Authors: Dr. Daniel Vázquez¹; Dr. Nelson Carreras²; Dr. Alex Zamora³; Ing. Alejandro Ramírez⁴. ¹Matachana Test Center Coordinator, ²Global Product Manager Consumables, ³RDI Chemist, ⁴Global Product Manager Low Temperature Sterilizers. Abbreviations: VH202 – Vaporized Hydrogen Peroxide, LTSF – Low Temperature Steam and Formaldehyde, RMD – Reprocessable Medical Device, PCD – Process Challenge Device

WFHSS-GUIDELINES

According to WFHSS-Guidelines “heat sensitive RMD’s require a range of cycles adapted to their material and geometrical specificities. Some heat compatible, minimally invasive surgery instruments are subject to accelerated aging (e.g., laparoscopy devices). Some countries offer the flexibility to use low temperature sterilization; other countries do not”. ^[1]

THE EFFECT OF FORMALDEHYDE AGAINST MICROBIAL PROTEIN

In solution, formaldehyde can be found in various forms, bounded to water molecules. We can find monomeric (monohydrate) species known as methylene glycols and polymeric (polyhydrated) species named polyoxymethylene glycols in the formaldehyde solution. At room temperature and low concentrations, the monomer/polymer solution ratio is 1:1200, in accordance with data from various studies. ^[2-6]

In addition, polyoxymethylenes can consist of various numbers of glycol groups:

• CH₂O – formaldehyde
• CH₂(OH)₂ – methylene glycol, formed by adding a water molecule
• (CH₂O)₃ – trioxymethylene glycol or paraformaldehyde
• (CH₂O)_n – different polyoxymethylene glycols

These polymeric species can polymerize to form a white precipitate depending on temperature and concentration. In the e-bag^® solution, ethanol serves to stabilize formaldehyde and prevent its polymerization, thereby avoiding the formation of precipitates. ^[7-9]

Formaldehyde is stable in its gaseous state, and its biocidal activity originates from its ability to interact with amino groups from proteins and nucleic acids, as illustrated in Figure 1. Its carboxyl group is highly reactive and interacts with proteins and nucleic acids, conferring it broad-spectrum effectiveness against microorganisms. ^[10]

Microbicidal mechanism:

Formaldehyde’s aldehyde group cross-links membrane proteins, denaturing them and also damages DNA and RNA, disrupting cellular function and leading to microorganism death. ^[11-12]

Figure 1. Cross link and formation of methylene bridges by formaldehyde between (A) proteins and (B) proteins and nucleic acids. ^[17]

THE EFFECT OF VH2O2 AGAINST MICROORGANISMS

Vaporized Hydrogen Peroxide (VH2O2) is a highly oxidizing substance and its active derivatives produced after decomposition have strong oxidation effects which directly disrupt the cell cytomembranes of microorganisms. However, this powerful oxidative action can also impact the materials used in medical devices, potentially leading to issues such as corrosion or gradual material degradation over time. ^[13]

Loading the sterilizer is a crucial step during the terminal sterilization process. After washing, inspecting, assembling (if required), drying and packing/pouching the laparoscopic devices, we’ll need to properly load the sterilizer according to the specification of the sterilization program selected.   Proper loading process following the sterilizer’s Instructions For Use, will ensure that after selecting the load-related sterilization program, the sterilization conditions on the load will be achieved.

In this regards, VH2O2 sterilizers are known for their complexity during the loading chamber process.  In general, the maximum length and minimum internal diameter of each medical device, as well as the total number of devices with lumen should be checked. ^[14-16] But not only, as in all terminal sterilization modalities, also the total load weight should be controlled. ^[14-16] The different combinations of these loading requirements play a crucial role to achieve sterilization, as if any of them is not fulfilled there is no sterilization warranty in the complete load. This is an extra stress factor to the operator.

THE EASE OF LOAD – Low Temperature Steam & Formaldehyde

On the other hand, Low Temperature Steam and Formaldehyde technology offers excellent penetrability performance, thanks to the use of steam to transport the sterilant into the narrow lumens and the high stability of the formaldehyde molecule. This allows the technology to require simple loading specifications; only the total load weight should be confirmed.

The following table shows penetrability tests results from Matachana Test Center using biological indicators according to ISO 11138-5, inside a process challenge device (PCD) receptacle with different lumen lengths and inner diameters.

