Terragene https://terragene.com Biotechnology Company Tue, 02 Jun 2026 18:55:28 +0000 en hourly 1 https://wordpress.org/?v=6.9.4 https://terragene.com/wp-content/uploads/2020/12/cropped-FAVICON-TERRAGENE-AZUL-Rev.1-32x32.png Terragene https://terragene.com 32 32 Residual Protein Monitoring in Cannulated Medical Devices https://terragene.com/residual-protein-monitoring-in-cannulated-medical-devices/ https://terragene.com/residual-protein-monitoring-in-cannulated-medical-devices/#respond Tue, 02 Jun 2026 17:56:09 +0000 https://terragene.com/?p=66985 Standard cleaning protocols leave measurable protein residues in most cannulated instruments. Here’s what three leading hospitals discovered — and what reprocessing teams should do about it. Hospital Italiano · Fundación Favaloro · Hospital El Cruce | Buenos Aires, Argentina The reprocessing of reusable medical instruments is one of the most consequential — and most undermonitored […]

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Residual Protein Monitoring in Cannulated Medical Devices

Standard cleaning protocols leave measurable protein residues in most cannulated instruments. Here’s what three leading hospitals discovered — and what reprocessing teams should do about it.

Hospital Italiano · Fundación Favaloro · Hospital El Cruce | Buenos Aires, Argentina

The reprocessing of reusable medical instruments is one of the most consequential — and most undermonitored — activities in any healthcare facility. While visible soil is easy to address, the invisible threat of residual protein deep inside narrow instrument channels is far harder to detect and far easier to overlook. Protein residues shield microorganisms from disinfectants and sterilants, creating a latent pathway for healthcare-associated infections (HAIs) that standard visual inspection or ATP bioluminescence simply cannot catch.

To quantify this risk under real clinical conditions, a multicenter evaluation was conducted across three leading hospitals in Buenos Aires, Argentina: Hospital Italiano de Buenos Aires, Fundación Favaloro (University Hospital), and Hospital El Cruce Dr. Néstor Kirchner. The study assessed 19 distinct cannulated instrument types using the Chemdye® Pro1 Endo quantitative protein detection system — a BCA-based colorimetric assay adapted for internal lumens.

19

INSTRUMENT TYPES
EVALUATED

3

PARTICIPATING
HOSPITALS

5.7×

MORE PROTEIN IN MANUAL VS. ULTRASONIC
CLEANED INSTRUMENTS

Why Residual Protein in Cannulated Instruments Is a Patient Safety Issue

Cannulated devices — instruments with narrow internal lumens such as ureteroscopes, hysteroscopes, suction tubes, and aspiration cannulas — present unique reprocessing challenges. Their complex geometry limits fluid dynamics, reduces the shear forces needed for soil removal, and creates dead spaces where biofilm and proteinaceous residue can accumulate and persist.

The consequences are well-documented: residual proteins and biofilm impair the efficacy of high-level disinfection (HLD) and steam sterilization. Among cannulated devices, endoscopes represent the greatest cleaning challenge because of their complex geometries, narrow lumens, and diverse material composition. Several outbreaks of multidrug-resistant organisms have been traced directly to inadequate cleaning of these devices, prompting FDA safety communications and accelerated regulatory scrutiny of automated endoscope reprocessors (AERs).

“The persistence of protein residues — even at levels well below visual detection thresholds — constitutes a latent patient safety risk, as these residues can shield microorganisms from disinfectants and sterilants.”

— MULTICENTER STUDY CONCLUSIONS

Guidelines from AAMI ST91 and the CDC support routine, preferably daily, monitoring of manual cleaning processes, and emphasize ongoing staff training and gap analysis. Yet in practice, most reprocessing departments lack the tools to verify cleaning eectiveness at the level of individual instruments and individual
lumens.

The Limits of Current Detection Methods

Conventional post-cleaning verication methods each carry signicant limitations when applied to cannulated instruments:

Visual inspection

cannot detect sub-visible protein lms or biolm within internal channels

ATP bioluminescence

not able to detect viruses or prions or even dead cells, which still represent an organic contamination

Ninhydrin-based tests and TOC analysis

lack the sensitivity for low-level residues or are impractical for internal lumen access.

