Probe into Risk Management of Medical Device Manufacturing Enterprises

Release date: 2009-06-29

- Pay attention to the implementation of information feedback preventive measures Beijing Mengtaiyin Medical Devices Co., Ltd. Zhang Yuhua Zhang Yue
Medical risks are ubiquitous, and risk management of production companies is an important part of risk management in the pharmaceutical industry. At present, there are three main defects in the risk management of medical device manufacturing enterprises in China, namely, weak risk management awareness, low professionalism of risk management, and lack of attention to information collection after production and production. Improving the risk management level of medical device manufacturers is conducive to enhancing the competitiveness of production enterprises. Therefore, enterprises must pay attention to this, and proceed from risk management training, improve relevant organizations, implement relevant measures, and solve the problems that enterprises appear in production practice. Risk management issues.

The risk management of medical devices runs through the entire process of material selection, design, production, transportation, storage and use. Among them, as a production source that manages the “source”, it is responsible for implementing risk management for the design and manufacture of the device, and it is responsible for the factors related to the performance of the device itself when an accident occurs after the hospital is put into use. Therefore, in the management of medical devices, it is necessary for production companies to introduce risk management systems. Only when risk management is performed on medical devices, the risk is known, and according to legal and regulatory requirements, market demand, design and development cycle costs, etc., risk acceptance criteria are established, and risk is controlled manually; only risk management can be used to implement the device. The safety is judged; only the judgment of safety can determine the suitability of the device for the intended use, in order to determine whether the intended purpose of the product can be achieved, and to ensure that the safety of the device is in a controllable state.

Defects in production risk management
Medical devices always have risks throughout their life cycle. Therefore, the application of risk management theory should go through the whole process of product design and development, raw material procurement, production, installation, sales and service. The production enterprise shall, in accordance with the requirements of the “Guidelines for the Implementation of the Quality Management System for Medical Device Enterprises (Consultation Draft)”, based on the process method, formulate a quality management system suitable for the development requirements of the enterprise, form a document, resolutely implement and ensure its effectiveness. Sex. Using the risk management theory method, the production enterprise conducts risk analysis, risk assessment, risk control, acceptability evaluation of all remaining risks, completes the risk management report, and uses the post-production and post-production information to take corresponding measures in a timely manner. Important practical significance.

At present, there are mainly the following defects in the risk management of medical devices in manufacturing enterprises:

1. Risk management personnel have no awareness of full process risk management
The key to successfully avoiding the risks of the production and use of medical devices is to start risk management as soon as possible. However, in the current medical device manufacturing enterprises, the problem of formalism is widespread. Manufacturers only regard the standard as a procedure for implementing risk management, and do not pay attention to risk analysis and feedback of information after production and production, so that risk management exists in name only.

Second, the professional level of risk management personnel has not met the relevant standards
The executor of the risk management work should have the knowledge and experience appropriate to the task. Where appropriate, knowledge and experience of medical devices and their applications, as well as risk management techniques should be included, and appropriate qualification records should be maintained. However, at present, because the knowledge of risk management theory is rarely involved in the university education curriculum in our country, so that the shortage of personnel in this aspect can only select talents from relevant majors, resulting in the overall professional level of risk management personnel is not high. At the same time, because management personnel must be trained before they can be employed, it also greatly increases the cost of the enterprise.

Third, the relationship between the various departments of the production enterprise, and between the production enterprise and the hospital that implements clinical verification is not clear.
Risk management is a systematic process, and “post-production and post-production information” is an important part of the risk management system. According to this requirement, the managers of the production companies should ensure that appropriate communication processes are established within the organization and that effective communication of the effectiveness of risk management is ensured. At the same time, the design and development department, procurement department, production department, quality inspection department and sales department of the production enterprise should establish a clear responsibility system to ensure the smooth flow of information. But at present, these tasks have yet to be further strengthened. At the same time, due to the inequality of the status of production enterprises and hospitals, the hospitals generally do not provide feedback information to the production enterprises after clinical verification, which affects the formulation and improvement of enterprise risk management measures.

Measures to improve production risk management
In view of the main defects in the risk management of medical device manufacturers, the author suggests to improve from the following three aspects:

First, establish and improve organizational structure and establish risk awareness
The managers of production enterprises should pay attention to risk management from the ideological point of view and set up corresponding risk management teams within the enterprise. For example, the head of the risk management team of Beijing Montain Medical Devices Co., Ltd. is the general manager. His responsibility is to be responsible for the planning and implementation of risk management; the responsibility of the management representative is to assist the general manager in implementing risk management; The responsibility of the personnel is to estimate possible operational errors from the perspective of application; the technical department's responsibility is to determine possible design defects from a technical point of view; the responsibility of the production department is responsible for the management of the production process and the implementation of the production process; The department's duty is to determine possible manufacturing defects and precision defects from the inspection point of view; the responsibility of the supply and marketing department is to determine the possible defects in raw material manufacturing from the perspective of raw material procurement; the responsibility of the equipment department is responsible for estimating the probability of equipment failure; Responsible for the cleaning and packaging of products. Effective and sensible organizational settings reduce medical risks while reducing the incidence of accountability.

