Device-related Incidents Research Articles

Complications of Pediatric Mandibular Distraction Osteogenesis Hardware: A 10-Year Retrospective Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database

Background: The United States Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database provides access to device related adverse event reports. This database mandates national reporting of complications that lead to “death and serious injury” by manufacturers, importers, and device user facilities. This study used MAUDE to conduct post-market surveillance of pediatric mandibular distraction osteogenesis (MDO) hardware. Methods: A MAUDE database search with terms related to mandibular distraction was performed for report dates between October 1st, 2011, and October 1st, 2021. Duplicate reports, reports from literature reviews, and vague reports were removed. Manufacturers were contacted to establish which devices were pediatric-use-only. Adult-use and mixed-use devices were excluded. Each remaining report was manually reviewed/categorized to compile summative data. Results: Seventy pediatric-use-only device reports were identified. The damaged/non-functioning part of the device included the distractor itself (57.14% of reports), footplate(s) (37.14%), or screw(s) (5.71%). Intraoperative and postoperative complications made up 15.71% and 84.29% of reports, respectively. Twenty percent of complications occurred during the activation phase and 1.43% occurred during device removal. The most common report was failure of the device to advance (37.14% of total complications). Some form of operative treatment or explantation was performed for 51.43% and 34.29% of complications, respectively. External distractors and related hardware made up 8.6% of reports and the most common complication in this group was the screw backing out at 33.3% of all reports. Conclusions: The MAUDE database is a useful tool in evaluation of MDO device-related incidents. Most complications occur in the postoperative period, during the distraction phase, and often require device removal. The most common complication in external distractors was screws backing out. Mindful activation of the distractor, careful device/screw handling, technical improvement of the devices, and thorough preoperative planning may minimize these untoward events.

A quality improvement study for medical devices usage in an acute healthcare setting

The objectives of this study were, for a large NHS Trust, to (1) Implement a medical devices training information system which connects the medical equipment inventory to the electronic staff record. (2) Monitor the changes in safety-related practice in the Trust after implementation (3) Examine the association between training compliance and Trust-wide adverse incident data for high risk medical devices. (4) Identify possible gaps in training course content from adverse incident data. A new system was made available, showing medical devices training records for staff in each location. Relevant staff members were trained on how to set up courses, record training, adjust training requirements and view reports. Training practice, compliance and adverse incidents for high-risk equipment were monitored over 30 months after implementation. Trends and changes in training practice were analysed. The Trust now has monitoring information on medical devices training available that had previously been absent. Training compliance increased from 23% to 59%. The frequency and severity of adverse incidents remained relatively constant throughout and was not associated with the increased uptake of training Trust-wide. Training gaps were identified. A Trust-wide system for recording medical devices training has provided training assurance. After implementation changes in practice with training have been identified. It was not possible to show a direct association between increased training compliance and reduced medical device-related incidents Trust-wide. There were specific training courses where changes in content could increase the safe use of medical devices.

Situation-Dependent Medical Device Risk Estimation: Design and Evaluation of an Equipment Management Center For Vendor-Independent Integrated Operating Rooms.

The complexity of surgical interventions and the number of technologies involved are constantly rising. Hospital staff has to learn how to handle new medical devices efficiently. However, if medical device-related incidents occur, the patient treatment is delayed. Patient safety could therefore be supported by an optimized assistance system that helps improve the management of technical equipment by nonmedical hospital staff. We developed a system for the optimal monitoring of networked medical device activity and maintenance requirements, which works in conjunction with a vendor-independent integrated operating room and an accurate surgical intervention Time And Resource Management System. An integrated situation-dependent risk assessment system gives the medical engineers optimal awareness of the medical devices in the operating room. A qualitative and quantitative survey among ten medical engineers from three different hospitals was performed to evaluate the approach. A series of 25 questions was used to evaluate various aspects of our system as well as the system currently used. Moreover, the respondents were asked to perform five tasks related to system supervision and incident handling. Our system received a very positive feedback. The evaluation studies showed that the integration of information, the structured presentation of information, and the assistance modules provide valuable support to medical engineers. An automated operating room monitoring system with an integrated risk assessment and Time And Resource Management System module is a new way to assist the staff being outside of a vendor-independent integrated operating room, who are nevertheless involved in processes in the operating room.

