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Design of medical equipment

Medical device design standards are crucial in to the manufacturing of medical devices. Due to the large amount of regulations in the industry, the design of medical devices presents large challenges from both manufacturing and legal perspectives. If you are developing products that shape the future of healthcare, learn how medical device design standards can improve patient outcomes and quality of life.

Safeguarding lives with standardized design

Prepare for the unpredictable with medical device design standards

Healthcare standards for safer syringes
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Healthcare standards for safer syringes

Some 16 billion injections are administered around the world every year, each one bringing with it a risk of transmitting disease. Reusing syringes increases that risk exponentially. With the global rollout of the COVID-19 vaccinations, never has the safety of injections been more critical. There are many reasons to enhance the safety of administering injections. The price and chronic shortage of medical supplies force desperate measures, which include the reuse of single-use injection equipment. Moreover, scientific studies reveal that administering injections is not only a risk for medical personnel but also for ancillary staff such as cleaners, laundry workers, or laboratory technicians. To reduce the risks of injury and disease transmission, the World Health Organization (WHO) launched in 2015 a new policy on injection safety, calling on the international community to switch to safety-engineered syringes, whenever appropriate. It issued highly detailed injection safety guidelines, which outlined several safety features for syringes that not only protect the recipient of the injections but the healthcare worker who administers them as well. WHO stressed that the transmission of infection is not just limited to developing countries as reuse of syringes occurs in many places. The adoption of safety-engineered syringes is critical to protecting people worldwide from becoming infected with HIV, hepatitis, and other diseases. This should be an urgent priority for all countries. Key Standards for Safety Engineered Syringes Published in 2015, the WHO guidelines on the use of safety-engineered syringes for intramuscular, intradermal, and subcutaneous injections in healthcare settings provide basic rules for syringes with “sharps injury protection” features. It defers to the definitions of BS EN ISO 23908 Sharps injury protection – Requirements and test methods – Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling, which provides internationally agreed minimum standards to reduce the risk of injury from sharps. This standard gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single-use, introducers for catheters, and lancets, and other needles used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection. In addition, the BS ISO 7886 series, which specifies properties and requirements for sterile single-use hypodermic syringes, also covers auto-disable syringes (BS ISO 7886-3) and syringes with reuse prevention features (BS ISO 7886-4). This makes it a highly useful tool both for the manufacturers that produce them and for users who can rest easy in the knowledge that the syringes meet minimum requirements for quality and safety. The WHO document references safety-engineered syringes according to their standardized definition to provide an exact characterization of the safety mechanism of each type of syringe and allow a common understanding between all guideline users. These standards are updated regularly to ensure they continue to meet the needs of manufacturers and users. They also take into account any new technologies that will contribute to reducing the risk of transmissible diseases. In your compliance-critical industry, ensure you are meeting the industry safety standards. A BSI Knowledge subscription gives you instant access to the resources you need to improve the safe design, manufacture, and distribution of safe syringes. Build your own custom collection of standards, or opt for access to over 4,800 documents in our GBM05 Sciences & Healthcare module and keep up-to-date with any relevant changes to your standards strategy. Request to learn more. Shaping the Future of Syringe Safety But it doesn’t stop there. BSI’s involvement in expert committees continually evolving and evaluating its work to develop standards that meet the needs of injection use in more and more settings. Whatʼs more, though developed standards were originally focused on devices for use by healthcare professionals, with the increased number of devices for self-administration, we decided to expand the work to include pen-injectors, auto-injectors, and body-worn injectors. This will lead to more efficient and convenient administration of the medicinal products, with great benefits for healthcare systems and patients. All of this bodes well for countries that have met the WHO’s 2020 deadline to transition to safety-engineered syringes. It also paves the way for achieving some of the UN’s Sustainable Development Goals while saving lives in countries where the re-use of syringes remains high. Ensure your organization’s syringes meet minimum requirements for quality and safety, by adding these standards to your collection today.Read more
How to tackle hazards in AI medical devices using BS AAMI 34971
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How to tackle hazards in AI medical devices using BS AAMI 34971

As AI becomes a more prevalent technology in medical devices it’s become clear that the associated risks need special consideration. This article charts the development history of a new, jointly produced document that answers this emerging need. Artificial intelligence (AI) has a strong role to play in healthcare and medical devices. It can improve clinical outcomes as well as efficiency and healthcare management. That said, it can also bring its own unique risks that can jeopardize patient safety or increase inefficiency. Recognizing the issues, BSI, the US Standards Development Organization and the Association for the Advancement of Medical Instrumentation (AAMI) have worked together to develop guidance on the use of AI as a medical technology. Initially we held a series of joint workshops with stakeholders in the US and UK and two whitepapers were published on the topic. One of the key outcomes from this work was a recommendation to develop “risk management guidance to assist in applying BS EN ISO 14971 to AI as a medical technology”. BS EN ISO 14971: Risk management guidance BS EN ISO 14971 is the established international standard that provides a methodology for assessing and managing the risks associated with medical devices. It’s been recognized by medical device regulators and adopted as a national standard in countries around the world. It has become the global standard used by medical device manufacturers and regulators to govern risk management – so it made sense to use it as the foundation of the new work.    It was then agreed that the new standard on applying BS EN ISO 14971 to medical technology with AI should be jointly developed and published by BSI and AAMI. A BSI drafting panel worked in conjunction with an AAMI drafting panel to agree on a common text for publication by AAMI and BSI. For simplicity purposes, BSI is publishing this joint work as a British Standard in the UK and AAMI is delivering a Technical Information Report (TIR) for the US market. The culmination of this work in the UK is the British Standard now available as BS/AAMI 34971:2023 Application of ISO 14971 to machine learning in artificial intelligence. Guide. Incidentally, the ambition all along has been for this guidance to become the basis of ISO/IEC guidance on risk management of AI as a medical technology in the future – so it’s been written with that in mind. Also it may be the first of a series of jointly developed work items by AAMI and BSI.   What’s in BS/AAMI 34971?  BS/AAMI 34971 provides guidance on applying a BS EN ISO 14971 risk management process to the evaluation of medical technology using artificial intelligence, and in particular, machine-learning. It tackles how hazards already identified in BS EN ISO 14971 could affect the safety and effectiveness of medical technology incorporating machine-learning AI. It also provides examples, suggests strategies for eliminating or mitigating the associated risk and explores additional unique or emergent hazards/hazardous situations. It’s important to state that BS/AAMI 34971 doesn’t modify the risk management process—rather it provides information and guidance to inform the application of BS EN ISO 14971 to AI/ML medical technology. What are the benefits of using BS/AAMI 34971? The benefit of using the standard is that it will help medical AI software developers and medical device manufacturers to identify the particular hazards relating to AI that need to be considered.  This will ultimately make devices more compliant and safer, plus it will help manufacturers to: enter new markets innovate more quickly develop their expertise and efficiency increase market confidence in their devices.  Ensure you are managing the AI risks in your medical devices by adding BS/AAMI 34971 to your collection today. Discover BSI Knowledge Over 100,000 internationally recognized standards are available for simple and flexible access with a BSI Knowledge subscription. Build your own custom collection of standards or opt for access to one of our pre-built modules and keep up to date with any relevant changes to your standards strategy. Request to learn more.

Key Medical Equipment Design Standards

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