Medical device processing assistant

Are technical prevention measures in place?

Technical measures have to be used first, when substitution was not possible. The first technical measure of choice is the use of a closed, encapsulated system. Various possibilities and technical solutions are available that might be suitable to reduce exposure to as low as technically possible. These risk reduction measures vary in their effectiveness and need to be assessed for your working environment individually.

Are organisational prevention measures in place?

Organisational measures can support your exposure reduction strategy. Organisational measures must be used only when substitution was not possible, and all technical measures have been exhausted. Various organisational measures are available that might be suitable to reduce exposure. These risk reduction measures vary in their effectiveness and need to be assessed for your working environment individually.

Furthermore, the following list provides you with general or organisational targeted solutions provided by others within your occupation/branch.

Creating Control Guidance Sheets (CGSs)

Is a good measure to reduce exposure to Ethylene oxide

Managing the risks of carcinogens in the workplace through an educational game

Is a good measure to reduce exposure to Ethylene oxide

Basic training module 'Chemicals Hazards at the Workplace'

Is a good measure to reduce exposure to Ethylene oxide

...

The HotSpot Scan (HSS) tool for Product Life Cycle Estimations

Is a good measure to reduce exposure to Ethylene oxide

Estimating the emissions of and exposure to hazardous substances over the life cycle of a product can be a tedious and difficult task. Nevertheless, it is an imperative task for...

Are limit values in place?

Limit values for carcinogens are one mean to assess the exposure situation and to assess whether minimum requirements are met, or further risk reduction strategies have to be applied. The links provided above can support assessment whether technical and organisational measures have been sufficiently exhausted to minimise exposure. Please be aware that you can also assess internal exposure by biomonitoring.

Independent whether there is an European limit value in place or not, it is mandatory to minimise exposure to carcinogens as low as technically achievable. Please refer to your national legislation how to comply with minimisations duties.

As Medical device processing assistant, the following (process-generated) carcinogens could be a potential risk for your health and the following EU limit values are in place.

Ethylene Oxide EU Limit values

EU directive 2017/2398

Exposure limit: 1,8 mg/m³

Read more

Is exposure determined?

Ethylene Oxide on the GESTIS substance database.

You should check the likelihood of exposure and route of exposure by checking the GESTIS substance database.

Please be aware that for this carcinogen you need to be more cautious when determining potential skin contact and how to regard dermal exposure in your risk reduction strategy.

Read more (External link)

If you come to the conclusion that exposure is likely, there are multiple options to assess your exposure situation.

Descriptions by the occupational prevention organisation or insurances, in practice approved control guidance sheets, REACH exposure scenarios or exposure modelling are further and eligible sources that help assessing the exposure situation as well as by comparing workplace situations. This must be documented in the risk assessment. Finally, if these methods do not allow for a conclusive exposure assessment, exposure measurements with the help of your respective insurance organisation or an external company can be performed.

Furthermore, you might want to check exposure data sources compiled here.

Is personal protective equipment provided?

You should be aware that personal protection equipment (PPE) should be used only after technical and organisational measures have been used to reduce exposure as much as possible.

Furthermore, there are strict rules for the use of PPE. For respiratory protection equipment (RPE), the filter class needs to fit the purpose, the size of the mask needs to fit the individual worker, maximal wearing time needs to be defined and workers need training for correctly equipping/un-equipping RPE.

For dermal protective equipment, adequate glove material and size needs to be assessed. Commonly, there are very rare situation when handling carcinogens, that PPE is not necessary to fulfil minimisation duties. When you decide to not use PPE, this has to be well-documented.

Furthermore, the following list provides you with solutions provided by others:

No data was found

Further duties and additional helpful measures

Duties for employers

Ensuring the well-being of your employees is further guaranteed by certain duties laid down in the Carcinogens, Mutagens and Reprotoxicants Directive (CMRD). Additionally, other measures have a positive impact on workplace safety and workers health by boosting awareness of all involved actors.

The following list provides support for these important aspects. However, national requirements might deviate from the Directive and therefore, please consult with your national authorities about regulatory requirements for hazardous substances:

Performing a risk assessment is mandatory.
Instructing and training before workers start a task is mandatory.
Documentation of tasks involving carcinogens is mandatory.
Offering medical surveillance is mandatory.
Organising the chemicals within a substance inventory is regarded as very helpful.
Getting ‘external expertise’ from occupational physician or safety experts is regarded as very helpful.

Employee rights

Your well-being is further guaranteed by certain duties of your employer laid down in the Carcinogens, Mutagens and Reprotoxicants Directive (CMRD). However, it is also important that you act according to i.e. workplace instructions.

Performing a risk assessment is mandatory for your employer and serves to identify all potential health risks and install countermeasures to prevent or reduce these risks.
You have to be instructed and trained before you start a task. Repetition of training and adaption of operational instructions help you to stay alert to the risks.
Should you ever experience health problems that might be work-related even after changing the company or retirement, the documentation duty for tasks involving carcinogens will ensure that you receive recognition for an occupational disease.
Offering medical surveillance to you is your employers duty and serves to inform you about potential health risks related to your task.
Please be aware that cooperation with your employer is your duty as well. Workplace and personal hygiene protocols (for example, do not carry work clothes home) are one key factor to ensure your health and that of your family and should be followed at any time.