The frequency, types and causes of medical device-related errors reported in the literature: a Rapid Review (Preprint)

2020 ◽  
Author(s):  
Emilia Anderson ◽  
Simon Poon ◽  
Jonathan Penm
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Improve Patient Safety ◽  
Near Miss ◽  
Rapid Review ◽  
Future Research ◽  
Surgical Equipment ◽  
Cardiovascular Devices ◽  
Automated External Defibrillators ◽  
Design Error

BACKGROUND The use of medical devices is rapidly expanding. Despite this, there is a huge gap in the literature surrounding the use of devices in healthcare and the adverse events occurring. Given that these errors can be life-threatening, it is imperative to have a thorough understanding of the problem in order to improve patient safety. OBJECTIVE To conduct a Rapid Review to identify the frequency, types and causes of medical device-related errors which are reported in published peer-reviewed literature. METHODS Following PRISMA guidelines, a literature search strategy was developed. Databases searched until 23 February 2018 included Pubmed, International Pharmaceutical Abstracts and Cinahl. Articles were included if they: defined medical devices, reported the frequency, causes and types of errors, were published in peer-reviewed literature. Articles were screened and discussed by two authors. RESULTS Database searching yielded 7,559 unduplicated articles. After two rounds of screening, 24 articles were included in the Review. Device types included cochlear implants, defibrillator leads, anaesthetic & intensive care devices, surgical equipment, automated external defibrillators, radiation oncology devices, ambulance stretchers, breast pumps, cardiovascular devices, orthopaedic devices, and patient controlled analgesia devices. The frequency of errors was 3.83-33.0%. The most common causes were user error, malfunction and design error. CONCLUSIONS This Review identified a range of device types associated with errors. The frequency of errors was lower than published literature. User error was confirmed as a leading cause, alongside malfunction and design error. Future research should examine near-miss events and expand the device types studied.

Software-as-a-Medical Device: demystifying Connected Health regulations

2016 ◽  
Vol 18 (2) ◽  
pp. 186-215 ◽  
Author(s):  
Noel Carroll ◽  
Ita Richardson
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Healthcare Service ◽  
Healthcare Sector ◽  
Future Research ◽  
Extensive Literature ◽  
Comprehensive Overview ◽  
Content Type ◽  
Connected Health ◽  
The Impact

Purpose Connected Health is an emerging and rapidly developing field never before witnessed across the healthcare sector. It has the potential to transform healthcare service systems by increasing its safety, quality and overall efficiency. However, as healthcare technologies or medical devices continuously rely more on software development, one of the core challenges is examining how Connected Health is regulated – often impacting Connected Health innovation. The purpose of this paper is to present an understanding of how Connected Health is regulated. Many of these regulatory developments fall under “medical devices”, giving rise to Software-as-a-Medical Device (SaaMD). Design/methodology/approach Through an extensive literature review, this paper demystifies Connected Health regulation. It presents the outcome of expert discussions which explore the key regulatory developments in the context of Connected Health to provide a practical guide to understanding how regulation can potentially shape healthcare innovation. Findings Several key issues are identified, and the authors present a comprehensive overview of regulatory developments relating to Connected Health with a view to support the continued growth of IT-enabled healthcare service models. The authors also identify the key challenges in Connected Health and identify areas for future research. Originality/value A key outcome of this research is a clearer understanding of the opportunities and challenges that regulation and standards present to Connected Health. Furthermore, this research is of critical importance in a first attempt towards recognising the impact of regulation and standards compliance in Connected Health.

Informed consent and compulsory medical device registries: ethics and opportunities

2021 ◽  
pp. medethics-2020-107031
Author(s):  
Daniel B. Kramer ◽  
Efthimios Parasidis
Keyword(s):  
Informed Consent ◽  
High Risk ◽  
Medical Device ◽  
Clinical Evaluation ◽  
Medical Devices ◽  
Marketing Approval ◽  
Legal Requirements ◽  
Ethical Obligation ◽  
Cardiovascular Devices ◽  
The Usa

Many high-risk medical devices earn US marketing approval based on limited premarket clinical evaluation that leaves important questions unanswered. Rigorous postmarket surveillance includes registries that actively collect and maintain information defined by individual patient exposures to particular devices. Several prominent registries for cardiovascular devices require enrolment as a condition of reimbursement for the implant procedure, without informed consent. In this article, we focus on whether these registries, separate from their legal requirements, have an ethical obligation to obtain informed consent from enrolees, what is lost in not doing so, and the ways in which seeking and obtaining consent might strengthen postmarket surveillance in the USA.

