The new facilities, designed, installed and maintained by the company MATACHANA, offers a comprehensive solution for the entire healthcare complex. It meets the very highest quality standards and is equipped with the most advanced technology, ensuring its full compliance with the new European Medical Device Regulation 2017/745.

In line with the current sustainable development goals of healthcare institutions, Hospital San Pedro carefully selected the devices for the project, prioritizing the acquisition of those that offer balanced consumption of essential resources, such as water and electricity, without compromising productivity. This is especially relevant due to the significant increase in the activity and complexity of surgeries in recent years.

In addition, and to ensure an efficient throughput rate, the hospital assessed all technical aspects related to automation, ergonomics and computer connectivity. These details reduce human errors and improve data communication and processing, ensuring the traceability of sterilized materials, the organization of the service and the correct operation of the devices, all of which supported by future artificial intelligence-based capabilities.

Among the devices installed, the MAT UIRI ultrasonic irrigator stands out for its uniqueness, allowing the automation and validation of the complicated pre-cleaning stage of the instruments used in robotic surgery, as well as a multitude of complex materials from various specialities.

Likewise, for the terminal sterilization of thermosensitive materials, the hospital has opted for a technology complementary to Hydrogen Peroxide, acquiring a Steam and Formaldehyde Sterilizer MATACHANA 130LF®. Its universality, cycle time and capacity will increase the range of possibilities for the hospital, also improving aspects of worker safety compared to previous sterilization technology.

The facilities will be 100% operational at the beginning of November 2024, once users have been adequately trained in the handling of all this new equipment and all processes have been validated prior to the start of the activity.

A state-of-the-art facility prepared for all the reprocessing challenges that new instruments, materials and advanced surgical practices generate every day in our hospitals. And always with patient safety as our top priority.

A giant leap forward… Congratulations, Hospital San Pedro!

La entrada NEW REPROCESSING UNIT FOR MEDICAL DEVICES AT HOSPITAL SAN PEDRO, LOGROÑO (SPAIN) se publicó primero en Matachana.

1. Improve documentation and clinical studies: The MDR requires more comprehensive and rigorous documentation for Medical Devices (MD). The importance of clinical studies to support the safety and efficacy of devices is also emphasised.

2. Post-Market Surveillance (PMS): The MDR establishes a more rigorous monitoring system once the devices are on the market. This allows the early detection of problems and a more effective response to protect patients and users.

3. Improved traceability: Both the manufacturers and authorities of member countries must guarantee solid traceability of MD. The public unique identification system (UDI code) makes this task easier.

In short, the MDR seeks to increase patient and user safety through closer monitoring of devices throughout their lifetime.

Antonio Matachana, S.A. is one of the leading companies in our sector in obtaining the MDR certification for all its sterilizers since May this year. This achievement was possible after a complex and demanding audit process carried out by our Notified Body, the TÜV Rheinland (0197), which lasted for several months.

La entrada SINCE MAY 2024 MATACHANA HAS BEEN MDR-CERTIFIED FOR ITS WIDE RANGE OF STEAM AND LOW TEMPERATURE STERILIZERS se publicó primero en Matachana.

At the Al Alba Clinic, the 130LF® High Speed sterilizer was commissioned and training was given in the use of Biovelox20 chemical and biological indicators.

At the Farallones Clinic in Cali, knowledge was updated on Steam sterilization in S1000 units and Low Temperature Steam sterilisation and 2% Formaldehyde with the 130LF® sterilizer.

The University of Santiago de Cali was the venue for a talk on the importance of RUMED as a cornerstone of health care. The positive consequences of an adequate treatment at the point of use of instruments throughout the entire process circuit were discussed. In addition, Low Temperature sterilization using Hydrogen Peroxide and Steam with 2% Formaldehyde was discussed.

Finally, at the Instituto para Niños Ciegos y Sordos (Institute for Blind and Deaf Children), experiences were shared and knowledge on table top and large steam sterilizers was updated.

All these activities contribute significantly to good practices in the hospital sterilization environment, positively impacting quality at every stage of the process.

We thank all the human talent of these institutions for opening their doors and allowing us to share experiences. We congratulate their dedication and celebrate their confidence in MATACHANA as a manufacturer of equipment for RUMED.

At MIEC, we train to transform, and our commitment to education is constant.

La entrada MATACHANA AND KAIKA: DRIVING INNOVATION IN STERILIZATION IN CALI se publicó primero en Matachana.

The seminar, which was attended by around 100 healthcare professionals, focused on quality management and patient safety. In addition to MATACHANA’s presentations, Felipe Coros and Dr. Luis Robles shared their knowledge. Dr. Robles’ lecture was particularly interesting, highlighting the importance of trust in quality management and in the human talent that executes the processes.

MATACHANA thanks ASEPSIS for the invitation and congratulates Peru for celebrating Nursing Day. It also applauds the initiative of ASEPSIS in the continuing education of professionals and celebrates that Peru will host the next Pan-American Congress in 2025, an excellent opportunity to continue learning and sharing experiences on the reprocessing of reusable medical devices.

