Phases in the lifespan of a medical device

The major phases in the lifespan of a medical device include conception and development, manufacture, packaging and labeling, advertising, sale, use, and disposal, with each phase containing many different activities that may have an effect on the safety and performance of the device. Examples of how each phase can create health hazards are described below. 

Advertising has the potential to create expectations and powerfiiUy influence the belief in a medical device s capabiUties. It is important, therefore, that medical device marketing and advertising are regulated to prevent misrepresentation of a device and its performance. Misleading or fraudulent advertising of medical devices may increase sales but from the buyer s perspective, the purchase of an inappropriate medical device is a waste of money that may deprive the patient of more appropriate treatment and could lead to patient or user injury. 

The sale of medical devices is a critical stage that leads to a device being put into actual use. If the vendor is not subjected to regulation, there is a high risk of exposing the public to low-quality or ineffective devices. 

Disposal of certain types of devices should follow specific and stringent safety rules. For example, devices that are contaminated after use (e.g., syringes) or those that 

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In general, it is people who manage each phase in the lifespan of a medical device, and these people should be identified and called on to participate in ensnring device safety. Several different groups of people are involved in the commercial process of delivering a medical device to its final user. The role of each participant in ensnring product safety is described below. 

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