The second is to improve the professional quality of risk management personnel.
Risk managers need expertise in the following areas: the construction of medical devices, the principles of production and use of medical devices, and the risk management of medical devices. The risk management of production enterprises requires knowledge of different industries or disciplines. In addition to contributing his expertise, each risk management personnel must have basic knowledge of medical device risk management. Therefore, the education department should adjust the corresponding majors and expand the talents in risk management that are suitable for the development of the market economy. After recruiting personnel from the human resources department of the production enterprise, it shall provide training in risk management, formulate an internal assessment system, and improve the professional level of risk management personnel.

The third is to focus on risk analysis, feedback on production and post-production information, and implement risk prevention measures.
Risk management includes risk analysis, risk assessment, risk control, acceptable evaluation of all remaining risks, risk management report, production and post-production information. Risk analysis and risk assessment are essentially risk assessment. Risk control and post-production and post-production information have feedback effects on risk assessment. According to the feedback of risk information, risk assessment can be adjusted. These include:

1. Risk analysis and prevention of raw materials and production equipment used in medical device production.

Before the production of medical devices, procurement personnel and engineering and technical personnel should thoroughly understand and analyze in detail the various risk problems that may arise in raw materials and equipment. First, the production enterprise should conduct raw material procurement according to international and domestic relevant standards, and require the production unit of the purchased raw materials to have the corresponding production license, and provide the certificate of conformity and the inspection form of the third party, and meet the relevant standards. The technical department shall formulate corresponding technical documents for material procurement, and the supply and marketing department shall assess the qualified suppliers. Purchasing personnel must purchase raw materials in accordance with the requirements of procurement standards, and the inspection of incoming goods must be strictly checked. Secondly, the use of production equipment should comply with relevant national industry standards. For the production of Class III implantable medical devices, the use of the equipment must comply with the standards of YY/T0313-1998 "Packaging, Labeling, Transportation and Storage of Medical Polymer Products". At the same time, the manufacturer must clearly mark according to the standard, equipped with surgical tools that are compatible with the operation, and clearly use the precautions in the "Product Instructions for Use".

2. Risk analysis and prevention of medical devices under different environments and conditions.

The production enterprise shall store and transport the medical equipment produced according to the industry standard. The storage conditions of the product shall be within the specified relative humidity range, and the drying and ventilation shall meet the requirements; the raw material warehouse, the in-process product warehouse and the finished product warehouse shall be established. Returned products, sterilized products and unsterilized products should be stored separately to avoid contamination. When the product is transported, protective measures should be taken to prevent the product from cracking or breaking due to heavy pressure, bumping, etc., so that the product can not be used normally or the service life is shortened.

3. Risk analysis and prevention of medical devices after production and production.

Post-production and post-production information risk analysis is an important part of risk management, and medical device manufacturers should establish and maintain a relatively systematic process to obtain information about medical device products during the post-production and post-production phases. In the production stage, through the effective management of production enterprise managers, effective communication between various departments, timely prevention of possible risks. After the clinical verification of the hospital, the relevant information of the medical device should be promptly feedback. The manufacturer shall timely improve the product according to the feedback information, and re-evaluate the risks associated with the medical device. The results of the assessment shall be recorded in the risk management document. Medical institutions should also formulate relevant rules and regulations, coordinate the relationship with production enterprises, and clarify the responsibilities of both parties (production enterprises should bear responsibility for medical devices, and hospitals should bear the responsibility for medical accidents and medical errors).

Risk management is a preventive measure. Although it can not bring direct economic benefits, it can improve the standardization and scientificity of production management through risk management, thereby improving product safety, establishing its own brand and expanding market share. Finally, improve the economic benefits of production enterprises.

Related Links
Medical device risk management concept
The definition of risk was first proposed by American scholar Willett in 1901. In 1921, American economist Knight further made a clear distinction between risk and uncertainty based on Willett's risk theory. In 1964, American scholar William and Hans introduced human factors into risk analysis. In the early 1980s, Japanese scholar Wu Jingxun re-expressed the meaning of risk on the basis of absorbing the results of previous studies: risk is the change in economic loss that occurs naturally in a specific environment and in a specific period of time. In 1992, Yates and Stone further proposed three factors of risk: 1 potential loss; 2 size of loss; 3 uncertainty of potential loss. Yates and Stone's risk three-factor model essentially summarizes the basic connotation of risk and is the basic framework theory of modern risk theory.

For medical device manufacturers, the definition of risk is the possibility of harm to patients and users due to the raw materials, design, and production and application of medical devices that do not meet the standards. Risk management generally refers to management activities that minimize, at a minimum, risk loss by identifying, measuring, processing, and evaluating risks. (China Medical News)

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