Home Healthcare Medical Devices

Designing devices for home healthcare? Some key areas to consider…

The collateral safety standard that applies to active medical devices is #IEC 60601-1-11.

The standard was developed because, it is expected that the home environment is less controlled than that of a professional healthcare facility. With this in mind, additional or new risks may be introduced with the use of your medical devices in a home environment.

In your risk assessment, you should consider the following areas:

1. Electric shock – The standard is clear that the Means of Protection (MOP) excludes protective earth (PE). The required MOP must be double or reinforced insulation. The base standard IEC 60601-1 allows PE to be used, but for functional earthing purposes.

This makes sense since in the residential environment, especially older homes, may have poor (i.e., high impedance) or faulty protective earth systems. It cannot be relied upon with high confidence as you would in a medical facility.

2. Accessibility to live parts and moving parts – In a home environment your devices may be exposed to children. Support your analysis with anthropometric data and design accordingly against access to hazardous live parts and hazardous moving parts.

3. Electromagnetic interference – In a home environment, your device may be bombarded with electromagnetic interference radiated from electronic gadgets, kitchen appliances, etc. Design for optimal immunity.

4. Strangulation – Length of tube-sets or tubing must be considered in your design.

5. Temperature and humidity – Design for worst-case temperature and humidity conditions.

6. Portable or body-worn device – If it is expected that your device can be exposed to wet conditions (i.e. outdoors), design with corresponding IP rating.

We provide Clarity on global medical device regulations. We can help.

Expert guidance and execution: #FDA#FDA510k#FDAPMA#ISO13485#ISO14971#IEC60601 series standards complemented with unparalleled customer-focused #regulatory services.

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