Sterilization Description:

Sterilization refers to a process which results in the complete elimination or destruction of all forms of microbial life. According to the Association of periOperative Registered Nurses (AORN), sterilization provides the highest level of assurance that surgical items are free of viable microbes and should be used for critical devices. Critical devices are defined as medical devices, implants, surgical and dental instruments that have contact with the bloodstream or normally sterile areas of the body.

The U.S. Food and Drug Administration (FDA) and associations such as AORN and Association for Professionals in Infection Control and Epidemiology (APIC) define a sterilized device as one that has been processed in a system that delivers a sterility assurance level of 106, which is a one in a million chance of a non-sterile occurrence.

High-Level Disinfection Description:  

High-Level Disinfection (HLD) refers to the treatment of medical devices and dental instruments to remove all viable microorganisms, except some spores when present in a significant load. HLD is the accepted standard for the reprocessing of semi-critical medical devices and dental instruments, or for sterilization of critical or semi-critical devices that are heat-sensitive or incompatible with traditional sterilization methods. Semi-critical devices are devices that contact intact mucous membranes or non-intact skin, and typically do not penetrate tissues or otherwise enter normally sterile areas of the body.

Further, the FDA recommends that semi-critical devices undergo an HLD process after each use. HLD involves devices undergoing a liquid chemical process in which they are treated with a high-level disinfectant and processed with a rinse cycle of water to remove chemical residue.

NOTE: Sterility Assurance - FDA guidance states that Biological Indicators (BI) are not appropriate or required for monitoring HLD. Instead, Chemical Indicators (CI), typically provided by the vendor in the form of test strips are appropriate and are required for monitoring the Minimum Required Concentration (MRC) of the liquid chemical agent used in HLD. According to the FDA recommendations, the users have to refer to the manufacturer’s instructions for a compatible CI and proper monitoring of the disinfection process.

Gluteraldehyde is an organic compound that is a colorless, oily liquid used to disinfect medical and dental equipment that cannot be exposed to the sterilization process. Exposure to gluteraldehyde can occur through inhalation or skin contact and can pose health risks to include throat and lung irritation, dermatitis, burning eyes and conjunctivitis.  Gluteraldehydes have been shown to be the number one cause of occupational asthma, exposure to greater than 0.2PPM is not recommended and exposure should be limited. To protect yourself from exposure to glutaraldehyde use local exhaust ventilation and use a fume hood where possible. Avoid contact with the skin by using nitrile or rubber gloves (latex does not provide adequate protection). Wear goggles and face shields when handling glutaraldehyde.  Otrho-phthalaldehyde (OPA) is considered an effective and safe alternative to gluteraldehyde providing the same high-level disinfection. Rapicide OPA/28 is a Food and Drug (FDA) approved OPA and is an example of a gluteraldehyde alternative.

What should I need to know about gluteraldehydes before selecting a high-level disinfectant?

Rapicide® OPA/28 High-Level Disinfectant is a fast-acting, long lasting, highly compatible high-level disinfectant ensuring a safe and healthy environment for patients and staff.

High-Level Disinfection is the accepted standard for the reprocessing of semi-critical medical devices and dental instruments that are heat-sensitive or unsuitable for traditional sterilization methods. Per the Spaulding schematic, High-Level Disinfection is appropriate for semi-critical devices that contact intact mucous membranes and typically do not penetrate tissues or otherwise enter normally sterile areas of the body. Rapicide® OPA/28 is an FDA approved High-Level Disinfectant proven to inactivate vegetative bacteria, mycobacteria, fungi and viruses within 10 minutes when used at room temperature.

Rapicide® OPA/28 should not be used for application other than specified on the label instructions. Do not use as an environmental surface disinfectant, instrument-holding solution, cold sterilant, or sporicidal agent when used under 32 hours.

