Manufacturer Obligation to Declare the Lifetime of its Medical Device?

Marcelo

Inactive Registered Visitor
#11
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?
 
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F

freelovefest

#12
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.
 
E

ezeeze

#13
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.
 
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