The most common locations for complications were the cheek (915 [32.5%]), lips (503 [17.9%]), and nasolabial fold (412 [14.6%]). The commonly reported adverse events were swelling (1,691 [60.1%]), nodule (948 [33.7%]), and pain (636 [22.6%]). Severe complications included intra-arterial injections resulting in necrosis and visual symptoms (eg, blurred vision and blindness). Forehead and dorsal nasal injections were significantly associated with intra-arterial complications resulting in necrosis and visual symptoms (P<.01). Injections with Radiesse were significantly associated with intra-arterial injections resulting in necrosis and visual symptoms (P<.01). A total of 11 malpractice cases were analyzed. The median award in the cases resolved by a verdict in favor of the plaintiff or settlement was $600,000. In 10 of the 11 cases, a lack of informed consent had been alleged. The complications associated with injectable facial fillers varied greatly, depending on factors involved with their application. The most common adverse effects were swelling, nodule formation, and pain. Serious complications stemming from intra-arterial injections included necrosis and visual disturbances, including blindness. These complications have been raised in legal cases, in which the lack of informed consent was frequently alleged. The present analysis has documented some of the potential risks involved with injectable facial fillers and demonstrated the need for a thorough informed consent process before their administration.

&lt;p&gt;Reporter’s occupation and source of adverse device event reports contained in the FDA’s MAUDE database&lt;/p&gt;

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.

Adverse events and modes of failure related to the Impella percutaneous left ventricular assist devices: a retrospective analysis of the MAUDE database.

Robust data on the commonly reported complications and failure modes associated with Impella (Abiomed Inc, Danvers, MA) is limited. We analyzed the post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to assess these

Building Usability Knowledge for Health Information Technology: A Usability-Oriented Analysis of Incident Reports.

The contribution of usability flaws to patient safety issues is acknowledged but not well-investigated. Free-text descriptions of incident reports may provide useful data to identify the connection between health information technology (HIT) usability flaws and patient safety. This article examines the feasibility of using incident reports about HIT to learn about the usability flaws that affect patient safety. We posed three questions: (1) To what extent can we gain knowledge about usability issues from incident reports? (2) What types of usability flaws, related usage problems, and negative outcomes are reported in incidents reports? (3) What are the reported usability issues that give rise to patient safety issues? A sample of 359 reports from the U.S. Food and Drug Administration Manufacturer and User Facility Device Experience database was examined. Descriptions of usability flaws, usage problems, and negative outcomes were extracted and categorized. A supplementary analysis was performed on the incidents which contained the full chain going from a usability flaw up to a patient safety issue to identify the usability issues that gave rise to patient safety incidents. A total of 249 reports were included. We found that incident reports can provide knowledge about usability flaws, usage problems, and negative outcomes. Thirty-six incidents report how usability flaws affected patient safety (ranging from incidents without consequence, to death) involving electronic patient scales, imaging systems, and HIT for medication management. The most significant class of involved usability flaws is related to the reliability, the understandability, and the availability of the clinical information. Incidents reports involving HIT are an exploitable source of information to learn about usability flaws and their effects on patient safety. Results can be used to convince all stakeholders involved in the HIT system lifecycle that usability should be considered seriously to prevent patient safety incidents.

Adverse events and modes of failure related to the FilterWire EZ Embolic Protection System: Lessons learned from an analytic review of the FDA MAUDE database.

To assess the commonly reported complications and failure modes for FilterWire EZ Embolic Protection Devices (EPD) by analyzing the postmarketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. EPDs prevent distal embolization of atheroembolic materials during percutaneous interventions resulting in reduced microvascular obstruction and improved microcirculation while maintaining tissue perfusion. The FilterWire EZ EPD (Boston Scientific, Natick, MA) is approved for use in interventions of de novo saphenous vein grafts (SVG) and carotid artery stenosis. Robust data on the commonly reported complications and failure modes associated with the FilterWire EZ device are limited. The MAUDE database was queried from September 1, 2008, through September 30, 2018, for FilterWire EZ system, yielding 474 reports. After exclusion of duplicate and incomplete reports, 464 device reports were included in the final analysis. Device-related adverse events were most commonly reported for carotid (n = 281) and SVG (n = 101) interventions. The most commonly reported major complications were: ischemic stroke (n = 57), vessel perforation or dissection (n = 12), death (n = 8), and myocardial infarction (n = 5). Minor complications included: hypotension (n = 68), bradycardia (n = 41), and vasospasm (n = 27). The most commonly reported failure modes were: detachment and/or damage of the device components (n = 118), device entrapment (n = 90), and stent-related issues (n = 46). Analysis of the MAUDE dataset is helpful in identifying the commonly reported adverse events and failure modes of FilterWire EZ devices. This platform serves as an important tool for both physicians and manufacturers to optimize device performance and clinical outcomes.

