Elsmar Cove Forum Header Graphic The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Miner's MSA (Measurement Systems Analysis) Blog 

Welcome to the Elsmar Cove discussion forums! Registering to participate in the Elsmar Cove Forums is Free. You do have to Register for many features and functions such as E-Mail Digests, Notification of New Posts and/or Threads, Personal Messaging and downloading of Post Attachments to work. If your intent is to simply scan/search for information, there is no advantage to registering. If you would like to Register, click HERE. If you would like to just browse the message base without registering, feel free to do so. Many of the forum software features are disabled for Unregistered Guests for security reasons. See This Thread for more information. If this is your first visit, be sure to check out the FAQ and The Basic "How To's" in the Elsmar Cove Forums forum. By proceeding to browse these forums, you are expressing your interest in reading information in discussion threads and files attached to posts in discussion threads for research and/or educational purposes in accordance with Title 17 U.S.C. Section 107.
To browse without Registering, go to the forum or discussion thread that you want to view and click on it. A 'Lock' icon on a forum only means you can not Start a New Discussion Thread or Reply to a Post in an existing Discussion Thread in that forum.

This message header and advertisement will not show after you Register and Log In.
Registration is FREE!

The Elsmar Cove Forum (http://Elsmar.com/Forums/index.php)
-   ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems (http://Elsmar.com/Forums/forumdisplay.php?f=44)
-   -  

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


58431Check 1st May 2013 12:59 PM

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

Ronen E 1st May 2013 08:25 PM

Re: Major Nonconformance for not "clearly" defining the "device lifetime"
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 (?).


Sam Lazzara 1st May 2013 11:50 PM

Re: Major Nonconformance for not "clearly" defining the "device lifetime"
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).

The time now is 02:38 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


FAIR USE and CORRECTNESS NOTICE: This site contains copyrighted material the use of which has not always been specifically authorized by the copyright owner. We are making such material available in our efforts to advance understanding of environmental, political, human rights, economic, democracy, scientific, and social justice issues, etc. We believe herein constitutes a 'fair use' of any such copyrighted material as provided for in section 107 of the US Copyright Law. In accordance with Title 17 U.S.C. Section 107, the material on this site is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes. For more information go to: http://www.law.cornell.edu/uscode/17/ If you wish to use copyrighted material from this site for purposes of your own that go beyond 'fair use', you must obtain permission from the copyright owner. In addition, I do not guarantee the correctness of the content. The risk of using content from the Elsmar Cove web site and forums remains with the user/visitor.

Responsibility Statement: Each person is responsible for anything they post in the Elsmar Cove forum. Neither I, Marc Timothy Smith, nor any of the forum Moderators, are responsible for the content of posts people make. Liability for post content resides with the poster as does interpretation and/or acceptance and/or use of advice by the reader.

Complaints: If you have a complaint with a post in a forum discussion thread, including Content in general, fighting, flaming, copyright infringement, defamation and/or 'slander', please use the 'Report This Post Report This Post Button button which appears at the top of every post in every thread.

Site courtesy of:
Marc Timothy Smith - Cayman Business Systems, 8466 Lesourdsville-West Chester Road, West Chester, Ohio 45069-1929 - USA
(513) 341-6272

If you are having problems Registering, Activating your Registration, or other problems, you can phone me in the US. I'm not here 24/7/365, but if I'm here I'll try to help.