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Frequently Asked Questions
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Blood borne Pathogens
What is an exposure control plan?

The exposure control plan is the employer's written program that outlines the protective measures an employer will take to eliminate or minimize employee exposure to blood and OPIM.

The exposure control plan must contain, at a minimum:

  • The exposure determination which identifies job classifications with occupational exposure and tasks and procedures where there is occupational exposure and that are performed by employees in job classifications in which some employees have occupational exposure.
  • The procedures for evaluating the circumstances surrounding exposure incidents;
  • A schedule of how other provisions of the standard are implemented, including methods of compliance, HIV and HBV research laboratories and production facilities requirements, hepatitis B vaccination and post-exposure evaluation and follow-up, communication of hazards to employees, and recordkeeping; 
    Methods of compliance include:
    • Universal Precautions;
    • Engineering and work practice controls, e.g., safer medical devices, sharps disposal containers, hand hygiene;
    • Personal protective equipment;
    • Housekeeping, including decontamination procedures and removal of regulated waste.
  • Documentation of:
    • the annual consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure, and
    • the solicitation of non-managerial healthcare workers (who are responsible for direct patient care and are potentially exposed to injuries from contaminated sharps) in the identification, evaluation, and selection of effective engineering and work practice controls.

 

Source: OSHA.gov, for more information visit:

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21010

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How often must the exposure control plan be reviewed?

The standard requires an annual review of the exposure control plan. In addition, whenever changes in tasks, procedures, or employee positions affect, or create new occupational exposure, the existing plan must be reviewed and updated accordingly.

Source: OSHA.gov, for more information visit:

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21010

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What type of personal protective equipment (PPE) must employees in a dental office wear?

The standard requires that PPE be "appropriate." PPE will be considered "appropriate" only if it does not permit blood or OPIM to pass through to, or reach, the skin, employees' underlying garments, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time that the PPE will be used. This allows the employer to select PPE based on the type of exposure and the quantity of blood or OPIM which can be reasonably anticipated to be encountered during performance of a task or procedure.

Source: OSHA.gov, for more information visit:

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21010

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Who is responsible for providing PPE?

The responsibility for providing, laundering, cleaning, repairing, replacing, and disposing of PPE at no cost to employees rests with the employer. Employers are not obligated under the standard to provide general work clothes to employees, but they are responsible for providing PPE. If laboratory jackets or uniforms are intended to protect the employee's body or clothing from contamination, they are to be provided at no cost by the employer.

Source: OSHA.gov, for more information visit:

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21010

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Does protective clothing need to be removed before leaving the work area?

Yes. OSHA requires that personal protective equipment be removed before leaving the work area. While "work area" must be determined on a case-by-case basis, a work area is generally considered to be an area where work involving occupational exposure occurs or where the contamination of surfaces may occur.

Source: OSHA.gov, for more information visit:

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21010

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What type of eye protection do I need to wear when working with blood or OPIM?

The use of eye protection would be based on the reasonable anticipation of facial exposure. Masks in combination with eye protection devices, such as glasses with solid side shields, goggles, or chin-length face shields, shall be worn whenever splashes, spray, spatter, or droplets of blood or OPIM may be generated and eye, nose, or mouth contamination can be reasonably anticipated.

Source: OSHA.gov, for more information visit:

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21010

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When should gloves be changed?

Disposable gloves shall be replaced as soon as practical after they have become contaminated, or as soon as feasible if they are torn, punctured, or their ability to function as a barrier is compromised. Hands must be washed after the removal of gloves used as PPE, whether or not the gloves are visibly contaminated.

Source: OSHA.gov, for more information visit:

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21010

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What type of disinfectant can be used to decontaminate equipment or working surfaces which have come in contact with blood or OPIM?

OSHA's position is that EPA-registered tuberculocidal disinfectants, diluted bleach solutions and EPA-registered disinfectants that are labeled as effective against both HIV and HBV as well as Sterilants/High-Level Disinfectants cleared by the FDA, meet the requirement in the standard and are "appropriate" disinfectants to clean contaminated surfaces, provided that such surfaces have not become contaminated with agent(s) or volumes of or concentrations of agent(s) for which higher level disinfection is recommended.

