When it comes to PPE (acronym for Personal Protective Equipment), you can refer to a wide range of wearable protection, for example safety shoes, helmets, protective gloves, masks, and all these accessorizes and instruments that are used to protect who wears them and reduce possible external risks.
In healthcare and hospitals we often hear about MD (Medical devices) to indicate devices that safeguard the health of users.
It would be wrong, though, to confuse these definitions, even if some disposables can be used either as PPE or DM, from a regulatory point of view there are substantial differences between them.
These two types of disposables, are regulated by two different European regulations: UE Guideline 425/2016 fof PPE and CEE Guideline 93/42 for MD.
PPE and MD: Definitions and Uses
Personal protection equipments are designed to protect the wearer from risks and are generally used in working environments.
The requirements to be met with PPE are:
- Appropriateness to prevent risks, without posing a higher risk
- Appropriateness to the existing external conditions
- Respect of the ergonomic and health needs of the worker
- Compatibility between the different PPE equipment where the requested tasks involved requires the simultaneous use of more than one.
- Can be easily worn and removed according to the operator’s needs.
Medical device, on the other hand, means an instrument, implantation, substance or other product which can be worn or used by an operator to:
- Diagnose, monitor or mitigate a disease or disability
- Mitigate or compensate an injury or handicap
- Perform a study or modification of the anatomy or a physiological process
- Intervene on conception
Medical devices must never perform the main action in or on the human body, but may assist with pharmaceutical or immunological therapies.
We can therefore note that the substantial difference between these two different devices lies in the final purpose and in the subject that you want to protect: PPE devices are used to protect the user from external risks, regardless of whether you are in the medical field or not.
Medical devices are used on patients who need a diagnosis, to integrate a cure, to protect from possible infections, or that in their condition are potentially contagious and must therefore limit the risks to those around them.
Why do we then confuse these two definitions? This happens because, especially in health and hospital sectors, many devices were thought just for one need, but in many cases end up performing both functions.
Can a device be either a PPE and a Medical Device?
To establish if a product is a PPE device or a Medical device, as we already sayd, it is necessary to understand whether it is aimed at the protection of the wearer or the protection of the patient in medical sectors.
Despite this, some products born initially to protect the patient end up providing protection to the wearer and vice versa.
Some examples of devices that are able to perform as PPE devices and Medical devices are the facial masks, born initially to protect the patient during surgical operations, but can be also designed as a filtering device to protect the health of the wearer from infectious risks.
The same applies to surgical gloves, visors and eye protection devices. Either way the producer has to specify the destination use of the device and its respond to the requested requirements.
PPE and MD devices must be marked CE, that has to be clearly mentioned on either the packaging and the product for both categories of devices, certifying the comformity of the latter with the European regulations in defence of the worker and/or patient.
PPE Categories and Reposa’s PPE
The existing PPE categories are 3:
1st to protect against minor physical damage, 2nd to prevent medium risks, 3rd for cases where serious injury is at risk, up to the risk of death.
The division of PPE in categories is something that tells us a lot about the destination of use of these accessories and their protection it gives to the person who wears them.
Where is REPOSA collocated on PPE/DM issues?
Reposa clogs and shoes , 100% made in Italy, worn for decades by professionals in hospitals, health care, food and many other sectors, are classified as PPE, personal protection equipment.
To wich category do they belong?
All work clogs and shoes are part of the 2nd category with gloves, helmets, protective glasses, visors and other protective clothing.
For any other informations regarding our sanitary clogs and work shoes don’t hesitate to contact us or visit our catalogue.