Table 1. Sterilization efficacy comparison between VH2O2 and LTSF technologies in stainless steel lumens.

Table 1 confirms the highest penetrability performance compared to VH2O2 sterilizers, which typically are not compatible with rigid lumens below 0.7 mm inner diameter and longer than 500 mm. ^[14] In any case, some manufacturers^[16] claim 0.48 mm inner diameter with length no longer than 100 mm, but always limiting the number of lumens up to 20.

CONCLUSIONS

In conclusion, LTSF sterilization process is gentler with materials compared to other low temperature technologies, as its microbicidal effect, rooted in denaturalizing proteins rather than oxidation, minimizes damage to materials.

• Sterilization Efficacy: Both LTSF and VH2O2 provide high sterilization efficacy, yet their mechanisms differ significantly.

• Material Compatibility: LTSF distinguishes itself for its gentle treatment of materials, particularly sensitive instruments, due to its protein denaturation mechanism, contrasting with VH2O2’s potential long-term oxidative impact on materials.

• Operational Ease: LTSF technology offers operational simplicity, requiring only adherence to total weight requirements during the loading process.

Choosing between these technologies depends on factors such as device materials, facility protocols, and regulatory compliance. Understanding these nuances ensures optimal sterilization outcomes while maintaining the integrity of medical instruments.

BIBLIOGRAPHY

¹ Reusable medical device – Wfhss Guidelines. (n.d.). Retrieved June 20, 2024, from https://wfhss-guidelines.com/reusable-medical-device/

² Rivlin, M., Eliav, U., & Navon, G. (2015). NMR studies of the equilibria and reaction rates in aqueous solutions of formaldehyde. Journal of Physical Chemistry B, 119(12), 4479–4487. https://doi.org/10.1021/JP513020Y

³ Gold, A., Utterback, D. F., & Millington, D. S. (1984). Quantitative Analysis of Gas-Phase Formaldehyde Molecular Species at Equilibrium with Formalin Solution. Analytical Chemistry, 56(14), 2879–2882. https://doi.org/10.1021/AC00278A058

⁴ Winkelman, J. G. M., Ottens, M., & Beenackers, A. A. C. M. (2000). The kinetics of the dehydration of methylene glycol. In Chemical Engineering Science (Vol. 55, Issue 11). PERGAMON-ELSEVIER SCIENCE LTD. https://research.rug.nl/en/publications/the-kinetics-of-the-dehydration-of-methylene-glycol

⁵ Winkelman, J. G. M., Voorwinde, O. K., Ottens, M., Beenackers, A. A. C. M., & Janssen, L. P. B. M. (2002). Kinetics and chemical equilibrium of the hydration of formaldehyde. Chemical Engineering Science, 57(19), 4067–4076. https://doi.org/10.1016/S0009-2509(02)00358-5

⁶ Matubayasi, N., Morooka, S., Nakahara, M., & Takahashi, H. (2007). Chemical equilibrium of formaldehyde and methanediol in hot water: Free-energy analysis of the solvent effect. Journal of Molecular Liquids, 134(1–3), 58–63. https://doi.org/10.1016/J.MOLLIQ.2006.12.002

⁷ Kent, D. R., Widicus, S. L., Blake, G. A., Goddard, W. A., & Iii, W. A. G. (2003). A theoretical study of the conversion of gas phase methanediol to formaldehyde  A theoretical study of the conversion of gas phase methanediol to formaldehyde. J. Chem. Phys, 119, 5117–5120. https://doi.org/10.1063/1.1596392

 ⁸ Kleimeier, C. F., Turner, N. F., Singh, A. M., Fortenberry, S. K., & Kaiser, R. C. (2022). Synthesis of methanediol [CH 2 (Oh) 2 ]: The simplest geminal diol. Proceedings of the National Academy of Sciences, 119(1), 2111938119. https://doi.org/10.1073/pnas.2111938119

⁹ Lilienblum, W. (2012). Opinion of the Scientific Committee on Consumer Safety on methylene glycol; Opinion of the Scientific Committee on Consumer Safety on methylene glycol. https://doi.org/10.2772/83316

¹⁰ World Health Organization. (2016). Decontamination and Reprocessing of Medical Devices for Health-care Facilities. http://www.who.int

¹¹ Mcdonnell, G., Russell, A. D., Operations, L., & Louis, S. (1999). Antiseptics and Disinfectants: Activity, Action, and Resistance. CLINICAL MICROBIOLOGY REVIEWS, 12(1), 147–179.