The particular disinfectant used, as well as the frequency with which it is used, will depend upon the circumstances in which a given housekeeping task occurs (i.e., location within the facility, type of surface to be cleaned, type of soil present, and tasks and procedures being performed). The employer's written schedule for cleaning and decontamination should identify such specifics on a task-by-task basis.

Source: OSHA.gov, for more information visit:

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21010

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Who must be offered the hepatitis B vaccination?

The hepatitis B vaccination series must be made available to all employees who have occupational exposure, except as provided. The employer does not have to make the hepatitis B vaccination available to employees who have previously received the vaccination series, who are already immune as their antibody tests reveal, or for whom receiving the vaccine is contraindicated for medical reasons.

Source: OSHA.gov, for more information visit:

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21010

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When must the hepatitis B vaccination be offered to employees?

The hepatitis B vaccination must be made available within 10 working days of initial assignment, after appropriate training has been completed. Thus, arranging for the administration of the first dose of the series must be done at a time which will enable this schedule to be met.

Source: OSHA.gov, for more information visit:

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21010

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When are labels required?

A warning label that includes the universal biohazard symbol (see 29 CFR 1910.1030(g)(1)(i)(B) followed by the term "biohazard," must be included on bags/containers of contaminated laundry; on bags/containers of regulated waste; on refrigerators and freezers that are used to store blood or OPIM; and on bags/containers used to store, dispose of, transport, or ship blood or OPIM (e.g., specimen containers). In addition, contaminated equipment which is to be serviced or shipped must have a readily observable label attached which contains the biohazard symbol and the word "biohazard" along with a statement relating which portions of the equipment remain contaminated.

Source: OSHA.gov, for more information visit:

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21010

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What are the required colors for the labels?

The labels must be fluorescent orange or orange-red or predominantly so, with symbols and lettering in a contrasting color. The label must be either an integral part of the container or affixed as close as feasible to the container by a string, wire, adhesive, or other method to prevent its loss or unintentional removal.

Source: OSHA.gov, for more information visit:

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTERPRETATIONS&p_id=21010

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Cotton/Non-Wovens
I use non-woven sponges daily in my practice, what should I consider when evaluating manufacturer sponges for absorbency? And what is basis weight?

The fluid absorption rate and retention rate of a sponge are directly related to its basis weight – a measure of the thickness of the material used in its manufacture. For example, Crosstex non-woven sponges come in basis weights of 30, 40 and 50 grams (weight per square meter of fabric). 30 gram material is considered a light absorption material suitable for general purposes, while 50 gram is a heavy-duty material offering maximum absorbency.

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Environmental Hygiene/Operatory Protection
When using barrier film on my equipment (lights/countertops) will it leave a residue behind?

Crosstex barrier film has a light tack adhesive that will easily attach to surfaces without leaving any residue behind. Barrier film can also be utilized while wearing gloves and the Crosstex finger-lift edge barrier film has a 3/16” non-adhesive finger lift edge so you can easily grab to place and remove the disposable film. 

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Should my practice be concerned about protecting office equipment such as the remote controls in the patient waiting area, or electronic devices (such as electronic tablets) that are shared amongst staff?

It is best practice to protect all of your equipment from cross-contamination. According to Microbiologist Dr. Charles Gerba, University of Arizona, Cold and flu viruses can survive on surfaces for up to 72 hours.

Crosstex offers a barrier product for both tablets and remotes that is for single-use and can easily be disposed after each use. Fitting most sizes of electronic tablets and remote controls they help to ensure proper infection prevention.

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High-Level Disinfection
What is the difference between Sterilization and High-Level Disinfection?

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.

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

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?

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What is the High-Level Disinfectant Rapicide® OPA/28 and how can it be used?

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.

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What is the right procedure for manual use of HLD Rapicide® OPA/28?

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.

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How does Rapicide® OPA/28 differ from other OPA based solutions?

