The RN in the OR plays a critical p...

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

REGULATIONS

generally received 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 design of these regulations is to make secure 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 incident that it is found to perplex serious health risks. Manufacturers are responsible for adequately implementing tracking courses 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 material part 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 hearthstone 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 unforeseen catastrophic failure,

* likelihood of significant adverse clinical issue and

* ne for alert professional intervention.

generally the following devices must be tracked according to manufacturers:

* temporomandibular joint prostheses,

* glenoid fossa prostheses,

* mandibular condyle prostheses,

* implantable pacemaker measured [i]or[/i] regular beat generators,

* cardiovascular permanent implantable pacemaker electrodes

* replacement heart valves (mechanical only)

* automatic implantable cardioverters/defibrillators,

* implantable cerebellar stimulators,

* implantable diaphragmatic/ phrenic courage stimulators,

* implantable infusion pumps

* dura mater, and

* abdominal aortic aneurysm grafts.

Items used outside a user facility that must be tracked include

* breathing oftenness monitors,

* continuous ventilators,

* ventricular bypass assist devices,

* direct generally received defibrillators and paddles, and

* infusion cross-examines (electromechanical only).

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

TRACKING SYSTEMS

The FDA requires manufacturers to establish and maintain a written standard operating course related to tracking devices, quality direction and audit procedures. Regardless of the tracking rule 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 from a nonuser facility that are intended for use.

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

* immediately after receipt of implants,

* on implantation, and

* with explantation or other permanent disposal.

Information that must be bring togethered at the point of care includes device identification (eg apportionment batch, model number, serial number); the date the device was shipped by dint of 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 turn backed to the manufacturer, permanently retired from use, or otherwise disposed of permanently must be provided as well. (2)

forward 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 actions to ensure that the correct information is garner uped and reported. To increase compliance with these requirements, the same staff members consistently should perform these duties. Furthermore, there should be a proces to monitor compliance with these policies and operations on a regular basis.

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