{"id":4301,"date":"2026-06-26T08:16:17","date_gmt":"2026-06-26T08:16:17","guid":{"rendered":"https:\/\/www.perimed-instruments.com\/us\/?p=4301"},"modified":"2026-06-26T08:16:18","modified_gmt":"2026-06-26T08:16:18","slug":"why-medical-device-lifetime-matters-a-shared-responsibility","status":"publish","type":"post","link":"https:\/\/www.perimed-instruments.com\/us\/blog\/why-medical-device-lifetime-matters-a-shared-responsibility\/","title":{"rendered":"Why medical device lifetime matters: a shared responsibility"},"content":{"rendered":"\n
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by Sara Gyllensporre<\/mark><\/a> (Clinical<\/em> Application Specialist<\/em>)<\/p>\n\n\n\n

During a recent visit to a customer in Finland, one of the hospital’s vascular specialists spoke to me about the increasing regulatory scrutiny surrounding the medical devices used in clinical decision-making, specifically the need to ensure that equipment remains within its supported lifecycle.<\/p>\n\n\n\n

Several factors are driving this trend. While patient safety is and has always been the top priority for healthcare providers, manufacturers, and regulatory bodies, many modern medical devices are significantly more technically complex than their predecessors. Regulatory frameworks such as the EU Medical Device Regulation (MDR) have evolved in parallel, reinforcing a lifecycle-focused approach that enables ongoing improvement, transparency, and sustained patient safety.<\/p>\n\n\n\n

In this post, I examine the unique challenges of medical devices and the shared responsibilities of manufacturers and healthcare providers in ensuring compliance and patient safety through effective lifecycle management.<\/p>\n<\/div>\n\n\n\n

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The Medical Device Regulation (MDR) (EU) 2017\/745, Annex I<\/mark>,<\/a> General Safety and Performance Requirements,
GSPR 6, states:<\/p>\n\n\n

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The characteristics and performance of a device shall not be adversely affected to such a degree that the health or safety of the patient or the user and, where applicable, of other persons are compromised during the lifetime of the device, as indicated by the manufacturer<\/strong>, when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained in accordance with the manufacturer’s instructions.<\/em><\/p>\n<\/div>\n\n\n\n

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The shared responsibility<\/h3>\n <\/div>\n\n\n\n
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To demonstrate compliance with MDR and similar international standards governing the use of medical devices in clinical settings, manufacturers are required to specify the intended lifetime of the devices they place on the market.<\/p>\n\n\n\n

For manufacturers like Perimed, this is not an arbitrary decision. To be commercially viable, a medical device needs to remain clinically useful for as long as possible. To uphold patient safety and information security, manufacturers must ensure the availability of spare parts, provide service and maintenance, deliver user training, and, where applicable, release software updates, hardware upgrades, and cybersecurity protections \u2014 throughout the device\u2019s intended lifetime<\/p>\n\n\n\n

Compliance, however, ultimately rests with the healthcare provider. In practice, this responsibility usually falls to the biomedical engineering department, which must ensure that the installed base of medical devices is regularly assessed and maintained, and either replaced or decommissioned when it reaches end-of-life.<\/p>\n\n\n\n

Many hospitals rely on dedicated asset management systems to track the hundreds or even thousands of devices under their care, together with associated software licenses, support agreements, and maintenance schedules. However, these systems are only as effective as the information in them. Ultimately, effective lifecycle management depends on accurate and up-to-date information flowing from the manufacturer into the hospital’s asset management processes.<\/p>\n<\/div>\n\n\n <\/div>\n <\/section>\n\n\n

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PeriFlux 6000 \u2014 one system, multiple lifetimes<\/h3>\n <\/div>\n\n\n
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Like many modern medical devices, PeriFlux 6000 is an integrated system comprising multiple technologies and components. It includes a range of hardware and software elements, each with its own defined lifetime and support requirements. <\/p>\n\n\n\n

A typical installation consists of a PeriFlux 6000 main unit, an all-in-one medical-grade computer, sensors and accessories, firmware, our proprietary PSW ExM software, and the underlying Microsoft Windows operating system.<\/p>\n\n\n\n

A PeriFlux 6000 main unit has an expected lifetime of ten years. If you\u2019ve opted for the recommended medical-grade computer, it is subject to the manufacturer’s lifetime warranty \u2014 typically at least 5 years. But these computers are, in turn, subject to multiple deadlines, such as battery lifetime, which is also a function of usage. Laser Doppler probes have an expected lifetime of three years, while TcpO2 electrodes should be replaced after eighteen months. In addition, we release new software features and enhancements at least every two years, and Microsoft Windows needs to follow approved software updates. You can read more about why that\u2019s crucial for healthcare services in this post: Why upgrading to Windows 11 is crucial<\/mark>. <\/a>\u00a0<\/p>\n<\/div>\n\n\n <\/div>\n <\/section>\n\n\n

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Managing a medical device system, therefore, means managing multiple overlapping lifecycles rather than a single expiry date.<\/strong><\/p>\n\n\n\n

Why is this the case? Why don’t manufacturers design systems with a single, uniform lifetime?<\/strong><\/p>\n\n\n\n

The simple answer is that components age in different ways and are subject to varying technological, regulatory, and clinical requirements. As manufacturers, we want to provide systems that remain clinically useful for as long as possible. At the same time, we know that electronic components become obsolete, operating systems evolve, cybersecurity requirements change, and materials and measurement technologies continue to advance.<\/p>\n\n\n\n

Our task is to maintain measurement confidence and patient safety in a constantly changing technical and regulatory environment. For that reason, we design the central instrument for longevity. The core system is intended to remain in service for many years, while peripheral components such as probes, electrodes, and pressure cuffs are managed according to their own lifecycles. These components are exposed to wear, repeated use, sterilization processes, and, in some cases, direct patient contact, all of which influence how long they can be supported and relied upon.<\/p>\n<\/div>\n\n\n <\/div>\n <\/section>\n\n\n

