From April 21st 2018, the new EU Regulation 2016/425 has been in force, replacing the previous Directive 89/686/EEC and establishing the requirements for the design and manufacture of personal protective equipment (PPE).
PPE belongs to a complex and highly regulated world.
Since the beginning of this year, a legislative update has come into force that should be dwelled upon, especially for the impact it has had on the choice and use of Personal Protective Equipment (PPE) for the respiratory tract.
The most impactful changes are represented specifically by the amendments made to DL April 9th 2008, no. 81 (Art. 79: Criteria for the identification and use, 2-bis), which are part of the process of adopting a respiratory tract PPE, which see all the following steps regulated.
SELECTION AND USE
TRAINING
ADAPTABILITY (FIT TEST)
MAINTENANCE
The passage that concerns the Choice and Use (1) of PPE looks at the standards that regulate its choice, which must be weighted on the basis of the airborne concentrations of the pollutant and what the standard defines as operational protection factors. The latter take into account several factors: Protection Factor (PF), Required Protection Factor (RPF), Nominal Protection Factor (NPF), Operational Protection Factor (OPF), Leakage Factor (LF).
With this DL, the handling of these activities is spelled out in great detail.
"Training consists of the practical test, for the correct and safe use of equipment, machines, plants, substances, devices, including personal protective equipment; training also consists of applied exercise, for safe working procedures. The training operations performed must be recorded in a dedicated register, also in computerised form."
The highlighted passages highlight all the novelties introduced, which in essence outline a new approach to checking the assimilation by each trained subject of all safety procedures. In fact, it becomes mandatory to repeat the training periodically, at least once a year. In addition, the training will have to be held by a competent person, defined as one who has received special training for this purpose and who, at appropriate intervals, follows a refresher course.
The 'fit test' is the test to verify the suitability of the device; the fit of the device to the wearer is an operation that from now on will be included in the so-called Respiratory Protection Programme.
INAIL (Istituto Nazionale per l'Assicurazione di Infortuni sul Lavoro - National Institute for Occupational Accidents Insurance) pushed for the introduction of new criteria for the choice of PPE and the introduction of the Fit Test as a test to verify the goodness of the choice made, to a compulsory extent.
Whenever PPE is used, a fit test must be performed before use (commonly referred to as a 'fit test'), i.e. an individual assessment of the fit before use by the user. Before the fit test can be performed correctly, the user must perform a fit test on the device being worn.
The fit test must be performed on facepieces depending on the specific wearer. In fact, a facepiece will only provide the estimated protection if the seal on the face is ensured. It is possible that one size or model may not fit all wearers. Assessing the correct fit is a fundamental part of the selection process. The fit test is used to verify that the tight-fitting facepiece fits the subject's face. The most commonly used methods are the qualitative test and the quantitative test, commonly referred to as qualitative fit test (A.2) and quantitative fit test (A.3).
Briefly, during the qualitative fit test, the test subject must state whether or not he or she perceives the substance. The assessment is subjective. In contrast, the quantitative fit test returns an objective data on what is happening inside the worn device by means of a special measuring device. In addition, the quantitative fit test makes it possible to record the passing or failing of the test, because all fit test results are entered into an automated register designed to keep track of the tests performed.
In other countries, such as Great Britain and Belgium, the Fit Test has been compulsory for many years. However, in none of these countries is the type of competence of the person carrying out the Fit Test defined. In the absence of an official qualification of the operator, in fact, a voluntary qualification scheme based on 14 competences was introduced to guarantee the suitability of the tests performed.
The same model has also been adopted in Italy.
In Italy, Assosistema will manage this qualification scheme, in a totally transparent manner. This qualification scheme is called 'Fit2Fit' and has been adopted in recent years by an increasing number of European states, in a general progress of expansion of competence assessment schemes.
To summarise, registering has now become mandatory and this will mean more safety for users and more obligations for manufacturers and distributors of Personal Protective Equipment.
CRITERIA FOR USE
ADEQUACY OF PPE
TRAINING
From April 21st 2018, the new EU Regulation 2016/425 has been in force, replacing the previous Directive 89/686/EEC and establishing the requirements for the design and manufacture of personal protective equipment (PPE).
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