Misconceptions and Countermeasures of Risk Management in Medical Device Manufacturing Enterprises
The purpose of risk management of medical devices is to control the risk of medical device products at an acceptable level, which is an important measure to ensure the safety and effectiveness of the products. The following is the misunderstanding and countermeasures of risk management of medical device manufacturing enterprises that I brought for you, welcome to read.
Risk Management Misconceptions
1.1 As long as the product meets the registration standards (now technical requirements) can meet the requirements of risk management
The production enterprises have a vague understanding of risk management, just stay in the as long as the product can meet the registration standards (now technical requirements) can, do not need to be a medical device. The company's goal is to provide the best quality products and services in the marketplace, and to provide the best quality products and services in the marketplace, and to provide the best quality products and services in the marketplace. The actual review found that the application for registration of the essence of risk management does not understand, only to meet the requirements of the product registration standards as a management program, the majority of enterprises in the product registration of the registered product risk management report is to refer to the same template or other products slightly modified from a formal document, the registered product risk management is virtually non-existent.
1.2 Risk management is only a part of product registration
Any medical device in its entire life cycle of design, research and development, clinical, manufacturing, sales, installation, use and maintenance, and even the end of the various aspects of the failure of the probability of a certain amount of risk, so risk management is always throughout the entire life cycle of medical devices. YY/T0316-2008 (equivalent to SO13485-2003) requires that in the whole product realization process, not only the risk of the design process should be taken into account, but also the risk of procurement, production process and post-production information must be included in the risk management, and ultimately risk management will be integrated into and become an integral part of the quality management system of the enterprise. The risk management system is an integral part of the quality management system of the enterprise.
The registration review found that most manufacturers believe that risk management is risk analysis, is only an important part of product registration; or only manage the risk of pre-market; some individual companies do not even know the meaning of the life cycle of medical device products. In the risk management report provided by the lack of production and production information, especially after the listing of risk control measures, the lack of risk analysis and control measures arising from the product manufacturing process, rarely in accordance with the requirements of YY/T0316 to save the risk management documents, and product quality system management is out of touch. At the same time for the implementation of a specific risk control can lead to new risk awareness is insufficient, there is a tendency to push all the remaining risks to the user. This situation is similar to the findings of Dare Lu[2] and others on risk management in manufacturing companies.
1.3 Risk management does not require full participation
The project content of risk management, such as formulating risk management plans, establishing management objectives, allocating resources, and dividing responsibilities, is very similar to that of the management of quality management systems, and also requires the participation of all employees in the enterprise. Although many companies after years of risk management practices have realized that risk management requires full participation, but in the specific practice of risk management has not been put into practice, the main performance is still by the R & D technical staff and quality management personnel to carry out "risk analysis" rather than full participation in the "risk management" [3]. Risk management" [3]. It is not known that after the design and development process of `risk analysis, risk control and verification of measures, does not indicate that the product risk has been eliminated, but need to invest more energy and time for product risk management. It should fully consider the production process, production environment, use of the environment, the target customer base and customer feedback, relevant laws and regulations, and many other aspects of the impact of the factors, and these as the risk management of continuous improvement management cycle of inputs.
Another prominent issue is that many companies lack the participation of clinical staff in the risk management team, and clinicians have the most say in the safety and effectiveness of medical devices. Medical devices are a fringe discipline involving electromechanical engineering, clinical medicine and other disciplines, and require the close cooperation of R&D engineers, clinical engineers and clinicians, that is, the so-called close integration of industry, academia and research, in order to effectively transform new technologies into new products
[4]. Foreign medical device manufacturers to hire a large number of clinicians as consultants, in the research and development will listen to the views of clinicians before, in order to ensure the safety and effectiveness of the product on the basis of continuous innovation, even more humane. The common practice of domestic enterprises is as long as which products sell well, the first copy of the registration, some individual enterprises even the principle of the product and performance are not clear, not to mention the risk management of the product.
1.4 Don't know how to carry out risk management
Many enterprises do not know how to carry out comprehensive and effective risk management activities. Although the vast majority of enterprises registered to provide risk management report basically contains risk analysis, risk evaluation, risk control, acceptable evaluation of all remaining risks, risk management report, production and post-production information and other six parts, but not many really meet the requirements of risk management activities. Such as the lack of risk management plan; the lack of risk management process documents and records; do not understand and will not use risk analysis tools; the probability of occurrence of hazards, the degree of harm and the acceptable criteria for the qualitatively inappropriate; residual risk evaluation and control is incomplete; the lack of risk control measures to implement and validate the records; the production and post-production information is not clear responsibility for the collection and collation of information, and so on. The result of risk management in many enterprises is an incomplete risk management report prepared at the time of product registration, far from meeting the risk management requirements for medical device products.