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Measurement confidence<\/h3>\n <\/div>\n\n\n\n
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Laser Doppler probes and TcpO2 electrodes rely on precision-engineered electronic components to deliver accurate measurements. Even with careful handling, these components may, over time, undergo subtle yet critical changes due to factors such as material fatigue, microscopic contamination, and mechanical wear. Optical fibers can experience signal attenuation, coatings may degrade, and sensor alignment may shift at a microscopic level \u2014 all of which can reduce signal quality and introduce measurement drift.<\/p>\n<\/div>\n<\/div>\n\n\n\n

Prolonged exposure to biological fluids, sterilization processes, and certain environmental conditions can further contribute to wear that is often invisible but can directly impact performance. To ensure continued accuracy, reproducibility, and compliance, probes and electrodes should be replaced when they reach end-of-life. Worn components can lead to unreliable data, misinterpretation, and ultimately compromised clinical decisions. Correct replacement is therefore essential to maintain high-quality diagnostics.<\/p>\n\n\n

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We also recommend routine inspection of cuffs to identify signs of wear such as fraying, air leakage, or loss of elasticity. Any visible damage or compromised functionality should be treated as an indication for replacement, even if the cuff has not reached its expected end of life. Usage frequency and maintenance practices will influence overall wear and service life. You can check for leakage using PeriFlux 6000. During the deflation phase of a measurement, the pressure curve will drop nonlinearly.<\/p>\n<\/div>\n\n\n\n

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From local practice to regulatory focus<\/h3>\n <\/div>\n\n\n
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The conversation I had with my customer in Finland was not an isolated one; it reflects a broader shift taking place across healthcare. As regulations evolve, providers must demonstrate traceability, maintenance history, and ongoing measurement reliability; the age and support status of medical devices are becoming directly linked to clinical defensibility.<\/p>\n\n\n\n

This is also where manufacturers play a more active role than simply defining product lifetimes. For example, we recently adopted Microsoft Windows 11 IoT Enterprise LTSC 2024 for the computers supplied with our instruments. Unlike standard editions of Windows, the Long-Term Servicing Channel (LTSC) is designed for regulated environments where stability and extended support are essential. Microsoft provides security updates for ten years, making it well-suited to medical devices with long operational lifecycles.<\/p>\n\n\n\n

At Perimed, we support our customers in navigating these lifecycle challenges by providing clear end-of-life information, proactively communicating software and hardware support timelines, and helping biomedical engineering teams identify when components are approaching or have reached end-of-life. This enables hospitals to plan replacements and upgrades in a structured manner, rather than responding reactively when problems arise.<\/p>\n\n\n\n

Medical-device lifecycle management is ultimately a shared responsibility. By working together, manufacturers and healthcare providers can ensure that the equipment used in clinical decision-making remains safe, reliable, and fully supported throughout its intended lifetime.<\/p>\n\n\n <\/div>\n <\/section>\n\n\n

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If you would like to learn more about the support and lifecycle services available for your Perimed system, please contact us<\/mark><\/a> through our website.<\/p>\n\n\n

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Sara Gyllensporre<\/mark><\/a><\/p>\n\n\n\n

Clinical Application Specialist<\/p>\n\n\n\n

With over 16 years at Perimed, Sara has held multiple roles and developed a broad understanding of medtech and its application in healthcare settings. She holds a degree in pharmacology and an MSc in molecular biology and plays a vital role ensuring technology meets the needs of clinical practice, supported by strong relationships with clinicians across Europe.<\/p>\n<\/div>\n\n\n\n

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Disclaimer<\/strong>
The views expressed in this blog post are those of the author and do not necessarily represent the official position of Perimed. The content is provided for informational purposes only and is not intended to constitute clinical claims or medical advice. Clinical decisions should always be based on professional judgment and applicable clinical guidelines.<\/p>\n","protected":false},"excerpt":{"rendered":"

by Sara Gyllensporre (Clinical Application Specialist) During a recent visit to a customer in Finland, one of the hospital’s vascular specialists spoke to me about the increasing regulatory scrutiny surrounding the medical devices used in clinical decision-making, specifically the need to ensure that equipment remains within its supported lifecycle. Several factors are driving this trend. … Continued<\/a><\/p>\n","protected":false},"author":2,"featured_media":4065,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"_FSMCFIC_featured_image_caption":"","_FSMCFIC_featured_image_nocaption":"","_FSMCFIC_featured_image_hide":"","footnotes":""},"categories":[38],"tags":[],"class_list":["post-4301","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog-post"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.perimed-instruments.com\/us\/wp-json\/wp\/v2\/posts\/4301","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.perimed-instruments.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.perimed-instruments.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.perimed-instruments.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.perimed-instruments.com\/us\/wp-json\/wp\/v2\/comments?post=4301"}],"version-history":[{"count":2,"href":"https:\/\/www.perimed-instruments.com\/us\/wp-json\/wp\/v2\/posts\/4301\/revisions"}],"predecessor-version":[{"id":4305,"href":"https:\/\/www.perimed-instruments.com\/us\/wp-json\/wp\/v2\/posts\/4301\/revisions\/4305"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.perimed-instruments.com\/us\/wp-json\/wp\/v2\/media\/4065"}],"wp:attachment":[{"href":"https:\/\/www.perimed-instruments.com\/us\/wp-json\/wp\/v2\/media?parent=4301"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.perimed-instruments.com\/us\/wp-json\/wp\/v2\/categories?post=4301"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.perimed-instruments.com\/us\/wp-json\/wp\/v2\/tags?post=4301"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}