Medical device processing assistant: The risks and solutions

As a medical device processing assistants you are responsible for cleaning, sterilizing, and preparing medical instruments and devices for use. Your occupation involves exposure to various hazardous substances, which can pose significant health risks if proper safety protocols are not followed.

Most importantly, this work is related to exposure against ethylene oxide which is used for sterilizing medical devices that cannot withstand high temperatures. The substance is a known carcinogen and can cause respiratory irritation, headaches, nausea, and long-term health issues, including cancer.

Conducting a thorough risk assessment before starting any work to identify potential hazards is of utmost importance. Use ventilation systems for adequate ventilation to remove harmful vapors and fumes from the work area and fumes hoods to contain and ventilate hazardous substances during use.

Regular training on safe handling, storage, and disposal of hazardous substances and training on how to respond to chemical spills, exposure incidents, and other emergencies are useful organisational measures. Maintaining a clean and organized work environment to minimize risk of accidental exposure.

Regular health check-ups to monitor for signs of exposure-related illnesses. Use respirators for protection again inhalation and gloves to protect against skin contact, if necessary. By understanding the hazards and implementing appropriate safety measures, medical device processing assistants can minimize the risks associated with exposure to hazardous substances in their work environment

Note: The CarcCheck is based on data collected for the EU. Therefore, uses of a substance might not be of equal relevance in all member states. The CarcCheck indicates were a carcinogen can potentially be involved or released; exposure potential will also vary in different sectors. Only the risk assessment will show whether this is the case in a real workplace or in a user situation.

Medical device processing assistant: The risks and solutions

As a medical device processing assistants you are responsible for cleaning, sterilizing, and preparing medical instruments and devices for use. Your occupation involves exposure to various hazardous substances, which can pose significant health risks if proper safety protocols are not followed.

Most importantly, this work is related to exposure against ethylene oxide which is used for sterilizing medical devices that cannot withstand high temperatures. The substance is a known carcinogen and can cause respiratory irritation, headaches, nausea, and long-term health issues, including cancer.

Conducting a thorough risk assessment before starting any work to identify potential hazards is of utmost importance. Use ventilation systems for adequate ventilation to remove harmful vapors and fumes from the work area and fumes hoods to contain and ventilate hazardous substances during use.

Regular training on safe handling, storage, and disposal of hazardous substances and training on how to respond to chemical spills, exposure incidents, and other emergencies are useful organisational measures. Maintaining a clean and organized work environment to minimize risk of accidental exposure.

Regular health check-ups to monitor for signs of exposure-related illnesses. Use respirators for protection again inhalation and gloves to protect against skin contact, if necessary. By understanding the hazards and implementing appropriate safety measures, medical device processing assistants can minimize the risks associated with exposure to hazardous substances in their work environment

Note: The CarcCheck is based on data collected for the EU. Therefore, uses of a substance might not be of equal relevance in all member states. The CarcCheck indicates were a carcinogen can potentially be involved or released; exposure potential will also vary in different sectors. Only the risk assessment will show whether this is the case in a real workplace or in a user situation.

Which carcinogen(s) are present?

As Medical device processing assistant, the following (process-generated) carcinogens could be a potential risk for your health.

Can the carcinogen(s) or process(es) be replaced?

Substitution is the first and top prevention measure to avoid exposure to carcinogens. The following substances or processes are considered safer alternatives for these carcinogens or represent less exposure potential.

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 systemVarious 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.

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

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.

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.

Is exposure determined?

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:

Further duties and additional helpful measures

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.

