PPE and Medical Devices, what's the difference?

PPE and Medical Devices, what's the difference?

Personal Protective Equipment and Medical Devices: reference standards, characteristics and purpose

We’re currently hearing a lot about PPE, a general term for any kind of Personal Protective Equipment. From a regulatory point of view, however, this equipment is divided into two different types of devices: Medical Devices and Personal Protective Equipment. What are the differences?

PPE and Medical Devices: understanding the difference

Personal Protective Equipment (PPE) is defined by EU Regulation 425/2016, implemented in Italy by Legislative Decree no. 17/2019. Its function is to protect the wearer from health or safety risks. The CE marking ensures compliance with specific technical standards, in order to protect the operator.

PPE is commonly used in healthcare settings, such as medical practices, dental practices, hospitals and clinical laboratories. When used correctly, PPE acts as protection between infectious materials and the skin, mouth, nose or eyes (mucous membranes). The barrier has the potential to block the transmission of contaminants from blood, body fluids or respiratory secretions.
PPE can also protect patients at high risk of infection, but its main purpose is to protect the healthcare operators who wear it.  When used properly and in conjunction with other infection control practices such as hand washing and the use of alcohol-based hand disinfectants, it reduces the spread of infection from one person to another to a minimum. It should be remembered that PPE must be properly disposed of, to prevent exposing the wearer and others to infection.

The PPE you use must always: 

  •     be appropriate to the risk to be prevented;
  •     must not pose a greater risk;
  •     respect ergonomic and health requirements;
  •     be compatible with other PPE in the case of multiple risks.

The regulation governing Medical Devices is Directive 93/42/EEC implemented in Italy by Legislative Decree no. 46/’92. Medical Devices are used for the diagnosis, prevention, control, treatment or mitigation of a disease. In other words, Medical Devices guarantee the protection of the patient and should only be used as indicated by the manufacturer who defines its intended use.
Also in this case, the CE marking guarantees compliance with specific technical standards in order to protect the patient.

Can a product be both PPE and a Medical Device?

Clear as the distinction is, there may still be some confusion due to the fact that some products can perform both functions at the same time.

Examples can include:

  •     surgical gloves: originally intended as a Medical Device, they can also be designed to provide the wearer with protection from external agents, as is the case now in our daily lives;
  •     face masks, designed to protect the patient during operations, can also act as an airway filtering device, to protect the user from infectious agents;
  •     protective glasses and visors, used for healthcare purposes but at the same time as protection for the wearer.

When deciding whether a product is covered by Directive 93/42/EEC (DM) or EU Directive 425/2016 (PPE specification), particular account must be taken of the main purpose of the product.
As a general rule, if the product is intended to be used in a medical context with the purpose of providing health and safety protection for the patient, it is to be considered a Medical Device and is covered by the dedicated Directive, regardless of the fact that it may, at the same time, also protect the user.
Where its main use is to protect the user, regardless of whether it can be used in a medical environment, it falls under EU Directive 425/2016, and is therefore considered Personal Protective Equipment.

Face masks: Medical Device or PPE?

The key point, which leads to a crucial distinction, is whether the main purpose of the device is to protect the wearer or to avoid external contamination. For the latter purpose, the so-called surgical masks have been developed, designed to protect the patient from the risk of contamination from micro-organisms exhaled by healthcare personnel; they are therefore effective at protecting the operator against biological agents transmitted by droplets, and less effective for those transmitted by air. Surgical masks are Medical Devices, not PPE.
Filtering facepieces (respirators), on the other hand, are specifically designed for the treatment of infectious diseases, as they reduce the risk of inhaling airborne particles, acting as a protective shield for the wearer: they are therefore classified as Personal Protective Equipment.

Knowing the differences to choose the right product

In recent months, as a result of the Covid-19 emergency, the different regulations and definitions applied to the two types of devices have often created confusion and uncertainty. In this case, as in the choice and medical use, it is necessary to have clear indications, in particular for operators and for those who have the task of managing outpatient resources.
Understanding the differences between PPE and Medical Devices, recognizing the different reference standards and the different purposes and areas of application is therefore essential to choose the most suitable and safest products, in compliance with the different needs and safety objectives.

28/05/2020

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