Quality Assurance in Medical Devices

2021 ◽  
pp. 302-314
Author(s):  
Juliana Shaibun
Keyword(s):  
Quality Assurance ◽  
Medical Device ◽  
Medical Devices ◽  
High Performance ◽  
Quality Management System ◽  
Business Environment ◽  
Future Research ◽  
Medical Device Manufacturers ◽  
Device Manufacturer ◽  
Assurance Process

Quality management system (QMS) is acknowledged as the primary method for any manufacturer, especially medical device manufacturers, in order to sustain the product quality in the competitive advantage in business environment. QMS is an essential requirement for regulatory control in high risk medical devices. Globally, the number of medical device manufacturers certified by ISO 13485 is escalating. Ownership of this certification symbolizes the medical device manufacturer acquired high performance in their QMS. This bibliometric provides a brief review of the quality assurance and how safety plays an important role in medical devices. Bibliometric analysis guided user to summarize the essential part of quality assurance process in medical device. The insights presented in this research assist in building a firm theoretical base and direction for future research.

Training Decay Selection for Usability Validation

2016 ◽  
Vol 5 (1) ◽  
pp. 76-83
Author(s):  
Shannon E. Clark
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Validation Studies ◽  
Future Research ◽  
Medical Device Manufacturers ◽  
Selection For ◽  
The Moment ◽  
High Level ◽  
First Time ◽  
Validation Testing

When conducting usability validation testing, representative users must use the device in the expected conditions of use in the field. There is usually a period of time—days or weeks—between the point in time a user is trained, and the moment they use the device for the first time. For this reason, the FDA acknowledges the need for “training decay” as part of usability validation testing, but manufacturers face challenges simulating real-time decays. In response to challenges associated with lags of days or weeks between training and usability validation testing, medical device manufacturers typically simulate shortened training decay periods. This paper discusses the theory behind the shapes of various training decay curves and the variables that drive differences between training decay curves. The author proposes to use a task-based approach for defining training decay curves in usability validation studies and sets out generalized training decay curves at a high level. Future research could reveal detailed and generalizable training decay curves. Identifying generalizable training decay curves could standardize the usability testing required for medical devices, and ultimately improve use error identification while avoiding an undue toll on manufacturer resources.

scholarly journals Service-Oriented Medical Device Connectivity: Particular Interoperability Standards for High Frequency Surgical Equipment and External Control Devices

2021 ◽  
Vol 7 (2) ◽  
pp. 523-526
Author(s):  
Martin Kasparick ◽  
Marcus Köny ◽  
Björn Andersen ◽  
Kathrin Riech ◽  
Anton Keller ◽  
...  
Keyword(s):  
Medical Device ◽  
High Frequency ◽  
Improve Patient Safety ◽  
Healthcare Delivery ◽  
External Control ◽  
Surgical Equipment ◽  
Service Oriented ◽  
Control Devices ◽  
Modes Of Interaction ◽  
Ieee 11073

Abstract Manufacturer-independent medical device interoperability has been strongly demanded by the clinicians and healthcare delivery organizations (HDOs), however has not been achieved in practice for decades. The ISO/IEEE 11073 Service-oriented Device Connectivity (SDC) family of standards constitutes a paradigm shift. This work supplements SDC with Device Specializations (DevSpecs) or Modular Specifications (ModSpecs): particular interoperability standards for high frequency (HF) surgical equipment and external control devices, such as foot or finger switches. They provide models to describe these devices in a service-oriented medical device system and modes of interaction with other network participants. Additionally, we contribute to the ISO/IEEE 11073-10101 nomenclature standard to provide semantic descriptions of the exchanged information. This is a key enabler for safe and effective medical device interoperability to support the caregivers and improve patient safety as well as clinical outcome.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

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