Medical Device Risk Management Research Articles

Methods for Medical Device Design, Regulatory Compliance and Risk Management

Despite the evolution of design controls and compliance as critical elements in the medical device development process, as stipulated by both domestic and international regulations and standards, a comprehensive model describing the comprehensive approach to medical device design is needed. This gap exists because design controls and regulatory compliance have become integral to the medical device design process, mandated by regulations and standards at both national and international levels. The medical device sector prioritizes design controls and compliance with regulatory requirements in isolation. On the other hand, the integration of design controls and compliance, such as those associated with projects involving complex medical device designs, have not been considered nearly enough. This review focuses on the integration of design controls and compliance in the medical device sector. Initially, the definition of a medical device and the different phases of medical device development are introduced. Afterwards, medical device development using the basic safety and essential performance concepts outlined in the IEC 60601-1 standard is discussed. The role of risk management practices about medical devices is also elaborated upon.

A hybrid Bayesian network for medical device risk assessment and management

A hybrid Bayesian network for medical device risk assessment and management

A review of 3D printing utilisation in radiotherapy in the United Kingdom and Republic of Ireland

The use of three-dimensional (3D) printing in medical applications is quickly becoming mainstream. There have been an increasing number of publications discussing its implementation in radiotherapy, and the technology has become more affordable.The objective of this study was to establish how widely 3D printing is currently being utilised and what has been done to validate the processes and outcomes. A survey was sent to the UK and Ireland medical physics mailing lists. The questions were designed to establish how many centres were using 3D printers, how 3D printers were being utilized, the type of printing technologies being used, and how risk was being addressed.A total of 60 radiotherapy centres responded to the survey, with 38 % of the respondents currently using 3D printing. The majority (85 %) of the remaining respondents said they may or would have a 3D printer in the next 3 years. The majority of users were using FDM-type printers. The main variability among 3D printer users was how risk management and QA were addressed.This survey has demonstrated that there is an increased appetite for 3D printers in radiotherapy even beyond phantoms and bolus. Yet, despite this, guidance on implementation, compliance with the medical device directive and risk management remains sparse. As a consequence, centres have adopted a variety of approaches to risk management and QA.

Quantification of Benefits for Medical Devices

One of the most prominent challenges in safety risk management of medical devices is the Benefit-Risk Analysis. This paper proposes a methodology to quantify benefits, thereby creating more consistency, and explainability in the evaluation of benefits and the benefit/risk ratio.
 Leveraging the guidance from the FDA, we define four Dimensions for appraising benefits. The product of the rankings of a benefit in all four Dimensions is used as a quantitative measure of a benefit.
 The quantitative score for the overall benefit of a medical device would be the sum of the scores of the individual benefits.

IT risk management for medical devices in hospital IT networks: a catalogue of measures and indicators

ObjectivesConnecting medical devices to hospital IT networks can create threats that must be covered by IT risk management. In practice, implementing such risk management is not trivial because the IEC...

Analysis of Common Questions in Medical Device Technical Review

Risk management is an activity running through the full life of medical device, which has a significant effect on ensuring the safety and effectiveness of medical device. Many researchers do the research on medical device risk management from different perspectives, but few people discuss it from the technical perspective. The risk management issue in technical review of medical equipment was discussed, the reasons of the issue were analyzed, and suggestions were given in this study.

Using Medical Device Standards for Design and Risk Management of Immersive Virtual Reality for At-Home Therapy and Remote Patient Monitoring.

Numerous virtual reality (VR) systems have received regulatory clearance as therapeutic medical devices for in-clinic and at-home use. These systems enable remote patient monitoring of clinician-prescribed rehabilitation exercises, although most of these systems are nonimmersive. With the expanding availability of affordable and easy-to-use head-mounted display (HMD)-based VR, there is growing interest in immersive VR therapies. However, HMD-based VR presents unique risks. Following standards for medical device development, the objective of this paper is to demonstrate a risk management process for a generic immersive VR system for remote patient monitoring of at-home therapy. Regulations, standards, and guidance documents applicable to therapeutic VR design are reviewed to provide necessary background. Generic requirements for an immersive VR system for home use and remote patient monitoring are identified using predicate analysis and specified for both patients and clinicians using user stories. To analyze risk, failure modes and effects analysis, adapted for medical device risk management, is performed on the generic user stories and a set of risk control measures is proposed. Many therapeutic applications of VR would be regulated as a medical device if they were to be commercially marketed. Understanding relevant standards for design and risk management early in the development process can help expedite the availability of innovative VR therapies that are safe and effective.

