What are retail or prescribed medical devices?

Retail or prescribed medical devices are also sometimes called home health devices or home medical services. These are products used by a sick or disabled individual manage their medical condition. These devices may be used at the direction and under the care of a physician or physical therapist, or they may be purchased over-the-counter by the patient.

Prescription medical devices may only be used under the supervision of authorized personnel, and such authorization is usually documented by a prescription. Licensed practitioners may include a doctor, dentist, optometrist or veterinarian.

Examples of prescription medical devices include various prostheses, ventilators, apnea monitors, respiratory disease management services, sickle cell tests, and ultrasound monitors. In some jurisdictions, hypodermic syringes may fall under this classification. In other areas they are a special class of their own and regulated separately.

Other medical devices are available in retail stores such as drugstores and stores specializing in home health equipment. These may include products such as safety equipment for the bath, incontinence supplies, lift chairs, orthopedics, reading glasses, scooters and accessories, hearing aids, specialty wound care products and other similar devices. Patients may be able to obtain these items without a prescription, but they may seek the advice of a pharmacist or technician for assistance and instruction for use.

What are the risks from defective medical devices?

The manufacturers of medical devices have a responsibility to test their products for safety before they are provided to people and to alert consumers immediately if a problem with their product becomes apparent. Defective medical devices may cause serious permanent injury or even death.

What can I do?

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