When to issue a Class II Device Recall (failure not harmful nor a safety issue)

[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.

[MIREGMGR]

Presumably you've already reviewed the FDA guidance on this. You may have a Correction situation. In any case, you should write up a memo-to-file, explaining the situation and why you think it's X and not Y. You should prepare an addendum to your risk management file, covering why the situation doesn't constitute an increased safety risk to patients or clinical personnel.

Note that in some instances, a device-loss-of-effectiveness situation can constitute an increased risk to the patient, if clinical personnel may be using your device in a context where its failure to perform as expected, or at all, might result in ineffective or inadequate patient care.

As to what further to do, the FDA has a number of Regional, District and Field offices. Go to the CDRH webpage, and do a search on FDA and your nearest major city name. Or, call DSMICA. What you want is the phone number of the Medical Device Recall Coordinator that covers your location. Call them up and have a discussion. We've done so a couple of times, with uniformly useful and informative results.

[aoldendo]

"Note that in some instances, a device-loss-of-effectiveness situation can constitute an increased risk to the patient, if clinical personnel may be using your device in a context where its failure to perform as expected, or at all, might result in ineffective or inadequate patient care."

This is certainly our greatest concern at the moment.

After we have performed our analysis of the situation, I will definitely look into calling the nearest coordinator or FDA office for their take on the situation.

Thanks again MIREGMGR!