MedRadio
   HOME

TheInfoList



OR:

The Medical Device Radiocommunications Service (MedRadio) is a specification and communication spectrum created for and set aside by the U.S.
Federal Communications Commission The Federal Communications Commission (FCC) is an independent agency of the United States federal government that regulates communications by radio, television, wire, satellite, and cable across the United States. The FCC maintains jurisdiction ...
(FCC) for the communication needs of diagnostic and therapeutic
medical implants An implant is a medical device manufactured to replace a missing biological structure, support a damaged biological structure, or enhance an existing biological structure. Medical implants are man-made devices, in contrast to a transplant, whi ...
and body-worn
medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
s. Devices operating on MedRadio include
cardiac pacemaker 350px, Image showing the cardiac pacemaker or SA node, the primary pacemaker within the electrical_conduction_system_of_the_heart">SA_node,_the_primary_pacemaker_within_the_electrical_conduction_system_of_the_heart. The_muscle_contraction.htm ...
s,
defibrillator Defibrillation is a treatment for life-threatening cardiac arrhythmias, specifically ventricular fibrillation (V-Fib) and non-perfusing ventricular tachycardia (V-Tach). A defibrillator delivers a dose of electric current (often called a ''coun ...
s, neuromuscular stimulators, and drug delivery systems. , communications spectrum for these and other similar devices is set aside at various points in the 400
MHz The hertz (symbol: Hz) is the unit of frequency in the International System of Units (SI), equivalent to one event (or cycle) per second. The hertz is an SI derived unit whose expression in terms of SI base units is sāˆ’1, meaning that one he ...
frequency Frequency is the number of occurrences of a repeating event per unit of time. It is also occasionally referred to as ''temporal frequency'' for clarity, and is distinct from ''angular frequency''. Frequency is measured in hertz (Hz) which is eq ...
band, as well as the 2360-2400 MHz band, though specifically for medical body area network (MBAN) devices. The specification supersedes and incorporates a previous specification called the Medical Implant Communication Service (MICS). The specification and nearly identical spectrum have also been created by the
European Telecommunications Standards Institute The European Telecommunications Standards Institute (ETSI) is an independent, not-for-profit, standardization organization in the field of Information and communications technology, information and communications. ETSI supports the developmen ...
(ETSI), with the specification largely referred to as MICS/MEDS (Medical Data Service) in Europe and other parts of the world.


History

The FCC created the Medical Implant Communication Service (MICS) in 1999 "in response to a petition for rule making by edtronic, Inc.to permit use of a mobile radio device, implanted in a patient, for transmitting data in support of the diagnostic and/or therapeutic functions associated with an implanted medical device." This set aside the 402ā€“405 MHz band and designated a low maximum transmit power,
EIRP Effective radiated power (ERP), synonymous with equivalent radiated power, is an IEEE standardized definition of directional radio frequency (RF) power, such as that emitted by a radio transmitter. It is the total power in watts that would hav ...
=25 microwatt, in order to reduce the risk of interfering with other users of the same band. Ten channels of 300 kHz each were assigned to the
bandwidth Bandwidth commonly refers to: * Bandwidth (signal processing) or ''analog bandwidth'', ''frequency bandwidth'', or ''radio bandwidth'', a measure of the width of a frequency range * Bandwidth (computing), the rate of data transfer, bit rate or thr ...
. MICS provided additional flexibility to medical device developers compared to previously used inductive technologies, which required the external
transceiver In radio communication, a transceiver is an electronic device which is a combination of a radio ''trans''mitter and a re''ceiver'', hence the name. It can both transmit and receive radio waves using an antenna, for communication purposes. The ...
to touch the skin of the patient. MICS was later adopted by the ETSI in 2002. In 2006, the FCC reevaluated the spectrum requirements at the prompting of Medtronic, which sought to expand the spectrum "to support advances in medical sensor technology and the expected proliferation of such devices, especially those used for lower-cost medical monitoring and non-emergency reporting applications." A similar process was initiated by the ETSI in Europe in July 2004, with both the FCC and ETSI considering the 401ā€“402 and 405ā€“406 MHz ranges. The ETSI formalized the proposal into a standard called MEDS (with the core MICS bands remaining under that name and the new "wing" bands being referred to as MEDS) in December 2007, while the FCC added the same additional spectrum to MICS and dubbed the expanded plan the Medical Device Radiocommunications Service or MedRadio in May 2009. The FCC expanded MedRadio's spectrum again in November 2011, adding 24 megahertz in the 413-419 MHz, 426-432 MHz, 438-444 MHz, and 451-457 MHz ranges as part of an "effort to recognize and facilitate the significant advances in wireless medical technologies that are revolutionizing treatment for a wide variety of medical conditions." The FCC allocated additional spectrum (2360-2400 MHz) specifically for MBAN devices in May 2012, effective on October 10, citing "significant public interest benefits associated with the development and deployment" of MBAN devices. Additional modifications to the MBAN rules were released in August 2014, including the "narrowing fthe definition of health care facilities that may use MBAN devices in the 2360-2390 MHz band" and relaxing MBAN network topology restrictions among others.


Operational parameters

In the United States, the FCC states that: * MedRadio devices can only be operated by an authorized health care providers such as a
physician A physician (American English), medical practitioner (Commonwealth English), medical doctor, or simply doctor, is a health professional who practices medicine, which is concerned with promoting, maintaining or restoring health through th ...
or legally authorized entity able "to provide health care services using medical implant devices"; * MedRadio device manufacturers and representatives can only operate the device "for the purpose of demonstrating, installing and maintaining the equipment" for authorized health care providers; and * MedRadio devices are only "authorized on a secondary status" and must accept any interference created by devices of primary status. Operational parameters in other parts of the world may vary slightly based on local law. In Canada, for example, devices that fall under the MEDS standard also fall under secondary status, but they are classified nationally as Category I equipment that require a technical acceptance certificate (TAC) or equally recognized certificate before they can be used.


See also

*
Wireless Medical Telemetry Service Wireless Medical Telemetry Service (WMTS) is a wireless service specifically defined in the United States by the Federal Communications Commission (FCC) for transmission of data related to a patient's health (biotelemetry). It was created in 2000 b ...


References

{{reflist, 33em Bandplans Implants (medicine) Regulation of medical devices Radio regulations Regulation in the United States