Adverse Events and Modes of Failure Related to Impella RP: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database.

Right ventricular (RV) mechanical circulatory support remains an important adjunctive therapy for RV failure refractory to medical therapy. Impella RP (Abiomed, Danvers, MA) is approved for providing temporary RV support for patients with acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery. Robust data on the most commonly reported complications and failure modes for the Impella RP are lacking. We analyzed the post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to assess these endpoints. The MAUDE database was queried for the time period January 1, 2009, through December 31, 2018, for Impella devices by Searching for the following event types: "injury", "malfunction", "death", and "other". The search yielded 436 device reports. Impella RP medical device reports were screened, and 35 reports were included for the final analysis. In cases of reported complications, Impella RP was placed most commonly for right ventricular failure (RVF) developing in postcardiotomy patients (20%). The most commonly reported complications included bleeding (42.9%) and vascular complications (22.8%). The modes of failure included damage or fracture of the device elements (34.2%); thrombus, or clot in the system (17.1%); and device detachment (8.6%). Findings from the MAUDE database highlight the failure modes of the Impella RP device that should be addressed in order to improve the device performance and obtain improved clinical outcomes when utilized for RVF.

Techniques to Optimize the Use of Optical Coherence Tomography: Insights from the Manufacturer and User Facility Device Experience (MAUDE) Database.

Optical coherence tomography (OCT) is a high-resolution intravascular imaging modality used to assess coronary arteries and as an adjunctive tool for optimization of percutaneous coronary interventions. Overall, the rate of complications and adverse events related to intravascular imaging is low. Limited data exist on the most commonly reported complications and modes of failure related to the use of OCT. Therefore, we analyzed the post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to assess the reported complications and failure modes for OCT and reviewed techniques to optimize device use. The MAUDE database was queried for all event reports involving coronary OCT devices. Two independent reviewers identified 49 device reports included in the final analysis. Modes of failure and device-related patient complications were assessed. Of the 49 cases with reported device-related issues, 6.1% involved malfunction prior to insertion of the OCT catheter, and 30.6% of reported events did not result in an associated patient-related adverse event. The most commonly reported adverse events included coronary dissection and difficulty removing the catheter within a previously stented segment. No events of contrast-induced nephropathy were reported. Findings from the MAUDE database highlight the modes of device-related events associated with OCT. Device issues are uncommon, and as a result, users should be aware of optimal techniques to prevent and minimize adverse events related to device use.

ACOG Committee Opinion No. 769 Summary: Reprocessed Single-Use Devices.

The reprocessing and reuse of single-use instruments has become increasingly common. Although there are limited data on reprocessed single-use devices, existing studies have found a significant rate of physical defects, performance issues, or improper decontamination. There are currently no data in the medical literature of studies evaluating the cost-effectiveness of reprocessed single-use devices in gynecologic surgery. The use of a reprocessed single-use device provides no direct benefit to an individual patient or her physician. It is the operating surgeon's ethical responsibility to make a good faith effort to know whether reprocessed single-use devices are to be used, and to not use instruments if he or she has concerns about the quality or safety of the instrument(s). Studies on the safety, quality, and cost-effectiveness of reprocessed single-use devices in gynecologic surgery are needed. Physicians should be informed whether the instruments used in surgery are original or reprocessed, and adverse events should be reported to improve the safety information about reprocessed single-use devices. Obstetrician-gynecologists are encouraged to report adverse events and outcomes associated with medical devices to the U.S. Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database.

ADVERSE EVENTS AND MODES OF FAILURE RELATED TO THE IMPELLA PERCUTANEOUS LEFT VENTRICULAR ASSIST DEVICES: A RETROSPECTIVE ANALYSIS OF THE MAUDE DATABASE

Robust data on the commonly reported complications and failure modes associated with Impella (Abiomed Inc, Danvers, MA) is limited. We analyzed the post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database to assess these

Adverse Events Associated with the Use of Guide Extension Catheters during Percutaneous Coronary Intervention: Reports from the Manufacturer and User Facility Device Experience (MAUDE) database.

