•A novel systematic method for medical device risk management during production and post-production using hybrid Bayesian networks (BNs).•The BN approach resolves the limitations of commonly used ...risk analysis methods.•The BN approach supports full benefit-risk analysis and individual risk assessment of medical devices.•The BN approach can produce quantified and auditable risk estimates with limited or no testing data.
Risk analysis methods for medical devices, including fault tree analysis, have limitations such as handling uncertainty and providing reasonable risk estimates with limited or no testing data. To address these limitations, this paper proposes a novel systematic method for medical device risk management using hybrid Bayesian networks (BNs). We apply the method to a Defibrillator device to demonstrate the process involved for risk management during production and post-production using 4 different scenarios: (1) where there are available testing data; (2) where there are limited or no testing data; (3) where it is a completely new device with no testing data; (4) where we are reassessing the risk of a previous model on the market based on reported hazards and injuries. In each scenario, the BN model, for the available data, provides the full probability of failure per demand distribution for each category of injury severity (fatal, critical, major, minor, negligible) and the probabilities associated with various risk acceptability criteria. The model results are validated using publicly available data for the LIFEPAK 1000 Defibrillator (PN: 320371500XX), which was recalled by Physio-Control in 2017. The results show that the device would fail the acceptability criteria for probability of fatal injury.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPUK, ZAGLJ, ZRSKP
Inadequate risk management by medical device providers is significantly impacting the safety of the customers they serve, the quality of their products and their profitability. Billions of dollars ...are being spent yearly in the medical device industry on the direct costs of poor quality. One would not expect this to be happening given that the medical device Industry is one of the most regulated industries in the world. The required steps and volume of paperwork required to obtain medical device approval is second to no other industry. The question that must be asked is if all this work is being done why are the direct costs of poor quality so high?
The Federal University of São Paulo is developing a low-cost insulin infusion pump in cooperation with a Brazilian company to provide an affordable treatment option for individuals with type 1 ...diabetes, especially from low-incoming countries. Risk management according to standard ISO 14971 is required for certification and safe use of the insulin pump. This paper describes the risk management performed to include safeguards in the architectural design of the insulin pump in development. The risk management process activities were carried out simultaneously and integrated with equipment development, generating requirements to protect against adverse effects on safety due to physical components failures, development errors, and user errors. Design solutions for the safety requirements, implemented in hardware and software, were incorporated in the low-cost insulin pump architecture. Comparison with applicable standards and certified insulin infusion pumps showed that these safeguards align with the best practices adopted for this type of equipment.
Quality control (QC) practices are changing in US laboratories as Centers for Medicare and Medicaid Services adopts individualized QC plans as a new option for compliance with the Clinical Laboratory ...Improvement Amendments regulations. The Joint Commission provides general guidance for applying risk management in health care organizations. The EP23A (Evaluation Protocol 23A) document from the Clinical and Laboratory Standards Institute provides specific guidance on the use of risk management for developing analytical QC plans. Medical laboratories should integrate risk management tools with existing quality management techniques and activities to provide an overall plan for analytical quality management.
Today, Many industries are studying methods that enhance and measure dependability. Dependability measurement methods use fault injection to monitor the state of a system. A fault/error that occurs ...in an unexpected situation, giving rise to an extreme status, can be inspected. To obtain high Automotive Safety Integrity Level (ASIL) in automotive safety standard (ISO 26262), any system must be tested using fault injection technique. NASA standard (8719.13B) also recommends the fault injection test. In contrast, the medical device safety standard (ISO 14971) does not mention the fault injection test. In this paper, we compare the difference between two standards and introduce a method of fault injection in medical device.
According to the latest amendment of the Medical Device Directive standalone software qualifies as a medical device when intended by the manufacturer to be used for medical purposes. In this context, ...the EN 62304 standard is applicable which defines the life-cycle requirements for the development and maintenance of medical device software. A pilot project was launched to acquire skills in implementing this standard in a hospital-based environment (in-house manufacture).
