Hello,

We're a medium-sized company entering the market for medical
devices. We're looking for examples of how things are organized practically
in function of vigilance. How do you cope with incident reporting during weekends etc ?


:thanx:

Eddie,

Welcome to the cover!!!

What are your customer requirements and needs? They should tell you what there expectations are.

At a minimum you should have published emergency contacts (monitored email, mobile phone that get answered) able answer and respond to customer inquiries. Responses should include expert advice, troubleshooting, replace product.

You might have legal requirements as well (such as notifying authorities).

all incidents get reported (database), even near misses. If you do not report the incident, you probably have only one more paycheck coming your way, the one for the week in which you are working your last hours in.

Is that what you meant?

Thanks for the replies.
What we mean is the practical organization (hotline ? email ? ...)
What about watchguarding your products in other countries? etc ..

:agree1:

I think what Kales said still holds: it depends on your customer requirements and needs. If you have a device whose failure has potentially severe consequences, you had better have a manned hotline 24x7. If you have a device whose failure can cause no harm with no serious consequences on response delay, maybe email is ok.

Don't underestimate what Steel said also! Regardless of your means of collection, every one has to be recorded and managed.

What I've seen others do for support in other countries is to have a local sales center in that country take the initial report. This has to be well managed and the sales team needs to understand the responsibilities (and gravity). This was for a device whose failure would have no severe consequences.

hello all:
the complexity of the procedure depends on the risk analysis of your products.
detail you can see the Meddev guidelines on a medical devices vigillance system which is updated in 2007
regards.

Are following remarks correct ?

- Initial incident reporting should be done in the country where the incident took place
- Initial incident reporting should be done in the normal language of the
country where the incident took place
Thanks,
Eddy

What to report and to whom all depends on what countries you are working in. I generally create a complaint handling/reporting flow chart for each entity that would require a report; FDA, Health Canada, competent authority, etc.

As far as organization of a system, anyone who can become aware of an incident should be trained in your incident processes. These generally include Sales, Customer or Tech Services, even receiving. Think about all the ways complaints could be received and train everyone.

In my opinion everything has to be evaluated by a competent person who can determine whether something is reportable. Your structure should depend mostly on the volume of complaints, but I feel the best way to make sure nothing "slips through" even on a weekend, is to train all people who could become aware of an event to submit as much info as they can into a central repository like events@XXXX.com. That way you can review each of them most likely in the 2 days minimum you would need to in the case of a sever event.

How many people need to do this and databases etc, all depends on your volume. If you have a form for sales, service, etc to completed upon becoming aware that is faxed or e-mailed to your repository, then you can review and manage each one. Just create a form, a Database and go from there. With electronic reporting available for the FDA a compatible DB might be a good idea and speed things along for you. Just make sure everyone sends all issues to the same place. Then you can go from there as far as evaluating them and sorting them out. Hope this helps out some....