To ensure the safety of patients is a top priority, manufacturers and healthcare providers must have systems in place regarding tracking devices for hospital equipment.
Medical device traceability ensures that medical devices and the materials they’re manufactured with can be tracked from prototyping and manufacturing to end-use in a healthcare setting. The goal is to improve patient care and safety by helping reduce the risk of counterfeit or faulty products entering the supply chain. Traceability also helps healthcare providers act quickly and efficiently in the event of a recall or other issues.
There are several different types of regulations that apply to different regions, countries, and manufacturers. In general, they govern how companies should label their products, as well as processes for serializing devices so they can be easily identified.
The U.S. has its own set of medical device traceability requirements known as Unique Device Identification (UDI) regulations, which require class I and unclassified medical devices marketed in the U.S. to have a unique identifier (barcode or RFID tag) that can help link the device back to the manufacturer of record and other information about its production history.
According to the FDA, their staff has discretion to order manufacturers to initiate a program to track their devices down to the patient level. The types subject to a tracking order include any Class II or Class III device that may:
- Have serious adverse health consequences;
- Be implanted in the human body for more than one year; or
- Be intended to be a life sustaining or life supporting device used outside a device user facility.
The FDA states that manufacturers who receive a tracking order are required to establish a written standard operating procedure (SOP) with details regarding a method for following the device throughout distribution and a quality assurance program that includes auditing procedures.
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The FDA has issued tracking orders to manufacturers of the following devices:
- An automated, external, and wearable defibrillator
- A permanent pacemaker, its battery, pulse generator, and lead adapter
- A mechanical heart valve
- A non-life-supporting, continuous ventilator
How Do You Know if a Device Must Be Tracked?
When a new device receives FDA clearance or approval for marketing, it’s added to their tracked devices list. At that point, they will issue tracking orders to the manufacturer to confirm the tracking requirements for that device. It’s important to note that no obligations exist unless orders have been issued.
What Medical Device Tracking Method Should My Manufacturer Use?
It’s important to understand that different manufacturers may have different tracking methods and procedures. The most important thing is that their system provides the necessary information that meets FDA regulations, demonstrating that their products are safe and up to standard.
What’s the Goal of the Manufacturer’s Tracking Method?
Manufacturers have three working days to provide critical information about a device that has not yet been distributed to a patient, including its exact location and status in the distribution process. For those already given out, manufacturers have 10 working days to give the same information.
These tracking requirements improve patient safety by making sure manufacturers can respond quickly to any potential issues and take corrective action. Additionally, detailed tracking information will also help medical personnel identify which patients are using which certain devices and track any changes in their medical condition.
Can a Medical Device Registry Satisfy Tracking Program Requirements?
If a registry collects the information required by the Code of Federal Regulations (CFR) 21, then it can be used to manage a device firm’s tracking program. It’s the manufacturer’s responsibility to ensure that they are in compliance with the requirements set forth by the CFR.
What Are the Auditing Requirements?
To avoid the challenge of a recall, manufacturers should perform audits of their tracking methods at least every six months for the first three years after receiving tracking orders and annually afterward. The audit should be thorough enough to verify that the method accurately collects the necessary information. It may be conducted on-site or through some other effective way of communication with distributors, professionals, and patients.
Are There Exemptions?
A manufacturer, importer, or distributor may request an exemption in the form of a petition, which should be submitted in compliance with the requirements of 21 CFR 10.30. For devices with an approved premarket approval (PMA) that are also subject to a tracking order, the need for continued tracking may be reassessed, at the sponsor’s request or by the Agency’s initiative, 10 years from the date of the original PMA’s approval.
As an experienced manufacturer, Remington Medical can help you navigate the murky waters of medical device tracking regulations. When you partner with us, we’re notified immediately during the premarket submission process if your device was flagged by the FDA to be tracked, allowing us to take care of all the requirements on your behalf. Contact us today to learn more.
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