Who is responsible for ethylene oxide (EtO) in the healthcare logistics supply chain?

Ethylene oxide (EtO) is a supply chain risk. Although the gas is used to sterilise medical devices, it may still pose a risk during transport, storage and logistics handling. This means that several parties share responsibility for maintaining a safe supply chain. For employers, however, one key principle applies: where employees may be exposed to EtO, the risk must be demonstrably assessed and controlled.

Why is ethylene oxide a shared supply chain responsibility?

Ethylene oxide does not stop at the sterilisation facility. Once medical devices have been sterilised, they move through the entire logistics supply chain. Various organisations may therefore encounter EtO, including:

• manufacturers;
• sterilisation providers;
• transport companies;
• freight forwarders;
• warehouses;
• third-party logistics providers (3PLs);
• distribution centres;
• end users.

Each party controls part of the process, but no single party controls the entire supply chain.

What is each party responsible for?

Every organisation within the healthcare logistics supply chain has its own role.

Together, these parties form one supply chain. Effective information sharing is therefore essential.

Why does the employer remain responsible?

Many logistics organisations do not use ethylene oxide themselves. However, this does not automatically mean that there is no risk. EtO may still be released from sterilised medical devices, packaging or pallet loads during activities such as:

• receiving goods;
• storage;
• order picking;
• repacking;
• quality control;
• staging;
• processing returned goods.

The key question is therefore not:

“Do we use ethylene oxide?”

It is:

“Could our employees be exposed to ethylene oxide while carrying out their work?”

Where exposure may occur, EtO should be included in the workplace risk assessment, occupational exposure assessment and control measures.

What information should you expect from supply chain partners?

An effective approach to EtO starts with clear information throughout the supply chain.

In practice, this information is not always fully available to QHSE, Operations or Facility teams. Independent verification therefore remains important. Review the product documentation, request additional information from suppliers and support your assessment with workplace air monitoring.

Why is cooperation between departments important?

An effective EtO strategy requires cooperation between several disciplines.

Combining this knowledge provides a complete picture of the risks within the organisation.

What are the most common challenges in practice?

Based on our experience in healthcare logistics, we regularly see the following pitfalls.

1. EtO is not recognised as a logistics risk
   Many logistics organisations do not use ethylene oxide themselves. As a result, they may not realise that EtO can enter their operations through sterilised products.
2. The risk is not included in the workplace risk assessment
   When EtO is not recognised, it is often also omitted from the workplace risk assessment and occupational exposure assessment.
3. No one takes ownership
   Manufacturers, sterilisation providers, transport companies and warehouses sometimes assume that another party has already assessed the risk.
4. Important information does not reach the workplace
   Information about sterilisation, packaging or potential EtO off-gassing may remain with the customer or Quality department without reaching Operations or Facility teams.
5. Monitoring takes place in the wrong locations
   General area measurements do not always provide sufficient insight into exposure during activities such as opening packaging, repacking or staging.
6. Control measures are not properly embedded
   A one-off measurement without periodic evaluation, trend analysis or clearly assigned responsibilities provides insufficient assurance.

What does a mature EtO strategy look like?

Effectively controlling ethylene oxide involves several steps.

1. Identify relevant goods flows
   Determine which customers, products and shipments may involve medical devices that have been sterilised with ethylene oxide.
2. Define information requirements
   Agree with suppliers and customers which information must be provided about the sterilisation method, packaging and potential residual emissions.
3. Analyse logistics processes
   Identify where goods are received, stored, opened and handled.
4. Monitor the workplace
   Carry out measurements where employees actually work, including loading docks, staging areas and repacking stations.
5. Implement appropriate measures
   Where necessary, introduce technical and organisational control measures, such as adapted storage arrangements, ventilation or air filtration.
6. Assign responsibilities
   Clearly define who is responsible for monitoring, evaluations, communication and follow-up actions.
7. Maintain audit-ready documentation
   Systematically document monitoring results, actions, maintenance and reassessments.

What are the benefits of an effective supply chain approach?

Clearly assigning responsibilities provides:

• greater insight into potential exposure;
• clear ownership within the organisation;
• improved cooperation between departments;
• demonstrable evidence for audits;
• a safer working environment for employees.

This ensures that ethylene oxide is no longer treated as an isolated safety issue, but as a controlled part of the logistics process.

Frequently asked questions

1. Is the manufacturer solely responsible for ethylene oxide?
   No. The manufacturer is responsible for the product, but every employer remains responsible for providing a safe working environment.
2. Should a warehouse include EtO in its workplace risk assessment?
   Yes. Where employees may be exposed to EtO during the storage or handling of medical devices, the risk must be assessed.
3. What if a logistics provider does not use EtO itself?
   Exposure may still occur through incoming goods. A workplace risk assessment therefore remains necessary.
4. Which departments should be involved in controlling EtO?
   QHSE, Operations, Facility, Quality and Procurement all play an important role.
5. Why is workplace air monitoring important?
   Workplace air monitoring identifies where employees may actually be exposed and provides the basis for selecting appropriate control measures.
6. Is information from suppliers sufficient?
   No. Supplier information is important, but it should be supplemented by an assessment of the actual conditions within the warehouse.

Need greater insight into responsibility for ethylene oxide within your logistics supply chain?

An effective EtO strategy starts with understanding your goods flows, working processes and potential exposure. Discuss your situation with one of our specialists and identify which measures are required to demonstrably control ethylene oxide.