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  Our enziMed Products are cleaning agents (detergents) based on enzymatic technology. Enzymes are natural catalysts that break down organic matter such as soil, blood, tissue... into soluble molecules without being consumed in the reaction. Being a catalyst also means that enzymes speed up specific biochemical reactions and in this case, they improve the cleaning efficacy drastically. Our main focus and expertise lies in our capacity to assemble enzymatic cocktails that are effective to remove soils but also microbial biofilm which can colonize medical instruments (surgical instruments and endoscopes). 

In biofilms, the polymers of the matrix are often complex and diverse. OneLife has selected the enzymes that target important and structural component of the biofilm matrix in order to dissolve it effectively. 

OneLife has also selected carefully the most potent proteases on the market to break down proteins from blood, mucus and tissues that remain on medical devices such as instruments and endoscopes after use. These proteases must be effective against soluble but also insoluble proteins like fibrin.

Detergents intended to treat medical devices are medical devices according to the European Directive 93/42 EC on medical devices. This is also the case for the new EU regulation 2017/745 which will replace Directive 93/42 EC in 2020. As a result, our OneLife products are classified as Class I medical devices.That said, detergents are also subject to 3 other European regulations:1 / EU Regulation N ° 1907/2006 = REACH Regulation on all chemical substances2 / EU Regulation No. 648/2004 = Regulation on detergents3 / Regulation (EC) n ° 1272/2008 = CLP (Classification, Labeling & Packaging) which regulates the marking, packaging and classification (pictograms) of chemicals.OneLife products meet the requirements of the 4 regulations and the directive mentioned above and are therefore compliant

All of our performance tests and field tests show that detergent products are more effective than combined detergent-disinfectant products for cleaning DMs. The main reason is that disinfectant principles interfere with organic soils and biofilm and tend to fix them on the surface of DM rather than eliminate them from it.

 

By ensuring a more thorough cleaning of the DMs and a good rinse afterwards, we obtain better results and cleaner DMs than with detergent-disinfectant products.

 

The use of a pre-soak disinfectant partially lowers the microbial load (generally a maximum of 4 logs of CFU, the total load can go up to 12 logs of CFU) but does not eliminate it completely. In addition, it usually takes at least 5 minutes but usually 15 minutes to reach a disinfection of 4 logs of CFU. The use of these products does not guarantee the worker that there is no risk of contamination by DM. These disinfectants could even contribute to a false sense of user safety.

 

We always advise our customers to work with the appropriate personal protective equipment to protect themselves. As for the environment, discharges of used solutions into the sewers are not a problem: other hospital discharges are more loaded, those of sanitary for example.

 

Cases of cross-contamination are unlikely as long as the contact times of the DMs in the detergent are respected, the DMs are correctly rinsed and dried before sterilization. Autoclave sterilization is able to effectively kill germs still present on DM (up to more than 12 logs of CFU) but it is not able to clean DM. We are convinced that it is crucial that manual, ultrasonic or automated cleaning is as efficient as possible and that the DM is free from organic contamination at the time of sterilization. If this is the case, no cross-contamination is to be feared.

Our products are meant to be used in the first phase of reprocessing (pre-cleaning and cleaning) in order to physically lift off soils and microbes from the surface of the instruments. Our product do not kill viruses and bacteria, they simply put the microbes and soils into suspension so they are not attached to the instruments any more and can be rinsed off easily.

 

Thorough (pre-)cleaning using OneLife products ensures that medical devices are fully clean before chemical disinfection or sterilization can be achieved. This is essential as instruments that are not 100% clean cannot be sterilized or disinfected effectively (source : CDC). 

 

Our products do not have disinfectants inside and will therefore have no inactivation claim against viruses, bacteria, fungi, yeast or Giardia. These will be killed in the disinfection or sterilization phase for sure. 

• The 2-in-1 products that claim cleaning and disinfection efficacy are in general poor cleaning agents. The main reason is that the disinfectants used in these products are detrimental to the cleaning process. Indeed, quaternary ammonia (positively charged) are fixating proteins (most abundant soils on medical device - negatively charged) causing their irreversible adhesion to the surface of medical devices. Oftentimes, it results in instruments that are still visibly dirty. This would endanger the sterilization or disinfection process because residual soils and biofilms interfere with sterilization/disinfection. 

