News Feature | December 3, 2014

FDA Updates Guidance For Home-Use Medical Devices

By Chuck Seegert, Ph.D.

FDA EHR Pilot Program

Though only recently issued, the final guidance document on design considerations for home-use medical devices has been updated. Clarifying details have been added to sections pertaining to power mains and electromagnetic compatibility.

As part of the Medical Device Home Use Initiative, the FDA recently released a final guidance document to prompt manufacturers to focus on a number of design considerations effecting the home environment. The primary focus of the initiative is to encourage the safe use of medical devices in the home, where certain factors exist that may not be applicable in other environments.

The final guidance, originally issued on August 5, 2014, was intended to make the design process for home-use devices more rigorous, according to a recent article on Med Device Online. Given the fact that these devices will primarily be used by people who are not medical professionals, several unique risk scenarios should be considered when formulating the risk management plan for a device.

The revised final guidance is designed to mesh with the existing FDA quality system regulations. While not binding, the new document, which supersedes the original guidance, provides guidance on some of the key technical issues to consider during the design control process of home-use medical devices.

The design considerations section consists of 5 important areas:

  1. Lock-out Mechanisms
  2. Maintenance
  3. Calibration
  4. Mechanical
  5. Electrical Issues

In the new revision of the guidance document, the section covering electrical issues has been updated to include clarifying details related to power mains and electromagnetic compatibility.

Updates to the power mains portion of the document recommend that device makers “consider using the applicable specifications of ANSI/AAMI ES60601-1:2012 (Edition 3.1) and ANSI/AAMI HA60601--1­ -11:2011.” The latter set of specifications provides information on voltage ranges that life-supporting and non-life-supporting medical devices should utilize to ensure “basic safety and essential performance.”

Considerations for electromagnetic compatibility, which is defined as the ability for a device to perform despite other electromagnetic activity, were also clarified in the new guidance. In these revised design considerations, the FDA recommends considering the specifications from the ANSI/AAMI/IEC 60601-1-2 Edition 4:2014-02 standard. This newer revision of the standard has updates addressing the fact that electromagnetic disturbances in the home healthcare environment can be greater than the levels seen in the hospital environment. While it is valid to use ANSI/AAMI/IEC 60601-1-2 Edition 3:2007 of the standard until April 2, 2017, these issues must be considered even though they are only included in the newer version of the standard.