Familiar domestic healthcare devices include for instance thermometers and blood pressure gauges, but there is a considerably larger range of healthcare devices for domestic use, such as: hospital beds, muscle stimulators, air purifiers, wheelchairs, oxygen concentrators, blood glucose meters and artificial limbs.

As the autumn brings with itself shorter periods of daylight, lamps are turned on around most homes, to alleviate winter depression.

When Does a Lamp Become a Healthcare Device?

In contrast to common electrical devices, Finnish regulation 629/2010, regarding healthcare devices and materials, determines that when a manufacturer has intended his device to be used, among other things, for the diagnosis, prevention, observation, care or relief of sickness, it becomes a healthcare device and is subject to specific requirements. The manufacturer has to demonstrate that the device is safe and effective in clinical use. When the manufacturer claims that its bright-light lamp prevents winter depression, there has to be clinical evidence based on sufficient patient data to sustain that claim.

Tighter Requirements For Safety And Usability

The essence of devices for domestic use does not arise from their place of use, but from the fact that they can be used by anyone, instead of only by professionals. This is why tighter than normal requirements are set for their safety and usability. Apart from fulfilling basic requirements, these devices must be able to withstand changing environments, rough handling, humidity and various electrical disturbances. The device must be so easy to use that after reading the instructions it can be successfully used without any further training.

Instruction Manual, Usability And Risk Management As Stumbling Blocks

Most of the devices that come for testing are technically excellent – as they have been designed by qualified engineers. Instead, problems normally arise from difficulties in fulfilling documentation requirements.

Risk management is required for all healthcare devices. This is documentation which is drawn up through the controlled process and covers the whole lifetime of the device, from design, to use and recycling. At this stage the manufacturer should consistently and thoroughly go through the different risk situations linked to the device and plan how these situations can be avoided or the seriousness of their consequences be minimized.

The requirements which are strongly linked to risk management include planning the usability of the device and the communication of said usability. When the manufacturer has identified the most common situations in which the device will be used, it is easier to plan the controls, design and logical use in such a way that the user will not cause accidents and other dangerous situations. An easily understood example is the door handle. Most people will assume that a door will open if the handle is pressed down. If the manufacturer produces a door handle which opens “in a wrong way”, this could lead to people crashing into the door and other dangerous situations.

Writing good and clear instructions is not always easy. Apart from the fact that the user has to understand from the manual how to use the device, it must also contain obligatory information based on defined standards. For example, the meaning of the markings on the device and its package must be explained in the instructions. It is not automatically clear to everyone what “IP22” printed on the top of a domestic device means. It is about anti-shock protection and protection against water dripping on it at a maximum angle of 15 degrees.

What Consumers Should Know

There are not many downright dangerous domestic healthcare devices on the market. However in Europe, since early inspection of electrical devices has been substituted by market surveillance, there is nothing to stop an unscrupulous importer from selling untested products. Luckily a partial pre-surveillance system is in use in the health-technology sector. Products whose usage implies greater risk can only be put on the market after being evaluated by a notified body. This includes an evaluation of both the technical safety and the clinical effectiveness of the device. The notified body is identified by its four-digit code which is beside the CE mark. Devices evaluated by SGS Fimko are identified by the code 0598.

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For more information on SGS services for the consumer electronics and healthcare devices, visit SGS EE or contact:

Seppo Vahasalo
Product Line Manager – Consumer Goods
SGS Fimko
t: +358 40 560 9500