Medical devices supply chain management

Demonstrating resilience in the medical device supply chain

Learn how standards support medical device supply chain processes

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How to manage risk in medical device manufacturing

Risk management standards are an important aspect of the development of medical devices. Patients are already in a vulnerable position and, during diagnosis and treatment, they should be protected from risks that could further impact their health. International medical device manufacturing standard BS EN ISO 14971 was developed to provide a process to assist manufacturers in identifying the hazards associated with medical devices, assessing the corresponding risks, controlling these risks where needed, and monitoring the effectiveness of the risk control measures. The third edition of this standard was published in December 2019, followed in June 2020 by the updated companion report PD CEN ISO/TR 24971, which provides extensive guidance on the application of the standard. A transitional period of 3 years following publication is usual to allow all stakeholders to adapt to the requirements in the new edition. Risk Management Regulations for Medical Device Manufacturers Performing risk management became an essential requirement for medical device manufacturers in order to comply with industry regulations. The risk management requirements only covered risk analysis and were expressed in general, not very specific terms. Risks needed to be reduced as far as possible while taking account of the generally acknowledged state of the art and maintaining a high level of protection of health and safety. Similar requirements can be found in the regulations of other countries. The risk management process described by standard BS EN ISO 14971 consists of several steps which apply to the design, development, and production of every medical device. It is important to recognize that these steps need to be documented in procedures in the manufacturer’s organization. The procedures for risk management can be embedded in a quality management system, but this is not required by BS EN ISO 14971. The reason is that regulations in some countries do not oblige manufacturers of low-risk medical devices to implement a quality management system. However, if a manufacturer has implemented a quality management system, such as BS EN ISO 13485 it is recommended to integrate the risk management procedures into that system. In this context, it is emphasized that the European MDR and IVDR require the manufacturer to implement a quality management system that addresses risk management. To read more about quality management systems for medical devices, click here. What is Medical Device Standard BS EN ISO 14971? Recognized by regulatory authorities in the US, Canada, Europe, and more, international standard BS EN ISO 14971 helps medical device manufacturers establish, document, and maintain a systematic risk management process across all phases of the lifecycle of a medical device. The process described will help medical device manufacturers: Identify the hazards associated with the medical device Estimate and evaluate the associated risks Control these risks Monitor the effectiveness of the controls The risk management standard’s requirements apply to all phases of the life cycle of a medical device. The process described applies to risks associated with a medical device, such as those related to biocompatibility, data and systems security, electricity, moving parts, radiation, and usability. It can also be applied to products that are not necessarily medical devices in some jurisdictions and can also be used by others involved in the medical device lifecycle. The use of the risk management standard helps streamline the regulatory processes that enable entry to selected markets. It is used by all parts of the medical device industry, and by organizations dealing with the design, development, production, installation, or servicing of medical equipment, devices, and technology. There is no doubt that using standards can help you to manage risk in the manufacturing of your medical devices, building crucial trust between you and the rest of your supply chain. With a BSI Knowledge subscription, quality, risk management, and compliance are at your fingertips. Build your own custom collection of standards, or opt for access to our GBM05 Sciences & Health Care module for instant access to over 4,800 documents. Request to learn more. Ensure your organization is complying with regulations and managing medical device risks effectively by adding standard BS EN ISO 14971 to your collection today.

Revised standard goes to the heart of medical device manufacturing differences

Standards must apply across several different situations. That is in their very nature. Manufacturing provides real challenges, particularly in niche applications involving highly specialized manufacturing processes. The question is often how to continue to adjust a standard to make sure that it continues to work effectively, whilst minimizing disruption to those processes. Preferably without requiring unnecessary new work to make sure that the manufacturer remains compliant. This third edition of the standard for sterilizing medical devices like biological heart valves (BS EN 14160 Liquid chemical sterilization of health care products) is a good example of fine-tuning a standard to do exactly that. Valves, Clots, and Sterilization The story of this standard goes back to the early 1990s when it began to be used for a very small range of medical devices that include a small part of animal origin, of which an example is biological heart valves. Today, if a heart valve needs to be replaced, surgeons will choose between one of the latest versions of biological valves, which incorporate animal materials, or a mechanical heart valve made from man-made materials. The former behaves more like a natural human valve normally would, but they may not last if a mechanical valve is made of metal and pyrolytic carbon. Another important characteristic of a mechanical heart valve is that blood clots can form on them. If these are released into the bloodstream, they could have an adverse effect on the patient. Before implantation, heart valves need to be sterile. Medical devices are most sterilized with processes using ethylene oxide, radiation, or moist heat during manufacturing. However, these treatments affected the performance characteristics of the animal tissue used in a biological valve. A different sterilization procedure was required. This alternative process – outlined in the current standard, BS EN 14160, now in its third edition – involves immersing the product into a liquid that contains chemical agents which ensure the microorganisms living on it are inactivated. This process turns non-sterile single-use products into sterile ones. To learn about how standards support the sterilization of other medical devices, click here. Accommodating the Little Differences There are only approximately ten manufacturers worldwide who make these products, often in small batch sizes of between ten and 50. Niche manufacturing indeed. For each of them, it entails a small, manual process, as opposed to the kinds of big industrial operations that might be used for manufacturing syringes, for instance, where billions of units are sterilized every year. Usually, there is clear guidance regarding the required conditions to use during a sterilization process. For biological heart valves, however, the manufacturer chooses the agent or combination of agents that it needs, based on its own products. Each manufacturer uses a slightly different sterilization process for these single-use devices, such as employing a different combination of chemicals, for example. Different Processes, Shared Solution Clearly, the issue is that the process used by one manufacturer may not be universally applicable to a different manufacturer’s products. This standard was established to ensure that a universal, common method could be followed to show that the sterilization process is effective, by pioneering the common features of the action for killing microorganisms. It considers the combined scientific knowledge of how microorganisms are killed and then shortcuts that process for all manufacturers. Now, no matter which bespoke, single-use medical device sterilization method is used – or which combination of chemical agents is employed – during this niche manufacturing process, the outcome across the industry is the same. With BS EN 14160, one standard really does fit all. Add standard BS EN 14160 to your collection today. Discover BSI Knowledge Subscriptions In your quality-critical industry, our tailored BSI Knowledge subscription service puts the control in your hands, with traceability to monitor and demonstrate your business's access to standards. Build your own custom collection of standards, or opt for access to our GBM05 Sciences & Health Care module and keep up-to-date with any relevant changes to your standards strategy. Request to learn more.

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