Periodic Reporting for period 1 - ASCLEPIOS (Advanced Sterilization Capability with Low Environmental footprint for Patient Infection Optimized Safety)
Período documentado: 2023-12-01 hasta 2024-08-31
The MedTech industry is witnessing the development of innovative medical devices [MD] with ever more complex forms and sensitive components (including biomaterials, electronics, polymers…). However, before they come into contact with patients, all MD (whether they are reusable or not) must be sterilized under optimal safety conditions while preserving their physical integrity and medical functionalities.
On the one hand, Hospitals are confronted with a limited range of sterilization methods owing to the security issues some techniques bear (typically chemicals and radiations which are not used anymore in hospital environment). These dwindling options have put hospitals in a dead end, spurring them into trading off some degrees of health safety (thus favouring hospital-acquired infections) to be able to treat their patients. Typically, endoscopes [250,000,000 operations/year worldwide] are subject to worrying contamination levels with 1 device over 5 that should be quarantined for not meeting sterilization standards.
On the other hand, MDs manufacturers are also encountering their share of difficulties. EtO, the most widely used sterilant in the sterilization industry is facing increasing political and regulatory pressure, given the risks it poses to human health (Lymphoma and leukemia being the most documented cancers) and the environment (water and air pollution). Even though it has been banned in EU hospitals, it remains the gold-standard in the MD industry with no ideal alternative available. Indeed, other technologies are struggling with capacity issues that are unlikely to improve soon, given the 5-7% annual growth in MD production which demands a corresponding increase in sterilization capacity. Compared to EtO, which offers a broad sterilization spectrum, competing technologies are limited by the types of materials and shapes of medical devices they can sterilize, further weakening this critical step in the medical device supply chain. This situation also highlights the growing need for new sterilization technologies that can address these challenges.
AURORA has developed the first sterilization process for MD using natural plasma as the sterilizing agent. Plasma is obtained by placing a gas low [oxygen, nitrogen, argon] under low pressure while being exposed to a radiofrequency field. Gas molecules are thereby ionized and converted into reactive species [electrons, metastable, ions...] which inactivate biological agents and degrades active chemicals.
Natural plasma holds outstanding characteristics for MD sterilization:
- Safety of the sterilizing agent which does not involve chemicals (and therefore toxic residue), nor harmful radiations
- Wide decontamination potential and capacity to remove both chemical and biological agents even biofilms and spores [the most difficult pathogens to sterilize]
- Gentle process that is respectful of materials [optics, electronics, biopolymers, metals] and compatible with a wide range of MD designs including the most complex shapes (strong penetration power)
On the one hand, Hospitals are confronted with a limited range of sterilization methods owing to the security issues some techniques bear (typically chemicals and radiations which are not used anymore in hospital environment). These dwindling options have put hospitals in a dead end, spurring them into trading off some degrees of health safety (thus favouring hospital-acquired infections) to be able to treat their patients. Typically, endoscopes [250,000,000 operations/year worldwide] are subject to worrying contamination levels with 1 device over 5 that should be quarantined for not meeting sterilization standards.
On the other hand, MDs manufacturers are also encountering their share of difficulties. EtO, the most widely used sterilant in the sterilization industry is facing increasing political and regulatory pressure, given the risks it poses to human health (Lymphoma and leukemia being the most documented cancers) and the environment (water and air pollution). Even though it has been banned in EU hospitals, it remains the gold-standard in the MD industry with no ideal alternative available. Indeed, other technologies are struggling with capacity issues that are unlikely to improve soon, given the 5-7% annual growth in MD production which demands a corresponding increase in sterilization capacity. Compared to EtO, which offers a broad sterilization spectrum, competing technologies are limited by the types of materials and shapes of medical devices they can sterilize, further weakening this critical step in the medical device supply chain. This situation also highlights the growing need for new sterilization technologies that can address these challenges.
AURORA has developed the first sterilization process for MD using natural plasma as the sterilizing agent. Plasma is obtained by placing a gas low [oxygen, nitrogen, argon] under low pressure while being exposed to a radiofrequency field. Gas molecules are thereby ionized and converted into reactive species [electrons, metastable, ions...] which inactivate biological agents and degrades active chemicals.
Natural plasma holds outstanding characteristics for MD sterilization:
- Safety of the sterilizing agent which does not involve chemicals (and therefore toxic residue), nor harmful radiations
- Wide decontamination potential and capacity to remove both chemical and biological agents even biofilms and spores [the most difficult pathogens to sterilize]
- Gentle process that is respectful of materials [optics, electronics, biopolymers, metals] and compatible with a wide range of MD designs including the most complex shapes (strong penetration power)
There has been no major technological breakthrough in sterilization since the mid 90’s and the introduction of H2O2 to replace EtO in hospitals. The use of Natural Plasma will be a paradigm-shift for MD sterilization by:
1/ Offering the highest safety levels to MD in contact with patients, standing as an adapted response to the contamination issues experienced on MD with complex shapes (typically endoscopes and their long lumen)
2/ Enabling the emergence of innovative MDs that do not have an adapted sterilization process: custom-made MDs (Prostheses, innovative surgical tools, bioimplants etc.), small series, MD with sensitive materials/components.
3/ Acting as an alternative to EtO for the sake of human health and environmental sanity.
In terms of stakeholder-oriented benefits, natural plasma sterilization can have a huge impact on the sterilization market by filling two unmet needs:
- On the segment of reusable medical devices sterilization in health care facilities, where it enables sterilization of complex MDs which are currently impossible to sterilize.
- On the segment of single-use medical device sterilization after manufacturing, where it could replace EtO which is threatened by regulator's restriction.
1/ Offering the highest safety levels to MD in contact with patients, standing as an adapted response to the contamination issues experienced on MD with complex shapes (typically endoscopes and their long lumen)
2/ Enabling the emergence of innovative MDs that do not have an adapted sterilization process: custom-made MDs (Prostheses, innovative surgical tools, bioimplants etc.), small series, MD with sensitive materials/components.
3/ Acting as an alternative to EtO for the sake of human health and environmental sanity.
In terms of stakeholder-oriented benefits, natural plasma sterilization can have a huge impact on the sterilization market by filling two unmet needs:
- On the segment of reusable medical devices sterilization in health care facilities, where it enables sterilization of complex MDs which are currently impossible to sterilize.
- On the segment of single-use medical device sterilization after manufacturing, where it could replace EtO which is threatened by regulator's restriction.