Fluorescence imaging

cannot reach or quantify contamination within long, narrow, or tortuous lumens.

How the Chemdye® Pro1 Endo System Works

The Chemdye® Pro1 Endo Hygiene Monitoring System is built around the well validated BCA (Bicinchoninic Acid) assay, adapted specically for internal lumen sampling. The system uses Chemdye® SWE high-absorption swabs — available in four diameters (1.7, 2.0, 2.7, and 3.0 mm) and 2.5 meters in length — that traverse the full length of an instrument’s internal channel in a single pass.

DETECTION WORKFLOW

  1. A size-matched SWE swab is passed through the instrument’s internal channel in a single direction, collecting any residual protein.
  2. The swab is immersed in the Chemdye® Pro1 Endo reactive solution.
  3. Proteins reduce Cu²⁺ to Cu⁺, which forms a purple BCA–copper complex proportional to protein concentration.
  4. The device is incubated at 60 °C for 4 minutes in the Bionova® MiniPro reader.
  5. Absorbance at 562 nm is measured against a bovine serum albumin (BSA) calibration curve, delivering a quantitative result in μg of protein (range: 1–50 μg; LOD: 0.5 μg).

This design addresses a fundamental limitation of prior methods: no commercially available system could previously access and quantify contamination within long, narrow, or complex lumens. The 2.5 m swab length covers flexible endoscopic channels exceeding 120 cm in a single sampling pass.

Key Findings from the Multicenter Study

1. PROTEIN CONTAMINATION IS WIDESPREAD AFTER STANDARD CLEANING

Across all three hospitals and both cleaning modalities, the Pro1 Endo system detected protein residues in a signicant proportion of instruments that had already completed their institutional reprocessing protocol. Results ranged from 0 μg (undetectable) to 6.3 μg of protein per instrument conrming that standard cleaning does not universally eliminate internal organic contamination.

2. NARROW-LUMEN, LONG-CHANNEL INSTRUMENTS POSE THE GREATEST RISK

When protein results are normalized to internal surface area (μg/cm²), narrow instruments display disproportionately high contamination per unit area. The Olsen Cholangiography Forceps (2 mm diameter, 32 cm channel) showed an average surface density of 0.48 μg/cm², compared to 0.028 μg/cm² for the Ureteroscope and 0.010 μg/cm² for the Cystoscope. Reduced fluid shear, limited mechanical access, and laminar-to-turbulent flow transitions inside narrow channels all contribute to this pattern.

Selected instruments · average residual protein after standard cleaning - Residual protein monitoring

3. Ultrasonic Cleaning Significantly Outperforms Manual Cleaning

Instruments processed via automated ultrasonic cleaning showed an average residual protein level of 0.23 μg, compared to 1.31 μg for manually cleaned instruments — a 5.7-fold difference. Directed cavitation energy accesses complex internal surfaces more reproducibly than manual techniques, which are inherently subject to operator variability.

Critically, however, automated cleaning was not infallible. The Laparoscopic Forceps Sheath (ultrasonic) still registered 1.3 μg in one replicate, and the Cannula Pump showed 1 μg. Instruments with multi-section or multi-lumen architectures may include areas of incomplete cavitation access. Post-cleaning verification remains essential regardless of the cleaning modality.

⚠ CLINICAL IMPLICATION

Without post-cleaning verication, instruments carrying residual protein loads
could proceed directly to sterilization — possibly reducing the sterilant penetration and efficacy—
without any opportunity for corrective action.

4. PRO1 ENDO ENABLES REAL-TIME CORRECTIVE ACTION

The most operationally signicant finding of the study was the system’s role as an active feedback tool. At Hospital El Cruce, two instruments with initial readings above 5 μg were agged, re-washed, and retested: 

  • The Frazier 9 Fr Suction Tube started at >50 μg. Aer one additional manual
    wash, the result dropped to 0.5 μg — a greater than 98% reduction.
  • The Frazier 13 Suction Tube started at 6.3 μg. Two additional manual washes
    still le it at 4.9 μg. Only aer switching to ultrasonic cleaning did the result
    reach 0 μg. 

