Abstract:
INTRODUCTION: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. METHODS: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. RESULTS: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. CONCLUSIONS: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.
journal_name
J Patient Safjournal_title
Journal of patient safetyauthors
Kavanagh KT,Kraman SS,Kavanagh SPdoi
10.1097/PTS.0000000000000534subject
Has Abstractpub_date
2018-12-01 00:00:00pages
e89-e96issue
4eissn
1549-8417issn
1549-8425journal_volume
14pub_type
杂志文章abstract:PURPOSE:Although transparency is critical for reducing medical errors, physicians feel discomfort with disclosure. We explored whether overconfidence relates to physician's reluctance to admit that an error may have occurred. METHOD:At 3 university medical centers, a survey presented a clinical vignette of a girl with...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000255
更新日期:2019-12-01 00:00:00
abstract:OBJECTIVES:The use of peripherally inserted central catheters (PICCs) has increased substantially within hospitals during the past several years. Yet, the prevalence and practices of designated nurse PICC teams (i.e., specially trained nurses who are responsible for PICC insertions at a hospital) are unknown. We, there...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000246
更新日期:2019-12-01 00:00:00
abstract:OBJECTIVES:To determine if there is a relationship between the risk of postoperative complications and the nonclinical hospital characteristics of bed size, ownership structure, relative urbanicity, regional location, teaching status, and area income status. METHODS:This study involved a secondary analysis of 2006 adm...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0b013e3182995e5b
更新日期:2013-12-01 00:00:00
abstract:OBJECTIVES:Many patients with cancer believe that something has gone wrong in their care but are reluctant to speak up. This pilot study sought to evaluate the impact of an intervention of active outreach to patients undergoing cancer treatment, wherein patients were encouraged to speak up if they had concerns about th...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000510
更新日期:2018-06-27 00:00:00
abstract:OBJECTIVES:We report on a human factors evaluation project at a major urban teaching hospital that was intended to use human factors methods to assist the selection of a new infusion device among 4 commercially available models. METHODS:The project provided an expert evaluation of the pumps, collected data on programm...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0b013e3181a974d9
更新日期:2009-06-01 00:00:00
abstract:BACKGROUND:Although more than a decade has passed since the imperative to reduce fragmentation of care, high rehospitalization rates among Medicare patients with chronic diseases persist; at least 25% of these are considered preventable. Transitional care models that emphasize coordination among providers have demonstr...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000168
更新日期:2018-03-01 00:00:00
abstract:OBJECTIVE:The purpose of this study was to assess whether bundled team training interventions for surgeons and office staff could effectively improve the accuracy of surgery scheduling, minimizing scheduling factors that may contribute to occurrence of wrong site surgery. METHODS:This quasiexperimental observational s...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000370
更新日期:2017-02-24 00:00:00
abstract:OBJECTIVE:To develop an objective tool designed to standardize the identification of high-alert medications (HAMs) according to patient safety risk. METHODS:Medications were evaluated using the High-Alert Medication Stratification Tool (HAMST). Tool revision occurred through assessing medications on an organization-ap...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000445
更新日期:2017-12-12 00:00:00
abstract:AIMS:This study measured the effect of aviation-style team training on 3 surgical teams from different specialties. It focused on team working and communication, particularly briefing, time-out, and debriefing, and sought to understand how improvements in team skills could be implemented in a broad range of naturalisti...
journal_title:Journal of patient safety
pub_type: 杂志文章,多中心研究
doi:10.1097/PTS.0b013e3181f100ea
更新日期:2010-09-01 00:00:00
abstract:OBJECTIVE:Management of vitamin K antagonists (VKAs) is difficult, and overdoses can have dramatic hemorrhagic consequences. The adverse drug event (ADE) scorecards is a tool intended for the detection and description of adverse drug reaction/ADE developed during a European computerized medical data processing project....