Use of a human factors classification framework to identify causal factors for medication and medical device-related adverse clinical incidents

This study examined non-fatal adverse clinical incidents involving patient loss of function or requiring increased levels of care of a patient relating to medication and medical devices to determine if incident causal factors can be identified using the Human Factors Classification Framework (HFCF) for patient safety. A random sample of 200 medication- and 200 medical device-related clinical incidents in Australia were reviewed using the HFCF for patient safety. The framework identified key precursor events (PE) and contributing factors (CF) of these events. Descriptive statistics and correspondence analysis were used to examine the characteristics of the events. Medication and communication or documentation issues were the most common types of PE identified for medication incidents, while for medical devices the most common PEs were medical device breakage/failure or lack of medical equipment. Correspondence analysis for medication incidents showed that rule-based errors were strongly related to omitted dose or wrong drug. Factors relating to the organisation (86.5% and 25.0%) or the patient (7.7% and 17.9%) were the most commonly identified CFs for both medication and medical device-related incidents, respectively. The HFCF for patient safety identified the role of human factors, particularly human error, in non-fatal clinical incidents involving medication and medical devices, highlighting the need for targeted approaches to inform risk management strategies in the healthcare sector based on an understanding of how and why these incidents occur.

How can we improve the recognition, reporting and resolution of medical device-related incidents in hospitals? A qualitative study of physicians and registered nurses.

BackgroundTo explore factors that influence and to identify initiatives to improve the recognition, reporting and resolution of device-related incidents.MethodsSemi-structured telephone interviews with 16 health professionals in two tertiary care hospitals were conducted. Purposive sampling was used to identify appropriate study participants. Transcribed interviews were read independently by one individual to identify, define and organize themes and verified by another reviewer.ResultsThemes related to incident recognition were the hospital staff’s knowledge and professional experience, medical device performance and clinical manifestations of patients, while incident reporting was influenced by error severity, personal attitudes of clinicians, feedback received on the error reported. Physicians often discontinued using medical devices if they malfunctioned. Education and training and the implementation of registries were discussed as important initiatives to improve medical device surveillance in clinical practice.ConclusionsResults from the telephone interviews suggest that multiple factors that influence participation in medical device surveillance activities are consistent with results for medical errors as reported in previous studies. The study results helped to propose a conceptual framework for a medical device surveillance system in a hospital context that would enhance patient safety and health care delivery.Electronic supplementary materialThe online version of this article (doi:10.1186/s12913-015-0886-0) contains supplementary material, which is available to authorized users.

Factors that influence the recognition, reporting and resolution of incidents related to medical devices and other healthcare technologies: a systematic review.

BackgroundMedical devices have improved the treatment of many medical conditions. Despite their benefit, the use of devices can lead to unintended incidents, potentially resulting in unnecessary harm, injury or complications to the patient, a complaint, loss or damage. Devices are used in hospitals on a routine basis. Research to date, however, has been primarily limited to describing incidents rates, so the optimal design of a hospital-based surveillance system remains unclear. Our research objectives were twofold: i) to explore factors that influence device-related incident recognition, reporting and resolution and ii) to investigate interventions or strategies to improve the recognition, reporting and resolution of medical device-related incidents.MethodsWe searched the bibliographic databases: MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and PsycINFO database. Grey literature (literature that is not commercially available) was searched for studies on factors that influence incident recognition, reporting and resolution published and interventions or strategies for their improvement from 2003 to 2014. Although we focused on medical devices, other health technologies were eligible for inclusion.ResultsThirty studies were included in our systematic review, but most studies were concentrated on other health technologies. The study findings indicate that fear of punishment, uncertainty of what should be reported and how incident reports will be used and time constraints to incident reporting are common barriers to incident recognition and reporting. Relevant studies on the resolution of medical errors were not found. Strategies to improve error reporting include the use of an electronic error reporting system, increased training and feedback to frontline clinicians about the reported error.ConclusionsThe available evidence on factors influencing medical device-related incident recognition, reporting and resolution by healthcare professionals can inform data collection and analysis in future studies. Since evidence gaps on medical device-related incidents exist, telephone interviews with frontline clinicians will be conducted to solicit information about their experiences with medical devices and suggested strategies for device surveillance improvement in a hospital context. Further research also should investigate the impact of human, system, organizational and education factors on the development and implementation of local medical device surveillance systems.Electronic supplementary materialThe online version of this article (doi:10.1186/s13643-015-0028-0) contains supplementary material, which is available to authorized users.

A proposed framework to improve the safety of medical devices in a Canadian hospital context.