   

  In addition to being poor cleaning agents, the 2-in-1 products are generally weak disinfectants also. Their potency against bacteria, viruses and fungi is far from that of disinfectants alone (such as peracetic acid or hydrogen peroxide) which have better killing rates (faster killing curve and more complete inactivation of microorganisms).

   

  In short, our approach is to provide enzymatic products that are excellent cleaners to render 100 % clean instruments after the wash phase and prepare the instruments for optimal sterilization or disinfection.  

40 – 45°C has been determined as the ideal temperature for optimal enzymatic activity. In fact, tests on 10 Medical Device detergents (enzymatic and non-enzymatic) confirm that most products perform significantly better at 40°C than at 25°C. The reasons for that are the following : 

40 – 45°C is thus a trade-off.

In any case, enzymes should not be used in excess of 55°C as some of them (proteases) will be denatured and lose their activity. Denaturation is irreversible. 

All our enzymatic detergents should be kept between 4-25°C. We do our accelerated stability testings at 35°C for all products. Products like enziMed Prevent and enziQure and enziMed Instrument Washer resist very well at these temperatures for more than 10 weeks. enziMed Standard and enziMed Pre-cleaner are more sensitive but exposure to 35°C for up to 13 days was found to cause no degradation of the products. 

Ideally, the temperature should remain below 25°C. If not possible, then max. 35°C (above that temperature, the risk of losing enzymatic activity is high). In order to trace the shipping temperature in long shipments to hot countries, tracers can be placed with the products to record temperatures during shipment. 

Water hardness interferes with the efficacy of tensioactive principles and may therefore impede the cleaning efficacy of the detergent. Enzymes are not strongly affected by hard water but tensioactive principles help them to penetrate the soil and biofilm. Increasing the dosage (up to 2%) when using with hard water will balance out the effect of water hardness and guarantee an optimal cleaning efficacy. 

There are  videos comparing the performance of OneLife detergents against commercially available detergents using standard soil tests. In particular, we used the Browne STF Load Check indicator as standard test soil, it is distributed by STERIS and mainly composed of proteins. These videos can be found on the Youtube page of OneLife. 

 

www.bit.ly/youtube-OneLIFE

It is a triple-enzymatic ready-to-use foam spray cleaner that dissolves organic matter directly on the surface of instruments.  Our customers use it either in 

CSSD or at point-of-use (operating theatre).  For example, in Germany, it is purchased by CSSD and then distributed to the different departments that use the instruments as this then facilitates the work for CSSD (the instruments have been pre-cleaned and the organic matter has not been allowed to dry before removal).  

ð  Minimum contact time = 15 min 

ð  Enzymatic activity up to 72 hours 

What is the reason that enziQure & enzimed Prevent cannot be used for WD? 

These detergents are not non-foaming. Therefore, they are not suitable for use in washer-disinfector as they will induce excessive foaming and cause machine to set in alarm mode.

 

Soaking  Temperature for enziQure 

For optimal use, enziQure must be diluted in warm water (40-45°C). If users prepare a bath of 15L or more at around 40-45°C, it will take one hour to decrease to 35°C if the room is at 20-25°C. There is thus no need to use a water bath to maintain the temperature during the 1-hour cleaning process. 

 

enziMed Instrument Washer and enziMed Standard have been specially developed to be used in washer-disinfectors. They are very low-foaming, enzymatic detergents.

What is the difference between them? How many percentage of the enzyme level differed between them? what is their PH value? How many kind of enzymes do they have?  

·      These two products are enzymatic cleaner which have been designed to remove organic soils (blood, tissue, mucus) effectively but not specifically microbial biofilm. This is due to the fact that they have only 1 type of enzyme : a protease.

·       The main difference between enziMed Standard and enziMed Instrument washer is that enziMed Standard can be used in manual cleaning and enziMed Instrument washer cannot due to its cloudiness when diluted in water (the user cannot see clearly what he is doing). The second difference is the concentration of proteases, enziMed Instrument Washer contains about 4 times as much protease as enziMed Standard and cleans therefore medical devices much faster. 

