Active Implantable Medical Devices - Legal Traceability Requirements

[Aphel]

Dear all,

I am looking for obligatory european legal traceablity requirements for active implantable medical devices following the distribution chain:

What are the traceability requirements of the legal manufacturer - what are the requirements of the distributor - whatt are the requirements of the hospital which performs the implantation?
Any links to european directives or standards would be helpful...

Thank you very much in advance for your support!

BR Aphel

 

[Ronen E]

Re: Active Implantable Devices - Legal Traceability Requirements

This EC Commission Recommendation may be of interest.

61. Third, for certain devices such as implantable medical devices, health institutions should store both device identifier (static information) and production identifier (dynamic information) in the electronic patient record. Indeed, in case of recall, it should be possible to know exactly which medical device has been implanted to which patient.

 

[Aphel]

Re: Active Implantable Devices - Legal Traceability Requirements

Thanks Ronen...
But I still have a specific question...

Are there any specific requirements in ISO 13485 or EU MDD 90/385 EEC regarding traceability of AIMD?
I need to know what does a "distributor only organisation" has to consider regarding traceability of AIMD to customers and patients who receive the implantation?

Thanks a lot for your support!
Best regards,
Aphel

 

[pkost]

Re: Active Implantable Devices - Legal Traceability Requirements

Traceability is not really discussed in the directive, however ISO 13485 has a section on it - you should refer to this.

There is no specific obligations placed on distributors in the current directive, however ISO 13485 7.5.3.2.2 relates to particular requirements for active implantable medical devices and implantable medical devices. It specifically requires the manufacturer to require (presumably via contract) their distributors to keep records for traceability

 

[RDSally]

Re: Active Implantable Devices - Legal Traceability Requirements

Hello,

I believe the essential requirement 12 of 90/385/EEC is a specially related to AIMD traceability:

"Devices must bear a code by which they and their manufacturer can be
unequivocably identified (particularly with regard to the type of device
and year of manufacture); it must be possible to read this code, if
necessary, without the need for a surgical operation"

However, I would be really interested in knowing how to fulfill the part of reading the code without surgical operation. What type of identification is usually used?

Thanks!

 

[pkost]

Re: Active Implantable Devices - Legal Traceability Requirements

I have no experience of this specific directive or how this is fulfilled in these products, however a couple of thoughts:

1. For devices that are programmable/have a communication interface it should be relatively trivial for the device name/serial number to be included in the communications protocol
2. It should be possible to include RFID in the device
3. Perhaps a product feature that appears different in an x-ray
4. for non active implants we included patient labels for inclusion sticking in the patient notes, theatre log (anywhere any everywhere the HCPs could want) - this would identify the products used....not entirely sure this would meet the requirements of the AIMDD

 

[Pads38]

Re: Active Implantable Devices - Legal Traceability Requirements

3. Perhaps a product feature that appears different in an x-ray

When I was doing implants that is how we did it.
Metal foil letters and numbers were embedded in a polymeric part of the implant.

 

[RDSally]

Re: Active Implantable Devices - Legal Traceability Requirements

Pads and pkost, thank you very much for your ideas and suggestions for this topic! I have to look into option no2, since the others are not possible in this case.