Medical Devices

Wireless Medical Devices


Description

Radio frequency (RF) wireless medical devices perform at least one function that utilizes wireless RF communication to support health care delivery. Examples of functions that can utilize wireless include transferring patient data from the device to another source, device control and programming, and monitoring patients remotely. As this technology continues to evolve, it is increasingly incorporated in the design of medical devices.

Examples of the technologies that utilize RF wireless technology include:

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Coordination with Federal Communications Commission (FCC)

The Federal Communications Commission (FCC) oversees the use of the public radio (RF) spectrum within which RF wireless technologies operate. The FDA coordinates our policies on wireless medical device with the FCC to improve government efficiency in the oversight of broadband and wireless enabled medical devices. Our continued work with the FCC will provide medical devices manufacturers with more predictability and a better understanding of regulatory requirements for medical devices that utilize this technology.

For information on applicable FCC requirements for wireless medical devices, please refer to the following links:

A good summary of the specifications, output power, frequency bands, and international use of several applicable RF wireless technologies can be found in the ISO technical report TR 21730, Health Informatics – Use of mobile wireless communications and computing technology in healthcare facilities – Recommendations for the management of unintentional electromagnetic interference with medical devices (ISO/TR 21730: 2007(E)). disclaimer icon

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Benefits and Risks

Incorporation of wireless technology in medical devices can have many benefits including increasing patient mobility by eliminating wires that tether a patient to a medical bed, providing health care professionals the ability to remotely program devices, and providing the ability of physicians to remotely access and monitor patient data regardless of the location of the patient or physician (hospital, home, office, etc…). These benefits can greatly impact patient outcomes by allowing physicians access to real-time data on patients without the physician physically being in the hospital and allowing real-time adjustment of patient treatment. Remote monitoring can also help special populations such as our seniors, through home monitoring of chronic diseases so that changes can be detect earlier before more serious consequences occur.

As wireless developers and device manufacturers increasingly utilize RF wireless technology, they should consider the following:

  • Selection of wireless technology
  • Quality of service
  • Coexistence
  • Security
  • Electromagnetic Compatibility (EMC)

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Information for Patients

The use of RF wireless technology can translate to advances in health care, but patients should be informed about the safe and effective use of these devices in the course of daily life.
If you are sent home with a RF wireless medical device, talk with your physician or health care provider about any restrictions when it comes to the use of personal computers, cellular phones, or any other personal electronic devices that are commonly used in home environments, as they can interfere with signals coming from medical devices that also use wireless technology. In addition, the home electronic devices can add additional burdens on available wireless capabilities (e.g., bandwidth).

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Information for Health Care Facilities: Risk Management

Most well-designed and maintained RF wireless medical devices perform adequately. But, an increasingly crowded RF environment could impact the performance of RF wireless medical devices, which makes risk management an important part of integrating RF wireless technology into medical systems.

For additional information, please review FDA’s Recommendations for EMC/EMI in Healthcare Facilities.

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Information for Industry: RF Wireless Developers and Manufacturers

Medical devices that incorporate wireless technology introduce some unique risks that should be addressed. The Radio Frequency Wireless Technology in Medical Devices focuses on considerations that should be taken into account to support safe and effective wireless medical devices. Medical device manufacturers are encouraged to read this document to help in the development, testing, regulatory submission and use of wirelessly enabled medical devices.

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RF Wireless Coexistence Challenges

All types of wireless technology face challenges coexisting in the same space. For example, devices operating under FCC Part 15 rules must accept any interference from primary users of the frequency band. (Note: FCC Part 15 is applicable to certain types of low-power, non-licensed radio transmitters and certain types of electronic equipment that emit RF energy unintentionally.)

The FDA recommends that you periodically consult the FCC website for new specifications and updated information. Mobile wireless equipment can also transmit on an unlicensed basis in frequency bands such as the Industrial, Scientific, Medical (ISM) bands. ISM bands include 900 MHz, 2.4 GHz, 5.2 GHz, and 5.8 GHz and are commonly used for cordless phones and wireless data network equipment.

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Regulations

The FDA regulates manufacturers of any electronic product through theElectronic Product Radiation Control (EPRC) and medical device provisions of federal law.

Through federal law, the FDA has formally recognized several standards related to RF wireless medical devices. When manufacturers submit pre-market notification to the FDA for device clearance or approval, declarations of conformity to these standards may eliminate the need for certain safety and effectiveness data. For more information see:

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FDA Recognized Standards

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Other Relevant Standards for Wireless Medical Devices

The IEEE 802.11 family of standards refers to RF, over-the-air interface between a wireless client (such as a medical device) and a base station (or access point) or between two wireless clients. There are several specifications in the 802.11 family, including:

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Industry Guidance and Guides

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Reporting Problems to FDA

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with RF wireless medical devices. We encourage health care providers and patients who suspect a problem or hazardous event to file a voluntary report through MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

Health care personnel employed by facilities that are subject to Reporting Adverse Events (Medical Devices) requirements should follow the reporting procedures established by their facilities.

Manufacturers, distributors, importers, and device user facilities (which include many health care facilities) must notify the FDA immediately upon discovery of any accidental radiation occurrence or radiation safety defect by Reporting Adverse Events (Medical Devices).

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Page Last Updated: 06/12/2014
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