·       The pH of enziMed Instrument washer is slightly alkaline (pH between 9 and 9.5) whereas enziMed Standard has a pH in dilution of 8.0 (neutral pH)

·      Washer-disinfectors usually use softened water or a mixture of softened water and tap water for the cleaning phase. Therefore, water quality will impact the cleaning efficacy of the detergent but may also be the cause of mineral deposits on the walls of the washer tank or on instruments.

OneLife Rinse Aid (enziMed Dry), also contains citric acid to provide a slightly acidic pH in the thermodisinfection phase and prevent mineral deposit. The performance of our Rinse aid is similar to the performance of Dr. Weigert MediKlar Special which is commonly used on the market. The dosage of our product would ideally be 0.05 % (0.5 ml per liter), but could be increased to 0.1 % (1 ml per liter) if problems of mineral deposits appear. 

Regarding the programs in WD, we have validated a cleaning phase of 10 min at 45°C in softened water, the detergent enziMed Instrument Washer is added at 0.4 % (4 ml per liter). However, each WD should be validated each year for its cleaning performance and detergent concentration (0.3 – 0.5 %), wash temperature (45 – 55°C) and time (5 – 15 min) could be adapted to ensure adequate cleaning results are obtained.

Yes – both enziMed Instrument Washer and enziMed Standard can be used for both rigid and flexible endoscopes. Only for the automated cleaning of flexible endoscopes, the European standard ISO 15883-4:2018 requires a validation of the cleaning performance of an endoscope washer in combination with a certain cleaning agent/detergent. enziMed Standard and enziMed Instrument Washer have thus far not yet been validated by any endoscope washer manufacturer. This validation is usually taken in charge by hospitals for instrument washer-disinfectors (according to ISO 15883-1:2006)

There is no general rule as cleaning efficacy depends on many parameters in the decontamination process (time between instrument use and cleaning, detergent used, respect of detergent protocol, use of ultra-sound bath, level of training of the personnel etc.). In general, in CSSDs, contamination rates vary from 0% to 60%. In dental offices, these rates may increase to 100% of instruments that are contaminated.

Q : What are the advantages of DETECT2? 

A : OneLife DETECT2 is a quality control tool for cleaning or cleaning of surgical instrument process. Its main advantage is to highlight organic contamination in situ, directly on the surface of the instruments, thus eliminating potential sampling bias. DETECT2 also has the advantage of being quick: 1 DIN 1/1 basket of 20 to 30 instruments can be marked in 5 minutes and analysed visually in less than 10 minutes, or approximately 15 seconds per instrument on average. The visual results speak for themselves and can be used as an educational tool for training of personnel in Central Sterilization. It can also be used to optimise washing processes for complex geometry instruments.

 

Q : Can the instruments be immersed for more than 5 minutes in the COLORANT? 

A : Five minutes is the minimum time to ensure proper coloration of organic residues potentially present on the instruments. There is no risk of obtaining false-positive or false-negative results by letting the instruments soak longer in the COLORANT, staining process will saturate. Compatibility tests of DETECT2 with materials indicate that there is no risk of corrosion of stainless steel and non-porous polymeric materials in contact with DETECT2 COLORANT.

 

Q : What happens if the instruments are soaked for less than 5 minutes in the COLORANT?

A : The contact time of 5 minutes ensure a optimal coloration of organic residues on surgical instruments. In practice, a rapid coloration of protein stains is observed, from 15 seconds of contact. However, for small quantities of proteins, close to detection threshold of 0.5 micrograms, a shorter contact time can lead to false-negative result: no coloration is visible but organic residues are present on the surface of instrument.

 

Q : Why the instruments must be rinsed with clean water after immersion in the COLORANT?

A : Rinsing with clear water removes excess COLORANT and is necessary for the interpretation of results. 

 

Q : How many instruments can be soaked in a batch of COLORANT?

A : A 20L bath reused for 2 months and stored under the recommended conditions (see point 2F) can test 1500 instruments. A bottle of 950ml DETECT2 can test 100 instruments.

