The Healthcare and The Food and Drug Administration Corporation on The a Home-use Medical Devices

Since time immemorial, health care for patients has relied heavily on the effectiveness of medical devices. The Food & Drug Administration(FDA) Corporation defines ahome-use medical device as one that is designed for users in a nonclinical or transitory environment managed partly or wholly by the user (American Nurses Association, 2006). Medical devices include simple items such as tongue depressors, ventilators etcetera.At present, much of the health care facilitation has moved from the hospital setting to the home environment. According to Dressler, (1988), the use of advanced medical technologies in homeshas been rising steadily and this trend is expected to escalate rapidly in the future.

The shift to health care services for recuperation and long-term care has made the use of medical devices absolutely indispensable!In the United States, there are more than 7 million people under home health care. According to (Dumais, 2003), complex medical devices are frequently used in homes and unfortunately, they areoften utilized inappropriately!Most care givers do not possess prior knowledge required to handle home medical devices and this has made operation and maintenance of these devicesdaunting!Eventualities such as device faults, user error, environment eventualities, and electromagnetic interferences resulting from mishandling these devices have resulted in grievous aftermaths! Since 1997, the U.S. Food & Drug Administration has reported over 20,000 adverse incidents arising out of mishandling medical devices (American Nurses Association, 2006). In a survey conducted by National Home Hospice Care, it was found out that approximately 1.4 million patients were receiving home health care services from about 7,200 agencies. In view of these rising issues, the international regulatory community and the medical devices industry has undertaken initiatives to enhance home care.

A significant portion of the U.S. population with chronic diseases dependson daily home medical care. Additionally, patients discharged from the hospital continue with their medication at home and without appropriate medical homecare, they stand to suffer immensely! Apart from being cost effective, medical devices are indeed convenient and effective. Telemedicine and wireless monitoring devices for example, have made it possible for healthcare providers to observe and communicate with home care recipients remotely. Robotics and electronics on the other hand have permitted the use of automated delivery of care with less need for the intervention of a medical professional (Konecny, 2003).

As a home medical device user, it is indispensable to ensure that your home medical device functionsproperly and that you are capable of handling it when eventualities arise! FDA acknowledges the importance of safe, high-quality home healthcare and medical devices capable of meeting patients’ needs at home (Rowell, 2003). To support the safe use of medical devices at home, FDA urges home device users to always ensure that they properly understand how devices work. As a precautionary measure, reading manuals before using a device is encouraged. Routine safety checks such as looking for signs of damage in power cables and adjusting device settings to match manufacturer’s instructionsis required! One should spend quality time educating family members and caregivers on the usage of home devices and ensure that a back-up is in place in the event of an emergency (Haghenbeck, 2005). In case one requiresadditional training on the usage of a device, one should contact a qualified healthcare professional. Manufacturers of medical equipment should nevertheless undertake the initiative of educating the public on how to use medical devices and ensure that the devices are always labeled before they are sold.