当前位置： SCI文献检索 > BMJ Quality & Safety期刊下所有文献 > Identifying optimal postmarket surveillance strategies for medical and surgical devices: implications for policy, practice and research.

Identifying optimal postmarket surveillance strategies for medical and surgical devices: implications for policy, practice and research.

Abstract：

BACKGROUND:Non-drug technologies offer many benefits, but have been associated with adverse events, prompting calls for improved postmarket surveillance. There is little empirical research to guide the development of such a system. The purpose of this study was to identify optimal postmarket surveillance strategies for medical and surgical devices. METHODS:Qualitative methods were used for sampling, data collection and analysis. Stakeholders from Canada and the USA representing different roles and perspectives were first interviewed to identify examples and characteristics of different surveillance strategies. These stakeholders and others they recommended were then assembled at a 1-day nominal group meeting to discuss and prioritise the components of a postmarket device surveillance system, and research needed to achieve such a system. RESULTS:Consultations were held with 37 participants, and 47 participants attended the 1-day meeting. They recommended a multicomponent system including reporting by facilities, clinicians and patients, supported with some external surveillance for validation and real-time trials for high-risk devices. Many considerations were identified that constitute desirable characteristics of, and means by which to implement such a system. An overarching network was envisioned to broker linkages, establish a shared minimum dataset, and support communication and decision making. Numerous research questions were identified, which could be pursued in tandem with phased implementation of the system. DISCUSSION:These findings provide unique guidance for establishing a device safety network that is based on existing initiatives, and could be expanded and evaluated in a prospective, phased fashion as it was developed.

journal_name

BMJ Qual Saf

journal_title

BMJ quality & safety

authors

Gagliardi AR,Umoquit M,Lehoux P,Ross S,Ducey A,Urbach DR

doi

10.1136/bmjqs-2012-001298

subject

Has Abstract

pub_date

2013-03-01 00:00:00

pages

210-8

issue

eissn

2044-5415

issn

2044-5423

pii

bmjqs-2012-001298

journal_volume

pub_type

杂志文章,多中心研究

在线工具

Identifying optimal postmarket surveillance strategies for medical and surgical devices: implications for policy, practice and research.