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 

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Is Rapicide® OPA/28 a Sterilant?

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

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Is Rapicide® OPA/28 a Sporicidal Agent?

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

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Does Rapicide® OPA/28 require special ventilation?

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

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Is Rapicide® OPA/28 safe for commonly used metal instruments?

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.

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I have noticed a blue-grey staining on some instruments, what is causing this?

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.

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What can I do to increase the reuse life of my chemistry?

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%.

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Medical: Is Rapicide® OPA/28 compatible with my Automated Endoscope Reprocessor (AER)?

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.

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What is the proper way to change out my current chemistry to Rapicide® OPA/28?

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.

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What is the proper manual rinsing procedure to use with Rapicide® OPA/28?

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.

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DISPOSAL – Which states require neutralization before disposal?

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.

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Why am I seeing foaming with Rapicide® OPA/28?

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.

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How often should I be testing the MRC level of Rapicide® OPA/28?

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.

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Do I need to perform a Quality Test on the Rapicide® OPA/28 Test Strips?

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.

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I am noticing the need to add additional chemistry to my reservoirs after using Rapicide® OPA/28.

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.

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Are there any contraindications for urological cystoscopes?

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.

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Imaging Comfort
When purchasing dental radiography imaging cushions, can you advise on features I should consider?

Performance, size and quality are obviously key, but make sure to also patient discomfort that can be cause by the rigid edges of x-ray film packets. 20 years ago a RDH invented Edge-Ease®, the original dental imaging comfort cushion. By wrapping the edge of the film with Edge-Ease, the patient’s soft tissue was protected from abrasions and discomfort. This, in turn, enabled the patient to bite harder for more precise positioning and a more accurate x-ray, with less need for retakes. So consider rough seams vs smooth seams of digital sensor sleeves and hard vs smooth edges to maximize patient comfort. 

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PPE: Personal Protection Equipment
Which ASTM level mask provides the protection I need when using ultrasonics?

An ASTM level 2 mask would be appropriate if moderate to light amounts of fluid, spray, and/or aerosols are produced.  As ultrasonic and air polishing procedures may take 20 minutes or more, consider wearing an ASTM level 3 mask if moderate to heavy amounts of fluid, spray, and/or aerosols are produced such as with ultrasonics or air polishing.

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Preventatives/Treatment Accessories
When purchasing a topical anesthetic gel, can you advise on features I should consider?

Consider a produdt with rapid onset and a formulation that will minimize salivation. GumNumb contains 20% benzocaine and is aspartame-free and free from the following allergens: nuts, soy, milk, eggs and gluten. Always check manufacturer labeling information and ingredients before utilizing any product.

 

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Sterilization (Physical, Chemical, Biological Monitoring)
How often do I need to do biological monitoring at my practice? Weekly? Monthly?

The Centers for Disease Control recommend at least weekly biological monitoring for dental offices and monthly monitoring for medical offices and tattoo shops.  

According to the CDC Guidelines for Disinfection and Sterilization 2008:

Use biologic indicators to monitor the effectiveness of sterilizers at least weekly with an FDA-cleared commercial preparation of spores (e.g., Geobacillus stearothermophilus for steam) intended specifically for the type and cycle parameters of the sterilizer. Category IB. 1

 

 

It is best practice to comply with CDC guidelines which recommend to “monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e. biological indicator and control from the same lot number).  Use a biological indicator for every sterilizer load that contains an implantable device.  Verify results before using the implantable device, whenever possible.” Guidelines for Infection Control in Dental Health-Care Settings, 2003

 

 

According to AAMI: 10.5.3.2 Using biological indicators

Biological indicators should be used within PCDs (see 10.5.4, 10.7.2.1, 10.7.3.1, 10.7.4.1) for routine sterilizer efficacy monitoring at least weekly, but preferably every day that the sterilizer is in use (see 10.7). Additionally, BIs within PCDs should be used to monitor every load containing implants (see 10.6.1); implants should be quarantined until the results of the BI testing are available (CDC, 2008).

