In the realm of healthcare, patients have a fundamental right to transparency and information regarding the procedures they undergo particularly with respect to medical devices used for surgical procedures. One often overlooks the aspect of this right which is the traceability labels for medical devices used in surgical procedures regardless of whether the device is permanent or not. These labels, containing vital information about the product and its manufacturer, are crucial for patient safety and empowerment. Medical device traceability fulfills the aim of verifying pharmaceutical companies, who supply these devices, are compliant with legal and regulatory requirements. This reassures users that the devices are safe to use, and addresses risk minimization with respect to the use of these devices. Regulatory agencies encourage patient’s rights to medical device traceability labeling. For example, ANVISA’s notice and current guideline outlines that the it is “mandatory to provide at least three traceability labels”.
Demanding Your Right
First and foremost, it’s imperative for patients to advocate for themselves and demand transparency regarding the products implanted during surgical procedures. Whether it’s a cardiac device, orthopedic implant, dental fixture, or any other medical device, a patient has the right to know the specifics. Even if the implant is not permanent, you can still inquire about crucial information through device labels that include device registration number, codes, batch details, and manufacturer details.
Understanding Traceability Labels
The medical device traceability label is a comprehensive document containing essential data such as registration number, codes, model description, batch, and legal manufacturer/importer details. It is distinct from the label or instructions for use and must be affixed to the product packaging. One of the traceability labels should be provided to the patient or guardian post-surgery.
Traceability labels correspond to the official identification document for medical devices- similar to a National Identity Card of ANIVSA,. The document contains product and manufacturer data, enabling the consultation of the entire manufacturing history if needed, from raw material origin to finished product.
It’s essential to differentiate traceability labels from other documentation. They should not be confused with labels or instructions for use found on product packaging. These labels serve as additional documentation that must accompany the product. Patients should expect to receive one traceability label after a surgical procedure, akin to an official identification document.
The Importance of Traceability
At the heart of the matter lies patient safety. With concerns about the risks associated with medical devices, it’s crucial to ensure that manufacturers comply with legal requirements and adhere to good manufacturing practices. Traceability labels play a pivotal role in ensuring patient safety and regulatory compliance. They allow for:
- Verification of compliance with legal requirements: Inspections conducted during device registration processes ensure adherence to good manufacturing practices and regulatory standards.
- Prompt action in case of adverse events: In the event of technical complaints or adverse events, traceability labels facilitate swift intervention by regulatory agencies and manufacturers.
Conclusion
In the landscape of healthcare, information is power. It is essential for patients to recognize and exercise their rights, including the right to access crucial information about the medical devices implanted within them. By advocating for the receipt of traceability labels, patients (and users) not only assert their fundamental rights but also contribute to a safer and more transparent healthcare system. So, the next time you undergo a surgical procedure, remember to ask for your traceability label—it’s your right.
DDReg provides end-to-end regulatory services and safety solutions for medical devices. Reach out to the experts for more information. Read more about medical devices here: Streamlining Clinical Investigations for Medical Devices.