Before immersion in Rapicide®OPA/28 solution, it is important to thoroughly clean the used devices and instruments with a specially formulated cleaning solution such as “MediClean EZ”, a multi-enzymatic detergent for fast removal of blood, proteins, fats, carbohydrates, mucopolysaccharides and lipids. Thoroughly rinse all instruments and follow DIRECTIONS FOR USE instructions on the product label. Rapicide® OPA/28 is supplied ready-to-use, however the solution should be verified prior to each use with Rapicide® OPA/28 Test Strips ONLY. Check the date when the solution was poured out of the container - this product must be discarded after 28 days, even if the test strips indicate a concentration above 0.35% OPA. Following appropriate immersion time, 10 minutes minimum at room temperature, instruments should then be rinsed thoroughly three times to remove any residual chemicals. Refer to the reusable medical device manufacturer’s labeling for additional rinsing instructions. Failure to adequately rinse the instruments may result in staining of unprotected tissue or cloth materials.

Fastest Disinfection Time - the only OPA with 10 minute HLD contact time at room temperature

Lasts Longer – the only OPA with 28 day reuse life 

NO! According to FDA definition of Sterilant - an agent that destroys all viable forms of microbial life within 24 hours.

YES! It Passes the AOAC Sporicidal Activity Test in 32 hours at 22°C

Rapicide® OPA/28 is recommended to be used in a well-ventilated environment. Avoid unnecessary worker exposure.

Yes. Rapicide® OPA/28 contains specially formulated phosphorus based stabilizer that prevent formation of rusty spots on metal surfaces. This product is tested for material compatibility as described on page 7, Technical Monograph. It is recommended that instruments not be left overnight (after the appropriate soaking time), or on damp towel, to prevent corrosion due to electrolytic activity of metals in water.

VisitOPA28.com for more information.

All aldehyde-based chemistries, including glutaraldehyde and ortho-Phthalaldehyde (OPA) chemistries, inactivate bacteria via a crosslinking process. OPA based chemistries that come into contact with residual protein will naturally produce a blue/grey color during this reaction. Facilities converting to OPA based chemistries may initially experience blue/grey staining on basins and instruments, which is an indication of residual proteins left behind during the pre-cleaning process. Should this occur, it is recommended to review the efficacy of the pre-cleaning procedure to ensure thorough removal of all residual bioburden prior to contact with the HLD solution. It is recommended to use specially formulated cleaning solutions such as “MediClean EZ”, a multi-enzymatic detergent with advanced proteolytic cleaning action for fast removal of blood, proteins, fats, carbohydrates, mucopolysaccharides and lipids.

Reusable chemistries are stressed and diluted by a number of factors that can cause the chemistry to quickly fall below the MRC, ultimately shortening the life of any reusable product. An important consideration in maximizing the reuse life of Rapicide OPA/28 for both manual and AER applications, is a thorough manual cleaning process aided by INTERCEPT Detergent. In AER application, it’s also important to have annual AER Preventative Maintenance and to maintain a consistent chemistry temperature in the reservoir and basin. Rapicide OPA/28 is reusable for up to 28 days provided the MRC is verified to be above 0.35%.

Rapicide® OPA/28 has been validated for compatibility with the full line of MEDIVATORS® AERs supporting reusable chemistry. This includes the MEDIVATORS CER-1, CER-2, CER-OPTIMA, DSD-201 and SSD-102 models. Rapicide® OPA/28 is also available for manual High-Level Disinfection. For inquiries relating to the use of Rapicide® OPA/28 in other AER systems, please contact your AER manufacturer.

When using Rapicide® OPA/28 for manual application, triple-rinse the disinfectant basin with clean water and wipe down the interior of the basin with a lint free cloth to remove residual precipitate. Triple-rinse the basin a second time prior to filling with Rapicide® OPA/28.

For use with an AER, always refer to the manufacturer’s instructions for use when changing out HLD chemistries. The AER manufacturer will have specific instructions relating to any needed programming changes and proper chemistry change procedure. Thorough rinsing of reservoirs, basins, and AER disinfectant lines is encouraged to prevent any incompatibility between chemistries.

