Justification of Lifetime of a Medical Device including Component Aspects

[Sherif Amer]

Hi all,

We are about to release our medical product but we are having a difficulty determining the lifetime of the device. We have looked at the datasheets of the components the device is built of, found some information about most of them, not all of them. What should we do with the rest of the components that I can't find their lifetime?

Sherif

 

[Wes Bucey]

Re: Justification of lifetime

Of course, the first question in my mind is whether the device is external or implantable.

There is a guideline

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:

1. shelf life of the medical device
2. expiration date of the device or its components
3. the number of cycles or periods of use of the medical device
4. anticipated material degradation
5. stability of the packaging material
6. for implantable devices, the residual risk that results from the entire period of residence of the device inside the patient’s body
7. for sterile medical devices, the ability to maintain sterility
8. the organization’s contractual or regulatory obligation to support and service the device
9. spare parts cost and availability;
10. legal considerations including liability

Risk Management Considerations
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.

Typically, if the device has been designed so individual components are replaceable, then the primary consideration is whether continual repair and replacement may be feasible, extending the useful life of the device. In the absence of "easily" replaceable components, the lifetime devolves to the estimated life of the shortest lived component.

In an auto, windshield wipers are easily replaceable and don't affect the lifetime of the vehicle. Engines or transmissions "may" be replaceable, but at what point is the useful life of the original vehicle affected before it becomes "rebuilt?"

 

[AndyN]

Re: Justification of lifetime of a Medical Device

<snip> We are about to release our medical product but we are having a difficulty determining the lifetime of the device. We have looked at the datasheets of the components the device is built of, found some information about most of them, not all of them. What should we do with the rest of the components that I can't find their lifetime? <snip>

You may wish to get some expert advice about the specifics of the devices etc, since you haven't given us that information. Sadly, quoting a guide - even an ISO one - isn't going to help you it seems to me. If you don't have specific information and you release the product - wouldn't that put the patient and your organization at risk?

 

[Marc]

Re: Justification of lifetime of a Medical Device

<snip> What should we do with the rest of the components that I can't find their lifetime? <snip>

Help with this aspect from medical device experts here will be appreciated.

 

[Ajit Basrur]

Hi all,

We are about to release our medical product but we are having a difficulty determining the lifetime of the device. We have looked at the datasheets of the components the device is built of, found some information about most of them, not all of them. What should we do with the rest of the components that I can't find their lifetime?

Sherif

Welcome to the Cove, Sherif

Couple of questions -

1. When you refer as a medical product, is it a "finished medical device"?

2. What does "release" mean? Is the device approved by the regulatory agencies? If yes, the lifetime of the device would have been already submitted as part of label.

3. Which markets are you targeting for commercial release of the product?

 

[somashekar]

Hi all,

We are about to release our medical product but we are having a difficulty determining the lifetime of the device. We have looked at the datasheets of the components the device is built of, found some information about most of them, not all of them. What should we do with the rest of the components that I can't find their lifetime?

Sherif

Also look down this page in the "Similar Discussion Threads". You may find some useful information and your question may be answered perhaps.

 

[MIREGMGR]

You as a regulatory person need to have a talk with senior management about the extent to which your product design department understands the company's regulatory obligations. No product is properly designed without a design life as a design input, and an appropriate documented engineering analysis, probably backed by testing, to show that the design output meets the various aspects of that design input.

That might include product shelf stability before use, product functionality in use, sterilization stability of the product's terminal packaging if applicable, and other factors.

Sterilization stability, for one, might be validated via accelerated aging studies, backed up by post-release-completed real time studies. There's a considerable body of knowledge regarding how to do this.

The comment above about risk is very much on point. If your design hasn't been validated to conform to its requisite life requirements, you don't have any idea whether it's risk-acceptable.

 

[Sherif Amer]

Thanks a lot guys. The device is external that doesn't need any sterilization. We're after the CE mark. I think I'm going to ask for someone's help around me.

 

[Roland Cooke]

I believe the cool kids talk about "product life cycle" these, on the basis that any particular device could have a bunch of different "lifetimes" depending on its phase of use.

 

[Marcelo]

"Product life cycle" is generally related to the technology, not each product manufactured. But normally a device has only one defined lifetime.

In fact, I usually says there?s two lifetime:

- the "true" lifetime, meaning, how long the device can perform (tied to reliability)

- and the "regulatory" lifetime, which is how long the manufacturer wants to be responsible for the device (tied to other considerations, and can include reliability).