¹² Loshon, C. A., Genest, P. C., Setlow, B., & Setlow, P. (1999). Formaldehyde kills spores of Bacillus subtilis by DNA damage and small, acid-soluble spore proteins of the alpha/beta-type protect spores against this DNA damage. Journal of Applied Microbiology, 87(1), 8–14. https://doi.org/10.1046/J.1365-2672.1999.00783.X

¹³ Tao, M., Ao, T., Mao, X., Yan, X., Javed, R., Hou, W., Wang, Y., Sun, C., Lin, S., Yu, T., & Ao, Q. (2021). Sterilization and disinfection methods for decellularized matrix materials: Review, consideration and proposal. Bioactive Materials, 6(9), 2927. https://doi.org/10.1016/J.BIOACTMAT.2021.02.010

¹⁴ STERRAD User’s Guide REF A11150401. ASP. Retrieved June 20, 2024, from https://eifu.asp.com/

¹⁵ STERRADTM Low temperature sterilization.  ASP. Retrieved June 20, 2024, from https://www.asp.com/low-temp-esterilization

¹⁶ STERIS Instructions For Use | Operator Manual. STERIS. EN 10085896 Revision H. Retrieved June 20, 2024, from https://www.steris.com/healthcare/instructions-for-use

¹⁷ Adapted from “Kouchmeshky, A., & McCaffery, P. (2020). Use of fixatives for immunohistochemistry and their application for detection of retinoic acid synthesizing enzymes in the central nervous system. Methods in Enzymology, 637, 119–150. https://doi.org/10.1016/BS.MIE.2020.03.010” with BioRender.com  

La entrada REPROCESSING LAPAROSCOPY USING LOW TEMPERATURE STERILIZATION…VH2O2 or LTSF? se publicó primero en Matachana.

We are pleased to announce the availability of the new MATACHANA Consumables Catalogue for monitoring products (chemical and biological indicators) and packaging (sterile barrier system). All products will be at your fingertips, classified according to the different areas of a Reprocessing Unit for Medical Devices (RUMED).

It includes not only products for the RUMED of hospitals, clinics and primary care centres, but also includes products for the validation of reusable medical device processing processes, as well as products for the management of special biosanitary waste.

This new catalogue classifies the monitoring products in a simple and intuitive way, including both a user guide and an interpretation’s guide of the indicators. In addition, it also contains comprehensive product information according to standards.

With this catalogue we provide you with a very useful and comprehensive tool!

La entrada NEW MATACHANA CONSUMABLES CATALOGUE! se publicó primero en Matachana.

The MIEC of MATACHANA has emerged as an international benchmark thanks to its state-of-the-art facilities in Barcelona, which include a comprehensive sterilization central and lecture rooms equipped for both theoretical and practical instruction. This center of excellence facilitates learning on crucial aspects of sterilization and infection prevention, extending to the provision of personalised on-site training for users. The collaboration with distributors and hospital professionals’ underlines MATACHANA’S commitment to continual improvement and efficiency in medical device reprocessing. The company’s training encompasses technical, operational, procedural, qualitative, and legal aspects.

MATACHANA’s investment in training and technology underscores the importance of preparing professionals to meet the challenges of modern medical technology. Through tailored learning programmes and the use of state-of-the-art healthcare services, we not only contribute to infection prevention, but also ensure safe and effective medical care.

La entrada MATACHANA: Driving excellence in healthcare through technology and training se publicó primero en Matachana.

Furthermore, the new format design offers a more economical price (10% savings) and is designed to meet the demands of high-volume hospitals and medical centres, providing boxes with over 3200 units of chemical strips. This improved availability not only streamlines the management of steam sterilization processes, but also ensures a more responsive approach to the needs of institutions with a high volume of sterilization cycles, enhancing logistics and storage.

With these advancements, MATACHANA demonstrates its environmental commitment and enhances the operational efficiency of its users. This dual approach benefits both the planet and healthcare professionals by aligning sterilization practices with the principles of sustainability and efficiency. MATACHANA is at the forefront of promoting a more sustainable future in healthcare, setting a milestone in integrating innovation with environmental responsibility.

La entrada Innovation and sustainability: MATACHANA’s new format for Steam sterilization se publicó primero en Matachana.

