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Traceability refers to the ability to track the lineage of information, requirements, and design elements throughout the software development lifecycle and often involves keeping records of the relationships between various artifacts, such as user stories, requirements, design documents, code, test cases, and more.
Traceability verifies compliance, facilitates collaboration, and improves change management and testing, but in the world of validated medical devices, traceability demands even greater attention to detail to ensure patient health and safety.
Attention to detail
Traceability in medical devices is unique compared to other software. Industry regulations, complex systems, importance of patient safety, post-market surveillance, and long product life cycles are all characteristics providing a total, end-to-end view of the software’s life cycle and performance throughout development and real-world environments.
- Industry Regulations: Medical devices are subject to regulations, such as the FDA's Quality System Regulation (QSR) and the European Union's Medical Device Regulation (MDR), which require traceability to be maintained throughout the product lifecycle to ensure patient safety.
- Complex Systems: Medical devices often have complex systems and interdependencies, making traceability more challenging. For example, a change to one component of the device may have unexpected consequences for other parts of the system, and traceability can help ensure that all of these relationships are accounted for.
- Importance of Patient Safety: The primary focus of medical device traceability is patient safety, making it critical to ensure that all artifacts, including requirements, design documents, code, test cases, and more, are properly linked and accounted for.
- Postmarket Surveillance: Medical device traceability is not only important during the development phase, but also after the product is on the market. Traceability helps in postmarket surveillance by providing a clear understanding of the relationships between different components of the device, which can be critical in the event of a recall or other safety issue.
- Long Product Life Cycles: Medical devices often have long product life cycles, which means that traceability must be maintained throughout the entire life of the product. This can be challenging, especially as technology and regulations change over time.
Medical device companies must invest in tools and processes that support traceability to ensure patient safety and compliance with regulations. Traceability is a critical aspect of the development of software as a medical device, and maintaining clear documents throughout the product life cycle ensures that the device meets regulatory requirements and promotes patient safety.
Effective tools and processes
Best practices, such as implementing a robust and comprehensive documentation process, using tools to manage and track relationships between artifacts, and regularly reviewing and updating traceability information, can help organizations avoid missed requirements, oversights, and other issues that can impact product quality and safety.
Tools like Ketryx, a total product lifecycle management system that documents every step of development, provides a centralized repository for all product information, which eases the burden of traceability on developers and quality assurance staff. By investing in traceability, organizations can increase the likelihood of their products reaching the market, lessen the chances of a dangerous or expensive recall, and remove the burden of manually tracing and filing data throughout the life cycle.
Consequences of bad traceability
Traceability in medical device software is a necessity for long-term patient and business protection. It's a smart choice for any company looking to protect their bottom line and ensure that their products are safe and reliable. By putting in the effort to track every step of the development process, you can avoid recalls, build trust with customers, and sleep better at night knowing that you're doing everything you can to keep patients safe.
Recalls of medical devices can have serious consequences for both patients and the organizations responsible for producing them. In 2020, BD recalled the CareFusion infusion pump due to software errors, leading to an immediate, high-impact health risk for patients due to improper distribution of medication.
Damage to patient health is the worst consequence of software errors, but the consequences of recalls in the medical device industry do not stop there. For companies considering how to save money when handling software regulations, here is a list of major concerns to consider before skipping more reliable and risk-based tools for traceability:
- Patient harm: The most serious consequence of a recall is that it can put patients at risk. Medical devices are used to diagnose, treat, or monitor health conditions, and a recall can disrupt treatment and lead to harm or even death.
- Financial losses: Recalls can be very expensive for companies, as they have to pay for the cost of recalling the devices and also compensate affected customers.
- Damage to reputation: A recall can seriously damage a company's reputation, causing a loss of customer trust and negatively impacting their brand.
- Regulatory penalties: In some cases, regulatory bodies may impose penalties on companies that recall their medical devices. These penalties can be substantial and can add to the financial losses associated with the recall.
- Loss of market share: Companies that have recalled their medical devices may also lose market share to their competitors, which can have long-term effects on their financial performance.
It is crucial for medical device organizations to take every step necessary to avoid recalls and ensure the safety of their products. This includes implementing effective traceability practices to minimize the risk of recalls and to mitigate their impact if they do occur. At the end of the day, patient safety is the primary focus on software as a medical device. When the patient is prioritized, attention to detail will be too.
