cross contamination, dental assisting, dental hygiene, dentistry, infection control, rdh

The Dental Device IFU – Are You Putting Patients at Risk?

Last month at the Hinman Dental Convention in Atlanta, GA we introduced our newly designed Disposable DOVE evacuation valves.

Over the 3-day meeting, we held 100’s of conversations with Dental Professionals.  We also sponsored a leading Infection Control Workshop with 60+ attendees.  When conversing, we inquire how their office manages maintenance of both HVE and Saliva Ejector Valves between patients and ask if the office addresses backflow?  The protocol for cleaning varies from 1 respondent to another, responses include:

  • wiping the exterior surfaces between patients (100+ of respondents)
  • wiping the exterior and sheathing the valve between patients (25+ respondents)
  • autoclave the valve components between patients (2 responses)

We always note when we hear anything besides the typical “wiping only” response.  Flushing frequency receives a variety of responses as well:

  • flushing at the end of day (50+ responses)
  • flushing weekly (50+ responses)
  • flushing between patients (2 responses)
  • flushing?  (1 response)

Lastly, Saliva Ejector Backflow responses were all similar:

  • 0 respondents use any device to alleviate patient backflow
  • An estimated 5 respondents stated they warn patients to not close around suction straws

So what is the correct way to clean a valve or is the evacuation valve left up to the discrepancy of the user?  Why is there such a variation of responses?  Do all evacuation valves have an IFU?

Whats the correct way to clean a valve?

DOVE believes patient safety should be the #1 priority.  Regardless of the dental device, if there is the potential risk of cross contamination to a patient or dental professional, the IFU (Instructions for Use) should always be followed.  Metal Evacuation Valve IFU’s in the N. American market instruct users to reprocess routinely.  Some companies are more detailed in the instruction process stating to disassemble each part, scrub each part and reprocess each part routinely.  Finally, a few metal valve manufacturers have checklists instructing flushing & reprocessing to be a routine part room turnover process.

Why is there such a variation of cleaning suction devices?

This answer will vary dependent on the following:  where and how you were trained / your particular dentist & office expectations or lack there of / habits / and the office or space lacks the necessary tools and devices to manage patient care properly.

We’ve spoken with many dental school programs who only wipe the exterior surfaces between patients and state its too expensive to remove the valves.  While other programs have a instrument manager in charge of maintaining the valve components.  Many of these students, unfortunately, never learn the correct valve maintenance.  Many attendees at the Hinman Dental Meeting were unaware valves disconnect from the swivel adapters and its part of the IFU – every usage.

Often in private offices, strict budgets are set on infection control products.  In other offices, the doctor sets the tone that its not important to offer patients clean evacuation valves.  While in others, efficient patient turnover is the priority so the room needs to be turned over quickly vs correctly.  Proper valve maintenance requires patience and time.  Backflow is a proven risk from numerous studies and the CDC.  As evidenced from our conversations, less than 1% offer a backflow preventative device less than 1% warn patients of the potential risk.

Lastly, maintenance requires multiple parts because valve components can breakdown when they are cleaned and reprocessed.  Many offices have 1 valve per chair. Ultimately the room could not function if the valve were to be reprocessed.

All Traditional Dental Evacuation Valves sold legally in N. America contain IFU’s that were prepared by the manufacturer.  These can be found in Assistants Instrumentation Packets if sold with the chair or online at the respective dental chair unit manufacturer.  Or, if the valve(s) were sold separately, IFU’s most likely are included in the original packaging and or online.
Instructions for use (IFU) are based on:
-in most cases they are required or in accordance of FDA Guidelines to provide a clean safe product
-the manufacturer has validated the steps necessary to prepare a device that is
safe for patient use
-The Centers for Disease Control CDC recommends following device IFU’s
-the manufacturers’ IFU is necessary to deliver a safe product for surgery
Not following the Manufacturers’ IFU puts patient safety at risk because the devices may be cleaned improperly, wrapped improperly, and or loaded into sterilizer improperly.  Most common valve risks are backflow, leakage and unclean parts coming into patient contact.
Why the conversation needs to start?
The below chart displays the leading N. American metal valve companies IFU recommendations.  Given the recent meeting conversations, dental offices are failing to deliver clean safe HVE Valves, clean safe Saliva Ejector Valves, do not address backflow and do not effectively manage the flushing of suction systems.  When 99% respond that they do not follow the IFU, something needs to be said.
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cross contamination, dental hygiene, dentistry, infection control, rdh

Introducing NEWLY Designed DOVE Disposable Evacuation Valves at Hinman

March 10, 2018

DOVE Dental Products will exhibit in booth #11 at the upcoming 106th Annual Thomas P. Hinman Dental Meeting, March 22-24, 2018.  We will introduce NEWLY Designed DOVE Disposable Evacuation Valves that will include:

  • DOVE Disposable Saliva Ejector with Backflow Prevention offered now in Purple! Dental patient backflow risks occur when patients close their lips around suction straws. Prior patient backwash (or backflow) goes back into the mouth.  Only a backflow prevention device can eliminate this risk.
  • Our NEW High Volume Evacuation (HVE) is now offered in 2 comfort-driven designs! Valve comfort for Hygiene and Assisting is of the utmost importance.  Our 2 designs provide the greatest selection in the disposable market.
  • 2 NEW Connections for the HVE Valves! The current dental chair marketplace has many HVE connections.  Our new adaptors allow us to connect to over 95% of N. American Dental Chair units.

