Medical Device Tracking Requirements
- The FDA requires manufacturers to track medical devices.medical equipment image by Chad McDermott from Fotolia.com
The Food and Drug Administration requires medical device manufacturers to use a tracking method to monitor the location of the devices. The requirements are in place to aid in a federal recall of the devices. The tracking system allows manufacturers to find devices that are located in hospitals or clinics as well as devices that have been implanted in patients. - The devices that must be tracked by medical device manufacturers include those devices that doctors implant into the body, which are meant to stay implanted for a minimum of one year. The FDA also requires tracking of devices that are life supporting and that are used outside of a hospital or facility. The types of devices tracked are those that could cause an adverse health problem if the device fails.
Examples of implanted devices that must be tracked according to the FDA standards include silicone gel breast implants, implantable infusion pumps, implantable pacemaker pulse generator, implantable cardioverter defibrillator, TMJ prosthesis and abdominal aortic aneurysm stent grafts. Examples of devices that are used outside of the body and outside of a medical facility include breathing monitors, continuous ventilators and DC-defibrillators and paddles. - The FDA requires device manufacturers to develop a tracking method or standard operating procedure in writing that meets tracking requirements. The tracking method must follow the device though the manufacturing process and distribution of the device to medical facilities. The final location of these devices must be provided to the manufacturer by the distributor and include patient information. Patients have the option to refuse to release their information when receiving a device that meets the standards for tracking.
- Manufacturers and distributors that maintain records of tracked medical devices must allow audits by the FDA to review the records and tracking procedure. The manufacturer and distributor are required to maintain records of devices for its lifetime. Records of medical devices do not have to be kept if the manufacturer or distributor is aware that the device is no longer in use by removal from the body, returned or the patient with the device has died.
- Manufacturers must be able to provide the FDA with information within three days for devices that have not been tracked to a patient. The FDA requires the name, address and telephone number of the distributor and the location of the device. Within 10 working days, the manufacturer must be able to provide the FDA with information regarding patients who have received the device.
The records must contain information such as a serial number or identifier for the device. Manufacturers must include information such as the date of shipment. Tracking records should contain the name, address, Social Security number and telephone number of patients receiving the device. There should also be information regarding the physician who implanted the medical device. In the case of devices that have been removed or returned, the manufacturer must maintain information such as the date of explantation and return to the manufacturing facility.
Device manufacturers and distributors must conduct audits of the tracking system every six months to ensure the process works for the first three years the device is in distribution. Devices in distribution longer than three years are required to undergo audits a minimum of once per year.