 

Q : What type of contamination are detected by DETECT2?

A : DETECT2 specifically detects proteins found in patient's organic stains (blood, mucus, tissues, etc.) and in microbial biofilms. OneLife is not aware of potential interference with other organic compounds. However, porous or micro-porous materials can be coloured in a light blue tint. This colouration is non-specific and disappears if the instrument is soaked for a long time in water. 

 

Q : Is there a risk of contaminating DETECT2 COLORANT with the protein residues of the instruments tested?

A : Before being immersed in DETECT2, the instruments must have gone through all the cleaning steps (manual and automatic in LDI) and several rinsing steps. These steps remove the solubilized protein residues. The remaining proteins are on contrary fixed on the instruments and risks of stalling / redissolving after a simple soaking in the COLORANT bath is extremely low. 

 

Q : Is there a risk of microbiological contamination of DETECT2 COLORANT during its use?

A : The acidic pH of DETECT2 prevents growth of bacteria commonly found in hospitals. A microbiological test has been also carried out after 2 months of intensive use of the product on instruments in a hospital environment (before sterilization stage) and did not reveal presence of any bacteria. In addition, the alternative use of DETECT2 after sterilization step eliminates risk of contamination.

 

Q : Are there any materials that are incompatible with DETECT2? 

A : Stainless steel and various polymer materials (PP, PTFE, PPS ...) are compatible with DETECT2 for intensive use. In intensive use, aluminium shows a loss of shine after long-term exposure to the COLORANT. It is therefore advised to limit the use of DETECT2 for aluminium material. Other materials have not been tested and should be subject to further testing before submitting instruments made of these materials to DETECT2.   

 

Q : At what stage of surgical instrument reprocessing process can the DETECT2 test be performed? 

A : OneLife DETECT2 protein and biofilm detection test is designed to be performed on instruments which have passed all cleaning stages (after passing through LDI) in order to check whether all of these stages made it possible to clean the instruments effectively. It is not advised to carry out detection test on instruments which have not undergone all the cleaning stages. Likewise, it is possible to sterilize instruments before carrying out the protein and biofilm detection test. Since sterilization does not clean the instruments, residues potentially present before sterilization will always be present after sterilization.  

 

Q : What are the external validations available for this technology? 

A : DETECT2 technology has been tested in various hospitals. Four posters illustrating the multiple uses of DETECT (previous version) were also presented at the first SF2S conference in Antibes in 2017 and Marseille in 2018 as well as an oral presentation during this last edition. This research remains valid for DETECT2 whose operating principle is the same.

 

Q :  What are the validations available for this technology?

A : DETECT2 technology has been tested in our laboratories based on different aspects:

 

·        Sensitivity: detection of proteins from a concentration of 10mg/cm² Bovine serum albumin (BSA).

 

·        Detection spectrum: DETECT2 is capable of detecting proteins from patient's organic stains (blood, mucus, tissue) and biofilms of different species (Staphylococcus aureus, Klebsiella pneumoniae, Escherichia coli, Enterococcus feacalis, Pseudomonas aeruginosa…) 

 

 

·        The cytotoxicity of DETECT2 COLORANT: the cytotoxicity of the COLORANT is assessed using the MTT cell viability test on L939 cell lines (fibroblasts) according to ISO10993-5: 2009. The COLORANT used shows an absence of cytotoxicity up to concentrations of 0.0025 g / L. 

 

·        Biodegradability: DETECT2 COLORANT is more than 90% biodegradable according to OECD standard 302B (Zahn-Wellens test) (exact value: 92.7%). 

 

·        Compatibility with the materials often encountered in the hospital environment. 

 

Test reports from third parties or OneLife are available upon request.

 

Q : How toxic is DETECT2 COLORANT used?

A : The COLORANT used in DETECT2 is classified as non-toxic to the environment: not bio accumulative, nor persistent. The LD50 of the pure colouring substance is also 5000 mg / kg in the rat. For staffs, the COLORANT has a low irritant effect on the skin and the eyes which can be avoided by wearing personal protective equipment: gloves and glasses. Our tests also demonstrate that the concentrations of DETECT2 COLORANT residual on the instruments present a low risk of cytotoxicity. 

