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

Lawal, Oluwadolapo D; Mohanty, Maitreyee; Elder, Harrison; Skeer, Margie R.; Erpelding, Nathalie; Lanier, Ryan K.; Katz, Nathaniel

doi:10.1080/14740338.2018.1442431

Cited by 13 publications

(25 citation statements)

References 29 publications

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“…Misclassification of harmful IV-PCA errors was also reported in a similar study by Lawal and colleagues. 28 Taken together, these findings indicate that harmful IV-PCA errors are common and frequently lead to adverse outcomes warranting additional care and healthcare resource utilization.…”

Section: Discussionmentioning

confidence: 88%

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Medication errors involving intravenous patient-controlled analgesia: results from the 2005–2015 MEDMARX database

Mohanty

Lawal

Skeer

et al. 2018

Therapeutic Advances in Drug Safety

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Background:The aim of this study was to determine the current magnitude and characteristics of intravenous patient-controlled analgesia (IV-PCA) errors, and to identify opportunities for improving the PCA modality.Methods:We conducted a descriptive analysis of IV-PCA medication errors submitted to the MEDMARX database. Events were restricted to those occurring in inpatient hospital settings between 1 January 2005 and 31 December 2015. IV-PCA errors were classified by error category, cause of error, error type, level of care rendered, and actions taken.Results:A total of 1948 IV-PCA errors were identified as potential errors (3.9%), nonharmful errors (89.5%), or harmful errors (6.7%) based on the National Coordinating Council for Medication Error Reporting and Prevention taxonomy for categorizing medication errors. Of these, 19.1% required a clinical intervention to address the deleterious effects of the error, indicating an underestimation of the risks associated with IV-PCA errors. The most frequent types of errors were improper dose/quantity (43.2%) and omission errors (19.9%). While human performance deficit was the leading cause of error (50.2%), other common causes included failure to follow procedure and protocol (42.2%) and improper use of the pump (22.7%). Although remedial actions were often taken to prevent error recurrence, actions were taken to rectify the systemic deficits that led to errors in only a minority of cases (11.8%).Conclusion:Preventable errors continue to pose unnecessary risks to patients receiving IV-PCA. Multimodal analgesic regimens and novel PCA systems that reduce human error are needed to prevent errors while preserving the advantages of PCA for the management of acute pain.

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Section: Discussionmentioning

confidence: 88%

“…healthcare professionals and patients). 28 , 47 Additionally, since the acquisition of MEDMARX by Quantros in 2008, there has been a systematic decline in the number of facilities reporting opioid-related medication errors to the database. This decline may have led to an underestimation of the number of errors reported.…”

Section: Discussionmentioning

confidence: 99%

Medication errors involving intravenous patient-controlled analgesia: results from the 2005–2015 MEDMARX database

Mohanty

Lawal

Skeer

et al. 2018

Therapeutic Advances in Drug Safety

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“…Between 2005 and 2009, the FDA recorded more than 710 deaths related to infusion pumps, specifically citing drug overdoses as one cause [15]. A recent review of the FDA Manufacturer and User Facility Device Experience database by Lawal et al focusing on the intravenous administration route concluded that "patients on IV-PCA continue to experience serious complications as a result of preventable errors" [16]. However, changes in the design, improved user interfaces, and tightening of regulations might have led to a decrease of incidents compared to years at the beginning of the century although an increase in reporting due to legal requirements in recent years could contradict this hypothesis.…”

Section: Technology: Safety As Itsmentioning

confidence: 99%

“…However, changes in the design, improved user interfaces, and tightening of regulations might have led to a decrease of incidents compared to years at the beginning of the century although an increase in reporting due to legal requirements in recent years could contradict this hypothesis. In the event of a device issue, the majority of patients suffer from adverse events, whereby inadequate analgesia dominates [16,17].…”

Section: Technology: Safety As Itsmentioning

confidence: 99%

Quo Vadis PCA? A Review on Current Concepts, Economic Considerations, Patient-Related Aspects, and Future Development with respect to Patient-Controlled Analgesia