PurposeMedical devices are used to monitor, replace, or modify anatomy or physiological processes. They are important health care innovations that enable effective treatment using less invasive techniques, and they improve health care delivery and patient outcomes. Devices can also introduce risk of harm to patients. Our objective was to propose a surveillance system framework to improve the safety associated with the use of medical devices in a hospital.Materials and methodsThe proposed medical device surveillance system incorporates multiple components to accurately document and assess the appropriate actions to reduce the risk of incidents, adverse events, and patient harm. The assumptions on which the framework is based are highlighted. The surveillance system was designed from the perspective of a tertiary teaching hospital that includes dedicated hospital staff whose mandate is to provide safe patient care to inpatients and outpatients and biomedical engineering services.ResultsThe main components of the surveillance system would include an adverse medical device events database, a medical device/equipment library, education and training, and an open communication and feedback strategy. Close linkages among these components and with external medical device/equipment networks to the hospital must be established and maintained. A feedback mechanism on medical device-related incidents, as well as implementation and evaluation strategies for the surveillance system are described to ensure a seamless transition and a high satisfactory level among the hospital staff. The direct cost items of the proposed surveillance system for consideration, and its potential benefits are outlined.ConclusionThe effectiveness of the proposed medical device surveillance system framework can be measured after it has been implemented in a Canadian hospital facility.

Perioperative incidents associated with internal maxillary distraction osteogenesis: a retrospective study of 20 patients

This retrospective study aimed to assess the frequency and distribution of incidents encountered during the perioperative period of maxillary distraction with internal devices. The perioperative period was defined as the period between device placement and removal. Records of 20 patients treated during 2004-2011 with internal maxillary distraction osteogenesis were examined. Incidents were registered in terms of severity and need of intervention. Eighty percent of the patients experienced minor incidents, of which the most frequent were pain during activation and infections; 80% of these experienced ≥1 hard and soft tissue-related incidents, and 20% ≥1 device-related incidents. All incidents were solved with minimal or no intervention. Maxillary distraction using internal devices is a safe treatment with only minor incidents in the perioperative period. Preoperative planning and good cooperation are essential for preventing postoperative incidents. Prophylactic antibiotic treatment during the distraction period may be indicated.

A Team Approach: A Look at Ways Biomeds Can Improve Patient Safety

A Team Approach: A Look at Ways Biomeds Can Improve Patient Safety

Short- and Long-term Retrievability of the Celect Vena Cava Filter: Results from a Multi-institutional Registry

To evaluate retrievability of the Celect vena cava filter over time and to assess the safety of the retrieval procedure in a prospective multicenter registry. Between October 2005 and March 2008, Celect filters were placed in 95 patients (61 men; mean age, 51 years +/- 18.5) with a temporary need for an inferior vena cava (IVC) filter. All patients satisfied requirements for filter placement; the primary indications for placement were pulmonary embolism (PE) with a contraindication to or failure of anticoagulation (n = 40), high risk for further PE (n = 29), trauma (n = 23), or massive PE with residual deep vein thrombosis and risk for further PE (n = 3). Filter orientation, vena cava injury, and other device-related incidents were evaluated at implantation and retrieval. The degree of difficulty associated with retrieval was also assessed. Filter retrieval was attempted in 58 patients (mean indwell time of 179 days; median, 168.5 d; range, 5-466 d). Fifty-six filters (96.6%) were successfully retrieved. Unsuccessful retrieval attempts were attributed to filter tilt (n = 1) or excessive tissue growth with the hook embedded in the endothelium (n = 1). No adverse events were associated with the inability to retrieve these filters. A Kaplan-Meier product-limit survival estimate revealed that the probability of successful filter retrieval remained at 100% at 50 weeks and at more than 74% at 55 weeks after implantation. No adverse events were related to the retrieval procedures. Retrieval of the Celect filter was performed safely as long as 466 days after implantation.