The performance of OneLife’s detergents has been validated by several external laboratories (including Louvain Drug Research Institute, Catholic University of Louvain, Belgium) for their performance against protein soil and biofilm matrix. 

The latest test results have been published or presented:  

WFHSS – World Federation for Hospital Sterilisation Sciences:o  05/10/2017 - 10.45-12.15: Presentation Dr.Thomas Vanzieleghem  -  Subject: " Removing biofilms from endoscopes: the importance of the cleaning chemistry » 

o  October 2017 (05/2017) : ZentralSterilisation/Central Service, Siala et al.   (UCL)  « Biofilm removal properties of endoscope cleaners : a comparative study” 

o  June 2017 : Infection control and Hospital Epidemiology (ICHE ), Cattoir et al.   (UZ Gent) “Surveillance of Endoscopes: Comparison of Different Sampling Techniques”

o  March 2019 (7(4)) : Endoscopy International Open, Alfageme Gonzalez and Vanzieleghem et al.  (CHU de Liège)  « On-site comparison of an enzymatic detergent and a non-enzymatic detergent-disinfectant for routine manual cleaning of flexible endoscopes.”

o  September 2018 : SF2S Congress, Lambert  (CH Chambery)  “ Contamination des implants d’ostéosynthèse au bloc opératoire : mythe ou réalité ? »  Field study using DETECT Kit

What are the different dimensions available on order + delay?

 

At Healthmark (current supplier of OneLife for Babyscope), there is only one dimension available for the digital fiberoptic (end-of-fiber camera): 1.9 mm in diameter and 1.1 meter in length. The supplier can offer thinner diameters but it will be a conventional fiberscope in which the image is captured at an eyepiece and not at the end of the fiber. The quality of the image with these models is clearly reduced compared to the digital model.

 

However, the supplier warned us that he was working on increasingly thin models of digital fiberscopes, the progress in this area being always limited by the size of the camera capturing the images and which must be placed at the end of fiber.

 

Is the Babyscope considered a medical device?

 

In Directive 93/42 EC not all accessories for medical devices are medical devices. The Babyscope provides a means to inspect the condition of the channels and to determine if contamination is present in the endoscope or not. Such an inspection is not required before an endoscope is reused in clinical practice (as opposed to reprocessing, for example). In this regard, the Babyscope is an accessory to the endoscope that does not fulfill an essential step but instead provides (optional) help to the prevention and infection team and the technical team to keep the endoscopes clean and comfortable. safe. In addition, the babyscope has no risk of damaging the endoscope or endangering a patient. It is therefore not considered a medical device.

 

A review of this justification in the light of EU Regulation 2017/745 on medical devices will be necessary.

The accumulated soil on the lens of an endoscope could be organic or microbial contamination, in which case enziQure (our corrective cleaner) would remove it when it is present during manual cleaning phases.  enziMed Prevent   is to be used in routine cleaning (after each and every procedure) to prevent the contamination from accumulating on the lens surface. Of course, the use of adequate brushes would help to dislodge accumulating soil and increase the efficacy of cleaning.

 

In some cases (if hard water is used for cleaning), mineral deposits could form on the lens surface. Deposits can appear when water dries up on the lens surface and cloud the vision through this lens. In this case, we recommend to use a diluted acidic solution to dissolve the minerals. 

enziDent contains several types of enzymes that are part of our patented formula for biofilm removal: different types of proteases and polysaccharidases, lipases and laccase that are selected and combined for optimal performance against protein, fatty matters and biofilm matrix. The matter that forms biofilm matrix varies significantly from one microorganism to another (e.g. Pseudomonas spp. or Staphylococcus spp. etc.). OneLife’s patented detergents have a broader spectrum of activity on microorganisms found on dental instruments than any other detergents. This enables optimal elimination of bioburden during dental instrument cleaning and ensures effective sterilization.

OneLife detergents are not classified as biocides because biocides are classified based on product claims and OneLife products have no antimicrobial activity and do not kill microorganisms (which also has the advantage of do not create resistances as is the case for quaternary ammonium).