 It is recommended for veterinary offices to perform biological monitoring although a frequency is not stated.  However, testing requirements may vary according to state and it is recommended to check with your state regulatory authority for testing requirements.

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How many instruments can I put in a pouch?

The number of instruments per pouch will vary depending on the shape and size of the instruments as well as the size of the pouch.  Instruments should not overlap in the pouch.  The pouch should lay flat with no overlapping or crowding at the borders leaving at least a finger width space available on the sides and a 1 inch space available at the top of the pouch.  Overloading a pouch may cause a breach in integrity (seam break and/or tears) and may not allow the sterilant to circulate freely and fail to reach all surfaces of all instruments enclosed. Crosstex manufacturer’s pouches in numerous sizes and shapes from 2.25” x 4” up to 12” x 18”—so ensure you are starting with the best product to suit your needs.

It is best practice to comply with CDC guidelines which recommend to “monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e. biological indicator and control from the same lot number).  Use a biological indicator for every sterilizer load that contains an implantable device.  Verify results before using the implantable device, whenever possible.” Guidelines for Infection Control in Dental Health-Care Settings, 2003

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If I use Crosstex Sure-Check Sterilization Pouches with internal and external indicators, do I still need to use a Type 5 Integrator?

The CDC recommends cleaned instruments should be assembled into sets or trays, and wrapped or packaged for sterilization with an internal chemical indicator placed in every package.  Sure-Check Pouches with built in internal and external indicators are recommended for every load of instruments and will provide a definitive color change when two or more of the parameters for sterilization have occurred (time, temperature, steam).  Type 5 chemical indicators as defined by the Food and Drug Administration and the International Standards Organization contain a steam sensitive material that sequentially moves across the strip into a safe zone indicating all parameters of sterilization (time, temperature, steam) have been met.  The STEAMPlus Integrator is an example of a Type 5 chemical indicator and is intended for once a day use and for use in every load containing an implantable device.  The benefit of Type 5 indicators is the ability to provide a distinct pass/fail result providing the confidence of sterility prior to releasing the load.  Type 5 indicators closely mimic biological monitoring but since they do not contain spores, will not replace the need for weekly biological testing.

It is best practice to comply with CDC guidelines which recommend to “monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e. biological indicator and control from the same lot number).  Use a biological indicator for every sterilizer load that contains an implantable device.  Verify results before using the implantable device, whenever possible.” Guidelines for Infection Control in Dental Health-Care Settings, 2003

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What should I do when a weekly biological spore test fails?

In the event of a positive spore test, the CDC recommends:

  • Take the sterilizer out of service until the cause of failure is determined. A single positive spore test probably does not indicate sterilizer malfunction. However, once a failure is detected, the sterilizer cannot be considered safe to use until the problem is identified and resolved.
  • Review sterilization procedures (packaging, loading)  and  all records of chemical and mechanical monitoring since the last negative BI
  • Retest sterilizer using the same cycle and approximate load and observe cycle. Observe the sterilizer physical monitoring devices to determine whether proper sterilizing conditions are indicated.
  • If the spore test result is negative and if the chemical indicators have changed appropriately, the sterilizer may be put back into service.
  • If the repeat BI test is positive and the processing procedures are being performed correctly, the sterilizer should remain out of service until it has been inspected, repaired, and challenged with BI tests in three consecutive loads (Gravity displacement sterilizers full load chamber and Type B sterilizers empty chambers)

It is best practice to comply with CDC guidelines which recommend to “monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e. biological indicator and control from the same lot number).  Use a biological indicator for every sterilizer load that contains an implantable device.  Verify results before using the implantable device, whenever possible.” Guidelines for Infection Control in Dental Health-Care Settings, 2003

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How do I know my instrument packs are sterile?

Sterility assurance consists of a combination of process parameters including physical, chemical and biological monitoring.

Two types of chemical indicators exist for instrument packaging.  External indicators, like autoclave tape, that change color after a certain temperature has been reached is known as a process indicator. This identifies packages that have been heat processed and those that have not. These indicators do not signify sterilization has been met.

