Will an 'Implant Card' Put Patients at Risk?
An "implant card" is required by Article 16 of the Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002, and Regulation (EC) No 1223/2009.
This regulation states that an implant card must be provided together with the implantable device and “made available to the particular patient who has been implanted with the device.” A laudable objective, but it is clear that the regulators have neither worked in a device packaging area nor in an operating theater.
Labeling errors in the USA are the leading cause of device recall.1 European figures will be similar. The new requirement to associate an implant card with each product will complicate the packaging and labeling control process, thus increasing the potential for even more errors.
For example, when a sterile knee prosthesis with separate packages for the tibial and femoral component reaches an operating suite, each component will have its own card, and there will be a further card for the bone cement. All three devices will have their own cards with batch-specific data and advice for the patient. Upon opening the packaging, there will be three extra pieces of documentation to be controlled by the nurses, creating a distraction at a critical time. The used packaging and IFU will be discarded into the waste bin, the products will be placed onto the sterile trolley, but the implant cards will need associating with the patient records. Hopefully no one will contaminate their gloves picking up a loose card when one falls onto the floor (the regulations don’t provide for this mishap).
Many implants such as bone screws, plates, washers, and wires are distributed non-sterile by the manufacturer. Packaging is minimal and generally has a single IFU with a multipack. However, the provision of an implant card with each single item would increase dramatically the pack weight and volume. Loose cards that must be associated with the correct implant present an opportunity for error, and one implant card for each screw is obviously a waste.
Where a hospital arranges for non-sterile items to be assembled into sterilization kits and autoclaved, it is hard to imagine how the implant card can remain together with the device. Yet the proposed regulation states that the card “shall be made available to the particular patient who has been implanted with the device.” To provide the required level of control will inflate costs.
While I understand the value of a card for patients with an active device, I question the value of an implant card for recipients of passive devices. If the correct implant card actually reaches the patient, it will not put that patient at risk; however, three cards for a new knee may cause confusion.
Tracking implant cards from manufacturer to patient is a waste of resources. Surely it would make much more sense for the hospital discharging that patient to create a card in the patient’s language and personalize it with his name.
Medical Device Translation. Labeling Errors are Leading Cause of Device Recall. Available at http://crimsonlanguage.wordpress.com/2010/03/17/labeling-errors-are-lead....
Rolande Hall, FIMMM Pkg Prof