These cases illustrate the system’s unique value: it does not merely conrm a pass or fail — it identfies when a cleaning method is inadequate for a particular instrument and guides escalation to a more eective approach.

Six Evidence-Based Conclusions for Reprocessing Departments

1

Standard cleaning is not universally suficient.

Residual protein was found across all three institutions and both cleaning methods, confirming that compliance with IFUs alone does not guarantee internal cleanliness in cannulated instruments.

2

Automate where possible.

Ultrasonic cleaning reduces average residual protein by a factor of 5.7 compared to manual cleaning. Where instrument compatibility permits, automated cleaning should be the preferred modality.

3

Prioritize narrow-lumen instruments for enhanced protocols.

Instruments with internal diameters ≤2 mm and longer channels — particularly cholangiography forceps, ureteroscopes, and neuro aspiration cannulas — require dedicated monitoring programs

4

Use quantitative, not qualitative, monitoring.

Only a quantitative system can guide corrective action and document the degree of improvement aer re-washing. Pass/fail indicators are insucient for complex instruments.

5

Verify every cleaning episode, not just periodic audits.

Inter-procedural variability in soil load and cleaning thoroughness means that a single clean instrument does not predict the next. 

6

Document results for QMS and regulatory compliance.

Quantitative records from the Bionova® MiniPro reader create a traceable audit trail supporting compliance with ISO 15883, AAMI ST79, and accreditation frameworks that require evidence-based reprocessing quality monitoring.

Conclusion

This multicenter study provides clear, real-world evidence that residual protein contamination in reusable cannulated medical instruments is not a theoretical concern — it is a confirmed, measurable phenomenon occurring under standard institutional conditions. The Chemdye® Pro1 Endo system demonstrated superior sensitivity, broad instrument compatibility across all 19 device types evaluated, and direct clinical utility as a real-time corrective tool that no conventional method can replicate.

Adopting quantitative protein monitoring as a routine component of the reprocessing verication workflow represents one of the most actionable steps a facility can take to reduce the risk of device-associated infections in patients undergoing procedures with cannulated instruments.

“Pro1 Endo functions not merely as a passive quality indicator, but as an active component of the cleaning verication loop — one that prevents contaminated instruments from proceeding to sterilization and subsequent patient use.”


— MULTICENTER STUDY

OFFICIAL STUDY DOCUMENTS

Read the Full Multicenter Study Report

Access the complete technical document behind this article,
including detailed methodology, instrument-level data tables, and all annexes.

Download the Official Report

WEBINAR

Register now for the webinar “Quantitative Analysis of Protein Residues in Cannulated Instruments, from Argentina to the World.”

Register Now

References

AAMI ST79 · AAMI ST91 · ISO 15883-1 · ISO 15883-5 · ISO 13485 · Ofstead CL et al., Am J Infect
Control 2015 · Wang C et al., J Hosp Infect 2016 · Alfa MJ et al., Am J Infect Control 2013 · Primo MGB
et al., J Hosp Infect 2017 · Madureira RAS et al., BMC Infect Dis 2019 · Rutala WA, Weber DJ, Infect
Dis Clin North Am 2016 · CDC Guideline for Disinfection and Sterilization in Healthcare Facilities
· U.S. FDA Safety Communication on Reprocessed Duodenoscopes.

