Lifetime Advice – ISO/TR 14969:2004
ISO/TR 14969:2004 Medical devices – Quality management systems – Guidance on the application of ISO 13485:2003, clause 7.1.3 offers advice on setting the lifetime of a device.
The guidance recommends documenting the defined lifetime of the medical device as well as the rationale for determining the lifetime. Some considerations in the determination include:
Risk Management Considerations
- shelf life of the medical device
- expiration date of the device or its components
- the number of cycles or periods of use of the medical device
- anticipated material degradation
- stability of the packaging material
- for implantable devices, the residual risk that results from the entire period of residence of the device inside the patient’s body
- for sterile medical devices, the ability to maintain sterility
- the organization’s contractual or regulatory obligation to support and service the device
- spare parts cost and availability;
- legal considerations including liability
The defined product lifetime can help control residual risks that can increase to unacceptable levels over extended device periods of use.1
ISO 14971:2003 Clause 2.7 define the device life-cycle as all phases in the life of a medical device, from the initial conception to final decommissioning and disposal.
The Risk Management Plan needs to include the scope of the planned risk management activities, identifying and describing the medical device and the life-cycle phases for which each element of the plan is applicable.
Because risks appear throughout the product life-cycle, the life-cycle definition is important. Risks that appear at one point in the life-cycle may be managed by action or controls at a different point. This argues for the application of risk management throughout the life-cycle from design to disposal.