Thursday, June 7, 2012
A medical device is distinguished from a drug or biologic in that it does not achieve its primary intended purpose through chemical action. The FDC Act definition states that an in vitro reagent, which is a chemical agent used for an in vitro diagnostic reaction, is a medical device.
In the current dispensation, many of the devices which are used within the healthcare system are technically advanced. This means that patients benefit more. It is quite unfortunate that in some circumstances workers are often forced to use these devices without having a thorough understanding of how they work. Healthcare professionals need to accept the fact that there is a need to learn about these gadgets that are used in the healthcare profession.
To be able to use these devices with confidence and avoid the feeling of uncertainty, (which could also make the patent to feel anxious), staff must be aware of their responsibilities. Essentially, each country has its code of directives which stipulates on the guidelines to be followed when working with these devices.
There are various devices which are in use in the medical field. These are generally used in direct contact with the patient. Examples of these devices are the passive implantable products which include the prostheses and cardiac valves. In addition, the X-ray equipment, as well as the large group of low risk products that are being used within the healthcare system are also listed in these categories. The division of these devices into groups benefits many people. For instance, it benefits all the parties in the medical field. These parties include the healthcare personnel, the patients and the manufacturers of these devices. In order to ensure that the work is eased, the manufacturer must specify for what specific use the product is intended. If the product is used for a different purpose, the manufacturer ceases to have liability.
Before a medical device is ordered and used, the requirements should be analysed. This analysis should result in a requirement specification which consists of a list of desired performance features. It is crucial that the intended use is specified. If this is not clearly specified, it may later be impossible to claim that the device is not fulfilling the desired requirements. The degree of communication is very important especially with regard to medical devices. A line of communication has to be established, whereby the facility director is informed whether the devices which are being used comply with all the requirements regarding their suitability.