A final guidance document issued by the US Food and Drug Administration (FDA) aims to make medical devices used by patients in their homes safer and more reliable.
In general, medical devices can be divided into two categories: Those intended to be used in professional settings by healthcare professionals, and those intended to be used in home healthcare settings by patients or caregivers.
The latter category, often referred to as "home use devices," is associated with a unique set of concerns compared to its professional use counterparts. Because the devices are typically used frequently by those without medical training, FDA has taken an interest in making sure that they are designed appropriately for use within the home.
Factors FDA has said manufacturers need to consider include the age and structure of a home, the geographic location of a patient, whether a patient owns pets or lives with children, the sanitary condition of the patient's house, the temperature of a patient's house, potential fire hazards and more.
While these factors may seem benign, they can have potentially deadly effects on patients if not sufficiently controlled for. In a case study published by FDA last year, the agency cited the case of a feeding pump device. After the pump was hit with a power surge, its feeding rate reset to 10 times its normal rate, resulting in a child being overfed and dying of "a necrotic bowel situation."
(Almost) Final Guidance
FDA's now-final guidance document, Design Considerations for Devices Intended for Home Use, is the agency's attempt to ensure manufacturers design their products with home use settings in mind.
The guidance has been almost two years in the making. FDA first released a draft of the guidance in December 2012 as part of FDA's 2010 Home Use Initiative. Then, in August 2014, FDA issued a then-final version of the document significantly changing the definition of what a "home use device" is to include devices used in "outdoor environments, office environments, schools, vehicles, emergency shelters, and independent living retirement homes."
Another notable change was FDA's elimination of a requirement that devices should be "childproof." That provision has been entirely removed from the final guidance, and replaced with a cautionary note that, "You should consider that children or adults might interact with the device in inappropriate ways."
Another addition to the guidance regards storage. FDA says that manufacturers should "provide information to the user about proper storage of the device and its components and accessories." Some devices may need to be kept out of direct sunlight, be stored at a certain temperature or be kept dry, for example.
For more on FDA's Home Use Guidance, please see out August 2014 story.
New Electricity Recommendations
Now FDA is out with a revised final guidance document making still more changes to its December 2012 draft guidance.
The changes aren't so much electrifying as they are about electricity.
"This document provides clarification about the use of standards applicable to supply mains and electromagnetic compatibility," FDA explains in the guidance.
The new sections are as follows:
Supply Mains: If your device operates from the supply main, you should consider using the applicable specifications of ANSI/AAMI ES60601-1:2012 (Edition 3.1) and ANSI/AAMI HA60601--1 -11:2011. The latter specifies voltage ranges over which life-supporting medical devices and medical devices that are not life-supporting should provide their basic safety and essential performance. The following standards have specifications regarding short-term voltage interruptions and specifications regarding long-term interruptions of the supply mains:
ANSI/AAMI/IEC 60601-1-2 Fourth edition 2014-02, Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests.
Electromagnetic Compatibility (EMC): Electromagnetic compatibility (EMC) is the ability of a device to operate properly in the presence of electromagnetic disturbances that are expected to occur in the environments of intended use without introducing excessive electromagnetic disturbances into that environment. FDA recommends that you consider using the FDA-recognized ANSI/AAMI/IEC 60601-1-2 Edition 4:2014-02 standard, which describes EMC testing and includes tests for immunity of the device to outside electromagnetic disturbances in the use environment and also for emissions from the device into that environment. If you use ANSI/AAMI/IEC 60601-1-2 Edition 3:2007 during the transition period to Edition 4 that ends April 2, 2017, you should be aware that electromagnetic disturbance in the home healthcare environment can exceed the default test levels for the hospital environment that are specified in Edition 3. You should design your device intended for home use to be immune to disturbance levels that can be expected in the home healthcare environment.**
You should provide summary information in your premarket submissions to FDA describing the testing that was performed and how it was conducted, the device functions and modes that were tested, the pass/fail criteria used, reference standards and any deviations or allowances that were taken, any device modification needed to pass the testing, and appropriate labeling. Device manufacturers should consider appropriate levels of testing in accordance with the risks presented by the environments of intended use in addition to the general immunity testing specified in the standards.
You should also note possible sources of disturbance for electrically powered medical devices in the use location(s) that could be near or in contact with other objects that would interfere with their performance, such as large electric motors or amateur radio transmitters, radio and television transmitters, radar, anti-theft systems (including demagnetizers), stereo speakers, cell phone, and radio frequency identification (RFID).
**Although not a requirement, the Agency generally finds testing to the following immunity tests levels acceptable for the home environment based on FDA’s experience with home use devices: Electrostatic Discharge (ESD): ± 8 kV contact discharge, ± 15 kV air discharge; Power frequency magnetic fields: 30 A/m at 50 Hz or 60 Hz; Conducted RF: 3 V r.m.s outside industrial, scientific, and medical (ISM) and amateur radio bands between 0.15 MHz and 80 MHz, 6 V r.m.s. in ISM and amateur radio bands between 0.15 MHz and 80 MHz; Radiated RF: 10 V/m, 80 MHz to 2.6 GHz. You may provide justification for testing to alternative levels.
Design Considerations for Devices Intended for Home Use