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000182
更新日期:2018-06-01 00:00:00
abstract:INTRODUCTION:Significant resource is invested into investigation of adverse healthcare events. Outcomes of such investigations have varying degrees of effectiveness. The "hierarchy of effectiveness" model proposes system-focused changes have greater impact than person-focused actions. The traditional approach to invest...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000641
更新日期:2020-03-24 00:00:00
abstract:OBJECTIVE:Adverse drug events (ADEs) are a significant concern in daily practice; however, the profile of high-risk drugs remains unclear. Our objective was to categorize high-risk medication classes according to frequency and severity of ADEs. METHODS:The JADE study is a prospective cohort study of 3459 hospitalized ...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000235
更新日期:2020-03-01 00:00:00
abstract:OBJECTIVE:Pharmacists can play an important role as leaders to reduce patient safety risks, optimize the safe function of medication management systems, and align pharmacy services with national initiatives that measure and reward quality performance. The objective of this article is to determine the actions that pharm...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0b013e3181d108cb
更新日期:2010-03-01 00:00:00
abstract:OBJECTIVES:Pazopanib received US Food and Drug Administration approval in 2009 for advanced renal cell carcinoma. During clinical development, liver chemistry abnormalities and adverse hepatic events were observed, leading to a boxed warning for hepatotoxicity and detailed label prescriber guidelines for liver monitori...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000332
更新日期:2019-03-01 00:00:00
abstract:OBJECTIVES:Although nursing homes provide complex care requiring attention to safety, research on safety climate in nursing homes is limited. Our study assessed differences in attitudes about safety among nursing home personnel and piloted a new survey, specifically designed for the nursing home context. METHODS:Drawi...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0b013e31824badce
更新日期:2012-09-01 00:00:00
abstract::Patient safety reporting systems (PSRSs) currently operate at local, regional, and national levels within health care. This article analyzes 6 different PSRSs using a World Health Organization and public health classification system. Patient safety incidents (PSIs) are reported, analyzed, mitigated, and evaluated in a...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0b013e31821b8a6c
更新日期:2011-06-01 00:00:00
abstract:OBJECTIVES:Relatively little is known about rates of outpatient adverse drug events (ADEs), and most health systems do not routinely identify them. We developed a computerized ADE measurement process and used it to detect ADEs from electronic health records and then categorized them according to type, preventability, a...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0b013e3181dcae06
更新日期:2010-06-01 00:00:00
abstract:OBJECTIVE:Safety advocates have identified barcode verification technology as an important tool to improve health-care practices. METHODS:We evaluated the evidence for the role of barcode technology in improving a wide range of medication safety outcomes across a broad range of settings. Important implementation issue...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000049
更新日期:2015-06-01 00:00:00
abstract:BACKGROUND:Despite increasing recognition that patients could play an important role in promoting the safety of their care, little is known on this issue regarding health-care professionals' (HCPs') attitudes toward patient involvement. OBJECTIVES:To investigate physicians' and nurses' attitudes toward patient involve...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0b013e318267c4aa
更新日期:2012-12-01 00:00:00
abstract:OBJECTIVES:Serious adverse events at out-of-hours services in primary care (OHS-PC) are rare, and the most often concern is missed acute coronary syndrome (ACS). Previous studies on serious adverse events mainly concern root cause analyses, which highlighted errors in the telephone triage process but are hampered by hi...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000799
更新日期:2020-12-14 00:00:00
abstract:INTRODUCTION:The second victim is defined as the health professionals who commit an error and are traumatized by the event manifesting psychological, cognitive, and/or physical reactions that have a personal negative impact.The SVEST (Second Victim Experience and Support Tool) is a survey developed and validated in the...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000497
更新日期:2018-05-03 00:00:00
abstract:OBJECTIVES:The intensive care unit (ICU) is a complex environment in terms of data density and alerts, with alert fatigue, a recognized barrier to patient safety. The Electronic Health Record (EHR) is a major source of these alerts. Although studies have looked at the incidence and impact of active EHR alerts, little r...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000270
更新日期:2019-09-01 00:00:00
abstract:OBJECTIVES:Drugs can come in concentrated solutions that require dilution before intravenous bolus administration. Upon dilution, the syringe can contain more than the required amount of drug. The user may mistakenly administer the full contents of the syringe, resulting in an overdose. In this cross-sectional study, w...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000770
更新日期:2020-09-08 00:00:00
abstract:INTRODUCTION:The reported 90-day rate of death from living donor nephrectomy is 3 in 10,000 donations. Although this risk is low, the important question is how many deaths are preventable? METHODS:To study this question, all living donor nephrectomy cases, 139,186 procedures, recorded in the Scientific Registry of Tra...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000610
更新日期:2019-12-01 00:00:00
abstract:OBJECTIVES:As hospitals are increasingly consolidating into larger health systems, they are becoming better positioned to have far reaching and material impacts on safety and quality of care. When the Mount Sinai Health System (MSHS) was formed in 2013, it sought to ensure the delivery of safe, high-quality care to eve...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000578
更新日期:2021-01-01 00:00:00
abstract:OBJECTIVE:The objective of this study was to explore medical oncology outpatients' perceived experiences of errors in their cancer care. METHODS:A cross-sectional survey was conducted. English-speaking medical oncology outpatients aged 18 years or older were recruited from 9 Australian cancer treatment centers. Partic...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000368
更新日期:2019-12-01 00:00:00
abstract::Error disclosure is a high-stakes, emotionally charged interaction for patients and families as well as clinicians. A failed disclosure can result in emotional distress, reduced patient and family trust, litigation, and lost opportunities to learn from and prevent subsequent errors. However, many clinicians have littl...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000491
更新日期:2018-05-16 00:00:00
abstract:INTRODUCTION:ProVation Medical documentation software was introduced in our Department of Gastroenterology (GI). We evaluated the use of a simulation module to improve the introduction of new documentation software into a tertiary care center GI department. MATERIALS AND METHODS:Train-the-trainer education was provide...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0b013e31829e4cc0
更新日期:2014-09-01 00:00:00
abstract:OBJECTIVES:Despite endorsements for greater use of systems approaches and reports from national consensus bodies calling for closer engineering/health care partnerships to improve care delivery, there has been a scarcity of effort of actually engaging the design and engineering disciplines in patient safety projects. T...
journal_title:Journal of patient safety
pub_type: 杂志文章
doi:10.1097/PTS.0000000000000577
更新日期:2019-02-09 00:00:00
abstract:OBJECTIVES:Adverse drug events (ADEs) are common in ambulatory care and may result from poor patient-physician communication about medication-related symptoms. A module was developed within an electronic patient portal that was designed to enhance communication about medication symptoms and, in turn, reduce ADEs and he...
journal_title:Journal of patient safety
pub_type: 杂志文章,随机对照试验
doi:10.1097/PTS.0b013e31829e4b95
更新日期:2013-09-01 00:00:00