What is “enzymatic technology “?
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).
What is important when we compare enzymatic detergents?
To summarise, the most important comparison points for enzymatic detergents are the following:
- The types of enzymes used that will determine which types of organic matter are broken down. OneLife’s high-level detergents break down protein-based soil as well as the matrix of different bacterial biofilm (formed by different species). In our published tests of 11 different Medical Device detergents, we are the only detergent (enzymatic and non-enzymatic) to break down biofilm of all 5 different species tested. In order to achieve this, our detergents contains different types of protease and polysaccharidases, as well as lipase and laccase. Within each enzyme “family”, such as protease and polysaccharidase, there are different types available that need to be selected carefully by the manufacturer in order to target the desired polymers. OneLife’s multi-enzymatic formula with biofilm treatment is protected by a patent.
- The quantity of enzymes, or the concentration, will also naturally impact the detergent efficacy. OneLife’s detergents contain very high levels of enzymes; particularly enziQure. The concentration of enzymatic activity in our detergent is up to 50 times higher compared to other enzymatic detergents on the market. Enzyme concentration in a detergent is not a piece of information that can be found on a technical data sheet or a safety data sheet making it complicated to compare detergents.
is formulation a key factor?
How the enzymes are formulated will also have a strong influence on the efficacy (enzymatic activity and stability). OneLife’s ability to formulate enzymes is built on the 25 years’ experience of our parent company, Realco. The approach of traditional chemicals manufacturers is often to simply add some enzymes to their chemical formula. This approach can lead to enzyme destabilization and loss of enzymatic activity in the product. OneLife’s approach is to start with the enzymes and to add the appropriate surfactants that we know are complementary to the enzymes and appropriate for the particular application. In this way, there is a synergy between enzymes and surfactants. Surfactants help the enzymes penetrate the soil and biofilms and the enzymes solubilize soil and biofilm by degrading the polymers into small, soluble compounds. The result is a complete degradation of soil and a physical release and elimination of the microorganisms trapped in biofilms, exposing them to disinfectants.
The only real way to demonstrate efficacy is through performance testing. For the reasons described above, the arguments regarding the number of enzymes are not necessarily an indication as to the quality of the detergent.
How are OneLife enzymes chosen?
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.
Can OneLife detergents kill viruses and bacteria ?
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.
Why are OneLife detergents not 2-in-1 (detergent-disinfectant) products ?
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.
What external validations exist for the technology?
OneLife’s technology has been validated by external laboratories:
- WFK Testing Institute in Germany for protein detection
- Biotech-Germande Laboratories in France for biofilm matrix detection3 posters have been presented using OneLife DETECT at the French Society for Sterilization Sciences conference in September 2017.
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 ? » à Field study using DETECT Kit
How much contamination do we normally find on medical devices (surgical instruments)?
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.
OneLife is currently defined as an enzymatic detergent, why is it not a biocide ?
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).
Why is the water temperature important?
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.
What are the storage conditions of enzymatic detergents?
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.
Are there restrictions on shipping conditions?
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.
Is there a video to show the cleaning performance of OneLife products?
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.
Please visit our YouTube channel: https://www.youtube.com/channel/UCsfofwj-QeXgtE-8M72WYbw
What about endoscope lens cleanliness?
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.
Are detergents used to reprocess medical equipment medical devices?
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.
Is there not a microbiological risk for the environment and for medical devices (MD)? As well as the performance of the cleaned MDs?
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.
Is there an increased risk of Toxic Anterior Segment Syndrome ( TASS ) if OneLife products are used to clean ophthalmic equipment?
TASS can be caused by the presence of microbial endotoxins (bacterial components originating from Gram-negative bacteria) on ophthalmic instruments. These compounds induce a pathological reaction that can lead to the loss of one eye.Endotoxins can come from water as cleaners (all types of products are at risk, not just enzymatic) but are not destroyed by sterilization. It is therefore crucial to apply heavy rinses with deionized water (and not mains water or softened water that may also contain endotoxins) to remove endotoxins prior to sterilization.With regard to enzymatic detergents in particular, the cases of TASS associated with this type of detergent have been caused by improper use of the products or incomplete rinsing of the instruments. A recent article by Lawrence Muscarella (2018) states that if enzymatic detergents could be a risk factor for TASS, in no case can enzymatic detergents be considered as a leading cause of TASS.
Extract from the article : While the improper cleaning of intra- ocular instruments is recognized as a risk factor for TASS, this review found, however, that using an enzymatic deter- gent to clean intraocular instruments has not been shown to be either the primary cause of TASS or a more significant contributor to this inflammatory reaction of the eye than other documented risk factors, such as bacterial contamination of the water reservoirs of steam sterilizers, short-cycle sterilization, and damage to the intraocular instruments. More research is recommended to better quantify the relative risk of enzymatic detergents causing TASS, compared to these other risk factors, and to develop additional mitigations validated for the prevention of TASS.
Are your detergents able to inactivate prions and if so by which protocol?
OneLife detergents have not been tested according to the standard French prions protocol nor according to the German homonymous protocol. In general, although enzymes can degrade certain prion strains, no neutral enzymatic detergent has (as of September 2019) been prionicidal. The most commonly approved detergents for this are alkaline detergents, used at high concentrations, contact times and temperatures.
