Is there any standard (Europe, FDA or other) that obligates the manufacturer to declare the lifetime of its medical device? I am NOT referring here to the SHELF-LIFE of a device which has an expiry date. Annex I of the MDD (see clause 13.1) says that the device must be accompanied by the information needed to use it safely. Does this include declaring the lifetime of the device??

Thanks.

Asherlee

Have a look at ISO13485 4.2.3 and 4.2.4.

"The organisation shall retain records for a period of time at least equivalent to the lifetime of the medical device as defined by the organisation......"

Based on this, you would normally be expected to state the lifetime of the product, either in a procedure, quality manual, technical file or similar controlled document.

This lifetime might be the same as the shelf life or it can be a longer depending on how you expect the product to be used. I would not expect the see this lifetime quoted in the IFU, unless it involved safety implications.

Is there any standard (Europe, FDA or other) that obligates the manufacturer to declare the lifetime of its medical device? I am NOT referring here to the SHELF-LIFE of a device which has an expiry date. Annex I of the MDD (see clause 13.1) says that the device must be accompanied by the information needed to use it safely. Does this include declaring the lifetime of the device??

Thanks.

Asherlee

Declare where ?

Thanks for the input.

I would like to reword my question as follows:
May I determine the ‘lifetime’ of an active device by the period for which the manufacturer will support the device with spare parts, manuals, training, service, or repairs (for example); or am I obligated to carry out MTBF or ALT or other testing in order to backup and support any claim that I make for the lifetime of the device (irrespective of where I make this claim, be it in an internal document or in the IFU)?

Thanks.

In my experience, in this context the life-time only becomes an issue when deciding how long documents need to be retained for. In general MTBF type testing should not be required. The lifetime is really a justification for your record retention times and I would base your rationale for retention around lifetime. I would add the lifetime into a suitable procedure, such as document control. There's no requirment to put it into an IFU unless there are safety of commercial reasons.

Also, have a read through ISO14696, Section 7.1.3, which says that the ...lifetime may be based on technical, legal, commercial or other considerations...", and then expands on it further listing numerous items to consider. It also says the rationale should be documented.

One last observation, in the past I have been written up in a 13485 audit for not having the lifetime defined anywhere!

To be sure:
what difference would you see between LIFETIME and SHELF-LIFE?

I have a pacemaker installed. I certainly hope the lifetime of the battery (7 years) is an accurate number.

If there are no requirements for a medical device manufacturer to provide the lifetime of the device, there certainly should be.

Dear all:
shelf life and lifetime is different:
shelf life normally connected with "used by", and shall be shown in labelling or IFU.
lifetime is more likely connected with active device and re-usable device, and do not shown in labelling, but maybe need to be shown in IFU according to relevet product/ general standards.

more informaiton can refer to the "Guidelines relating to the application of derective 93/42/EEC on medical device-- "use by" "date", 2_2-3_06-1998.pdf", this file can be download free from the official website:)

Regards.

Would It be OK if you consider the lifetime of the device in your design input and go about your design process, there by the lifetime is defined in the DMR and going further based on this DMR lifetime defined by the organization, all records retention can be aligned. The device may be useable beyond the lifetime and so this info is not into the product IFU unless safety to the user or patient is involved, in which case you term it as "use before" period.

Would It be OK if you consider the lifetime of the device in your design input and go about your design process, there by the lifetime is defined in the DMR and going further based on this DMR lifetime defined by the organization, all records retention can be aligned. The device may be useable beyond the lifetime and so this info is not into the product IFU unless safety to the user or patient is involved, in which case you term it as "use before" period.


Hello Somashekar:
I think it is ok:
3. How to decide if a “use-by“ date is required:
A “use-by“ date is required where a safety-related characteristic or claimed performance is likely to deteriorate over time.
In deciding whether there is such a "safety-related" deterioration, the manufacturer must have regard to the results of the risk analysis and measures taken to manage risk. with sub-section a), b), c)
and
4.2 Information necessary if a “use-by“ date is not given:
B R

Just noted this post...

The new version of IEC 60601 (2005) and it´s EN and US implementation requires that the service life of the device be declare. This is aligned with the fact that in general regulatory requirements are based on risks management in the medical device lifecycle.

The rationale for lifetime and service life is that the manufacturer have to guarantee the safety (thru risk management) of the device during it´s lifecycle and be responsable for that. That means that, if it´s infinite, the manufacturer would be responsable indefinitely for the device safety.

This is not only related to documentation. It really related to the reliability if the device, meaning, how good it´s is in performing it´s function for a defined time and in defined conditions. What the regulations add is that it not only have to do this (provide its intended use) but it also have to do this in a safe way.

Although ISO 13485 and 14696 says that "...lifetime may be based on technical, legal, commercial or other considerations" i would not really trust a company that has no engineering-defined lifetime considerations. I mean, how can they be rally sure that the pacemaker won´t fail in the xxx years they define?

Most people use the weakest component of a device e.g. battery, to determine life. Usually data on that will be available from the MFG. They should be able to tell you at what rate it will deplete under specifc use conditions. Identify the weakest or most susceptible part and figure how long it will last.

ALT will work, but there are certainly other better ways, such as looking at risk management to determine what works best. I know with a lot of hi-tech products the life is listed as shorter than what it really is in that they plan on a newer product being released before 5 yrs or so. You can base the life on whatever you want, but make it too long and you will records to deal with and that can really add up in cost.

You need to consider the reason for this requirement. It is mainly for traceability. The point is that a manufacturer needs to have traceability during the expected lifetime of the device in order to respond properly to any vigilance issues (and it's just good business sense to retain them for any potential product liability issues).

As a manufacturer of long-term implantable fusion and trauma devices, we define it in our Control of Quality Records Procedure like this: "Quality records listed with a retention period of 'Lifetime of Device' will be kept indefinitely". Our thought process is that even though these products are only under loading for the period of time needed for the body to attain fusion (which is what is tested for in verification), the implants may be left in the patient for the patient's lifetime. Since we cannot define someone's lifetime, then we need to keep them forever.

We have a Quality Record Master List that lists the type of record, responsible department, method of indexing, location, and retention time. Records that we feel need indefinite retention include: All regulatory filings and technical files, engineering drawings, DHFs, test reports, change notices, supplier quality records, purchase orders, DHRs, receiving inspection reports, conformance certs, clean room validation/monitoring records, calibration records and NCMRs.

Shelf life only refers to the expiration date on the label, i.e, your sterilization validation.