Analysis of the causes of risk management problems
2.1 Risk awareness is weak and insufficient attention
Only by establishing risk management awareness and running it through the whole process of medical device product realization can risk management of medical devices be truly effective. The first step in the process is to make sure that you are aware of the risks involved. As the main body of risk management responsibility, the production enterprises pay too much attention to the product listing and benefits, and are not willing to put too much human and material resources into preventive, not produce direct benefits of risk management activities. They even think that risk management is only a procedure for product registration, as long as they provide qualified risk management reports, they can meet the requirements of product registration. Therefore, it is inevitable that risk management reports with the same template appear, and the phenomenon of looking for someone to write risk management reports is inevitable. The deeper reason is that even if a manufacturer's product generates risks, the liability or loss incurred is acceptable. In other words, there is a low opportunity cost to the producer for registering a product that does not meet the risk management requirements or for generating risks with the product in use.
2.2 Lack of professionals and weak management skills
Medical device products involve basic sciences such as physics (acoustic, optical, electrical, magnetic), chemistry, mechanics, and materials science, and active products are a cross-cutting and integrated application of various disciplines. Risk management professionals should not only have with the manufacturing products compatible, involving production technology, electromechanical, physical, optical and computer knowledge and experience in many disciplines, but also must understand and even master the knowledge of risk management. For example, not only to understand the product's working principle, mechanism, performance parameters, intended use and use of functionality, but also to be able to apply a variety of risk analysis tools to the product in all aspects of the possible hazards and the probability of occurrence of assessment. More importantly, it is necessary to work together with R&D personnel to take control measures and verify the effectiveness of possible risks, and determine whether there are new risks, and whether it is necessary to take further control measures to reduce. Finally, a risk reassessment of the residual risk is required to determine whether the residual risk is acceptable in comparison to the benefits, based on judgment criteria.
The current university curriculum rarely involves risk management theory, so risk management professionals are in short supply, and those who understand the construction, production, and use of medical devices, as well as those who are familiar with risk management, are even more rare. Risk management professionals after training or must have the relevant product experience to be competent, which undoubtedly increases the cost of enterprise management. In addition, most of the risk management training emphasizes the theory, and the actual gap between the product, the training effect is not obvious. So most manufacturers are in the dilemma of not having enough and not being willing to invest more.
Because risk management activities are not fully involved, the relationship between the authority and responsibility of the various departments of the production enterprise is not clear. There is a lack of effective communication between R&D, purchasing, production, quality control, and sales departments on risk management, and the channel of risk management information is blocked, so we can't talk about the actual effect of risk management.
2.3 Risk responsibility is unclear, only care about the front and not the back
Many manufacturers believe that as long as the production of qualified products in line with the technical requirements of the product and provide customers with the task is completed, as for the back of the risk of responsibility for the relationship between the small and medium-sized.
Some experts pointed out that medical device manufacturers are the first responsible for product safety, the main risk management and risk minimization implementers. Manufacturers should start risk management activities from product design, and quality management throughout the entire product life cycle from conception, including product design and development, production, sales, use and elimination. The reality is that most companies do not carry out effective risk management and risk control in the pre-market design and production stages, and there is no way to talk about the ability to control residual risks through post-marketing adverse event monitoring. The National Center for Adverse Drug Reaction (NCADR) reports less than 10% of adverse events from manufacturing companies, which is due to the imperfect regulatory system for post-market medical devices, weak risk management awareness of medical institutions or users, and lack of risk management efforts, as well as a greater consideration of the product's marketability and the company's reputation.
Countermeasures to Improve Risk Management in Manufacturing Enterprises
As mentioned earlier, although there are many objective factors that contribute to the effectiveness of risk management in manufacturing enterprises, the most fundamental reason for this is that decision makers in manufacturing enterprises believe that the risk management requirements are not met either in the registration stage of the product or the opportunity cost of the risk of the product is relatively low, so that the risk management of medical device products is not a good idea.