Multi-parameter indicators respond to a combination of time and temperature or time, temperature and presence of steam. These indicators may be strips placed in a package or Sure-Check pouches with a built in multi-parameter indicators.

Instrument pouches with built-in external and internal indicators that have shown a distinct color change following the sterilization cycle indicate the sterilant has penetrated the package.  Multi-parameter indicators are a more reliable indicator and are only available for steam sterilizers. 

It is best practice to comply with CDC guidelines which recommend to “monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e. biological indicator and control from the same lot number).  Use a biological indicator for every sterilizer load that contains an implantable device.  Verify results before using the implantable device, whenever possible.” Guidelines for Infection Control in Dental Health-Care Settings, 2003

 

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Does the sterilizer dry cycle matter?

Drying pouches and packs inside the steam sterilizer is important to maintain the sterility of the instruments.  The paper side of pouches is fragile when wet and can easily tear or be punctured, causing contamination of the instruments. Wet packs exposed to the surfaces outside of the sterilizer may result in wicking; this process allows microorganisms from the air, spatter, fingers or countertop to penetrate the wet paper and contaminate the instruments. Pouches and packs should be allowed to dry completely in the sterilizer before removing for storage.

It is best practice to comply with CDC guidelines which recommend to “monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e. biological indicator and control from the same lot number).  Use a biological indicator for every sterilizer load that contains an implantable device.  Verify results before using the implantable device, whenever possible.” Guidelines for Infection Control in Dental Health-Care Settings, 2003

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Surface Disinfectants and Cleaning Solutions
Can you suggest a germicidal disposable wipe that is both alcohol free, fragrance free and latex free?

Yes the Sani-Cloth® AF3 Germicidal Disposable Wipes meet CDC, OSHA and CMS Tag F441 guidelines and are alcohol, fragrance, bleach, acid, phenol, acetone, ammonia and latex free (not made of natural rubber latex). Bactericidal, tuberculocidal and virucidal these wipes are designed to make surface disinfection more pleasant for patients and staff alike, especially those with respiratory sensitivities. With a contact time of 3 minutes this wipe if effective against 44 microorganisms including: RSV, HBV, HCV, HIV, ESBL producing E. coli, CA-MRSA USA 300 and 400, Klebsiella pneumonia – NDM-1 and Klebsiella pneumonia – Carbapenem Resistant.

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Surgical & Waste Accessories
Is the company Aspen Surgical formerly Bard Parker?

Yes this is correct.

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Other/General Customer Service Inquiries
Can I purchase Crosstex products from Crosstex directly?

Crosstex manufactures the majority of the products that we sell in the United States, however, we do not sell direct. Please contact a Crosstex authorized distributor in order to purchase and thank you for your interest.

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Client Testimonials

Crosstex is a company that cares about education. They spend time and resources making sure that customers understand the products they are using and are using them correctly. Any company can make a sale, Crosstex makes lasting relationships.

Leslie Canham,
CDA, RDA Speaker/Consultant on Infection Prevention and Safety- lesliecanham.com
Client Testimonials

We are very pleased with both the service and the communication we receive from CrosstexBMS. The website is easy to use and it's great to have all of our test results available online anytime we need to see them. Thanks.

Maryjane L Bruning,
RDH, BS/UMKC-SOD
Client Testimonials

Innovation, Quality and Design are the 3 best words I can find to describe Crosstex Products.  Products like Sure-Check® Multi-Parameter Sterilization Pouches and the STEAMPlus™ Type 5 Integrators allow you to be on TOP of your game when it comes to optimal sterility. I love offering the entire Crosstex suite of products to my customers as they always have the patient in mind!

Carie Miskell,
CRDA / Dental Sales Director
Client Testimonials

Crosstex has come out with a lot of amazing product that are focused on excellent patient care and accurate infection control. As well Crosstex is always thinking about how to keep the patient safe and comfortable in the dental chair.

April Slater,
Dental Assistant - Milwaukee, Wisconsin