For information, the new version of the protocol prions 2018 in France (which will be in force in 2021) has become more stringent by asking for efficiency on several strains of prions. It is expected that several detergents / disinfectants that had been approved according to the standard protocol prions 2011 are no longer certified.
Should instruments be rinsed after pre-cleaning before being placed in the washer?
For enziQure and enziMed Prevent: Instruments can be inserted directly into the washer without pre-rinsing. The amount of detergent remaining on the instruments will be largely diluted with the volume of water in the scrubber tank.
On the other hand, rinsing is necessary when the Pre-Cleaner is used, the surfactant content is too high.
Detect: What does OneLife’s technology detect?
The patented reagents in OneLife’s DETECT adhere to any residual protein matter that has not been chemically broken down i.e. by the cleaning process. Biofilm matrix and/or soil of an organic nature that may remain on the surface of instruments after the decontamination process appear blue on the surface of the instrument. In this way, proteins and biofilms that are normally not visible with the naked eye become apparent and detectable through simple visual inspection.
The detection limit is 10 μg/cm2.
What are the advantages of OneLife DETECT?
OneLife DETECT is a cleaning control or quality control tool. One of the main advantages is the ability to detect contamination directly on the surface of instruments. Other techniques that rely on taking swab samples may fail to collect the full extent of surface contamination, whereas OneLife avoids such sampling bias that can lead to false negative results.
OneLife DETECT allows simultaneous detection of residual contamination on 10 instruments or more and provides visual results that are easily interpretable.
As well as being a cleaning quality control, OneLife DETECT can also be used to improve cleaning processes or as a pedagogical tool to educate new staff.
How many tests can be performed with DETECT CSSD ?
1 refill kit lasts for 1 months and can be used for around 30 DIN 1/1 instrument trays, each tray containing on average 25 instruments so a total number of 750 instruments can be tested.
DETECT Kit : is it used for the detection of protein residual detect or biofilm, or both? Is it used after the washing procedure or before?
The DETECT kit detects any residual protein matter, including biofilm matrix. So, it detects both. It is used after the washing/cleaning phase because it is meant to test whether instruments haven been correctly cleaned (or not). Once instruments have been subjected to the test, they need to be cleaned again – to remove any residual contamination and colorant. Therefore, the test is not conducted every time instruments are cleaned, but rather according to a pre-established sampling plan (e.g. x number of x type of instruments per week/month) in order to control the quality of the cleaning process and take any corrective (e.g. thorough cleaning with enziQure) and preventive (adaptation of procedures, change of detergent or cleaning brush, improvement of training) actions necessary.
What is OneLife’s DETECT Kit and how many tests can be performed?
The Kit is designed to provide dentists, small medical and veterinary cabinets with the necessary material to conduct testing of their own instruments for cleanliness after washing process.
The Kit can be used for 10 detections (1 detection = 1 full basket of instruments) or up to 1 month if the solution is left in the soaking tray provided with the lid closed. After 10 detections or 1 month, the reagent should be replaced.
How to perform a demonstration with the DETECT Kit ?
When the sales agents perform demonstrations, they use 1L of Colorant and pour it in a soaking tray placed in a sink or on an absorbent material.
A selection of instruments to be tested is chosen with the customer and they are placed in the tray and immersed for 5 min. After 5 min soak time, the instruments are rinsed ideally in a bath of tap water for 5 sec minimum.
Instruments are visually inspected for dark blue stains (synonymous of residual proteins/biofilm), ideally under a magnifying lamp or under homogenous lighting. An instrument with blue stains is considered non-conform and instruments without blue stains are considered conform. Pictures can be taken to document the results and provide a report to the customer.
The Colorant solution can be re- used several times, as long as there is sufficient liquid in the tray to cover the instruments being tested. This means that you need to transfer the Colorant back into the bottle using the funnel provided after
BABYSCOPE : 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.
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.
What about instrument compatibility and corrosion?
DETECT Colorant solution has a pH value of 2.25. At room temperature, the corrosion levels observed on stainless steel is very limited: weight loss of 316 L stainless steel after soaking for 290 hours was found to be 0.0002 g and after 50400 hrs 0.0012 g. These weight losses are very low. In terms of corrosion rate, these were estimated to 0.0134 mm/year and 0.0464 mm/year for soaking times of 290 hrs and 5040 hrs respectively. Given the relatively short exposure times of stainless steel to DETECT Colorant solution (10 min per detection) and the fact that detection is not performed after each use the instruments, DETECT Colorant and Indicator solution are deemed compatible with Stainless steel when used according to OneLife’s instructions for use. Our internal laboratory data simulating 144 detections confirms this conclusion. »
Why does the dosage need to be increased in hard water?
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.
OneLife enziDent ®:
What enzymes are used in enziDent detergent to achieve the best cleaning performance?
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.
What is OneLife enziMed® Pre-cleaner meant for?
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.
Which product do you recommend for WD ?
enziMed Instrument Washer and enziMed Standard have been specially developed to be used in washer-disinfectors. They are very low-foaming, enzymatic detergents.
Can EnziMed Instrument Washer & EnziMed Standard wash off biofilm? 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)
What about the quality of water in washer disinfectors?
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.
Can both the rigid and flexible endoscope use OneLife’s products?
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)