Best practice for manual rinsing would entail filling a basin with a large volume of fresh rinse water, and immersing the endoscope into the solution ensuring the inner channels and lumens of the endoscope are thoroughly flushed with rinse water. The endoscope should then be removed, and the basin emptied and refilled with fresh water. This process is repeated three times to ensure the OPA component is thoroughly removed from the endoscope.

It is not recommended to fill the basin with water while the instrument is present, as the splashing of the water as it hits the instrument could cause potentially harmful worker exposure.

Residual Rapicide® OPA/28 Disposal: Strictly adhere to Germicide Disposal Procedures according to the local, state, and Federal regulations. Due to specifics in water treatment and water management systems the local regulations should be considered and monitor periodically for updates. If required, “Neutra-Hyde” (glycine-based white crystals) shall be used as a neutralizer for Rapicide® OPA/28 solution prior to disposal.

Directions for Use: A minimum of 25 grams of “Neutra-Hyde” should be used to neutralize one gallon of solution for the minimum recommended neutralization time of one hour. Discard residual solution into drain. Flush drain thoroughly with water.

Container Disposal: Do not reuse empty container. Rinse thoroughly with water and dispose of per facility policy.

NOTE: For environmentally safe disposal of residual solution of Rapicide® OPA/28 in the drain it is recommended to use neutralizing agent “Neutra-Hyde.” The minimum recommended neutralization time is one hour, then discard residual solution into drain and flush drain thoroughly with water.

Rapicide® OPA/28 is a new breakthrough OPA based chemistry that has increased stability, longer reuse life, and faster disinfection & rinsing times over competitive products. Customers will notice cosmetic changes in this new formulation over competing OPAs. Noticeable factors will include a change in color, a slight change in smell, and the appearance of surface foam during the HLD and preliminary rinsing cycles in an AER.

These properties are normal aspects of Rapicide® OPA/28 and are to be expected when using this product. The foaming present with this chemistry is a natural property of the proprietary blend of surfactants used to provide the extended 28 day reuse life and decreased contact time for the chemistry. The foam will generate during the disinfection cycle and will dissipate during the subsequent rinses to be completely removed at the end of the completed cycle.

It is recommended that the MRC of any High-Level Disinfectant be tested prior to each use to ensure the efficacy of the HLD process. HLD chemistries should be tested with the appropriate test strip to ensure the minimum effective concentration of the product is above levels needed to achieve high-level disinfection.

NOTE: Only Rapicide OPA/28 Test Strips should be used to test the MRC of Rapicide® OPA/28 High Level Disinfectant.

All lots of Rapicide® OPA/28 Test Strips are tested and certified for efficacy prior to shipment. Users can download the Certificates of Analysis for each lot of test strips used by visiting the following website:

http://www.medivators.com/customer-support/certificates-analysis

Facilities may also perform additional quality testing according to their facilities’ policy and procedure.

Periodic testing ensures the test strips are being properly stored and consistently providing accurate MRC readings. A quality assurance protocol is outlined on the instructions for use provided with every box of

Rapicide® OPA/28 Test Strips.

AERs will naturally lose small volumes of HLD chemistry during each cycle performed. In a MEDIVATORS

AER, customers can expect to lose approximately 20–30 ml of HLD chemistry during each cycle run due to normal equipment performance, drainage, and rinsing. It is expected that customers will need to top-off the

HLD chemistry with an additional half-gallon of product every 60-70 cycles. The need to top off chemistry may not have been noticed with previous OPA products which are typically discarded and replaced prior to

70 cycles. Users experiencing the need to top-off chemistry with significantly higher volumes of chemical, or at more frequent intervals should contact their AER manufacturer to ensure proper function of the equipment.

OPA based disinfectants have been associated with anaphylactic reactions in bladder cancer patients undergoing repeated cystoscopies, and consequently, OPA is contraindicated for use with all urological instrumentation utilized for cystoscopy or any other urological procedures for patients with a history of bladder cancer.