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MEDICAL DEVICE RECORD RETENTION
Keeping records is a matter of determining how long a
product will be in circulation. ISO 13485 as well as other standards and FDA
policy indicates that a record should be kept for the life of the product or if
short lived - at a minimum two to five years or more (depending on local laws).
This isn’t always easy to determine and sometimes has to be calculated as a
result of a guesstimate.
Records are kept because something can go wrong down the road. A hip replacement
can start to fracture or a valve replacement can start to malfunction – after
time. In such cases there isn’t usually a lot of clinical evidence to
demonstrate the expected life of such implantables. When (if) something goes
wrong – there will usually be an investigation. If no records are available then
the manufacturer is vulnerable to a lot of legal finger pointing.
FDA’s POLICY
“The QS regulation in section 820.180(b) requires that all records pertaining to
a device shall be retained for a period of time equivalent to the design and
expected life of the device, but in no case less than two years from the date of
release for commercial distribution by the manufacturer. Manufacturers of
longlife products should make prudent decisions as to how long to keep
records.”
The FDA also makes a distinction of “long life” devices such as stretchers and
surgical tools where maintaining records is of no value if the probability of
post distribution remedial activity will occur. They also go on to say that you
should keep maintenance and repair records on devices requiring such upholding.
If you the manufacturer sell a medical device and consequently follow-up with
maintenance activities, it is your responsibility to keep the record of the
maintenance of the device on file. This record will be part of the Device Master
Record (DMR).
Medical Device Sterilization and Record Retention
Medical device sterilization is often overlooked as being an important component
to the device’s manufacturing process. Yet Ethylene Oxide sterilization and
Gamma sterilization service providers often are overlooked with respects to
record retention. It is your responsibility as the manufacturer to ensure your
service providers are maintaining records associated with the sterilization
(manufacturing) of your device. If your sterilization provider has a specific
record retention period, then it is your responsibility to obtain the records
from them if your device has a longer retention period.
Records that you should ask for:
- Sterilization process batch records
- Maintenance Activities including equipment calibration
Basically, you will need a copy of anything that would have had an influence on
the sterilization of your product. Sterilization batch records alone will not
tell you if there was a non-calibrated thermocouple measuring chamber
temperature (Ethylene Oxide sterilization) or if the inbleed filters were
adequately changed, etc.
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