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  1. Digital Health Center of Excellence

Wireless Medical Devices

Description

Radio frequency (RF) wireless medical devices perform at least one function that utilizes wireless RF communication such as Wi-Fi, Bluetooth, and cellular/mobile phone to support health care delivery. Examples of functions that can utilize wireless technology include controlling and programming a medical device, monitoring patients remotely, or transferring patient data from the medical device to another platform such as a cell phone. As RF wireless technology continues to evolve, this technology will increasingly be incorporated into the design of medical devices.

Examples of areas 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 Frequency (RF) spectrum within which RF wireless technologies operate. The FDA’s policies on wireless medical devices are coordinated with the FCC and provide medical device manufacturers with more predictability and a better understanding of regulatory requirements for medical devices that utilize these technologies.

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

All types of wireless technology face challenges coexisting in the same space. Mobile wireless equipment can transmit using either licensed radio spectrum or on an unlicensed basis in specified frequency bands. Licensed spectrum allows for exclusive, and in some cases non-exclusive, use of particular frequencies or channels in particular locations. Unlicensed radio frequency devices operating under FCC Part 15 rules are subject to the conditions that no “harmful interference” is caused and any interference from primary users of the frequency band must be accepted.

The FDA recommends that you periodically consult the FCC website for new specifications and updated information.

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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 seniors, through home monitoring of chronic diseases so that changes can be detected earlier before more serious consequences occur.

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Information for Patients

The use of RF wireless technology can translate to advances in health care, and patients should be informed about the safe and effective use of these devices in the course of daily life.

Because the airways are shared, the functioning of your wireless medical device may be affected (such as data loss or disruption) by other wireless devices near you. As with any medical device, if you have problems or questions, please consult the information provided by the manufacturer or contact your health care provider.

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Information for Health Care Facilities: Risk Management

Most well-designed and maintained RF wireless medical devices perform adequately.  However, the increasingly crowded RF environment and competition from non-medical wireless technology users could impact the performance of RF wireless medical devices. FDA recommends that health care facilities develop appropriate processes and procedures to assess and manage risks associated with the integration of RF wireless technology into medical systems.

Health care facilities should also consider the following:

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

The following FDA recognized standards can provide useful information:

In addition, the FDA recommends that health care facilities periodically consult the FCC website for new specifications and updated information that may affect their wireless infrastructure.  

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 provides recommendations to develop and support safe and effective wireless medical devices. Medical device manufacturers are encouraged to read this guidance, and review related recognized standards and guidance documents to help in the development, testing, regulatory submission and use of wirelessly enabled medical devices.

The FDA recommends that manufacturers 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.

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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RF Wireless Coexistence Challenges

All wireless technologies 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 Association for the Advancement of Medical Instrumentation (AAMI) TIR 69 - Risk Management of Radio-frequency Wireless Coexistence for Medical Devices and Systems and American National Standards Institute (ANSI) C63.27: Standard for Evaluation of Wireless Coexistence discuss testing and risk management for wireless medical device coexistence.

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Regulations

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

Through federal law, the FDA has formally recognized several consensus 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 FDA's Standards Program (Medical Devices).

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FDA Recognized Standards Related to Wireless Medical Devices

Below are several recognized standards related to RF wireless medical devices. For more information on recognized standards, go to the FDA Recognized Consensus Standards database.

Standards for risk management of IT Networks incorporating medical devices:

In addition, there are standards on electromagnetic compatibility (EMC) that relate to wireless medical devices:

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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Additional Information



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