La entrada EXCELLENCE AND QUALITY: MATACHANA PRESENT AT THE ASEPSIS SEMINAR IN PERU se publicó primero en Matachana.

Around 15 professionals from the surgical block, as well as from the reprocessing unit itself, updated their knowledge in this field, observing the great technological and regulatory advances that have taken place in recent years.

During the practical session, the most important aspects for the correct operation of the equipment present in the unit were reviewed, adapting these concepts to the design, flow and communications that the sterilization service establishes with the rest of the hospital, especially the surgical block.

The session was very well appreciated by all the attendees, especially the newer staff who were coming into contact with this area of knowledge for the first time. The day served to lay the foundations for more uniform working guidelines for all the service’s staff, which will surely lead to an improvement in the practices of all professionals and, therefore, in the safety of all patients.

La entrada KNOWLEDGE UPDATE AT THE SAGRADA FAMÍLIA CLINIC IN BARCELONA, SPAIN se publicó primero en Matachana.

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.

This session was organised through our distributor in Bolivia, the company COSIN and the Spanish company MAKIBER, specialised in supply and turnkey projects in the health, education, industry and agribusiness sectors.

MAKIBER, together with MATACHANA, technically equipped the Medical Device Reprocessing Unit of the aforementioned hospital, as well as the endoscopy unit, with the installation of an automatic reprocessor and a cabin for the drying and storage of the gastrointestinal and respiratory endoscopes of the service.

During the session, topics related to nosocomial infection associated with endoscopes were discussed and the fundamental steps for cleaning and disinfection of these devices were reviewed, with the aim of minimising the risk of contagion between patients and ensuring the safe use of these elements.

The course was academically accredited by MATACHANA, which was received with great enthusiasm for its high technical and scientific value.

We would like to thank our technician in the area, Mr. Ítalo Mejías, for his great involvement in this project.

La entrada ON-LINE UPDATE ON FLEXIBLE ENDOSCOPE REPROCESSING AT THE HOSPITAL OF CHUQUISACA, BOLIVIA se publicó primero en Matachana.

This session responded to the commitment made by MEDILAB, MATACHANA’s distributor company in Poland, as well as MATACHANA, after the public tender award of the washing equipment and sterilizers for this facility. Specifically, 5 washers MAT LD1000, a MAT LD2000 unit, 2 Steam sterilizers S1008 and a sterilization unit by Vaporised Hydrogen Peroxide, MATACHANA 130HPO®.

The management team has fostered a strong and supportive connection of the new staff, following the merger between the two former hospitals, which has allowed for a smooth and efficient integration of all personnel. This rapport enhances the working environment and ensures that all team members are aligned in the mission to maintain the highest standards of safety and efficiency in the reprocessing of medical devices.

Supervisors have promoted efficient practices, ensuring that all materials are processed to the highest quality standards. Their attention to the continuous development of their team of professionals is admirable and is reflected in the excellence of service.

And of course… Our thanks for the excellent work carried out by the company MEDILAB. Great job!!!

From MATACHANA, we wish that the tools and knowledge shared those days contribute to their already outstanding work.

Additional information:

https://www.linkedin.com/posts/uniwersytecki-szpital-kliniczny-w-poznaniu_centralnyzintegrowanyszpitalkliniczny-uskpoznaagm-activity-7217203675830624258-CQ9c?utm_source=share&utm_medium=member_desktop

https://www.linkedin.com/posts/elena-lorenzo-marfil-19761848_cssd-medilab-rumed-activity-7214667840740614145-vSoB?utm_source=share&utm_medium=member_desktop

La entrada KNOWLEDGE UPDATE AT THE UNIVERSITY HOSPITAL OF MEDICAL SCIENCES IN POZNAN, POLAND 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 company MATACHANA was awarded the contract for this major project, following a public tender launched in 2023. This new unit, a pioneer in many aspects in the Catalan region, replaces the old service that had become too small and obsolete for the high surgical demand and the complexity of the surgeries performed at the hospital. Among the most significant aspects, we would like to highlight its degree of automation and adaptation to more advanced surgical techniques, such as robotic surgery.

During all these months, the work and installation of the equipment has been carried out by the MATACHANA Technical Assistance Service, with the plan to start work in the last four months of 2024.

For this objective, it was essential to train all the personnel, so that they could familiarise themselves with the equipment and the new work spaces of the service. More than 30 professionals in 2 shifts have been trained in the most current reprocessing concepts, with the aim of facilitating their adaptation to the new service in a progressive manner.

From MATACHANA, we would like to thank the Health Institution for their drive to organise this conference and their commitment to constant improvement. We would also like to congratulate all the attending staff for their level of interest and the enriching dialogue that was generated during the two days of work.

La entrada STAFF TRAINING AND EQUIPMENT COMMISSIONING AT THE UNIVERSITY HOSPITAL JOSEP TRUETA IN GIRONA, SPAIN se publicó primero en Matachana.