Sterile compresses can be sterilized by three methods: ethylene oxide (EO), radiation (gamma irradiation or electron beam), and saturated steam. In light of health concerns related to EO residues, which are classified as carcinogenic, steam sterilization (EN ISO 17665) stands out as the most relevant alternative for textile and non-woven compresses.
Why look for an alternative to ethylene oxide?
Ethylene oxide is currently the most widely used sterilization method: it is used in more than 50% of the sterile medical devices in the world [source: DeviceMed, 2025]. Effective and compatible with many materials, it nevertheless has one major drawback: its residues are classified as CMR (carcinogenic, mutagenic and toxic to reproduction).
This toxicity concerns both the patient (residues on the finished product) and the production operators exposed to the gas. This is why French and European regulations are increasingly strictly regulating its use, in particular for devices intended for fragile populations such as newborns.
The regulatory framework driving change
Several texts point toward a reduction in the use of EO:
- The French Labor Code (Article R4412-66) requires the substitution of any hazardous substance with a less risky alternative as soon as it is technically possible.
- The ANSM is strengthening the supervision of devices sterilized with EO, particularly in neonatology and pediatrics, in application of the NF EN ISO 10993-7 standard, which sets the tolerable daily intakes of residues.
- In June 2025, the HAS issued a favorable opinion on the reimbursement of steam-sterilized compresses, confirmed by their inclusion in the LPP in October 2025, a regulatory precedent for this alternative.
The three alternatives to ethylene oxide
Radiation sterilization (irradiation)
Gamma or electron beam irradiation sterilizes without chemical residue. It is effective but can alter certain sensitive materials (yellowing, embrittlement of polymers) and requires heavy facilities. It is mainly used for high-volume single-use devices.
Steam sterilization (EN ISO 17665)
Saturated steam sterilization is the most suitable method for textile and non-woven compresses. It leaves no chemical residue, does not require a desorption phase (unlike EO, which requires a degassing time), and is ideally suited for cotton and non-woven compresses, as confirmed by industry manufacturers.
This is the alternative chosen by the actors who recently made their compresses eligible for reimbursement in France, proof of their regulatory and industrial maturity. Paul Hartmann Laboratories thus had their steam-sterilized compresses MEDICOMP (non-woven) and STERILUX (hydrophilic gauze) listed on the LPP, by the order of 16 October 2025, following the favourable opinion of the HAS of 17 June 2025. This precedent confirms the eligibility of the process for the LPP reimbursement of compresses.
Emerging processes (supercritical CO2, cold plasma)
Newer processes such as supercritical CO2 or cold plasmas are currently being studied, driven in particular by French companies [source: DeviceMed, 2025]. Today, they remain marginal and have limited availability on an industrial scale for compresses.
Why steam is the best choice for compresses
For a sterile compress, a simple textile product without electronic components or heat-sensitive plastic, steam sterilization combines all the advantages:
- No ethylene oxide residue, therefore no CMR risk for the patient
- Compatible with fragile skin, neonatology, and EO-allergic patients
- A strong CSR argument: elimination of a toxic gas in the production chain
- A LPP reimbursement pathway is now open under a brand name
For a pharmacist, a pharmacy group, or a laboratory, offering steam-sterilized compresses means anticipating regulatory changes while responding to a growing demand for products free of concerning substances.
Where to find steam-sterilized compresses under a private label?
Still few manufacturers offer sterilized steam packs that comply with the French specifications; this is precisely what makes it an opportunity for pharmacies and groups to differentiate themselves.
Smart Agents Healthcare supports laboratories, pharmaceutical groups, and distributors in the white-label manufacturing of steam-sterilized gauze swabs, certified ISO 13485 and compliant with the MDR 2017/745 regulation. Our non-woven and absorbent gauze swabs are produced in facilities whose CE scope covers steam sterilization in accordance with the EN ISO 17665 standard, with zero ethylene oxide residue.
Discover our range of white-label steam-sterilized compresses →
