Do you know about risk management for medical devices

Posted by izielgroup1 on August 27th, 2021

Risk is common word in human definition and even child learns the word risk from very age when he starts learning and start doing some adventure of childhood

Everybody knows the word risk as common word vocabulary it has lot of importance in Medical device field. Though various documents are available, and experts have devised various methods to assess the same.

Though we learnt risk based on our perception like we consider certain act as very risky and scared to do the same, stunt man who has practiced that act, does it so easily and risk in his or her perception for that act is very low.

This type of perception cannot work in regulated world where we define risk based on assessment as defined in various well accepted standard documents. Let us understand this

Medical devices, those have actually helped improve the standard of life for thousands and thousands of individuals. All those are associated with some sort of risk but are still released based on assessed risk. That risk is overcome based on advantage

Risk is measured based on major two elements like severity and probability of its occurrence. If we assign the number to these two elements, then multiplication becomes risk number and higher the number, higher the risk. Sometime third element detectability is also considered. If possibility of detection is at early stages, then lowest number is allotted, and it increases from lower to higher end when detection becomes later or no detection at all. Thus, multiplication of all three becomes risk number which becomes assessed risk

Above approach, is now well accepted by most of regulated bodies and same is documented by manufacturer of device and submitted to regulated bodies along with other documents like device master file.

Risk Management method includes –

Risk Analysis (to find out risk number as mentioned above) Expert discuss and define numbers for each element and multiplication becomes risk number.

1. Risk analysis: if this shows that risk is more than its advantage for patient then device cannot qualify.

2. Risk Controls: If device cannot qualify then we need either to scrap the project or introduce some measure whereby we can bring risk number low. This is termed as risk control. This also can be used to reduce the probability factor even in case of high or medium risk to lower it to medium and low risk.

3. Residual Risk: After risk control whatever risk is left. This will have to be certainly very low over its advantage.

4. Risk Management Review: Once whole process is done; this is then monitored to validate and evaluate the assigned values in actual field.

5. Production & Post-Production data: This is continuous process of learning and data will help to assess our assigned values are correct or not and will also show improvement action. PMS Post marketing surveillance is one such mandatory activity defined by regulated body for all medical device manufacturer.