Risk assessments for medical devices are important because using any medical device brings with it an element of risk at the clinical level.
Risks associated with medical devices can cause damage to patients as well as medical staff. Other associated risks may be to the environment or even with collected data crucial for patient diagnosis and care.
Risks for medical devices are set out in ISO 14971, an important standard that points out that it’s incumbent upon the purchaser or distributor to assess a new supplier of medical devices for the relative risk to patients and users posed by these devices.
Risk assessment tools such as FMEA and FTA are commonly used to help evaluate critical factors that relate to both the medical device and its usage.
Design and manufacture of medical devices are two of those critical factors.
The medical device risk management assessment should determine if the hazards are caused by the omission or commission of the new device. Where quality by design principles are not in place, a medical device can present a hazard in the following cases:
- If it is poorly manufactured
- If inadequate attention is paid to the design elements influencing its performance
- The medical device does something that can cause harm
- It fails to provide its intended benefit
Experts in this area point out that the purchaser should perform visual and functional inspections as per the product specification form to ensure that this factor has been adequately addressed.
A related measure is to assess the certificate of compliance (which should be provided with each lot). This acts as a statement that the product has been manufactured in compliance with applicable cGMP requirements.
Want to learn more? Tonex offers FMEA, FTA and Risk Assessment for Medical Devices, a 2-day course designed for software and hardware engineers, quality assurance, testers, managers, and employees with little or no FMEA experience. The course is also useful for those who have experience with FMEA but have never had any formal training.
Participants learn how to use risk assessment methods, Failure Mode and Effects (FMEA) and Fault Tree Analysis (FTA) Analysis, widespread methods in root cause failure analysis, reliability, safety, risk assessment and quality management. Also learn how FMEA and FTA are used by medical device manufacturers to prevent medical devices and product errors and failures and thus, increase product safety.
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