Background Information Or Related Documents:
Medical devices can range from walking sticks to bone cement to pacemakers to in-vitro diagnostic kits. The range is broad and complex. Examples include surgical sutures, bandages, blood bags, irrigation solutions intended for mechanical rinsing, X-ray equipment, drug delivery pumps, HIV test kits, pregnancy test kits.
Under the Medical Devices Directive 93/42/EEC and the In-vitro Diagnostic Medical Devices Directive 98/79/EC, a manufacturer is obliged to provide adequate information that ensures the safe use of his device.
This information is usually provided in the format of either instructions for use (IFU) or the operating manual or in some cases both.
The instructions for use is therefore a key tool that professional users should use to determine the:
- intended purpose of the device
- functioning, calibration and operation of the device
- management of the device
- commissioning of the equipment e.g. imaging and laboratory equipment
- repair and maintenance
- sterilisation or decontamination e.g. endoscopes
- storage e.g. heat or light sensitive devices
- decommissioning
- limitations of the device
- performance characteristics
The instructions for use are also a valuable reference guide or training tool for staff. Staff using a device for the first time should read and understand the IFU prior to using the device. While this puts extra demands on the health care system it is essential in the interest of patient safety.
Inappropriate device use and inappropriate device management can result when the instructions for use are not adequately examined.
Instructions for Use provided by the Medical Device Manufacturer Document