Celebrating 10 years of MAGAZINE MATACHANA!
The newest edition is now available.

From the inauguration of Matachana Portugal to cutting-edge sterilization solutions, this magazine is an essential compendium of progress and commitment to excellence.

Download it today and explore the latest Healthcare trends with MATACHANA.

La entrada Celebrating 10 years of MAGAZINE MATACHANA! The newest edition is now available. se publicó primero en Matachana.

On 18, 19 and 20 March, the 2024 conference organised by the Sterilizing Research and Advisory Council of Australia was held at the Opal Cove Resort in the city of Coffs Harbour. Under the slogan “Breaking out of your shell”, several presentations were given related to the latest advances in procedures and equipment used for reprocessing medical devices, alongside other more educational presentations.

On Wednesday 20 March, the Head of MIEC (Matachana International Education Center), Elena Lorenzo, gave a presentation titled “LTSF as the best complementary technology to VH2O2 sterilization”. This presentation highlighted the need for TERMINAL STERILIZATION of any medical device used in a critical procedure, in accordance with the requirements of the new Australian standard AS 5369. This would include flexible endoscopes from specific areas that are currently only disinfected to a high level or are sterilised using liquid procedures, but that should be terminally sterilised. In this sense, LTSF technology is the only means that could guarantee the safe sterilization of these devices, as VH2O2 does not offer the same guarantee of penetrability.

The conference generated a lot of interest among participants, who subsequently posed a lot of questions on this matter.

We would like to thank IN VITRO TECHNOLOGIES INFECTION CONTROL for their support throughout the conference, especially Bree Brown, Product Manager of MATACHANA’s Low Temperature range. We would also like to congratulate the NSW SRACA organising committee for the excellent event and the interesting content selected.

For more information, we recommend reading these social media posts:

https://www.linkedin.com/posts/elena-lorenzo-marfil-19761848_ltsf-vh202-nswsraca-activity-7171177171724427264-hoEB?utm_source=share&utm_medium=member_ios

https://www.linkedin.com/posts/franciosa-briones-brown-mba-98b87416_in-coffs-harbour-nsw-for-the-regional-sraca-ugcPost-7175684065843458048-3z4g?utm_source=share&utm_medium=member_ios

https://www.linkedin.com/posts/invitroinfectioncontrol_nswsraca-nswsraca-healthcare-ugcPost-7176754453549625345-m6Ff?utm_source=share&utm_medium=member_ios

La entrada NSW SRACA Conference, Coffs Harbour – Australia se publicó primero en Matachana.

MATACHANA and KIMS join their leading positions in the hospital sector to bring customers better service and a complete range of global solutions in the infection control field.

20th March 2024

Barcelona, Barcelona, Spain and Buenos Aires, Argentina – Since the beginning of the 90’s, MATACHANA, with direct presence in the country since 1991 and KIMS, founded in Buenos Aires in 1993, treasure a long and broad experience within the hospital and industrial sectors in Argentina. These sectors are constantly and dynamically evolving, which creates new challenges and forces us to adapt, in order to provide the best services and solutions to our customers. The alliance between MATACHANA and KIMS is a sign of the will of both companies to further expand the application of their knowledge, experience and products in the Argentinean market.

This strategic partnership allows the best of KIMS and MATACHANA’s product lines, distribution and services to be leveraged bilaterally and globally. KIMS will focus on the exclusive distribution of MATACHANA sterilizers, washer-disinfectors and the full range of MATACHANA products in Argentina, including the technical service, to the extensive installed base of equipment currently in operation.

MATACHANA, founded in 1962, is a second generation family business, manufacturer of a wide range of disinfection and sterilization equipment with direct presence in the Spanish, French, German, Italian, Portuguese and Indonesian markets and with a network of distributors in more than 120 countries. “We are very proud of the alliance signed with KIMS for the Argentinean market because it will reinforce our already extensive direct presence of more than 30 years, providing national coverage whilst extending our brand and prestige,” stated Manuel Matachana, CEO of MATACHANA.

KIMS SRL is an Argentinean company founded in 1993 dedicated to the research, development, manufacture and marketing of sterilization consumables for healthcare. Its main products are packaging, containers and chemical & biological indicators for sterilization, with a strong presence in Argentina and in the international market. “This alliance generates great expectations and we are sure it will increase MATACHANA’s presence in the Argentinean market, strengthening both companies”, declared Alexis H. Theriano, CEO of KIMS SRL.

