FDA has announced some changes that have the potential to improve medical device safety. Plastics Today 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.
FDA 510 k Clearance & Premarket Approval for Medical Device
Operon Strategist is FDA 510 k process consultant helps the clients to register SBU (Small Business Unit), if applicable. Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities.
On the heels of theImplant 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 medical device safety. “By tracing individual devices throughout their life cycle, identifiable makes it feasible for all partners at each progression along the supply chain—from the manufacturer to the healthcare supplier to the patient—to realize everything there is to know about any random device, anywhere in the world,” writes Bastarache on the Optel Group website.
Headquartered in the city of Québec, Optel develops traceability systems for healthcare and other industries.
“Will this be enough?” he asks in his article.
“不幸的是,没有。提前更改woefu下降lly short of giving the comfort the patients need and deserve about the safety, quality and credibility of the medical devices introduced in their bodies,” composes Bastarache. “During a time when innovative technologies exist to help to heal the ills of the medical device industry, such measures are no more than a bandage solution that doesn’t cover the source of the disease— absence 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 “let us know precisely where along the supply chain an individual device or part is at some random time, so we know whether it has been stolen, harmed, occupied or generally compromised,” clarifies 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 testingbefore设备的意图ches 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 any 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 point by point data that enables organizations to better manage recalls and battle counterfeiting by letting them know precisely where a product is, what condition it’s in at each progression of the supply chain, up to the end-user. One of the issues that were 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 progressively canny supply chains. It’s the solution the medical device industry needs presently to guarantee a more beneficial future for all.”