We aimed to assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters. The US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried for reported events. Of the 65 cases with reported GuideLiner-related issues, 15 (23%) involved the inability to pass equipment through or damage to percutaneous coronary intervention (PCI) devices in the GuideLiner catheter, 38 (58%) involved GuideLiner catheter fracture, 9 (14%) involved coronary artery dissection, 2 (3%) involved coronary artery perforation, and 1 (1.5%) involved thrombus formation in the catheter. Of the 408 cases with reported Guidezilla-related issues, 53 (13%) involved inability to pass or damaged PCI devices into the Guidezilla catheter, 117 (29%) involved inability to advance the Guidezilla catheter to the target lesion, 59 (14%) involved kinked Guidezilla catheter, mostly because of partial or complete catheter fracture upon further investigation, 164 (40%) involved a broken Guidezilla catheter, 10 (2.5%) involved coronary artery dissection, 2 (0.5%) involved coronary artery perforation, 1 (0.2%)involved aortic dissection, 1 (0.2%) involved thrombosis formation, and 1 (0.2%) involved no-reflow phenomenon. Findings from the MAUDE database highlight the complications and modes of events associated with the use of GuideLiner and Guidezilla extension catheters. To assess the reported complications and event modes for the GuideLiner and Guidezilla extension catheters, the US Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database was queried. There were more reports on Guidezilla-related events during the search period. The events for both extension catheters mainly involved the inability to pass equipment through or damage to percutaneous coronary intervention (PCI) devices in the extension catheter, extension catheter fracture, coronary artery dissection and perforation and, occasionally, the death of the patients.

Internal insulation breaches in an implantable cardioverter-defibrillator lead with redundant conductors

Internal insulation breaches (IBR) may result in implantable cardioverter-defibrillator lead failure and adverse clinical events. Concerns exist that the Durata lead may be prone to IBR. The goals of this study were to assess Durata failures in the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database and compare them to failures in MAUDE for Endotak Reliance and Sprint Quattro Secure (QS) leads. We searched the MAUDE database from 2008 to 2018 for IBR and other failure modes. Included were explanted leads whose manufacturers found an insulation or conductor defect not caused by extrinsic factors. The MAUDE search found 1011 qualifying leads. The cause of failure differed among leads (P < .001). The primary cause of Durata failure was IBR (293 of 316 leads [93%]), with IBR accounting for 47% (137 of 293); few QS (9 of 523 [1.7%]) and no Endotak Reliance leads failed because of IBR (P < .001). Durata IBR were responsible for 11 failures to treat ventricular tachycardia/ventricular fibrillation, and all were caused by high-voltage (HV) shorts between the proximal superior vena cava coil and a distal right ventricular coil cable (n = 10) or sensing conductor (n = 1); low values of HV impedance were found in these leads during defibrillation threshold testing (n = 3), after a shock or aborted shock (n = 7), and by an alert (n = 1). Inappropriate therapy was caused by 51 Durata IBR, but no QS IBR. Durata implantable cardioverter-defibrillator leads are susceptible to IBR that may result in failure to treat ventricular tachycardia/ventricular fibrillation or inappropriate therapy; such failures may occur without forewarning. HV testing of Durata leads may be indicated during pulse generator replacement or when an insulation defect is suspected.

Understanding Health Information Technology Induced Medication Safety Events by Two Conceptual Frameworks.

While health information technology (health IT) is able to prevent medication errors in many ways, it may also potentially introduce new paths to errors. To understand the impact of health IT induced medication errors, this study aims to conduct a retrospective analysis of medication safety reports. From the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience database, we identified reports in which health IT is a contributing factor to medication errors. We applied two conceptual frameworks, Sittig and Singh's sociotechnical model and Coiera's information value chain, to examine the identified reports. We identified 152 unique reports on health IT induced medication errors as the final report set for review. The majority (65.13%) of the reports involved multiple contributing factors according to the sociotechnical model. Three dimensions, that is, clinical content, human-computer interface, and people, were involved in more reports than the others. The transition of the effects of health IT on medication practice was summarized using information value chain. Health IT related contributing factors may lead to receiving wrong information, missing information, receiving partial information and delayed information, and receiving wrong information and missing information tend to cause the commission errors in decision-making. The two frameworks provide an opportunity to understand a comprehensive context of safety event and the impact of health IT induced errors on medication safety. The sociotechnical model helps identify the aspects causing medication safety issues. The information value chain helps uncover the effect of the health IT induced medication errors on health care process and patient outcomes.

An Analysis of the FDA MAUDE Database and the Search for Cobalt Toxicity in Class 3 Johnson & Johnson/DePuy Metal-on-Metal Hip Implants.

