Dataset Information

Quality improvement report: Learning from adverse incidents involving medical devices.

ABSTRACT:

Problem

The NHS is perceived to have a poor record of learning from incidents. Despite efforts of the Medical Devices Agency, which issues safety warnings, adverse incidents with medical devices continue to occur, some of which result in serious injury or death through device failures, user errors, and organisational problems.

Design

Introduction of feedback notes on a supportive investigation that seeks to determine latent factors, immediate triggers, causes, and positive actions taken by staff that minimised adverse consequences.

Background and setting

Medical physics department providing equipment management services in a major NHS teaching trust.

Key measures for improvement

Reduction in repetitions of adverse incidents and improved staff competency in using devices.

Strategy for change

A feedback note was developed to describe the incident and generic details of the equipment, summarise the investigation (focusing on latent causes and immediate triggers), and describe lessons to be learnt and positive actions by staff.

Effects of change

Feedback notes have been used in teaching sessions and given to ward link nurses. Despite being new, the positive supportive approach has encouraged an open reporting culture.

Lessons learnt

Adverse incidents are typically caused by alignment of different factors, but good practice can prevent errors becoming incidents. Careful analysis of incidents reveals both the multifactorial causes and the good practices that can help minimise repetitions.

SUBMITTER: Amoore J

PROVIDER: S-EPMC1123780 | biostudies-literature | 2002 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Quality improvement report: Learning from adverse incidents involving medical devices.

Amoore John J Ingram Paula P

BMJ (Clinical research ed.) 20020801 7358

<h4>Problem</h4>The NHS is perceived to have a poor record of learning from incidents. Despite efforts of the Medical Devices Agency, which issues safety warnings, adverse incidents with medical devices continue to occur, some of which result in serious injury or death through device failures, user errors, and organisational problems.<h4>Design</h4>Introduction of feedback notes on a supportive investigation that seeks to determine latent factors, immediate triggers, causes, and positive actions ...[more]

PMID: 12153928

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Project description:PurposeRadiation oncology relies on rapidly evolving technology and highly complex processes. The US Food and Drug Administration collects reports of adverse events related to medical devices. We sought to characterize all events involving radiation oncology devices (RODs) from the US Food and Drug Administration's postmarket surveillance Manufacturer and User Facility Device Experience (MAUDE) database, comparing these with non-radiation oncology devices.Methods and materialsMAUDE data on RODs from 1991 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems) and 5 device problem categories (software, mechanical, electrical, user error, and dose delivery impact). Outcomes included whether the device was evaluated by the manufacturer, adverse event type, remedial action, problem code, device age, and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by the Pearson χ2 test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions.ResultsThere were 4234 ROD and 4,985,698 other device adverse event reports. Adverse event reports increased over time, and events involving RODs peaked in 2011. Most ROD reports involved external beam therapy (50.8%), followed by brachytherapy (24.9%) and treatment planning systems (21.6%). The top problem types were software (30.4%), mechanical (20.9%), and user error (20.4%). RODs differed significantly from other devices in each outcome (P<.001). RODs were more likely to be evaluated by the manufacturer after an event (46.9% vs 33.0%) but less likely to be recalled (10.5% vs 37.9%) (P<.001). Device age and time since 510(k) approval were shorter among RODs (P<.001).ConclusionsCompared with other devices, RODs may experience adverse events sooner after manufacture and market approval. Close postmarket surveillance, improved software design, and manufacturer-user training may help mitigate these events.

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Dataset Information

Quality improvement report: Learning from adverse incidents involving medical devices.

Problem

Design

Background and setting

Key measures for improvement

Strategy for change

Effects of change

Lessons learnt

Publications

Quality improvement report: Learning from adverse incidents involving medical devices.

Similar Datasets

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