Major Nonconformance for not "clearly" defining the "device lifetime"

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#1
My company recently had a re-cert audit and received a major for not "clearly" defining the "device lifetime". I have made the revision to our QOP and was wondering if it would be an acceptable correction. The revision is as follows: IV RECORDS
1 Retention of Records
1.1 The retention of ALL records is FIVE years from the date the last product was manufactured. Manufacturing is considered complete once the President or Quality Director has received a Certification of Sterility from the approved sterilizing vendor. In addition to the Cert, the Quality Director and/or the President must also receive company's name FORM-159, Gamma Sterilization Instructions. It must then be signed and returned by either of the two company's name officers mentioned back to the sterilizer in order for the manufacturing process to be complete.
The FIVE year period was established through a validated FIVE year accelerated aging process. See Validation Protocol #024.

Any advice would be greatly appreciated!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hello and welcome to the Cove.

The device lifetime (shelf life + use life?) should be spelled out in the DHF (or Technical File), and is specific to each and every device model. Your text above seems to relate mostly to record retention time, and briefly reference the sterile barrier shelf life (?).

Cheers,
Ronen.
 

Sam Lazzara

Trusted Information Resource
#3
I assume the nonconformance was written against ISO 13485 clause 4.2.3 (Control of documents) which describes a requirement for obsolete document retention to ensure the manufacturing/testing documents are at least available for the device lifetime. Please note that records are a type of document.

The clause 4.2.3 requirement also reminds us to pay attention to relevant regulatory requirements for document retention, which could be more stringent than retention times based on the associated device lifetime. For example, the Annex II.6 of the European Medical Device Directive (MDD) 93/42/EEC requires certain records to be maintained for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, regardless of the specified device lifetime. For most companies, this is the most stringent requirement, and becomes the basis for their quality system requirement.

Interestingly, Essential Requirement 4 of the MDD mentions "lifetime of the device" too.
The characteristics and performances referred to in Sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical conditions and safety of the patients and, where applicable, of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use.

As Ronen indicated, the device lifetime = shelf life + service life. The service life begins when the device package is removed from the "shelf" and first opened to be put into service. For transient single-use devices, the service life can be a matter of minutes. For so-called permanent implants (> 30 days) the service life is measured in years. For example, many vascular stent and hip implant companies establish this as 10 years, and therefore base their accelerated cyclic fatigue tests to simulate at least 10 years.

I think your design input requirements document, whatever you call it, should state service life requirements. To make this systematic, your design control SOP should require the design input document to specify the service life. The device shelf life could be specified as a design input requirement but it must definitely be specified in your design output label-generation specifications or work instructions.

The guidance document for ISO 13485 is ISO/TR 14969. Section 7.1.3 provides lots of guidance regarding how to determine "lifetime of the device". You can affordably purchase the CEN publication of ISO/TR 14969 here. And no, I am not associated with EVS - just a very happy customer!

In summary, I do think your record retention procedure should address the concept of device lifetime but it should be specified in your design documents (service life) and manufacturing documents (shelf life).
 
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