This study was designed to determine whether systemic cobalt toxicity as an adverse event could be documented using the Food and Drug Administration's (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for cobalt-chromium containing hip implant recipients. Class 3 Johnson & Johnson (J&J)/DePuy devices were chosen for analysis because of the large number of adverse event reports related to their Pinnacle and ASR XL Acetabular hip replacement systems. A secondary goal was to characterize the reporters who are populating the information in the MAUDE database and to evaluate the quality of the data and information submitted. Using FDA MAUDE downloadable data files, 83,528 adverse event medical device narrative reports were identified with the product code of KWA (Prosthesis, Hip, Semiconstrained [Metal Uncemented Acetabular Component]) for J&J/DePuy (KWA Text File). These are class 3 devices and devices with known high failure rates. The ASR XL Acetabular hip replacement Systems and Pinnacle fall into this category. This group of implants was chosen because implant failure is associated with elevated cobalt levels. Two additional subfiles were created from Free Text records in the narrative reports containing key words that indicated a chromium or cobalt (CrCo) device and another for key words indicating elevated levels of cobalt or toxicity. These files were then searched for symptoms of systemic cobalt toxicity with Microsoft Excel using key words pertaining to symptom categories of: cognitive/memory loss, tremor, neuropathy, depression, auditory symptoms, visual symptoms, cardiac, and thyroid disease. Reports are submitted to the FDA at the device component level. It was common for multiple reports to be submitted for a single device. It was not possible to differentiate systemic versus local symptoms for adverse event reports in the neuropathy category. This category was not analyzed. The number of adverse event reports in the other categories ranged from 119 to 16 for the J&J/DePuy KWA Text File and 59 to 4 in the file of records having key words indicating potential elevation of CrCo or toxicity. Cardiac, visual, and auditory conditions were most frequently reported. With the possible exception of cardiomyopathy, the numbers of these reports are far below the prevalence expected in the general population of comparable age. The content of the MAUDE database records often contained little objective data. We found less than 4% of 14,714 records, which indicated cobalt elevation or toxicity contained units for quantitative measurement. There was also frequent use of nondescript, all-encompassing words and phrases such as "mental anguish," found in 321 KWA Text File records. Manufacturers submitted more than 99% of the reports and the most common reporter occupation was attorney, found in 42.24% of the 83,550 J&J/DePuy KWA Reporter File records. Physician was the reporter's occupation in 20.48% of reports but seldom reported directly to the FDA. We were not able find in the FDA MAUDE database meaningful warning signs to support the contention that chromium-cobalt-containing Class 3 J&J and DePuy hip implants caused systemic neurological or thyroid symptoms in patients. The incidence of reported cardiomyopathy was rare but frequent enough to be cause of concern. The redaction of most patient data along with the nonstructured nature of data entry would be expected to hinder the identification of warning signs. Even identification of the type of device could not be consistently carried out. In addition, the FDA needs to implement a methodology to identify and group all reports from a single device implanted into a patient, so duplication of event counting would not occur. Of 83,550 J&J/DePuy KWA Reporter File records, we found only two physician reports sent directly to the FDA. Almost all reports are submitted by manufacturers and are most commonly authored by attorneys. A standard of care needs to be set for physicians to report medical device adverse events to the FDA.

Timely recognition of total elbow and radial head arthroplasty adverse events: an analysis of reports to the US Food and Drug Administration

Recent recalls of several commonly used elbow arthroplasty implants have prompted interest in the modes by which elbow implants fail and the timing of reports of these failures. We reviewed the adverse event reports to the US Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database from 2012 to 2015 regarding elbow arthroplasty to determine the event date and the type of each adverse event. Among 179 total elbow adverse event reports, the most common modes of failure were implant dissociation (23%), loosening (22%), and infection (16%). The most common modes of failure among 58 radial head replacement reports were component dissociation (19%) and linkage screw failure (19%). The percentage distribution of adverse event types differed among different arthroplasty systems and from that reported in published reviews of elbow arthroplasty. Three implant recalls were implemented 2, 5, and 9 years after the first adverse event report in the MAUDE database. For 2 of the recalls, the first reports of the device failures were published 2 and 5 years after the first MAUDE reports. The MAUDE database is a publicly funded and publicly available means by which surgeons can identify adverse events for the prostheses they use before such information becomes available through journal publication or recall notification. In this study, MAUDE data revealed a higher relative frequency of mechanical dissociation of elbow implants than what has been represented in the literature. Early identification of these adverse events may help surgeons by informing their implant selection and surgical technique.