Industry Night: Medical Supplies
Poly Implant Prothese (PIP), is a French company that manufactures breast implants. However, rather than using traditional silicone, they used silicone designed to stuff mattresses in order to cut costs. After women started experiencing ruptures, it was estimated that 300,000 faulty implants had been sold across the world.
Obviously, with anything in the medical field, there are strict regulations—so how did PIP get away with this for over 12 years? Although the company received regular inspections, they were given a six-week notice, so it was easy to swap the industrial grade silicone for more expensive medical grade silicone, keeping inspectors at ease.
However, there’s also a lack of traceability within the system. Some clinics don’t always keep good records of which implants were used on which patient, causing confusion and uncertainty as to which women could be endangered. This needs to change. A unique identifier, such as a barcode or RFID chip, is needed in order to track and trace implants from distributor to patient.
In addition, there are no standardizations in place for record keeping, so it’s up to each clinic to track patients as they see possible. And should a clinic close, there are no requirements for what should be done with their patient information.
This is just one (potentially tragic) example of how traceability and standardizations are key. Are you doing everything to ensure proper tracking and traceability? Learn how to manage your supply chain.