Much ink has been spilled over the scrutiny procedure in the proposed medical device regulation, but relatively little has been said about article 16, which would require an “implant card” to be distributed with each implantable device and provided to the patient who has been implanted with the device. Rolande Hall, a medical packaging consultant based in Ireland, offers an interesting perspective on this measure in a blog on medicalpackaginginnovation.com. The objective is noble, writes Hall, “but it is clear that the regulators have neither worked in a device packaging area nor in an operating theatre.”
Hall cites the example of a sterile knee prosthesis with separate packages for the tibial and femoral components. “Each component will have its own card, and there will be a further card for the bone cement,” writes Hall. “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.” While implant cards may have a valid role to play for patients with active devices, Hall questions their usefulness in relation to passive devices. “It will not put that patient at risk; however, three cards for a new knee may cause confusion,” writes Hall.
Hall blogs regularly on medicalpackaginginnovation.com, an online community produced by the UBM Canon MedTech Group in partnership with DuPont to foster an an exchange of ideas between Europe’s medical packaging ecosystem and members of the larger medical manufacturing sector.