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]]> https://terragene.com/residual-protein-monitoring-in-cannulated-medical-devices/feed/ 0 Terragene en el 3° Congreso Iberoamericano de Esterilización https://terragene.com/terragene-en-el-3-congreso-iberoamericano-de-esterilizacion/ Tue, 05 May 2026 14:45:42 +0000 https://terragene.com/?p=66846 Del 30 de abril al 2 de mayo de 2026, Cartagena de Indias fue el epicentro de la esterilización hospitalaria iberoamericana. Más de 1.300 profesionales del reprocesamiento de dispositivos médicos, entre ellos enfermeros instrumentistas, jefes de central, biomédicos y gestores hospitalarios, se reunieron en el III Congreso Iberoamericano de Esterilización (CIBE 2026), organizado por IASSIPC®. […]

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Terragene en el 3° Congreso Iberoamericano de Esterilización

Del 30 de abril al 2 de mayo de 2026, Cartagena de Indias fue el epicentro de la esterilización hospitalaria iberoamericana. Más de 1.300 profesionales del reprocesamiento de dispositivos médicos, entre ellos enfermeros instrumentistas, jefes de central, biomédicos y gestores hospitalarios, se reunieron en el III Congreso Iberoamericano de Esterilización (CIBE 2026), organizado por IASSIPC®.

Terragene estuvo presente con una propuesta clara y diferenciadora: poner en el centro del debate un desafío que toda central de esterilización enfrenta hoy: ¿Qué hacemos con todos los datos que generamos en el Departamento de Procesamiento de Equipos (DPE)?

La participación de Terragene en el CIBE 2026 apuntó a generar una conversación de fondo: la transición de una gestión analógica, dispersa y reactiva hacia una gestión digital, integrada y basada en evidencia. Y Bionova Q fue el hilo conductor de esa conversación. 

A lo largo de los tres días del congreso, el stand de Terragene se convirtió en un punto de encuentro para equipos que ya están dando ese paso y para aquellos que buscan entender por dónde empezar. Las demos en vivo, el simposio interactivo y el Photon Challenge hicieron del espacio una experiencia completa.

Congreso Iberoamericano

Conferencia de Terragene en el Congreso Iberoamericano 2026.

Los momentos clave de Terragene en el Congreso Iberoamericano 2026

Demos on-demand del ecosistema Terragene

Los visitantes pudieron experimentar de forma directa el ecosistema completo desde los indicadores biológicos y el sistema Photon hasta Bionova Q como plataforma integradora de todos los datos del proceso

Simposio interactivo sobre gestión de datos en el DPE

Juan Diaz y Luciano Demarco lideraron el simposio ¿Qué hacemos con los datos que generamos en el DPE?", generando debate activo con los asistentes sobre el rol de la información en la mejora continua del reprocesamiento

Photon Challenge: velocidad y conocimiento en acción

Una experiencia interactiva que puso a prueba a los asistentes sobre Photon, uno de los indicadores biológicos más rápidos del mercado. Entretenimiento, educación y marca: todo en uno.

Bionova Q como eje del ecosistema digital

El foco de la participación estuvo puesto en demostrar cómo Blonova Q integra todos los datos del proceso lavado, esterilización, indicadores, despacho en una sola plataforma clara, intuitiva y accionable para la central de esterilización.

Bionova Q: el software de gestión del DPE que convierte datos en decisiones

Para entender por qué Bionova Q fue el centro de la propuesta de Terragene en el CIBE 2026, hay que entender primero el problema que resuelve. Una central de esterilización moderna genera cientos de datos por turno: ciclos de lavado, parámetros de esterilización, resultados de indicadores químicos y biológicos, trazabilidad de paquetes, control de stock. Pero en la mayoría de las instituciones, esos datos viven en planillas, registros en papel, o sistemas inconexos que hacen imposible una visión integrada del proceso.

Bionova Q es el software de gestión para la central de esterilización (CSSD/DPE) desarrollado por Terragene para resolver exactamente ese problema. No es una herramienta de registro pasivo ni un simple software de trazabilidad: es una plataforma de gestión activa que conecta cada etapa del reprocesamiento en un flujo digital continuo, con evidencia automática y capacidad de auditoría en tiempo real.

Bionova Q: el software de gestión del DPE que convierte datos en decisiones

La participación de Terragene en el III Congreso Iberoamericano de Esterilización no fue un evento más. Fue una apuesta por una conversación de fondo sobre el presente de la gestión de la central de esterilización en Iberoamérica.

El ecosistema Terragene —con Bionova Q como plataforma digital central y Photon como indicador de referencia— representa la convergencia entre la ciencia del reprocesamiento y la tecnología de gestión. No son productos aislados: son piezas de un sistema diseñado para que cada dato generado en el DPE tenga un destino útil.

