Tracking medical devices to ensure patient safety - Patient Safety First

AORN Journal, Jan, 2003 by Suzanne C. Beyea

The RN in the OR plays a critical role in ensuring patient safety by tracking medical devices. The tracking process is required by the US Congress as outlined in the Safe Medical Device Act of 1990. The US Food and Drug Administration (FDA) is responsible for issuing and enforcing regulations related to tracking certain medical devices.

REGULATIONS

Current FDA regulations require user facilities that implant or explant certain medical devices to submit reports to device manufacturers promptly after devices are received, implanted, or explanted. The overall purpose of these regulations is to ensure that manufacturers of certain devices can locate these devices after they have been distributed commercially. Tracking facilitates issuing notifications and recalls of a particular device in the event that it is found to pose serious health risks. Manufacturers are responsible for adequately implementing tracking methods and ensuring that their distributors, including hospitals, comply with reporting obligations. Devices that must be tracked include

* any item whose failure would be reasonably likely to have serious, adverse health consequences;

* any item that is intended to be implanted in the human body for more than one year; and

* any item that is life sustaining or life supporting and that is used outside a user facility (ie, hospital, nursing home, ambulatory surgery facility, outpatient treatment facility, outpatient diagnostic facility).

In addition, the following factors are considered when determining whether a tracking order should be issued:

* likelihood of sudden, catastrophic failure,

* likelihood of significant adverse clinical outcome, and

* need for prompt professional intervention.

Currently, the following devices must be tracked by manufacturers:

* temporomandibular joint prostheses,

* glenoid fossa prostheses,

* mandibular condyle prostheses,

* implantable pacemaker pulse generators,

* cardiovascular permanent implantable pacemaker electrodes,

* replacement heart valves (mechanical only),

* automatic implantable cardioverters/defibrillators,

* implantable cerebellar stimulators,

* implantable diaphragmatic/ phrenic nerve stimulators,

* implantable infusion pumps,

* dura mater, and

* abdominal aortic aneurysm stent grafts.

Items used outside a user facility that must be tracked include

* breathing frequency monitors,

* continuous ventilators,

* ventricular bypass assist devices,

* direct current defibrillators and paddles, and

* infusion pumps (electromechanical only).

The overall purpose of these regulations is to make certain that manufacturers remove potentially dangerous or defective devices from the market and/or notify patients of serious device-related problems. The FDA uses this tracking system when it must issue mandatory recalls and notify health care professionals and patients of device problems. (1)

TRACKING SYSTEMS

The FDA requires manufacturers to establish and maintain a written standard operating procedure related to tracking devices, quality control, and audit procedures. Regardless of the tracking system, manufacturers must record certain information before distributing medical devices. This includes the distributor's name, address, and telephone number and the device's location. Manufacturers are required to obtain and maintain information regarding any life sustaining or life supporting devices kept by a nonuser facility that are intended for use.

Facilities receiving certain medical devices must report information to manufacturers at three times, including

* upon receipt of implants,

* upon implantation, and

* upon explantation or other permanent disposal.

Information that must be collected at the point of care includes device identification (eg, lot, batch, model number, serial number); the date the device was shipped by the manufacturer; the name, address, telephone number, and social security number of the patient who received the device; the date the device was provided to the patient; and the name, address, and telephone number of the physician caring for the patient, if different than the prescribing physician. If applicable, the date of the device explant; the name, address, and telephone number of the explanting physician; and the date of the patient's death or the date the device was returned to the manufacturer, permanently retired from use, or otherwise disposed of permanently must be provided as well. (2)

On some occasions, implants arrive in the OR from a manufacturer's representative via the surgeon's office or from another hospital. In these instances, it is of critical importance to establish policies and procedures to ensure that the correct information is collected and reported. To increase compliance with these requirements, the same staff members consistently should perform these duties. Furthermore, there should be a process to monitor compliance with these policies and procedures on a regular basis.

An issue of increasing concern is using an individual's social security number for patient identification. Patients should consent to having their social security number used for tracking purposes. The current regulations, however, do not require the patient's written consent for tracking a device or releasing his or her identity to the manufacturer. Under federal regulations, patients do have the right to refuse to have their device(s) tracked. Such refusals should be documented by the product, model, and serial number, and this information should be provided to the manufacturer, who still is required to track the device.