A
aoldendo
Hi all:
This is my first post on Elsmar Cove, but I have been lurking for many months and have greatly benefited from the discussions here. I look forward to your opinions on the following matter..
My company produces a Class II device. We have begun to notice a failure in a key component of our device. However, this failure could never be harmful to the patient or become a safety issue. There's no increased risk to the patient or physician. Basically, it's a matter of effectiveness which necessitates the customer sending in the unit for service/repair.
We have addressed this by changing the design of the component. We have an ECN going on the changes with production controls in place to make the updated component.
We are going to analyze our data of the last few years and try to find out if the component failures are happening at less than a year or if the components are lasting longer than a year. Our warranties on the device are usually for a year or two years.
In your opinion, are we roaming into territory where a device recall w/ removal is necessary or should we simply send out an advisory notice to all customers regarding this component issue? Should our procedures have a threshold of x% failures which necessitate a mandatory recall? Is this all a moot point since the failure here does not constitute any risk to the user and patient?
Lastly, do you believe our current actions would satisfy the FDA? If not, what more can/should we do?
If you made it through all of that verbiage, thanks for your time and thoughtfulness.
This is my first post on Elsmar Cove, but I have been lurking for many months and have greatly benefited from the discussions here. I look forward to your opinions on the following matter..
My company produces a Class II device. We have begun to notice a failure in a key component of our device. However, this failure could never be harmful to the patient or become a safety issue. There's no increased risk to the patient or physician. Basically, it's a matter of effectiveness which necessitates the customer sending in the unit for service/repair.
We have addressed this by changing the design of the component. We have an ECN going on the changes with production controls in place to make the updated component.
We are going to analyze our data of the last few years and try to find out if the component failures are happening at less than a year or if the components are lasting longer than a year. Our warranties on the device are usually for a year or two years.
In your opinion, are we roaming into territory where a device recall w/ removal is necessary or should we simply send out an advisory notice to all customers regarding this component issue? Should our procedures have a threshold of x% failures which necessitate a mandatory recall? Is this all a moot point since the failure here does not constitute any risk to the user and patient?
Lastly, do you believe our current actions would satisfy the FDA? If not, what more can/should we do?
If you made it through all of that verbiage, thanks for your time and thoughtfulness.