Abstract
Risk management is a requirement that must be met by medical devices manufacturers; therefore, as established by the ISO 14971, a methodology to properly manage design, production and post-production risks was introduced at ICID. So, a team of experts conducted a preliminary diagnosis and proposed a schematic representation associated with the risk management process. Finally, a risk management procedure was implemented in January 2012. The procedure implementation allowed the identification, estimation and evaluation of the risks in the whole life cycle of products. It facilitated the analysis of the data related to the classification of the hazards, its effects and possible causes to determine which risks are unacceptable, and to propose necessary corrective and preventive actions to reduce the impact of these on the safety and efficacy of medical devices. The result in the application of a defibrillator validated the proposed methodology, identified 88 hazards, 32 of them unacceptable, which was proposed control measures and risk prior to introduction to the production were evaluated, becoming acceptable risks .
Keywords— risk management, risks, hazards, medical devices, safety
I. INTRODUCTION
ICID, a Digital Medical Technology Company, has worked for more than 30 years in the design, production and post- production of medical devices. Its portfolio includes devices for monitoring critical patient"s vital signs, as well as others mainly intended for cardiology [1]. Figure 1 show some medical devices developed at ICID.
Fig. 1: ICID"s Portfolio
The evaluation and validation of the design, production and post -production of medical devices regarding compliance with regulatory requirements of safety is mandatory for all manufacturers [2][3]. The adoption of a quality management system according to the international standard ISO 13485 [4] throughout the life cycle of the medical device ensures product safety. The above standard incorporates the risk management process in clause 7.1.The ISO 14971 [5] standard requires manufacturers to establish a process of risk management to medical devices. The manufacturer shall establish, document and maintain throughout the life cycle of the product, a process for identifying hazards associated with the medical device, estimate and evaluate the associated risks and ensure the effectiveness of its control. This process includes: the analysis, evaluation, and control of the risks, risk management report and the production and post-production information [4-6].
This paper presents both the experiences and the obtained results in the implementation of the risk management process at ICID.
II. MATERIALS AND METHODS
The first step for the implementation of the process of risk management was the creation of a commission integrated by experts with the necessary expertise in the design, production and post production of medical devices, and specialists with knowledge in systems of quality assurance and risk management techniques [6-8]. The created commission worked during several months using team work and brainstorming.
The group of experts carried out a diagnosis of the operation of the ISO 9001quality system [8] implanted at ICID to determine the common aspects to retain when establishing a new quality system based on the ISO 13485 standard. The group pointed out the strategies for the implementation of the risk management system during the cycle of life of the medical device, based on the analysis of the strengths, weaknesses, opportunities and threats, and also doing brainstorming sessions.
General, individual and collateral standards for safety of medical devices (eg IEC 60601-1) and standards related to techniques for risk management (eg, IEC 60812 and IEC 61025) were reviewed [9-12].
The elements of the process were defined: Plan risk management, analysis; evaluation and control of risks, the risk management report and the production and post- production information.
Finally, the commission elaborated a procedure considering the elements of ISO 14971 and PDCA cycle Deming (Plan-Do-Check-Act) [8].
In the presentation and discussion of the procedure for its approval for the top management were used brainstorming sessions and the innovation cycle.
To implement the procedure were used courses, seminars, case studies, techniques for the decision making, histograms and pie chart.
In the assessment of the efficacy of the process were used flow charts and the data collection sheet.
III. RESULTS AND DISCUSSIONS
As a result of the diagnosis the following weaknesses, strengths, opportunities and threats were identified:
Strengths: to have a multidisciplinary group of researchers, producers, technicians, buying specialists, marketing experts and specialists in quality assurance, the existence of system quality assurance based on ISO 9001:2008, and to have a failure database in production and post-production. Weaknesses: deficient risk management training of the production and post-production personnel, and inadequate information to ensure a productive process.
Opportunities: necessity to expand the export market of medical devices under a quality system based on ISO 13485 and CE marking.