Special Risk of Using Portable Emergency Ventilator Based on Clinical Application

Risk management of medical devices covers the whole life cycle of medical devices, which is of great significance to the life safety and health condition of patients. The existing risk management of medical devices, especially the risk analysis in the research and development stage, often becomes a mere formality. The special risks faced by the research and development products in the clinical application scenarios are not well addressed. This study proves the necessity and importance of the combination of risk analysis and clinical application in the research and development stage of medical devices by the analysis of several special hazard sources in the process of clinical application of portable emergency ventilator.

System Safety Bookshelf

Elsevier Academic Press has recently published a new safety book titled Safety Risk Management for Medical Devices, written by Bijan Elahi. This book explains how to conduct a risk management program that will show conformance to the FDA safety standards established for medical devices. It describes a safety process as well as some of the tools utilized in the process. Since medical devices are life-saving devices, they can be deemed as “safety critical,” requiring a rigorous process to ensure they are safe for public use.

Risk Management to Shanghai Medical Device Registrants

In Nov.2017, Shanghai CFDA began to pilot medical device registrant project in China. This project is a bold attempt to medical device supervision. And it's quite helpful for promoting innovation and development of medical devices in Shanghai. However, the "R&D-Production-separate" characteristic enhances risks in medical device life-cycle. It also brings more challenges to registrant on medical device risk management. In order to protect interested parties fully and effectively, we will discuss why registrants need to manage risk and what they should pay attention to in this article.

Assessing risk by analogy: a case study of us medical device risk management policy

Medical devices occupy an increasingly important place in global medical care, and yet the risk management systems that govern them are largely overlooked in academic literatures. In the US, home to the largest medical devices market, Food and Drug Administration (FDA) regulation allows most medical devices to enter the market based on analogy, or substantial equivalence, with previously marketed devices. Thus, risk assessment is administered without premarket clinical trials for safety and efficacy. This system represents a permissive regulatory regime based in neoliberal tenets, where risk, in the form of adverse events, is inherently tolerated within governance structures, evidencing risk colonisation. This paper employs a case study approach, examining market clearances of vaginal mesh surgical devices, which have been the subject of US multi-district litigation. We identified 266 devices cleared before 31 December 2017 and analysed the complicated web of device ‘ancestry’ whereby devices as disparate as cardiac patches and hernia mesh allowed clearance of surgical devices for urogynecology. Perhaps of greatest concern, 10 recalled or withdrawn devices influenced new device clearances for up to 17 years after their market-removal. While the FDA must balance its dual mandate to safeguard patients and promote innovation, we find that medical device regulation structurally favours innovation over safety. ‘Light touch’ risk assessment is not counterbalanced with postmarket mechanisms to safeguard against residual and developmental risks that are associated with medical devices, particularly permanent implants. The proportionality principle associated with a precautionary approach should inform medical device risk management.

Risk analysis for the design of a safe artificial pancreas control system

Closed-loop glucose control has the potential to improve the glycemic control in patients with diabetes mellitus type 1. Such an artificial pancreas (AP) should keep the user safe despite all disturbances and faults. The objective of this paper is to analyze those perturbations according to their effects on the glycemic status, and thereby supporting an informed design process of the control system. As suggested by the international standard ISO 14971 for risk management of medical devices, the well proven failure modes and effects analysis (FMEA) was chosen as instrument. An FMEA scheme was modified for this purpose and applied to a single-hormone system with subcutaneous and intraperitoneal routes for glucose sensing and insulin administration. Faults that imply urgent danger and thus require fast detection and diagnosis were identified and distinguished from disturbances that can be sufficiently addressed by basic control functions, e.g. by adaptive control algorithms. Requirements and testing criteria for basic control functions as well as fault detection and diagnosis functions can be derived from the provided overview.

Medical Device Risk Management from a Human Factors Perspective

This paper describes the ways in which human factors methods can help to enhance the work of established clinical engineering teams by placing a new emphasis on error reduction and patient safety. This approach in many ways represents a natural evolution for departments that are looking to enhance their usefulness and relevance to healthcare. Several examples are given of points at which the introduction of human factors methods can reveal issues related to the safe use of medical devices that are not easily accessible by other means. Adoption and implementation of these methods offers the potential for clinical engineering departments to enhance their role of helping to ensure optimal patient safety.