3.1 Improve the threshold of product registration and guide enterprises to establish a correct concept of risk management
Improving the level of risk management awareness of manufacturing enterprises is the basic guarantee for the implementation of effective risk management. The first thing that needs to be changed is that the production enterprises only take risk management as the implementation of the registered product program, or even a risk management report is not the correct risk management concept. In the technical review, the organization and product-related technical experts and clinical experts, on the basis of the textual information provided by the enterprise, to understand and judge the depth of risk management of registered products and the actual effect
Results. Such as audit to provide risk management documents are complete, whether the development of risk management plan, risk analysis records, risk evaluation records, risk control records, comprehensive residual risk evaluation records, risk management reports, production and post-production information on the management of each document is complete; on the list of safety and effective requirements of the judgment is correct, the basis is accurate; risk management team members are comprehensive, whether the responsibilities are clear, can reflect the full participation of all staff; the risk management team members are comprehensive, whether the responsibilities are clear, can reflect the full participation of all staff; the risk management team is not a good idea. Can reflect the participation of all staff; risk of the hazardous process, the probability of occurrence of the level of determination of the appropriate, acceptable guidelines are appropriate for registered products; on the hazard analysis is in place, whether the list is comprehensive, whether the control measures are feasible, whether the evidence provided is effective; there is no new risk, the residual risk evaluation and treatment is appropriate, whether most of the residual risk to the user Whether to determine the production and post-production information management of the corresponding responsible departments, the degree of perfection of the system. Ask the technical personnel and quality control personnel of the enterprises participating in the review, especially the decision makers of the manufacturing enterprises whether they attach importance to the risk management of the registered products, whether the communication between the departments is smooth, whether the division of labor is clear, and the degree of close cooperation. For risk management deficiencies, recommendations and deadline for rectification, and more serious problems can not pass the review.
3.2 Strengthen the production and market supervision, urge enterprises to pay attention to the production and post-production risk management
The new version of the national "Regulations for the Supervision and Administration of Medical Devices" on the registration of the product and the order of the license of the production site has been adjusted from the necessity to apply for a production license after the registration of the product to the registration of the product can be registered and then apply for the license of the production. This is to ease the financing of small and medium-sized enterprises, focus on product development, innovation is very favorable at the same time, the complexity and difficulty of production supervision has increased. Only through the strengthening of the production process supervision and post-launch market supervision, can manufacturers not only grasp
Registered product development stage of risk management, the same production process and after-sales stage of risk management to give more attention and implementation.
Manufacturing equipment, production processes, site environments, and personnel during the production process are also sources of hazards. While these hazards can be identified during the design and development phase, it is more important to document process control procedures during the production or post-production phase. Through on-site verification at the manufacturing facility, information from production, such as failure rates, rework rates, scrap rates, and other quality data is evaluated and compared to existing risk management outputs to confirm the adequacy and completeness of risk controls.
On-site verification of the company's post-production information collection and processing system to evaluate safety-related issues in post-production information, information on similar devices, such as whether one or more acceptable levels of risk have changed, whether the initial assessment has failed, whether a re-review has been carried out at the appropriate stage, whether appropriate control measures have been taken, and whether the results of the evaluation and validation have been recorded in the Risk management documentation, etc. Examination of the enterprise adverse event monitoring, tracking of after-sale products and the collection of information on product use, whether new risks have been identified and eliminated.
Strengthen the medical device market supervision, learn from foreign medical device management experience, increase the responsibility of medical device adverse events and penalties, the formulation of medical device related laws or regulations, the medical device adverse events into the scope of the legal system management, increase the cost of violation of the medical device enterprises, in order to promote enterprises to pay attention to and implement effective risk management.
3.3 Formulate guidelines, implement training, cultivate talents, and guide enterprises to implement risk management for the whole process of registering products
A series of Guiding Principles for Technical Review of Product Registration formulated and promulgated by the State General Administration of China plays a good role in guiding the review of the registration of medical devices, and it is recommended that the management department should organize the formulation of risk management guidelines for different categories of medical devices, as well as guidelines for different categories of medical devices.
Publicity and training should be conducted according to the classification of medical devices to improve the training effect. The content can include the corresponding category of regulatory requirements and standards requirements, as well as the implementation of guidance documents, so that manufacturers and other personnel to establish the concept of whole life cycle risk management. At the same time, it provides a platform for relevant personnel to master risk management methods and exchange experiences.
The key to improving the effectiveness of risk management is to have a group of professional and technical personnel with risk management knowledge and experience. In addition to strengthening targeted risk management training for technical staff of manufacturing enterprises, a risk management program should be set up in universities of science and technology to cultivate risk management talents with basic knowledge of medical devices; establish and implement a risk management qualification system in the medical device industry to improve the threshold and treatment of practitioners, which will stimulate professional and technical personnel to engage in the risk management work actively.
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