Risk Management File Research Articles

Analysis: Using the FDA MAUDE and Medical Device Recall Databases to Design Better Devices.

This article provides recommendations to manufacturers on using the Food and Drug Administration's MAUDE (Manufacturer and User Facility Device Experience) and Medical Device Recall databases to identify unknown use issues, discover design opportunities, and improve one's risk management file. These recommendations are based on the experiences of researchers who have spent time analyzing and working with both database systems and have developed a methodology for each. Manufacturers can leverage the suggested practices described in this article to address regulatory requirements.

Application of the IEC80001 standard towards integration of a real time alarm communication and management system

Purpose – The purpose of this paper is to report on use of the IEC80001 standard, Application of Risk Management for Information Technolody (IT) Networks Incorporating Medical Devices, to deploy a wireless alarm management solution in a long-term care home facility. Design/methodology/approach – The standard suggests the use of a unique responsibility matrix and a continuous quality improvement approach for analysis, evaluation and control of risks. A unique leadership committee and workgroup were formed to develop processes and procedures for integrating medical devices with IT systems; as well as execution of the project itself. The leadership committee oversaw the phased approach of assessing the technology, the clinical environment, proponent technology-based solutions and a specified risk management file. The project expanded its scope beyond the standard to include a risk focussed analysis of clinical workflow to evaluate the usability of the solution. Findings – The standard focussed approach identified numerous risks associated with the technical and network solution and the future state workflow. Medical devices proved to be the most limiting technology needing to be incorporated into the solution. Although faced with a daunting list of network related risks, it was concluded that all residual risks would have been acceptable. The analysis of the future state workflow identified various risks related to usability (human factors), battery management and the absence of additional operating dollars for supplementary staffing duties and new operational expenses. Originality/value – To the best of the authors knowledge, this paper is the first one to detail the process of following the IEC80001 standard in Canada. It offers insight into building an organizational framework around the standard and identifies gaps that should be considered by executive and project sponsors before proceeding with a project.

Association of Patient Satisfaction with Complaints and Risk Management among Emergency Physicians

Background Patient-physician interactions in the emergency department (ED) are unique in that prior relationships may not exist; interactions are brief, and the environment is hectic. Objectives The research hypotheses were that patient satisfaction scores on a commonly used national satisfaction survey are associated with patient complaints and risk management file openings or lawsuits (risk management episodes). Methods Administrative databases from an emergency physician management group that staffs 34 EDs in 8 states were merged with patient satisfaction data. Dates of inclusion were January 2002-April 2006. Estimates of physician contribution to satisfaction utilized a multi-level mixed-effects linear regression with a random-effect for practice site and physician, and fixed-effect adjustments for patient factors, time pressures, acuity mix, and physician productivity. Adjusted satisfaction scores were used to explore the relationship with complaints and risk management episodes. Main outcome measure Association of patient satisfaction scores with risk of complaint and risk management episodes. Results There were 3947 physician-quarters of practice data analyzed, representing 2,462,617 patient visits. There were 375 complaints and 61 risk management episodes. Those in the lowest quartile of satisfaction were nearly twice as likely to have a complaint (adjusted odds ratio 1.84; 95% confidence interval [CI] 1.29–2.63) as those in the highest quartile. Satisfaction was not directly related to risk management episodes. Complaints were more strongly associated with risk management episodes than other variables: those receiving ≥ 2 complaints in a quarter were 4.13 (95% CI 1.12–15.2) times more likely to have a risk management episode. Conclusions Patient satisfaction scores are not associated with increased risk management episodes but are closely related to receiving complaints. Receiving complaints is a strong marker for increased risk management episodes and should prompt early corrective action.

Risk Management: It's Not Just FMEA

Risk Management: It's Not Just FMEA

Patient Characteristics Predict Occurrence and Outcome of Complaints Against Physicians: A Study From a Medical Center in Central Taiwan

A better understanding of the risk factors for medical malpractice is essential for implementing long-term prevention strategies. Certain physician characteristics have been reported to be associated with malpractice litigation. However, patient characteristics have not been fully investigated. We conducted a hospital-based case-control study. We reviewed a total of 147 cases in the inpatient risk management file (RMF) and 44,045 inpatient controls. The RMF was opened if the patient's complaint may have led to legal action. We compared demographic data of RMF cases and controls to investigate the risk factors for filing a complaint. Outcomes of the RMF cases were classified as resolution, compensation, and lawsuit. RMF cases were associated with admission via the emergency room (odds ratio [OR]=1.62, p=0.005), surgical specialty (OR=1.86, p=0.001) and living in an urban area (OR=1.93, p<0.001). Once RMF cases were filed, living in an urban area was the only independent factor for filing a lawsuit (OR=4.10, p=0.007). RMF cases with medical injury were more likely to reach compensation (OR=10.51, p<0.001) and to receive significantly higher compensation (p=0.007). The severity of medical injury was correlated positively with the likelihood of reaching compensation and the amount of compensation. Only 15.0% of RMF cases entered the litigation phase. Patients with certain characteristics tend to file complaints, receive compensation, or bring a case to court. Understanding of patient characteristics may be useful for predicting occurrence and outcome of complaints against physicians.

