On Monday, November 26, 2018, the U.S. Food and Drug Administration announced plans to modernize the way it approves medical devices, finally bringing a process that dates to the 1970s into the 21st century.
The announcement came a day after the International Consortium of Investigative Journalists (ICIJ) published the disturbing results of its investigation into the human suffering caused by medical devices that were inadequately tested—or not tested at all—before being approved for use.
The yearlong investigation encompassed more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices over 10 years. Far from being restricted to the U.S., the probe spanned 36 countries and the findings include more than 14,000 injuries and 1,416 deaths reported in Canada.
Whatever the impetus, other nations’ governments tend to look to the U.S. agency as the example to follow in regulatory matters, so the opportunity for worldwide improvement is real.
Medical devices in the U.S. are currently approved based on a “substantial equivalence test” known as 510(k), which allows new devices to be sold based on their similarity to older devices that are already on the market. Unsurprisingly, according to the ICIJ, this may have contributed to hundreds of thousands of defective devices being implanted in patients around the world.
The FDA proposes to maintain a listing of all medical devices that were approved based on a previous version more than a decade old. It is also phasing in a system of unique device identification (UDI).
Will this be enough? Unfortunately, no.
The proposed changes fall woefully short of providing the reassurance patients need and deserve about the safety, quality and authenticity of the medical devices installed in their bodies. In an age when innovative technologies exist to help cure the ills of the medical-device industry, such measures are no more than a bandage solution that doesn’t cover the source of the malady: lack of visibility and transparency in the supply chain.
Supply chain traceability technologies can and need to play a key role in overseeing, improving and assuring the quality of medical devices, just as it can and does for pharmaceutical products. By tracking individual devices throughout their life cycle, traceability makes it possible for all stakeholders at every step along the supply chain—from the manufacturer to the healthcare provider to the patient—to know everything there is to know about any given device, anywhere in the world.
The U.S. FDA is on the right track with the introduction of unique identifiers, but it needs to take the next and crucial step: mandatory serialization for all medical implants and other high-risk devices. This is the first step in the traceability process. By requiring that all implants and their components carry a unique, scannable barcode, containing actionable data stored in a centralized database, legislators open the door to traceability and the incredible wealth of information it can generate. It is crucial to know whether a medical device is defective, but traceability technologies can also tell us what the components are, who manufactured it, when and where, as well as how it was handled and stored.
End-to-end traceability, the capacity to trace individual items from raw materials to the end user and beyond, goes even further. For instance, traceability can tell us exactly where along the supply chain an individual device or component is at any given time, so we know if it has been stolen, damaged, diverted or otherwise compromised.
Traceability also helps healthcare institutions manage their inventory and allows surgeons and doctors to know the full pedigree of the medical devices they are implanting in their patients. Should a device be recalled, a traceability solution will alert the user at any stage of the supply chain, eliminating a potentially dangerous or even lethal situation before it occurs.
Another technology, vision inspection, gives us the capacity prevent packaging and/or labeling errors—the source of more than half of all FDA medical-device recalls since 2014—while traceability enables faster, more efficient recalls.
The FDA states that “as medical devices become increasingly complex, it’s important that they meet the latest standards for cybersecurity, interoperability, biocompatibility and usability engineering.”
Today’s supply chains are also increasingly complex, and most are ineffective due to a lack of visibility and transparency. Traceability is the solution and the driver of more intelligent supply chains. It’s the cure the medical-device industry needs now to ensure a healthier future for all.
We have the technology to fix the problem, but like a book that sits unread on a shelf, it’s useless if we don’t use it. The U.S. FDA and global regulatory authorities are in a unique position to take a giant step forward to protect a vulnerable public from further harm, and to influence governments around the world to do the same.
We challenge them to take that step now.
Industry Leader, Medical Devices