On the heels of the Implant Files report—an investigation by a group of journalists into flawed medical devices that led to the injury and death of patients—Simon Bastarache, Industry Leader, Medical Devices, at the Optel Group posted an article detailing how supply chain traceability could improve the safety of medical devices. “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,” writes Bastarache on the Optel Group website.
Headquartered in the city of Québec, Optel develops traceability systems for the healthcare and other industries.
Bastarache acknowledges that FDA has announced some changes that have the potential to improve device safety. In PlasticsToday, we reported on proposed modifications to the 510(k) approval process, which allows new low- to medium-risk devices to be placed on the market if they can show substantial equivalence to an existing device. Currently, some of those predicate devices are decades-old. The agency is considering making public on its website cleared devices that have demonstrated substantial equivalence to devices that are more than 10 years old as the “starting point” of a broader overhaul of the regulatory process. FDA is also phasing in a system of unique device identification, notes Bastarache.
“Will this be enough?” he asks in his article. “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,” writes Bastarache. “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.”
Adopting end-to-end traceability technologies—assigning unique identification codes to each item, from the raw materials to the finished device, and tracking them—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,” explains Bastarache. Traceability is a useful tool once the device has entered the marketplace but it doesn’t address the issues raised by the Implant Files report regarding transparency of the regulatory process and a lack of sufficient oversight and testing before the device reaches the market. Yes, transparency and traceability are two separate issues, recognizes Bastarache, but they are complementary, he told PlasticsToday.
“When we talk about transparency, we’re talking about clinical tests, product approval, inherent risks, etc. Improving medical device safety at this early stage, before a product enters the market, requires improved standards and surveillance by regulatory agencies. Even so, it’s impossible to prevent all adverse events at this stage,” said Bastarache.
End-to-end traceability “helps improve public safety by gathering granular data on the who, what, where, when and how of the product’s life cycle,” continued Bastarache. “This extremely detailed data allows organizations to better manage recalls and fight counterfeiting by telling them exactly where a product is, what condition it’s in at every step of the supply chain, right up to the end user. One of the issues that was brought to light by the Implant Files was the challenge of locating patients who had received recalled implants. End-to-end traceability solves that problem.”
Optel has been developing serialization technologies for almost 30 years, and has been increasingly designing systems for the pharma industry over the last 12 years, as global regulations have multiplied. While several medical device manufacturers currently use serialization and traceability technologies to combat counterfeiting and improve visibility into the supply chain, “no regulation is in place to force them to implement serialization and traceability solutions, [making] the process slow,” says Bastarache.
“Today’s supply chains are increasingly complex, and most are ineffective due to a lack of visibility and transparency,” adds Bastarache. “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.”