Document Category:
State: Alabama
Subject Matter: Wireless Devices
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Comments:

The medical
device industry has gone wireless — as a GAO report from August 2012 and an episode of Homeland
demonstrated last year — and concerns regarding the safety and effectiveness of
wireless medical devices are heightened. As a result, FDA has finally released Guidance that:

  1. Addresses
    considerations that may affect the safe and effective use of medical
    devices that incorporate wireless technology; and
  2. Provides
    recommendations for information to be included in FDA premarket submission
    for medical devices and device systems that incorporate wireless technology.

In a blog
post discussing the Guidance, FDA stated its “goal is to help industry develop
a range of innovative, safe, and effective medical devices that incorporate
wireless technology, which can, in turn, help reduce health care costs, enhance
quality, and benefit patients and providers alike.”

Key
Guidance Points:

Considerations
for Design, Testing and Use of Wireless Medical Devices

Designers
and manufacturers of wireless medical devices should consider the ability of
their devices to function properly in the intended use environments where other
wireless technologies will likely be located. FDA requires a risk analysis of
wireless communications and control functions as part of the design validation
process. The following considerations are especially important during the
device design and development process.

1. Selection
and performance of wireless technology
. The medical device functions and
intended uses should be appropriately matched with the wireless technology’s
capabilities and expected performance. FDA recommends that manufacturers
consider:

  • International
    availability and band allocation;
  • Whether
    the device needs to have primary or secondary radio service
    classification;
  • Incumbent
    users of the selected adjacent bands;
  • Applicable
    interference mitigation techniques; and
  • For
    implantable and body-worn devices, tissue propagation characteristics and
    specific absorption rate.

2. Wireless
quality of service
. FDA recommends use of a risk management approach to
deployment, security and maintenance of the necessary level of service and
performance needed for the wireless functions of the medical device.

3. Wireless
coexistence
. FDA recommends that manufacturers address their device’s
environment specifications and needs by considering associated sources of
electromagnetic disturbance expected in specific environments, and channel
interference from other users.

4. Security
of wireless signals and data
. Authentication and wireless encryption play
vital roles in an effective wireless security scheme. FDA recommends that
wireless medical devices utilize wireless protection at a level appropriate
for:

  • The
    risks presented by the medical device;
  • Its
    environment of use;
  • The
    type and probability of the risks to which it is exposed; and
  • The
    probable risks to patients from a security breach.

5. Electromagnetic
compatibility of the wireless technology
. FDA recommends that risk
management activities should include using risk analyses to identify any
potential issues associated with electromagnetic compatibility and determining
risk acceptability criteria based on information about the device and its
intended use, including:

  • Foreseeable
    misuse;
  • Sources
    of environmental electromagnetic disturbance; and
  • The
    potential for the device radio frequency emissions to affect other
    devices.

6. Information
for proper setup and operation
. Appropriate information, including a
warning that other equipment could interfere with the medical device system,
should be provided to users of the device to help assure proper setup,
configuration and performance of the wireless medical device.

7. Considerations
for maintenance
. FDA recommends that the manufacturer continue to manage
the risks associated with the use of wireless technology for the entire life
cycle of the device. Procedures for implementing corrective and preventative
action must include analyses of possible trends in nonconformance information
and complaints.

Recommendations
for Premarket Submissions for Devices that Incorporate Wireless Technology

1. Description
of device
. In order to facilitate the review of the premarket submission,
the device description must include:

  • A
    description of the wireless technology and functions, and the intended use
    of the medical device and the intended use environment;
  • A
    description of how the design of the device’s wireless functions assures
    timely, reliable, accurate and secure data and wireless information
    transfer;
  • A
    description of the alarm signal, priority, how risks are managed and
    mitigated (if wireless technology is used for transmission, reception or
    processes involving alarm signals); and
  • Identification
    of whether other wireless products or devices are able to make a wireless
    connection to the device.

2. Risk-based
approach to verification and validation
. The submission should include
information on:

  • The
    wireless quality of service;
  • Any
    risks and potential performance issues that might be associated with
    wireless coexistence;
  • Any
    risks, potential performance issues and, if appropriate, risk mitigation
    measures that might be associated with wireless security; and
  • How
    electromagnetic compatibility has been addressed for the device and all
    wireless functions.

3. Test
data summaries
. FDA recommends submitting test summaries including
information on:

  • A
    description of the tests performed and the protocols used;
  • Reference
    to appropriate medical device, wireless technology or electromagnetic
    compatibility standards for the tests;
  • Explanations
    for any deviations from the selected standards;
  • Modes
    of device operation during the testing;
  • Specific
    pass/fail criteria for the testing; and
  • A
    statement that all modifications will be incorporated into all final
    production units.

4. Labeling
related to wireless medical devices
. Proposed labeling should include risk
mitigation measures that address wireless issues and any precautions users
should take. FDA recommends that the following information be included in the
device label:

  • A
    summary of the medical device wireless functions and incorporated
    technology;
  • A
    summary of the operating characteristics of the wireless technology;
  • A
    brief description of the wireless quality of service needed for safe and
    effective operation;
  • A
    brief description of the recommended wireless security measures;
  • Information
    addressing wireless issues and what to do if problems occur;
  • Information
    about any wireless coexistence issues and mitigations;
  • Appropriate
    electromagnetic compatibility test results;
  • Wireless
    communication information as required by the FCC rules; and
  • Warnings
    about possible effects from radio frequency sources in the device’s
    vicinity.

If you have
any questions regarding the guidance or FDA approval of medical devices using
wireless technology, please contact one of the authors.

Melissa
Gilmore

Mary
C. DeBartolo

 


Document Author: Melissa Gilmore
Firm/Company: McGuireWoods LLP
Document Date: Aug 2013
Search Tags: Wireless Devices
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