Devices that consumers use on their own, such as bed bars, breast pumps, contact lenses, hearing aids, sharp objects (needles and syringes), electronic muscle stimulators, and artificial pancreas device systems. In short, while medical supplies and medical equipment are an integral part of health care, they serve different functions. Medical supplies are consumable and often disposable items that aid in the care and treatment of patients, while medical equipment refers to more durable and complex devices used for the diagnosis, monitoring and long-term care of patients. Understanding the difference between these two types of medical devices can lead to better management of medical resources, safer patient care and smarter decision-making.
Whether you're storing medical supplies for a home care environment or investing in medical equipment for a health facility, this knowledge can make a difference in ensuring quality healthcare services. Medical devices range from simple lingual and urinary depressors to complex programmable pacemakers and closed circuit artificial pancreas systems. In addition, medical devices include in vitro diagnostic (IVD) products, such as reagents, test kits, and blood glucose meters. Some radiation-emitting electronic products that have a medical use or that have medical properties are also considered medical devices.
Examples of these include diagnostic ultrasound products, X-ray machines, and medical lasers. Durable medical equipment is equipment that can withstand repeated use (see A. Below) and that is primarily and routinely used for medical purposes (see B. Below) and is generally not useful to a person if there is no illness or injury (see B.
Below, and is suitable for use in the home. A medical device can be any instrument, apparatus, utensil, machine, apparatus, implant, reagent for in vitro use, software, material, or other similar or related article, intended by the manufacturer to be used, alone or in combination, for medical purposes. A medical device is any device intended to be used for medical purposes. The use of a device for medical purposes involves significant potential for danger and, therefore, medical devices must be demonstrated to be safe and effective with reasonable guarantees before regulatory governments allow the device to be marketed in their country. As a general rule, as the risk associated with the device increases, so does the amount of tests needed to establish safety and efficacy.
In addition, as the associated risk increases, the potential benefit to the patient must also increase. Medical supplies refer to clinical tools and equipment used in healthcare, including devices for dental, muscular and ophthalmic purposes, as well as instruments for research centers. Equipment that basically performs functions of comfort or convenience or that is primarily intended for the comfort of the person caring for the patient, such as elevators, stair lifts, postural chairs and lift chairs with cushions, do not constitute medical equipment. If you live in an area that has been declared a disaster or emergency, the usual rules for your healthcare may change for a short time.
Equipment that is primarily and commonly used for non-medical purposes will not be considered “medical equipment” (charged for the payment of the program), even if it has some remote use related to medicine. Understanding the difference between medical supplies and medical equipment can have a significant impact on patient care, health facility management, and personal healthcare decisions. Medicare Part B (health insurance) covers medically necessary DME if your doctor or other health care provider enrolled in Medicare prescribes it for use in your home. The carrier's medical personnel determine if the appliance specified in the claim is appropriate for domestic use.
Medical devices are used in very diverse environments, for example, by non-specialized people at home, by paramedical personnel and doctors in remote clinics, by opticians and dentists and by health professionals in advanced medical centers, for prevention and detection and for palliative care. We determine if the equipment serves medical purposes within the home when we determine if the equipment is DME for Medicare purposes. The WHO “global regulatory framework model for medical devices”, including in vitro diagnostic medical devices, helps member states to develop and implement regulatory controls and regional guidelines for good manufacturing to ensure the quality, safety and efficacy of medical devices available in their countries. Understanding the difference between medical supplies and medical equipment can help you make informed decisions for healthcare needs.
If a device is determined to be DME for use by a person with Medicare in their home, the person can also use the equipment outside their home. Member States recognized in resolutions WHA60, 29 (200) and WHA 67.20 (201) of the World Health Assembly (AMS) that medical devices are indispensable for the provision of health services, but that their selection, regulation and use present enormous challenges, especially for low and middle income countries (LMIC). Medical devices are used for the prevention, diagnosis and treatment of diseases and for rehabilitation. The DME must be appropriate for use in the home (see 42 CFR 414,202 and Chapter 15, Section 110.1, of the Medicare Benefit Policy Manual (CMS Pub. Any national health plan requires policies, strategies and action plans for health technologies, specifically for medical devices.
