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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).