Calibration cycle for monitoring & measuring tools used in medical device manufacturing

[Jake27]

Hello all,
What would be the appropriate calibration interval for monitoring & measuring tools used in medical device manufacturing? For instance, the instruments which are being used frequently say daily or 3 days in a week have been set 1 year as calibration interval. But what does not make sense to me is even the calibration cycle for the instruments & tools used less frequent say 1 or 3 times a month is also set 1 year as calibration interval. This takes huge toll on the economic condition of the company. So can the calibration interval can be made once a 2 years or 3 years based on the usability or is it mandatory to be calibrated every year to be compliant with ISO 13485?

Looking for your valuable insights on this. TIA.

 

[Jen Kirley]

Hello all,
What would be the appropriate calibration interval for monitoring & measuring tools used in medical device manufacturing? For instance, the instruments which are being used frequently say daily or 3 days in a week have been set 1 year as calibration interval. But what does not make sense to me is even the calibration cycle for the instruments & tools used less frequent say 1 or 3 times a month is also set 1 year as calibration interval. This takes huge toll on the economic condition of the company. So can the calibration interval can be made once a 2 years or 3 years based on the usability or is it mandatory to be calibrated every year to be compliant with ISO 13485?

Looking for your valuable insights on this. TIA.

Hello Jake27, welcome to The Cove!

As is the case with other ISO standards, ISO 13485:2016 does not specify calibration intervals. The standard calls for calibration/verification at specified intervals (it does not say who specifies) or prior to use... please see clause 7.6.

As always, industry good practices are to set calibration intervals based on specification tolerance, the instrument's age/sensitivity, amount of use, environment of use, handling/storage impacts on the instrument's physical condition and expected reliable accuracy, and the cost of getting it wrong.

I hope this helps.

 

[Tagin]

and the cost of getting it wrong

@Jake27, when you say 'medical device manufacturing', my thought immediately go to risk:

• what safety impacts are there to the lives and health of the patients if your M&M are out of calibration, and that condition goes undetected for as long 1-3 years?
• what reputation impacts are there to your company name if a recall is required for 1-3 years worth of product produced with out of calibration M&M?
• what financial impacts are there to your company name if a recall is required for 1-3 years worth of product produced with out of calibration M&M?
• what financial impacts are there to your company name if a lawsuit results from having 1-3 years worth of product produced with out of calibration M&M?

I wonder if 'huge toll on the economic condition of the company' is perhaps not so onerous in light of these risks.

 

[isprasad]

Hello all,
What would be the appropriate calibration interval for monitoring & measuring tools used in medical device manufacturing? For instance, the instruments which are being used frequently say daily or 3 days in a week have been set 1 year as calibration interval. But what does not make sense to me is even the calibration cycle for the instruments & tools used less frequent say 1 or 3 times a month is also set 1 year as calibration interval. This takes huge toll on the economic condition of the company. So can the calibration interval can be made once a 2 years or 3 years based on the usability or is it mandatory to be calibrated every year to be compliant with ISO 13485?

Looking for your valuable insights on this. TIA.

Appreciate your concerns and in this case you can take the help of ISO/IEC 17025 as well as ISO 10012 standards
1) it is the knowledgeable person that decides the calibration interval not any calibration service provider - once again i reaffirm that "it is the knowledgeable person that decides the calibration interval"
2) first of all, you need to check up whether there is bias or drift in the measurement results
3) to make it easy - you shall be having equipment that are likely to have drift due to usage and equipment that don't encounter drift due to usage.
4) example for the above is patient monitor Vs dialysis machine
5) you can refer to Ilac publication : ILAC g-24

 

[Jake27]

Hello all,
Thank you for shedding the lights. It helps All the above suggestions were considered but my concern was to be in compliant with the ISO 13485 as I did not find enough information about the calibration intervals in the standard. Once again, Thank you all

 

[yodon]

@Tagin nailed it. It should definitely be risk-based. Auditors may well ask you what your justification for the frequency is. Sounds like the current approach was just arbitrarily set at 1 year (which, in my experience, most auditors don't question)?