Cleaning, Sterilization, and Biocompatibility Risk Management for IEC 60601-1 Third Edition

With the examples above we have demonstrated for our selected topics that our device meets the risk management requirements of 60601-1. An expansion of the tables to include all of the risk management requirements would be useful to identify how the manufacturer has met all of the risk management requirements of the standard. By setting up a file system under the manufacturer's quality system that meets the requirements of the 14971 risk management standard, the manufacturer will be able to effectively demonstrate compliance with a number of applicable standards, including 60601-1, and also be able to demonstrate the device meets FDA product safety requirements. The file system would also be useful in creating the technical file for the MDD. A risk management summary table similar to the one recommended by the GHTF will assist the manufacturer in tracking the documentation required to support this effort. A list of the hazards identified for the product is contained in the summary table and the summary table will also aid in determining if all of the required steps in the risk management process have been completed for each hazard. This table will become an important record in the risk management file.

Cause-and-effect analysis of risk management files to assess patient care in the emergency department.

Identifying the etiologies of adverse outcomes is an important first step in improving patient safety and reducing malpractice risks. However, relatively little is known about the causes of emergency department-related adverse outcomes. The objective was to describe a method for identification of common causes of adverse outcomes in an emergency department. This methodology potentially can suggest ways to improve care and might provide a model for identification of factors associated with adverse outcomes. This was a retrospective analysis of 74 consecutive files opened by a malpractice insurer between 1995 and 2000. Each risk-management file was analyzed to identify potential causes of adverse outcomes. The main outcomes were rater-assigned codes for alleged problems with care (e.g., failures of communication or problems related to diagnosis). About 50% of cases were related to injuries or abdominal complaints. A contributing cause was found in 92% of cases, and most had more than one contributing cause. The most frequent contributing categories included failure to diagnose (45%), supervision problems (31%), communication problems (30%), patient behavior (24%), administrative problems (20%), and documentation (20%). Specific relating factors within these categories, such as lack of timely resident supervision and failure to follow policies and procedures, were identified. This project documented that an aggregate analysis of risk-management files has the potential to identify shared causes related to real or perceived adverse outcomes. Several potentially correctable systems problems were identified using this methodology. These simple, descriptive management tools may be useful in identifying issues for problem solving and can be easily learned by physicians and managers.

Cause-and-effect Analysis of Risk Management Files to Assess Patient Care in the Emergency Department

Objectives: Identifying the etiologies of adverse outcomes is an important first step in improving patient safety and reducing malpractice risks. However, relatively little is known about the causes of emergency department–related adverse outcomes. The objective was to describe a method for identification of common causes of adverse outcomes in an emergency department. This methodology potentially can suggest ways to improve care and might provide a model for identification of factors associated with adverse outcomes. Methods: This was a retrospective analysis of 74 consecutive files opened by a malpractice insurer between 1995 and 2000. Each risk-management file was analyzed to identify potential causes of adverse outcomes. The main outcomes were rater-assigned codes for alleged problems with care (e.g., failures of communication or problems related to diagnosis). Results: About 50% of cases were related to injuries or abdominal complaints. A contributing cause was found in 92% of cases, and most had more than one contributing cause. The most frequent contributing categories included failure to diagnose (45%), supervision problems (31%), communication problems (30%), patient behavior (24%), administrative problems (20%), and documentation (20%). Specific relating factors within these categories, such as lack of timely resident supervision and failure to follow policies and procedures, were identified. Conclusions: This project documented that an aggregate analysis of risk-management files has the potential to identify shared causes related to real or perceived adverse outcomes. Several potentially correctable systems problems were identified using this methodology. These simple, descriptive management tools may be useful in identifying issues for problem solving and can be easily learned by physicians and managers.

Risk management.

All of the risk analysis tables, the risk control measures, verification results, risk/benefit analyses, risk evaluations, and traceability analyses need to be documented and available for inspection by auditors. One way to organize this documentation is to have a risk management file that includes or references each of these documents.

Patient Complaints and Malpractice Risk

Hickson, Gerald B.; Federspiel, Charles F.; Pichert, James W.; Miller, Cynthia S.; Gauld-Jaeger, Jean; Bost, Preston

Patient complaints and malpractice risk.

A small number of physicians experience a disproportionate share of malpractice claims and expenses. If malpractice risk is related in large measure to factors such as patient dissatisfaction with interpersonal behaviors, care and treatment, and access, it might be possible to monitor physicians' risk of being sued. To examine the association between physicians' patient complaint records and their risk management experiences. Retrospective longitudinal cohort study of 645 general and specialist physicians in a large US medical group between January 1992 and March 1998, accounting for 2546 physician-years of care. Computerized records of all unsolicited patient complaints were recorded by the medical center's patient affairs office, coded to characterize the nature of the problem and alleged offender, and compared with each physician's risk management records for the same period. Both patient complaints and risk management events were higher for surgeons than nonsurgeons. Specifically, 137 (32%) of the 426 nonsurgeons had at least 1 risk management file compared with nearly two thirds (137 [63%] of 219) of all surgeons (chi2(1)= 54.7, P<.001). Both complaint and risk management data were positively correlated with physicians' volume of clinical activity. Logistic regression revealed that risk management file openings, file openings with expenditures, and lawsuits were significantly related to total numbers of patient complaints, even when data were adjusted for clinical activity. Predictive concordance of specialty group, complaint count, clinical activity, and sex for risk management file openings was 84%; file openings with expenditures, 83%; lawsuits, 81%; and multiple lawsuits, 87%. Unsolicited patient complaints captured and recorded by a medical group are positively associated with physicians' risk management experiences.