CIRSE Standards of Practice on Conducting Meetings on Morbidity and Mortality

Chun, Joo-Young; Bharadwaz, Arindam; Tun, Jimmy Kyaw; Bilhim, Tiago; González-Junyent, Carla; Kawa, Bhavin

doi:10.1007/s00270-021-02860-y

Cited by 3 publications

(6 citation statements)

References 32 publications

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“…Robust pre-procedural discussion and planning as well as enlisting tools such as safety checklists significantly contributes to establishing a culture of patient safety in IR practice (Fig. 1: WHO checklist) [21,[45][46][47]. When complications have occurred, they should be reviewed and discussed at regular Morbidity and Mortality (M&M) meetings [21,47].…”

Section: What Is a Complication In Ir?mentioning

confidence: 99%

“…1: WHO checklist) [21,[45][46][47]. When complications have occurred, they should be reviewed and discussed at regular Morbidity and Mortality (M&M) meetings [21,47]. These are an important part of the governance framework to ensure shared learning and to identify systems and processes that warrant change [21].…”

Section: What Is a Complication In Ir?mentioning

confidence: 99%

“…When complications have occurred, they should be reviewed and discussed at regular Morbidity and Mortality (M&M) meetings [21,47]. These are an important part of the governance framework to ensure shared learning and to identify systems and processes that warrant change [21]. The remainder of this article will explore a robust framework for dealing with complications as they occur with the aim of helping IRs to manage complications in their day-to-day practice.…”

Section: What Is a Complication In Ir?mentioning

confidence: 99%

“…This safety profile can be attributed partly to the leadership of national and international organizations, and to published standards of practice guidelines [15][16][17][18][19][20]. Widespread acceptance and knowledge of the content within these guidelines within the IR community represents a positive proactive shift toward embedding patient safety culture as a foundational tenet of IR practice [21]. However, beyond adherence to guidelines, global literature suggests that quality and service evaluation within IR is lacking [22].…”

Section: Introductionmentioning

confidence: 99%

“…However, beyond adherence to guidelines, global literature suggests that quality and service evaluation within IR is lacking [22]. In a survey of members of the Cardiovascular and Interventional Radiology Society of Europe (CIRSE), 47% of 150 respondents reported engagement in morbidity, mortality, and improvement meetings which we believe are crucial for dealing with complications, improving practice, and maintaining patient safety [20][21][22][23].…”

Section: Introductionmentioning

confidence: 99%

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Dealing with complications in interventional radiology

Oseni,

Chun,

Morgan

et al. 2024

CVIR Endovasc

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It is widely accepted that most misadventures, which lead to harm have not occurred because of a single individual but rather due to a failure of process that results in healthcare workers making mistakes. This failure of process and the pervasiveness of adverse events is just as prevalent in Interventional Radiology (IR) as it is in other specialities. The true prevalence and prevailing aetiology of complications in IR are not exactly known as there is a paucity of investigative literature into this area; especially when compared with other more established disciplines such as Surgery. Some IR procedures have a higher risk profile than others. However, published data suggests that many adverse events in IR are preventable (55–84%) and frequently involve a device related complication such as improper usage or malfunction. This article aims to discuss factors that contribute to complications in IR along with tools and strategies for dealing with them to achieve optimal patient outcomes.

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Section: What Is a Complication In Ir?mentioning

confidence: 99%

Section: What Is a Complication In Ir?mentioning

confidence: 99%

Section: What Is a Complication In Ir?mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Dealing with complications in interventional radiology

Oseni,

Chun,

Morgan

et al. 2024

CVIR Endovasc

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show abstract

A Proposed Systematic Approach to Safe Inter Hospital Patient Transfer in Interventional Radiology: From Referral to Repatriation

Wells,

Morgan,

Greenway

2024

Cardiovasc Intervent Radiol

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Insights From the FDA’s MAUDE Database Regarding the Real-World Safety of Jetstream Atherectomy for Peripheral Arterial Disease

Min,

Alkhalifa,

Ahrari

et al. 2023

J Endovasc Ther

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Introduction: Rotational atherectomy has shown promise as an adjunctive therapy to percutaneous transluminal angioplasty (PTA) and stenting for the treatment of peripheral arterial disease (PAD). However, published data regarding the safety of these devices are limited. The Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database collects reports of adverse event for medical devices. We present 3 years of MAUDE adverse events data for the Jetstream Atherectomy System (Boston Scientific) for the treatment of PAD. Materials and Methods: We searched MAUDE from January 1, 2019 to December 31, 2021. Duplicate reports and those with insufficient information were excluded, leaving a total of 500 reports for analysis. Adverse events were categorized as either patient complication, device malfunction, or both. Adverse events were classified using the Cardiovascular and Interventional Radiological Society of Europe’s (CIRSE) classification system for adverse events. Results: The most common patient complications were embolism (22; 4.4%), dissection (17; 3.4%), vessel perforation (12; 2.4%), and device fracture in the patient (6; 1.2%). The most common modes of device failure were entrapment of the device on the guidewire (134; 27%), loss of blade rotation (116; 23%), loss of aspiration (99; 20%), and mechanical damage (57; 11%). As per the CIRSE adverse events classification, most events had no post-procedural sequelae (475; 95%), followed by those requiring prolonged observation (14; 2.8%), and post-procedural therapy without long-term sequelae (10; 2.0%). One hundred six devices (21%) were returned for manufacturer analysis. Conclusion: We highlight important adverse events encountered in real-world practice with the Jetstream Atherectomy System. This analysis provides further understanding of the safety profile and modes of failure of Jetstream, and could help guide improvements in product design and manufacturer-user training. There is greater need for root-cause analysis that can aided by returning devices to the manufacturer. Clinical Impact We highlight important adverse events encountered in real-world practice with the Jetstream Atherectomy System. The MAUDE database is useful for capturing and characterizing modes of device failure/malfunction not typically described in conventional clinical studies. This may provide valuable information to help guide improvements in product design and manufacturer-user training. This information could also potentially be useful in helping establish manufacturer and product liability in the setting of medicolegal claims. We hope that by contributing to the growing understanding of the safety profile of the Jetstream Atherectomy System, our study may help physicians and patients come to more informed decisions regarding treatment options for PAD.

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CIRSE Standards of Practice on Conducting Meetings on Morbidity and Mortality

Cited by 3 publications

References 32 publications

Dealing with complications in interventional radiology

Dealing with complications in interventional radiology

A Proposed Systematic Approach to Safe Inter Hospital Patient Transfer in Interventional Radiology: From Referral to Repatriation

Insights From the FDA’s MAUDE Database Regarding the Real-World Safety of Jetstream Atherectomy for Peripheral Arterial Disease

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