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.
Relevance

Carcinogens involved

Sector(s) involved

Agents involved in the sale of food, beverages and tobacco
Agents involved in the sale of textiles, clothing, fur, footwear and leather goods
Agriculture
All sectors
Arts
Building completion and finishing
Building of ships and boats
Casting of light metals
Casting of other non-ferrous metals
Civil engineering
Cold forming or folding
Collection of hazardous waste
Construction
Construction of buildings
Construction of residential and non-residential buildings
Construction of roads and railways
Crop and animal production, hunting and related service activities
Cutting, shaping and finishing of stone
Defence activities
Demolition
Dental practice activities
Education
Electric power generation, transmission and distribution
Electrical, plumbing and other construction installation activities
Extraction of crude petroleum and natural gas
Finishing of textiles
Fire service activities
Forestry and logging
Forging, pressing, stamping and roll-forming of metal; powder metallurgy
Growing of perennial crops
Hospital activities
Human health and social work activities
Information and communication
Lead, zinc and tin production
Machining (incl. service life of hard-metal tools)
Maintenance and repair
Maintenance and repair of motor vehicles
Manufacture of air and spacecraft and related machinery
Manufacture of assembled parquet floors
Manufacture of basic chemicals
Manufacture of basic iron and steel and of ferro-alloys
Manufacture of basic metals
Manufacture of basic pharmaceutical preparations
Manufacture of basic pharmaceutical products
Manufacture of batteries and accumulators
Manufacture of builders ware of plastic
Manufacture of ceramic tiles and flags
Manufacture of chemicals and chemical products
Manufacture of coke and refined petroleum products
Manufacture of computer electronic and optical products
Manufacture of computer, electronics and optical equipment
Manufacture of doors and windows of metal
Manufacture of dyes and pigments
Manufacture of electronic components and boards
Manufacture of electronical equipement
Manufacture of engines and turbines
Manufacture of engines and turbines, except aircraft, vehicle and cycle engines
Manufacture of fabricated metal products
Manufacture of fabricated metal products, except machinery and equipment
Manufacture of fertilisers and nitrogen compounds
Manufacture of food products
Manufacture of footwear
Manufacture of furniture
Manufacture of glass and glass products
Manufacture of glue
Manufacture of instruments and appliances for measuring
Manufacture of instruments and appliances for measuring, testing and navigation incl humidity indicator cards
Manufacture of jewellery, bijouterie and related articles
Manufacture of machinery
Manufacture of magnetic and optical media
Manufacture of medical and dental instruments and supplies
Manufacture of motor vehicles, trailers and semi-trailers
Manufacture of musical instruments
Manufacture of other articles of concrete, plaster and cement
Manufacture of other chemical products n.e.c. (incl. catalysts)
Manufacture of other electronic and electric wires and cables
Manufacture of other fabricated metal products [incl. additive manufacturing]
Manufacture of other fabricated metal products n.e.c.
Manufacture of other inorganic basic chemicals
Manufacture of other organic basic chemicals
Manufacture of other porcelain and ceramic products
Manufacture of other rubber products
Manufacture of other transport equipment
Manufacture of paints and coatings
Manufacture of paints, varnishes and similar coatings, printing ink and mastics (incl. frits)
Manufacture of paper and paper products
Manufacture of paper and paperboard
Manufacture of perfumes and toilet preparations
Manufacture of pesticides and other agrochemical products
Manufacture of pharmaceutical preparations
Manufacture of pharmaceutical products
Manufacture of plastic plates, sheets, tubes and profiles
Manufacture of plastics and rubber machinery
Manufacture of plastics and rubber products
Manufacture of plastics in primary forms
Manufacture of plastics products
Manufacture of prepared feeds for farm animals
Manufacture of refined petroleum products
Manufacture of refined petroleum products (catalysts)
Manufacture of rubber and plastic products
Manufacture of rubber tyres and tubes; retreading and rebuilding of rubber tyres
Manufacture of soap and detergents
Manufacture of soap and detergents, cleaning and polishing preparations, perfumes and toilet preparations
Manufacture of steam generators, except central heating hot water boilers
Manufacture of synthetic rubber in primary forms
Manufacture of textiles
Manufacture of tools
Manufacture of wire products
manufacture of wire products, chain and springs
Manufacture of wiring and wiring devices
Manufacture of wood and of products of wood and cork
Manufacture of wood and of products of wood and cork, except furniture; manufacture of articles of straw and plaiting materials
Manufacture of wood and wood products
Materials recovery
Medical and dental practice activities
Mining and quarrying
Mining of other non-ferrous metal ores
Other building and industrial cleaning activities
Other cleaning activities
Other non-ferrous metal production
Other service activities
Paint and varnish industry
Painting and glazing
Plumbing
Plumbing, heat and air conditioning installation
Printing and reproduction of recorded media
Public administration and defence; compulsory social security
Public administration and national defence
Recovery of sorted materials
Repair and installation of machinery and equipment
Repair of electronic and optical equipment
Research and development
Roofing activities
Scientific research and development
Specialist medical practice activities
Tanning and dressing of leather; dressing and dyeing of fur
Taxi operations
Technical testing and analysis
Telecommunication
Transportation and storage
Treatment and coating of metals
Treatment and disposal of hazardous waste
Treatment and disposal of non-hazardous waste
Veterinary activities
Waste collection
Waste collection, treatment and disposal activities materials recovery
Water collection, treatment and supply
water supply, sewerage, waste management and remediation activities
Water supply; sewerage
Wholesale and retail trade; repair of motor vehicles and motorcycles
Wholesale of solid, liquid and gaseous fuels and related products
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