The combination of quality-oriented design, attention to customer needs and a philosophy of service excellence has enabled this strategic alliance between MATACHANA and KIMS to achieve their goal.

 
Press_Release_Alianza_Argentina_00_00_en.pdf

La entrada MATACHANA and KIMS announce a strategic alliance within the hospital sector in the Republic of Argentina se publicó primero en Matachana.

The notable participation in the 7th Conference of Hospital Sterilisation and Disinfection held recently in Uruguay was a reflection of the commitment to academic excellence and continuous improvement in the area of medical device reprocessing. The event, held on 14 and 15 March 2024, stood out for its academic focus and the quality of the papers presented, making it the ideal space for sharing knowledge and best practices.

The Uruguayan Sterilisation Association (AESTU), as the leading entity in hospital sterilisation in the country, played a key role in facilitating dialogue between its members and other attendees. Among the featured speakers were recognised experts such as Fabiola Casas, Patricia Gutiérrez, Maria Elena Yeckle and Giovanna Ruiz, who shared their knowledge of new technologies, cleaning and disinfection protocols, standards and their own experiences.

The event was not only an opportunity to gain more knowledge of the sector, but also to recognise and appreciate the hard work and dedication of all medical device reprocessing professionals in Uruguay. These types of initiative contribute significantly to raising the quality and safety standards in the healthcare sector in Latin America.

Congratulations on a great success!

For more information: https://www.linkedin.com/posts/giovanna-paola-ruiz-beltran-17bb9216b_aestu-uruguay-reprocesamiento-ugcPost-7174685330833342464-zocr?utm_source=share&utm_medium=member_ios

La entrada Ongoing commitment: Excellence in Reprocessing Medical Devices in Uruguay se publicó primero en Matachana.

Terminal sterilization will allow you to keep the sterile conditions of the reprocessed medical device for months…

The MATACHANA 130LF® LTSF sterilizer represents a unique technological breakthrough, uniquely capable of terminal sterilizing two duodenoscopes in less than two hours. This achievement overcomes the efficacy constraints of other systems and ensures an unparalleled level of safety and sterility. Using Low Temperature Steam and Formaldehyde (LTSF) technology, this system effectively addresses concerns about sterilization efficacy in medical devices with long and complex lumens. Other technologies, such as Vaporized Hydrogen Peroxide (VH2O2), can have limitations.

Beyond its immediate impact on patient safety and operational efficacy, the MATACHANA 130LF® LTSF sterilizer aligns with global trends and strict regulations in the sterilization of medical equipment.

This technological progress represents a significant step forward in the way medical professionals and sterilization services approach the challenges of terminal sterilization. With the MATACHANA 130LF® LTSF sterilizer, the healthcare industry is better equipped to face future challenges, ensuring patients receive the safest and most effective care possible.

La entrada Did you know that the MATACHANA 130LF® LTSF is the only sterilizer that can terminally sterilize two duodenoscopes in less than 2 hours? se publicó primero en Matachana.

The Hospital Universitario Gregorio Marañón is the first Spanish university hospital to be designated as a hospital that manufactures implants, surgical instruments and personalised prostheses certified according to ISO 13485, providing enhanced safety for patients and more accessible costs. For this certification process, all stages carried out by the Reprocessing Unit for Medical Devices were validated internally in order to ensure the compatibility and functional viability of the elements designed in 3D, highlighting the invaluable contribution made by these services and their teams. In this certification process, MATACHANA’s knowledge, in particular through its MATEC Department, was crucial when it came to substantiating and verifying all of these results.

Here at MATACHANA, we would like to thank UPAM3D for the visibility and importance given to the Reprocessing Unit for Medical Devices (RUMED) in a project with such a significant clinical impact.

For more information:

https://www.linkedin.com/posts/matachana_matachana-upam3d-qia-activity-7174004459516108800-QH–/?utm_source=share&utm_medium=member_ios

https://www.linkedin.com/posts/upam3d_poc-am-hgugm-activity-7174327864043921408-3wZ7/?utm_source=share&utm_medium=member_ios

La entrada The 3D unit (UPAM3D) at the Hospital Universitario Gregorio Marañón in Madrid, winner at the 2023 Quality Innovation Awards se publicó primero en Matachana.