Cybersecurity in safety‐critical systems

Abstract2016 saw cybersecurity standards appear in both automotive and medical device industries. Both standards are understandably based on processes that already exist in the respective industries. The automotive J3061 standard is very much focussed on existing categories for defining the cybersecurity threats, ie, systems, hardware and software. Cybersecurity is very much a multifaceted topic, and by restricting the scope to these 3 subject areas there is the risk that many significant threats could be overlooked, in particular the malicious acts of employees within an organisation.The medical cybersecurity report AAMI TIR 57 takes the approach based on ISO 14971 the medical device risk management standard, which encourages a more open‐minded approach to evaluating cybersecurity threats. Both of these documents, which are discussed in this paper, are short of practical examples or techniques for assessing and mitigating threats; the topic is handled in a more theoretical manner.Key issues such as trojan circuits in microcontrollers are not well represented in either document. Generally, software topics such as authentication and encryption are given good coverage in international standards; however, this not the case when reviewing hardware concerns. Both TIR 57 and J3061 are good starting documents for the topic of cybersecurity, but both could benefit from expansion to cover the wider topics affecting cybersecurity.

In vitro test methodology for expediting development and risk management of advanced medical devices

In vitro test methodology for expediting development and risk management of advanced medical devices

Design of a secure remote management module for a software-operated medical device.

Software-based medical devices need to be maintained throughout their entire life cycle. The efficiency of after-sales maintenance can be improved by managing medical systems remotely. This paper presents how to design the remote access function extensions in order to prevent risks imposed by uncontrolled remote access. A thorough analysis of standards and legislation requirements regarding safe operation and risk management of medical devices is presented. Based on the formal requirements, a multi-layer machine design solution is proposed that eliminates remote connectivity risks by strict separation of regular device functionalities from remote management service, deploys encrypted communication links and uses digital signatures to prevent mishandling of software images. The proposed system may also be used as an efficient version update of the existing medical device designs.

Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record.

ObjectivesThis paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea.MethodsMedical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods.ResultsSixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude, potential benefits, and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction, but relatively low for time-consuming and decision-making.ConclusionsWe were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.

Analysis of plasticizers in PVC medical devices: Performance comparison of eight analytical methods

A wide variety of medical devices (MDs) used in hospitals are made of flexible plasticized polyvinylchloride (PVC). Different plasticizers are present in variable amounts in the PVC matrix of the devices and can leach out into the infused solutions and may enter into contact with the patients. The ARMED11ARMED: Assessment and Risk Management of Medical Devices in Plasticized Polyvinylchloride. project aims to assess the migration of these plasticizers from medical devices and therefore the level of exposure in patients. For the first task of the project, eight methods were developed to directly detect and quantify the plasticizers in the PVC matrix of the MDs. We compared the overall performances of the analytical methods using standardized and validated criteria in order to provide the scientific community with the guidance and the technical specifications of each method for the intended application. We have shown that routine rapid screening could be performed directly on the MDs using the FTIR technique, with cost-effective analyses. LC techniques may also be used, but with limits and only with individual quantification of the main plasticizers expected in the PVC matrix. GC techniques, especially GC–MS, are both more specific and more sensitive than other techniques. NMR is a robust and specific technique to precisely discriminate all plasticizers in a MD but is limited by its cost and its low ability to detect and quantify plasticizer contamination, e.g. by DEHP. All these results have been confirmed by a real test, called the " blind test " carried out on 10 MD samples.

ISO/IEC 80001 (Risk Management of Medical Devices on a Network)

ISO/IEC 80001 (Risk Management of Medical Devices on a Network)

Establishment of the evaluation indicator system on clinical risk exposure of medical devices

Objective To build a scientific, comprehensive, operable evaluation indicator system on clinical risk exposure of medical devices from the perspective of medical institutions. It can provide reference and help for medical institutions to carry out medical device risk management activities. Methods Through literature analysis and expert interview, the draft index system was proposed. Select 20 experts and scholars to form a panel of experts. A 2-rounds Delphi survey was made on the proposed indicators. The reliability of this expert consultation was tested by the response rate, the authority coefficient and concordance coefficient of experts. Results The response rates of the 2 rounds were 90%, 100% respectively. After two rounds of expert consultation, expert opinion has been basically concentrated. Ultimately, an index system comprising 4 first-level, 14 second-level, and 48 third-level was built. Conclusion The expert consultation has achieved reliable results. The evaluation indicator system on the clinical application risk of medical device can be used as an evaluation tool for medical device. Key words: Delphi method; Medical device; Clinical application; Risk assessment; Indicator system