We get this question quite a lot:
Which systems should be used by Doctors and Nurses and
which devices can Beauticians, Cosmetologists and Physiotherapists use?
This is our understanding based on many conversations with officials – this article will be revised as the interpretation of the laws evolve.
Medical vs non-medical devices and systems
In Finland and all of European Union the division is effectively in two categories:
- Medical devices and systems should be used only in a registered medical facility and used by a registered medical personnel (doctor or nurse).
- Non-medical devices and systems can be used by beauticians, physiotherapists and general public. More education is better to avoid gray areas of interpretation. This category is typically called “Beauty” and most commonly used by beauticians.
There are two sets of laws that determine if a device is a medical device or not.
- Radiation law, observed by STUK, determines limits of absorption which should not be exceeded by the non-medical devices. Exceptions to be discussed later
- Healthcare law, observed by Valvira nationally and Avi locally, which determines what kind of professionals can use medical devices.
EU set a new directive and a law about a year ago and countries are supposed to set their laws congruent to this EU law within 5 years. During this time the content of the law is defined more precisely.
The radiation law in Finland changed 15. December 2018 and its interpretation will be clarified during spring 2019.
The new law requires that the medical systems and devices need to be used in a registered medical facility. It does not determine the requirements for the facility manager. There may be an upcoming interpretation of the manager’s qualifications based on the healthcare law.
Previously healthcare law has determined that a medical device should have a supervising doctor. New law determines that a medical device should be in a medical facility. The interpretation of the law is still in process and we are waiting for the officials to inform more.
What to do with the practice in light of the new and old laws?
If you have been operating, most likely you can continue – just apply for the new permit for the private medical facility.
If you are starting out, you can start the process and officials will inform if they require more than you have in your application for the pricate medical facility.
Medical Device and System Limits and Exceptions
According to STUK’s article and radiation law (859/2018) 162 §
the limits for a device to be used in the beauty treatments are:
- lasers can’t be class 4 according to european laser safety standards.
- Radiofrequency radiation absorption speed (local SAR) cannot exceed 6 minute average limits 10 W/kg (head and body) or 20 W/kg (limbs).
- for optical radiation and ultrasound the limits will be implemented after the 5 years transition time. Law has not defined limits for all non-ionized radiation.
When limits are not available, the practitioner needs to make sure otherwise that the treatments are safe.
Exception: absorption can be higher than the limit if there is a confirmation that the procedure does not cause tissue damage or changes in the organs functioning. Without this confirmation, limits should be followed.
In addition, the responsibility is with the person using the device or system. As distributors, we want to inform our customers as thoroughly as possible. We want our customers to make informed decisions to follow the law while performing safe and effective treatments.
Medical devices, non-medical and gray area subject to interpretation
Based on our understanding of the law and good practices we will outline which and what kind of devices and systems are in medical and which in the beauty category.
Independent of the level of education (doctor or nurse for example) the level of training and experience in the system at hand is most important for patient safety and good results.
We have our view on who we would expect to operate the device. If you have doubts, we are happy to help clarify the situation.
Clearly, medical devices are for example
- Gentle Lase, Gentle Yag and Gentle Max lasers – can be used by nurses, with doctor’s advice on parameters and special indications
- PicoWay – can be used by nurses, with doctor’s advice on parameters and special indications
- Vbeam Perfecta and Vbeam Prima – most indications require a doctor. Photorejuvenation can be done by a nurse.
- CO2RE – requires a doctor
- Profound – requires a doctor, recommended for plastic surgeons
Clearly, beauty devices are
- ProFacial – no radiation with aquapeel and low radiation with RF, Lonto and Ultra sound applicators. Can be used by anyone, we recommend a beautician or a nurse.
- CoolTech and Crystile – No radiation, can be used by anyone. We recommend a beautician, physiotherapist or a nurse.
Subject to interpretation
- eTwo and Venus Viva – higher power RF with possibility for ablation. Intended for the beauty sector, possibly some protocols are within limits or can be proven safe.
- PrimeLase and Elysion – diode lasers that possibly have some protocols under the limitations or can be proven safe
You can review the STUK articles:
How to calculate if the device is over or under the limits: https://www.stuk.fi/stuk-valvoo/kauneudenhoito-ionisoimatonta-sateilya-kayttaen/sateilevan-kauneudenhoitolaitteen-hankinta/rf-sateilyn-altistuksen-arviointi
What to consider before purchasing a beauty device:
How much should we worry about the new law?
We get these questions about “can we continue using this device” or ” can we purchase this system” given the law change.
Our understanding is that the new law will initially focus on new systems and devices that come to the market. If you own a device or system or if you purchase a system or device that is already in the market, this new law has less relevance to you. Our understanding is that many years after the transition is over, officials may be interested in checking the current install base. There are some exceptions and common sense should be followed.
For example, if you are purchasing a medical device, you should register your facility as a private medical facility and have a well-trained medical professional operating the system.
If you are purchasing a beauty sector device or system, it’s important to have good training on using the system and make sure the device and protocol are safe for the customers.
It’s important that the devices are made with good quality standards and have the CE mark. FDA is not required, but it helps to assess the safety and effectiveness of the system.
If you need any help with the interpretation of the law in your case – or to see which device or system is most suitable for you, you are free to contact us!
Latest Update 7. March 2019