Nardi-Hiebl

Eberhart

Gehling

et al. 2020

Anesthesiology Research and Practice

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This review assesses four interrelating aspects of patient-controlled analgesia (PCA), a long-standing and still widely used concept for postoperative pain management. Over the years, anaesthesiologists and patients have appreciated the benefits of PCA alike. The market has seen new technologies leveraging noninvasive routes of administration and, thus, further increasing patient and staff satisfaction as well as promoting safety aspects. Pharmaceutical research focuses on the reduction or avoidance of opioids, side effects, and adverse events although influence of these aspects appears to be minor. The importance of education is still eminent, and new educational formats are tested to train healthcare professionals and patients likewise. New PCA technology can support the implementation of efficient processes to reduce workload and human errors; however, these new products come with a cost, which is not necessarily reflected through beneficial budget impact or significant improvements in patient outcome. Although first steps have been taken to better recognize the importance of postoperative pain management through the introduction of value-based reimbursement, in most western countries, PCA is not specifically compensated. PCA is still an effective and valued technique for postoperative pain management. Although there is identifiable potential for future developments in various aspects, this potential has not materialized in new products.

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“…10 Using the MAUDE database, previous research found that 92% of the 1430 reports involving patient-controlled intravenous analgesia devices were classified as device malfunctions. 11 However, that study did not analyze the number of device malfunction reports related to elastomeric pumps. Elastomeric pump malfunctions resulting in overinfusion of anesthetic have also been reported in the literature, further supporting the need to evaluate reports of device malfunctions and events, such as LAST, associated with these devices.…”

Section: Introductionmentioning

confidence: 99%

Characterization of Device-Related Malfunction, Injury, and Death Associated with Using Elastomeric Pumps for Delivery of Local Anesthetics in the US Food and Drug Administration MAUDE Database

Teames

Joyce

Scranton

et al. 2020

DHPS

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Purpose To characterize medical device reports about elastomeric pumps delivering local anesthesia made to the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. Patients and Methods We conducted a retrospective review of medical device reports submitted to MAUDE from January 2010 to July 2018. A systematic, computerized algorithm was used to identify records pertaining to elastomeric pumps using local anesthesia. Included records indicated the use of local anesthesia or were determined to involve the use of local anesthetics (if they did not contain specific information on drug use). Reports were analyzed within the MAUDE event type categories of malfunction, injury, death, other, and missing. Possible cases of liver injury or surgical site infection were also identified. Manual review of narratives provided in MAUDE was performed by 2 reviewers to identify possible or probable cases of local anesthetic system toxicity (LAST). Results From a pool of 384,285 reports about elastomeric pumps from the MAUDE database, 4093 met inclusion criteria for involving elastomeric pumps to deliver local anesthetics, with the peak number of reports occurring in 2014. Of these identified reports, 3624 (88.5%) were categorized as malfunctions, 292 (7.1%) as injuries, and 8 (0.2%) as involving death. We identified 13 cases (0.3%) of possible liver injury and 51 cases (1.2%) of possible surgical site infection; 139 reports (3.4%) were determined to be probably (n=53) or possibly (n=86) associated with LAST. Conclusion Malfunction of elastomeric pumps delivering local anesthetics leaves patients vulnerable to injury or death. Our study indicates that reports of malfunction, injury, and death have been reported to the MAUDE database. These reports likely reflect an underrepresentation of cases in the real-world population, emphasizing the need for more comprehensive medical device reporting.

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

Abstract: Patients on IV-PCA continue to experience serious complications as a result of preventable errors. Multi-modal interventions including educational training and the development and adoption of PCA devices with improved safety features are needed to improve safety.

Cited by 13 publications

References 29 publications

Medication errors involving intravenous patient-controlled analgesia: results from the 2005–2015 MEDMARX database

Medication errors involving intravenous patient-controlled analgesia: results from the 2005–2015 MEDMARX database

Quo Vadis PCA? A Review on Current Concepts, Economic Considerations, Patient-Related Aspects, and Future Development with respect to Patient-Controlled Analgesia

Characterization of Device-Related Malfunction, Injury, and Death Associated with Using Elastomeric Pumps for Delivery of Local Anesthetics in the US Food and Drug Administration MAUDE Database

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