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Ways to deal with risks

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It was mentioned in lecture that there are 4 ways to deal with risks: avoidance, mitigation, acceptances, and transference. Transference isn’t really applicable in medical device companies, but the other 3 methods are good ways to deal with risks. Risk avoidance is the elimination of hazards or any risk that can negatively impact the goal. Risk mitigation is when action is taking to reduce the company’s exposure to the risks. Risk acceptance is when the company acknowledges the potential loss from the risk.  Can you share your experience with risk management in the industry? Give an example for each method for a single product within a medical device company perspective. 

Topic starter Posted : 09/11/2021 10:47 pm
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So in my perspective, I have worked in the pharmaceutical industry and many of the same points that are being taught in our class are essentially the same. The two often times coeincide with each other as each of them have an end product that is going into the body and must follow the stringent FDA requirements of safety. In my experience I have dealt with a few GLP machines that require proper safety protocols to be followed when operating such machinery to minimize any risk associated with. The one particular machinery that I have used is the Hamilton Star Automatic Pipette machine and we had to go through extensive risk mitigation training to minimize any danger associated with the device

In terms of what we did and what features are associated with the machine is as follows

Risk Avoidance- In terms of how the machinery utilizes risk avoidance, is by ensuring that every corner is rounded and avoids any injury to the user. It also has an anti-collision detection hardware that will detect if something is in its way and will stop working. In terms of the company policy, we have proper PPE when operating the device and have policy of not reaching inside the machine while it is in operation.

Risk Mitigation- To mitigate any risk that is possible, the Hamilton machine utilizes cover and guards to physically block anyone from access the deck, however this can still be bypassed to do lab work in it when necessary.

Risk Acceptance - Certain things are accepted such as the possibility of the robot to collide with the person, and or to collide with other moving parts and potentially cause an issue or error.

Posted : 14/11/2021 9:58 pm
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While working for my company, we do our best to handle risks as appropriately as possible. From an auditor point of view and our companies general view on risk, it is not satisfactory for us to accept risk for our medical devices (Intra-Aortic Balloons). Every risk that we have we try our best to mitigate the risk or, if possible, avoid the risk all together. To do this, our company has a lot of product inspections on the manufacturing line to ensure our product is tested and inspected before leaving the facility. This includes visual inspections, leak tests, inflate on pump tests, and many others that are used to make sure there are no defects to the product and no risk to releasing the product to the customers. Of course any test methods that are done in line are validated using a test method validation, to ensure the operators know what the failures are and can actively catch product that does not pass testing or inspection criteria. We also use risk avoidance a lot. For example, we have a gluing process where the glue requires 50% relative humidity to cure in 15 minutes. Of course below 50% humidity the glue still cures and can be used, but to avoid the risk of having the glue not dry in time, we only allow the gluing process to be used if the humidity in the room is above 60% humidity. This allows us some extra tolerance because we aren't using the bare minimum requirement where we could be over or under the humidity by a small amount at certain times. Of course, sometimes risk needs to be accepted, but if you can mitigate risk or avoid it all together, it looks much better in the eyes of the FDA and within the company than saying we accept the risk and accept that this may harm the product or a patient in the future.

Posted : 10/12/2021 9:25 pm