In a recent court case the Federal Court in Karlsruhe dismissed an accusation against TÜV Rheinland concerning the faulty inspection of defective breast implants from a French manufacturer.
Fraud went undetected
Seven years ago it surfaced that a French manufacturer had filled their breast implants with industrial silicon, which had not been approved for medical purposes. TÜV Rheinland was responsible for the quality assurance of the implants, but failed to detect the falsification when they inspected the products. In Germany alone, more than 5,000 women were affected.
The plaintiff was a 67-year old woman seeking to sue TÜV Rheinland for 40,000 Euros, which was the estimated amount she had spent trying to manage the pain caused by the implants.
Court unable to prove auditors responsible
The lawsuit was ultimately dismissed because the court could not find that TÜV Rheinland had violated any obligations in the inspection process.
A few weeks ago the European parliament voted to implement quality controls intended to prevent defective medical products from entering markets and thus human bodies. The new regulations require implants to be equipped with electronic chips linked to an implant register to store all information on the implant and its receiver.
How Blockchain could change medical supply chains
If this information was stored in a Blockchain, the complete history of a medical product could be shown transparently. Even the last component of an implant could be examined including its origins and falsifications, thus preventing incidents like this recent lawsuit.
Ambiguity in liability cases made clear with Blockchain
Blockchain is able to substantially improve supply chains in that all steps in the supply chain are written into a Blockchain in the form of transactions and are not erasable due to the decentralized nature of the database.
Blockchain eliminated third-party control systems and ensures the highest level of product safety, which is particularly important in the supply chain process of medical products.