Medical Device Lifetime
The medical device lifetime refers to the duration for which a medical device is intended to be used or remains functional. This duration is typically determined by factors such as the design, materials used, engineering specifications, and the expected wear and tear of the device during normal use.
End of Life: The medical device lifetime ends when the device is no longer considered safe or effective for its intended use. This can be due to factors like degradation of materials, loss of calibration, or wear and tear that affects its performance.
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Medical Device Lifetime MDR and IVDR Requirements
Annexe I GSPR 6 of MDR and IVDR states that the characteristics and performance of a device should not be adversely affected to such an extent that during the medical device lifetime of the health or safety of the patient or user and, where applicable, of other persons is compromised, as indicated by the manufacturer when the device is subjected to the stresses which can occur during normal conditions of use and has been properly maintained by the manufacturer’s instructions.
As per Article 18 of the MDR, it is a requirement that the manufacturer of an implantable device should provide together with the implantable device is any information on the expected lifetime of the device
Annex I GSPR 18.2 of the IVDR states that devices should be sufficiently stable under the foreseen operating conditions. They should be appropriate to withstand stresses inherent in the foreseen working environment and to retain this resistance during the devices’ expected lifetime, subject to any inspection and maintenance requirements as indicated by the manufacturer.
Annexe I GSPR 9.2 of the IVDR states that the performance characteristics of the device should be maintained during the lifetime of the device as indicated by the manufacturer.
Factors Affecting Medical Device Lifetime
The medical device lifetime can vary depending on several factors, they are, type of device, constructional materials used, packing methods and technology. Here are some general considerations:
Disposable Devices: Some medical devices are designed for single use and are disposed of after a single patient encounter. Examples include syringes, catheters, and certain surgical instruments.
Reusable Devices: Other medical devices are designed for multiple uses after proper cleaning and re-sterilization. The lifespan of these devices can depend on the materials used in their construction, the frequency of use, and the effectiveness of the cleaning and sterilization processes.
Implantable Devices: Implantable medical devices, such as pacemakers, artificial joints, and prosthetic devices, are designed to last for a specific duration. The lifespan of these devices is influenced by factors such as the material of construction, the patient’s physiology and nature, and the technology used in the design and development.
Monitoring Devices: Devices used for monitoring, such as blood pressure monitors, glucose meters, and electrocardiogram (ECG) machines, may have a longer lifetime but still require periodic and preventive maintenance and calibration.
Medical device manufacturers need to mention the lifetime details in the IFU/ User-manual / Instructions and or in maintenance protocols, and any other reading material provided to customers or users.
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Applicable International Standards
Shelf life explains the duration of the medical device to be stable to retain the sterility of the package and the device’s performance. It ends when the package is open or the shelf life claimed on the label, whichever comes first. Lifetime starts at the opening of the device package and ends until it works properly to attain its intended use.
International standards for Medical Device Reliability including Software devices are:
ISO 14971 (ensures the safety and reliability of medical devices)
IEC 60601-1 (safety standards for electromedical equipment)
ISO/TR 80002 (risk management requirements of Medical device Software)
IEC 62304 (life cycle requirements of software- software development and maintenance)
Lifetime Vs. Shelf Life Vs. Stability
Shelf Life: Shelf life refers to the duration during which a medical device remains suitable for use when stored under specified conditions.
Stability: Stability, in the context of medical devices, refers to the ability of a device to maintain its physical and chemical properties over time under specified storage conditions.
Lifetime: The lifetime of a medical device refers to the total duration over which the device is expected to function properly and safely in its intended use.