 “La participación de Terragene reafirma su compromiso con soluciones que ayudan a optimizar procesos a través de información clara, trazable y accionable.” 

El CIBE 2026 fue también una oportunidad de escuchar: los desafíos reales de los equipos de reprocesamiento de Argentina, Colombia, España, Brasil, México y el resto de Iberoamérica. Esas conversaciones en el stand y en el simposio son el insumo más valioso para seguir construyendo soluciones que respondan a lo que la central de esterilización realmente necesita hoy.

Other News

Residual Protein Monitoring in Cannulated Medical Devices

Terragene en el 3° Congreso Iberoamericano de Esterilización

CSSD Cleaning Monitoring: Safety & Traceability

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]]> CSSD Cleaning Monitoring: Safety & Traceability https://terragene.com/cssd-cleaning-monitoring-safety-traceability/ https://terragene.com/cssd-cleaning-monitoring-safety-traceability/#respond Thu, 16 Apr 2026 11:45:35 +0000 https://terragene.com/?p=66617 Why CSSD Cleaning Monitoring Is Critical Cleaning is the first and most important step in reprocessing. If organic residues remain on instruments, sterilization may fail regardless of the cycle parameters. A proper CSSD cleaning monitoring strategy must control all critical variables involved in the washing cycle: Time Temperature Detergent type and concentration Water quality Mechanical […]

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CSSD Cleaning Monitoring: Safety & Traceability

Why CSSD Cleaning Monitoring Is Critical

Cleaning is the first and most important step in reprocessing. If organic residues remain on instruments, sterilization may fail regardless of the cycle parameters.

A proper CSSD cleaning monitoring strategy must control all critical variables involved in the washing cycle:

  • Time
  • Temperature
  • Detergent type and concentration
  • Water quality
  • Mechanical action

Given the complexity of these parameters, relying on manual checks is no longer enough. Automated monitoring ensures consistency, repeatability, and compliance.

Other News

Residual Protein Monitoring in Cannulated Medical Devices

Terragene en el 3° Congreso Iberoamericano de Esterilización

CSSD Cleaning Monitoring: Safety & Traceability

A diagram illustrating the seven-stage sterile processing cycle, emphasizing critical control points for washing, disinfection, and inspection

Challenges in Cleaning Validation

Many CSSDs still face key limitations when validating cleaning processes:

  • No verification of every load and rack
  • Lack of objective and standardized evaluation
  • Limited or no traceability
  • Use of ATP-based systems that do not detect proteins or prions

Protein residues are among the most critical contaminants in medical device reprocessing. Unlike ATP systems, protein-based monitoring solutions allow a more accurate evaluation of cleaning effectiveness—including risks associated with prions.

Advanced CSSD Cleaning Monitoring with Terragene Solutions

A complete CSSD cleaning monitoring approach integrates multiple technologies to ensure performance, hygiene control, and full traceability.

For cleaning performance monitoring, Chemdye® Splat indicators use a specially formulated test soil that simulates organic residues typically found on medical instruments. These highly versatile indicators can be used in both washer-disinfectors and ultrasonic washers, depending on the holder selected, and can be processed with the load or in an empty chamber. They are suitable for both routine monitoring and equipment performance qualification.

For ultrasonic cleaning processes, CDWU & CDWU-Z cavitation indicators combined with holders allow you to evaluate cavitation energy distribution and detect ineffective zones inside the washer. When paired with CAVITEST® auto-reader, results become fully objective, delivering quantifiable data and clear Pass/Fail outcomes.

Cavitest and CDWU-Z – Quick User Guide

After cleaning, surgical instruments must be disinfected to ensure safe subsequent handling and processing. Thermal disinfection with moist heat, is the most common method for disinfection of medical devices in the hospital setting. Thermodisinfection can be specifically monitored using IT27W indicators,

For hygiene monitoring, Terragene introduces advanced protein detection systems such as PRO1 MICRO & PRO1 ENDO, enabling quantitative measurement of protein residues on surfaces and inside cannulated instruments. Together with the MiniPro auto-reader, these systems enable incubation and quantitative readout of protein detection pens such as Chemdye® PRO1 MICRO, designed for the detection of surface proteins and allergens.