The EN 62304 standard outlines minimum requirements for each stage of the software life-cycle, defines the activities and tasks to be performed and scales documentation and testing according to its criticality. The required processes were established for the pre-existent decision-support software FlashDumpComparator (FDC) used during the quality assurance of treatment-relevant beam parameters. As the EN 62304 standard implicates compliance with the EN ISO 14971 standard on the application of risk management to medical devices, a risk analysis was carried out to identify potential hazards and reduce the associated risks to acceptable levels.
The EN 62304 standard is difficult to implement without proper tools, thus open-source software was selected and integrated into a dedicated development platform. The control measures yielded by the risk analysis were independently implemented and verified, and a script-based test automation was retrofitted to reduce the associated test effort. After all documents facilitating the traceability of the specified requirements to the corresponding tests and of the control measures to the proof of execution were generated, the FDC was released as an accessory to the HIT facility.
The implementation of the EN 62304 standard was time-consuming, and a learning curve had to be overcome during the first iterations of the associated processes, but many process descriptions and all software tools can be re-utilized in follow-up projects. It has been demonstrated that a standards-compliant development of small and medium-sized medical software can be carried out by a small team with limited resources in a clinical setting. This is of particular relevance as the upcoming revision of the Medical Device Directive is expected to harmonize and tighten the current legal requirements for all European in-house manufacturers.
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IZUM, KILJ, NUK, PILJ, PNG, SAZU, UL, UM, UPUK
Medical device manufacturers are responsible for ensuring that their medical products are safe. However, safe does not mean zero risk. A safe product is one that has reasonable risks, given the ...magnitude of the benefit expected an d the alternatives available. Medical device manufacturers, the Food and Drug Administration (FDA) and medical device users have an important role to play in maintaining this risk-benefit balance, by making sure that products are developed, tested, manufactured, labeled, prescribed, dispensed, and used in a way that maximizes benefit and minimizes risk. The FDA approved ISO14971 standard specifies a risk management process by which a manufacturer can identify the hazards associated with their medical device, estimate and evaluate the risks, control these risks, and monitor effectiveness of the controls, through-out the lifecycle of the product. The main elements of the risk management process, i.e. risk analysis, risk evaluation, risk control and postproduction information, are generally documented in a risk management file. This risk management file is required to get FDA approval to market a medical device (prior to product launch). It is also useful after product launch to perform post-market risk assessments and make decisions on whether field action is needed in case of the occurrence of an adverse event. This paper describes a risk management process, an overview of risk management activities (13 steps) outlined in ISO14971, and an example of a risk management program for a Continuous Positive Airway Pressure (CPAP) medical device used to treat Obstructive Sleep Apnea (OSA).
Purpose: It can easily be understood that more rules and regulations need to be imposed on the medical device industry due to its impact on public health and hygiene. Domestic medical device ...manufacturers are thus required to comply with the requirements specified in the good manufacturing practice (GMP) system, and it is essential to abide by the international standards as well to sustain their global competitiveness. The main purpose of this study is to review the guidelines of the medical device GMP system in Korea and propose future directions for further enhancement of the GMP system.
Methods: Specific requirements prescribed in international standards, such as ISO 9001:2015, ISO 13485:2016, ISO 14971:2012, and ISO 14155:2011, are analyzed and compared with the domestic GMP system.
Results: It has been observed that the generic international standard related to quality management system, ISO 9001:2015, lays out the foundations for the development of quality management system relevant to medical device industry, ISO 13485:2003, with which the domestic GMP system is fully compatible. Further, several important aspects of risk management and clinical trials of medical devices are also recognized and included in the domestic medical device GMP system.
Conclusion: Even though specific requirements of individual ISO standards are slightly different from each other, their overall structure and framework may contribute to the development and enhancement of globally competitive GMP system of the domestic medical device industry.
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