Threats: the absence in Cuba of certification bodies or experienced consulting organization in quality systems ISO 13485.
The commission proposed a schematic representation of the risk management process (figure 2), taking into account all the stages in the life of a medical device from the initial conception to decommissioning and disposal. The procedure includes:
Responsibilities in the Risk Management Process: General Manager, Director of Research and Development, Project Managers, Technologists of medical devices and Risk Manager.
Risk Management Plan: Includes the scope of activities planned of the risk management process, the identification and description of medical devices and life cycle stages for which each element of the plan applies; the allocation of responsibilities and authorities; the requirements for the review of risk management activities; the criteria for risk acceptability and verification activities.
Risk Analysis: It describes and identifies the products, features related to the safety of medical devices, according to general safety standards (IEC 60601-1) and regulatory documents (CECMED), also it identifies individuals and organizations involved in risk analysis and the scope and date of analysis. Hazards are identified during the life cycle of medical devices.
Estimation of the Risk: Matrix qualitative risk (5x 5) into Research-Development and determining the Number of Risk Priority (RPN), using the criteria of probability, severity and detectability on a scale of 1 to 5 in Production and Post- Production.
Risk Evaluation: For each hazard identified the manufacturer decides whether the estimated risk is not sufficient to implement control measures to reduce them. Research- Development indicated in the risk matrix and Production and Postproduction compares the RPN calculated with the manufacturer.
Risk Control: Control measures are applied to reduce unacceptable risks. Also, in this phase it is checked whether the measures taken have been effective or not and new risks are identified if entered as a result of taken actions.
Residual Risk Evaluation: After applying the control measures, the residual risk is evaluated. If the risk of a medical device is greater than the manufacturer"s criteria for acceptable risk, it is necessary to apply additional measures and to evaluate the risk benefit for all the interested parts.
Risk Management Report: It provides evidence that the manufacturer has ensured that the risk management plan has been implemented appropriately, it is declared the methods to obtain the production and post-production information, including the training required by all the interested parts. Production and Post-production Information: Production and post-production data, from various sources, such as users, service personnel, training personnel, incident reports of adverse events, complaints and claims from customers are collected.
Risk Management File: Each process is controlled and saved in a file to show evidence of traceability of the process of risk management throughout the life of the medical device. The file contains the risk management plan, analysis, evaluation and control of risks, the risk management report and the production and post-production information.
The procedure was implemented gradually in all products. Table 1 shows the hazard identification for a class IIb medical device (defibrillator) in Research Development.
Table 2 presents the hazard identification defibrillator manufacturing process.
Production and Post-production information is an element to evaluate the impact of the risk management process, keeping in mind the description of the presented hazards, the probability of occurrence of them and the harm that it causes for the security of all parts. This information is the input for the process to control and reduce to acceptable levels the unacceptable risks. Insufficient control of the manufacturing process compromises safety requirements of medical devices. The preparation of production information, whenever a lot is done, identifies the most vulnerable steps of the production process and control actions needed to reduce unacceptable risks. Figure 3 shows the behavior of the hazards in the production of defibrillator.
Fig. 2: A schematic representation of the risk management process
Fig.3: Hazards in the defibrillator production
Post-production information is another source of data to identify, evaluate and control risks. Figure 4 shows the behavior of the hazards in the defibrillator after finishing the first post-production information.
Studies on the behavior of the hazards and the percentage of unacceptable risks have been conducted on the ICID products. The calculation of the risk index allowed comparing the results obtained in the production and post-production of the medical device (1):
(1)
rna: unacceptable risks pi: identified hazards IGR: risk index
Figure 5 shows the behavior of the risk index for the defibrillator.
Fig.4: Hazards in the defibrillator post-production
Fig.5: Behavior of the risk index for the defibrillator.