PRO1 Micro Hygiene Monitoring System and Bionova MiniPro  auto-reader for the detection and quantification of proteins on surfaces.

 

Finally, all data can be integrated into Bionova® Q CSSD software, enabling real-time monitoring, full traceability, and complete visibility of the reprocessing cycle—from cleaning to sterilization and final release.

Upgrade your CSSD cleaning monitoring strategy with real, measurable results.

Join our webinar:
 “Ensuring Effective Cleaning: Advanced Monitoring Solutions for CSSDs”

Discover how to implement automated monitoring, improve traceability, and ensure cleaning effectiveness in every cycle.

Choose the session that best fits your schedule:

  • 🌍 Region 1: Europe • Middle East • Asia (New Delhi, Bangkok / Hanoi & Jakarta) → Register Now

  • 🌏 Region 2: Asia (Hong Kong, Seoul, Tokyo, Shanghai, Beijing) • Australia • North America → Register Now

Save your spot for the next session:

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]]> https://terragene.com/cssd-cleaning-monitoring-safety-traceability/feed/ 0 Quantitative Protein Testing in CSSDs at KACSDN 2026 https://terragene.com/quantitative-protein-testing-in-cssds-at-kacsdn-2026/ https://terragene.com/quantitative-protein-testing-in-cssds-at-kacsdn-2026/#respond Thu, 09 Apr 2026 13:48:26 +0000 https://terragene.com/?p=66469 Terragene reinforced its global presence at the 2026 Annual General Meeting and Spring Conference organized by KACSDN in Seoul, presenting its approach to quantitative protein testing in CSSDs through evidence-based solutions. On Friday, March 20th, our Head of Product Specialists and Clinical Educator for Europe and APAC, Antonela Sdrigotti, delivered the lecture “From Assumption to […]

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Quantitative Protein Testing in CSSDs at KACSDN 2026

Terragene reinforced its global presence at the 2026 Annual General Meeting and Spring Conference organized by KACSDN in Seoul, presenting its approach to quantitative protein testing in CSSDs through evidence-based solutions.

On Friday, March 20th, our Head of Product Specialists and Clinical Educator for Europe and APAC, Antonela Sdrigotti, delivered the lecture “From Assumption to Evidence – Quantitative Protein Testing in CSSDs” to a full room, demonstrating how healthcare facilities can move from subjective assessments to measurable, data-driven cleaning validation, improving safety and process reliability.

KACSDN 2026 - Quantitive protein
KACSDN 2026 - Quantitive protein

Terragene team at KACSDN 2026, Seoul — presenting quantitative protein testing solutions for CSSDs

Other News

Residual Protein Monitoring in Cannulated Medical Devices

Terragene en el 3° Congreso Iberoamericano de Esterilización

CSSD Cleaning Monitoring: Safety & Traceability

From assumption to quantitative evidence

Transitioning from visual inspection to quantitative protein testing in CSSDs represents a critical evolution in sterilization workflows.

The presentation highlighted how objective measurement enables healthcare professionals to reduce uncertainty, standardize cleaning validation, and ensure consistent compliance with infection control protocols.

Pro1 Micro: Precision in protein quantification

Pro1 Micro was introduced as a high-sensitivity solution designed for quantitative protein detection on surfaces, enabling accurate measurement of residual contamination after cleaning.

This technology supports CSSDs in validating hygiene processes, particularly in complex and hard-to-access areas, delivering reliable and reproducible data.

PCD: Strengthening sterilization validation

PCD solutions play a key role in validating sterilization processes by simulating worst-case conditions.

Alongside quantitative protein testing in CSSDs, they contribute to a comprehensive approach to process control, ensuring both cleaning and sterilization stages meet the highest standards of safety and performance.

Explore how PCD solutions enhance sterilization validation:

👉 Process Challenge Device

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