Long-term Retrieval Success Rate Profile for the Günther Tulip Vena Cava Filter

To evaluate the likelihood of successful retrieval of the Günther Tulip vena cava filter after various implant durations (up to 494 days). Retrievable Günther Tulip filters were placed in 554 patients. All patients satisfied requirements for filter placement; the primary indication for placement was specified for 394 patients (71%), as follows: unspecified trauma (n = 164), bariatric procedures (n = 128), orthopedic procedures (n = 36), and other (n = 66). Filter tilt and vena cava injury were assessed at implantation. Filters were not repositioned after placement. At retrieval, filter orientation, vena cava injury, other device-related incidents, and the degree of difficulty associated with retrieval were reported. Filter retrieval was attempted in 275 patients and successful in 248 (90.2%). The mean filter indwell time was 58.9 days (range, 3-494 days). Unsuccessful retrievals (n = 27) were attributed primarily to improper hook orientation (n = 10) or excessive tissue in-growth at the filter legs (n = 16). Of the remaining 279 patients, 223 withdrew from the study, 41 were associated with a decision to keep the filter as a permanent device, 13 died for reasons unrelated to the study, and two had no reported endpoint data. A Kaplan-Meier product-limit survival estimate revealed that the probability of successful device retrieval remained greater than 94% at 12 weeks and greater than 67% at 26 weeks. This study contributes to the body of clinical data related to retrievable filters, demonstrating reliable retrieval rates at 12 weeks, with successful retrievals up to 17 months after implantation.

Called to Testify?

Called to Testify?

The Legacy of the CE and BMET: Safer Healthcare Technologies

The Legacy of the CE and BMET: Safer Healthcare Technologies

Trocar injuries in laparoscopic surgery

BACKGROUND: Disposable trocars with safety shields are widely used for laparoscopic access. The aim of this study was to analyze risk factors associated with injuries resulting from their use as reported to the Food and Drug Administration. STUDY DESIGN: Manufacturers are required to report medical device-related incidents to the Food and Drug Administration. We analyzed the 629 trocar injuries reported from 1993 through 1996. RESULTS: There were three types of injury: 408 injuries of major blood vessels, 182 other visceral injuries (mainly bowel injuries), and 30 abdominal wall hematomas. Of the 32 deaths, 26 (81%) resulted from vascular injuries and 6 (19%) resulted from bowel injuries. Eighty-seven percent of deaths from vascular injuries involved the use of disposable trocars with safety shields and 9% involved disposable trocars with a direct-viewing feature. The aorta (23%) and inferior vena cava (15%) were the vessels most commonly traumatized in the fatal vascular injuries. Ninety-one percent of bowel injuries involved trocars with safety shields and 7% involved direct-view trocars. The diagnosis of an enterotomy was delayed in 10% of cases, and the mortality rate in this group was 21%. In 41 cases (10%) the surgeon initially thought the trocar had malfunctioned, but in only 1 instance was malfunction subsequently found when the device was examined. The likelihood of injury was not related to any specific procedure or manufacturer. CONCLUSIONS: These data show that safety shields and direct-view trocars cannot prevent serious injuries. Retroperitoneal vascular injuries should be largely avoidable by following safe techniques. Bowel injuries often went unrecognized, in which case they were highly lethal. Device malfunction was rarely a cause of trocar injuries.

Trocar injuries in laparoscopic surgery

Abstract BACKGROUND: Disposable trocars with safety shields are widely used for laparoscopic access. The aim of this study was to analyze risk factors associated with injuries resulting from their use as reported to the Food and Drug Administration. STUDY DESIGN: Manufacturers are required to report medical device-related incidents to the Food and Drug Administration. We analyzed the 629 trocar injuries reported from 1993 through 1996. RESULTS: There were three types of injury: 408 injuries of major blood vessels, 182 other visceral injuries (mainly bowel injuries), and 30 abdominal wall hematomas. Of the 32 deaths, 26 (81%) resulted from vascular injuries and 6 (19%) resulted from bowel injuries. Eighty-seven percent of deaths from vascular injuries involved the use of disposable trocars with safety shields and 9% involved disposable trocars with a direct-viewing feature. The aorta (23%) and inferior vena cava (15%) were the vessels most commonly traumatized in the fatal vascular injuries. Ninety-one percent of bowel injuries involved trocars with safety shields and 7% involved direct-view trocars. The diagnosis of an enterotomy was delayed in 10% of cases, and the mortality rate in this group was 21%. In 41 cases (10%) the surgeon initially thought the trocar had malfunctioned, but in only 1 instance was malfunction subsequently found when the device was examined. The likelihood of injury was not related to any specific procedure or manufacturer. CONCLUSIONS: These data show that safety shields and direct-view trocars cannot prevent serious injuries. Retroperitoneal vascular injuries should be largely avoidable by following safe techniques. Bowel injuries often went unrecognized, in which case they were highly lethal. Device malfunction was rarely a cause of trocar injuries.

Software for Evaluating Device-Related Incidents

Software for Evaluating Device-Related Incidents