In the first lot of production and in the first post-production information for the defibrillator, risk indexes are equal and greater than those established by the ICID, so measures were taken to reduce the risk at a reasonable cost without affecting the safety of the medical device. Each improvement activity includes an analysis of the technical feasibility and economic evaluation that allows evaluating the medical device"s risk- benefit for all interested parts.
The causes of hazards situations in the defibrillator were reviewed to reduce the risks. Figure 4 shows that a large percentage of the risks are associated to the use of the medical device. The user and technical service manual were reviewed and modified to ease their use by the service personnel, as well as by the medical and paramedical personnel operating the device in health units. Training was provided to operators to improve their performance or ability to detect errors.
The impact assessment on the implementation of the risk management process during the life cycle is carried out by analyzing the trend of the residual index after applying and implementing control measures. Note that after controlling unacceptable risks at the end of the third post-production information, the risk index is reduced to 2%, applying additional measures with regard to the training of the personnel operating the medical device.
In the initial evaluation in the defibrillator, 88 hazards were identified, 56 acceptable and 32 unacceptable risks were estimated. The highest incidence of unacceptable risks was errors in the use, operation and design. Figure 6 shows the risk evaluation. All measures to control the risk or minimize the incidence of unacceptable risks focused on the use of standards for the design of medical equipment, the location of warnings or signals about the product and / or manual and preparation manuals for the operation of medical equipment in a clear and concise understanding for service personnel who install and repair the equipment, as well as for medical and paramedical personnel who operate the equipment in the health unit. Figure 7 shows that after implementing control measures the risks unacceptable became acceptable.
Fig.6: Risk evaluation in the defibrillator
Fig.7: Residual risk in the defibrillator
IV CONCLUSIONES
A risk management process for medical devices was implanted at ICID. The developed procedure was incorporated to the quality system ISO 13485, as an obligatory requisite that all manufactures must comply throughout the medical device"s life cycle.
The identification, estimation and control of risks in research and development, production and post-production enable monitoring of the risk index to assess the effectiveness of the processes according to the criteria set out in the risk management plan for the manufacturer the medical device.
The hazards data and their estimation in Production and Post-production allow the evaluation and control of the unacceptable risks. The application of well-timed improvement actions guarantees the security and effectiveness of the medical device.
The procedure application experience resulted in an improvement in the quality and safety of medical devices
We have identified a number of hazards in the defibrillator and was controlled non-acceptable risks at the stage of Research and Development. The monitoring in the process of Production and Postproduction identified new sources of unacceptable risks, which were monitored in real time, taking more secure medical device.
CONFLICT OF INTEREST
"The authors declare that they have no conflict of interest".
REFERENCES
1. http://www.combiomed.sld.cu/html/perfil.htm Portfolio of medical device.
2. CECMED. State Center for the Quality Control of Medicaments, Equipment and Medical Devices
3. http://www.ghtf.org. Global Harmonization Task Force.
4. ISO 13485:2003. Medical devices. Quality.management Systems. Requirements for regulatory purpose.
5. ISO 14971:2012. Medical devices. Application of risk management to medical devices.
6. ISO 31000:2009. Risk management. Principles and guidelines.
7. IEC ISO 31010, Ed 1.0: 2009 Risk management .Risk assessment techniques.
8. ISO 9001:2008. Quality.management .General requirements
9. IEC 60812: 2006. Analysis and techniques for system reliability. Procedure for failure mode and effects analysis
10. ISO Guide 73:2009. Risk management. Vocabulary.
11. IEC 61025: 2006.Fault tree analysis
12. IEC 60601-1:2012. Medical electrical equipment. Part 1: General requirements for basic safety and essential performance.
Autor:
Tamara Rodriguez-Parra Rivas1
Evelia Medina Martínez1
Arlem Fernández Sigler1
Jorge A. Rodriguez Rubio1
Leonor Calaña Fuentes2
José Folgueras Méndez2
Teresa González García2
Ing. Jorge Luis Espinosa Portieles2
1,2ICID / Miembro SCBI, Habana, Cuba