Providing a clean and safe evacuation valve is not possible when dental professionals only wipe the exterior surfaces and intermittently flush dental suction lines.

DOVE will also sponsor Ms. Nancy Dewhirst Infection Control Workshop on March 23 from 1- 4:00 PM.

For more, please inquire at sales@stomadental.com.

cross contamination, dentistry, infection control, rdh

Do you guarantee clean evacuation valves?

Disposable dental devices have come a long way in the past 10 years.  Not long ago, a disposable evacuation valve would have been unreliable in both fit and performance, not to mention prohibitively expensive.

DOVE Evacuation Valves changed all that.  These plastic valves are made in the USA in a clean-room ISO 13485 facility, guaranteed clean from contaminants.  Plastic molds are extremely accurate producing a disposable product with consistent quality and reliable standards, manufactured to assure outstanding performance in the dental office at an affordable price.

 

Furthermore, DOVE Valves have been evaluated by leading infection control experts; all agree our disposable valve is a cleaner and safer alternative.   Our valves were also voted by OSAP member’s at the most innovative infection control product in early 2017.

We encourage you to carefully consider what is specifically required of your dental office is to guarantee a clean, sterile evacuation valve for every patient.  As one dentist studying the situation commented, “It’s not a matter of if someone is going to get sick from a valve that was only wiped, it’s a matter of when.”

As you evaluate, consider the cleaning protocol that your staff learned in their training program, school or university.  Each teaching facility tends to instruct the student in a protocol that is biased by its orientation, for example “busy,” programs have patients that are so tightly scheduled that wiping a valve clean, the bare minimum, is reinforced.  Teaching programs, on the other hand, are constantly exploring ways to lower costs and shockingly some students never even learn that the valve can be removed!  Minimal steps may be taught, valves maintained infrequently, flushing occurring daily or even weekly.  Finally, larger universities tend to reinforce “central sterilization,” allocating the cleaning process to an outside team.  Here students may learn to flush the lines occasionally but have very little knowledge of how to remove and clean a valve, relying on outside personnel for maintenance and repair.

The below image is a typical parts room at a University.   Most students never see this side of the routine maintenance.

dental cleaning room

You might wonder why there is no industry protocol on sterilizing such an essential piece of dental equipment as an evacuation valve. especially in today’s climate of infectious disease awareness.  Shockingly, it’s not even on the radar, taking a back seat to money makers like 3D imaging, CAD CAM, etc.

Speak with each of your staff about their cleaning techniques.  You may be surprised to find that staff use different cleaning methods even within the same office, varying among rooms.  Some flush, some wipe, some are more thorough than others.  The following are various cleaning methods that we see when we visit dental offices.

#1 – wiping the exterior and flushing the lines at the end of the day

It’s important to note that wiping the exterior surfaces without scrubbing them does not remove debris.  Recent testing on 212 valve surfaces that were only wiped between patients “all failed” a ATP bacteria test.  Also flushing once a day is only considered a preventive maintenance step (like drano) and will not clean the lines for the patient.  If backflow is a concern, every line will fail a clean test.

#2 – wiping the exterior and flushing between patients

Wiping the surfaces, as in #1 above, without scrubbing, does not remove debris and consequently not all the valves will be clean.  Flushing the lines between patients is a great start, albeit rarely done, but without a backflow prevention device every line will fail.  The same applies to cleaning the interior surface of the lines.  Unless blood and debris is scrubbed and the surface sterilized contamination will still be present (see photo below of a flushed line).

interior valve after flushing

#3 – wiping the exterior and not flushing the lines, or flushing once a week or even once a month

This replicates the scenarios above.  Every week we encounter a new office that has never flushed the evacuation lines.  All the valves and lines maintained this way are not clean.

dirtyvalve

#4 – removing the valves, disassembling the parts and running them through a sterilizer.

This is actually what the manufacturers of the metal valves recommend be done between each patient.  We have found that only the VA clinics follow this recommendation.  This process, stipulated in the metal valve instruction guide, is the only process that will guarantee a clean traditional valve.  The major risks are in transporting the parts and assembly.  The downside of this method is time (approx 12 minutes per valve) and cost (over $3.00 per valve) which ranks it second to the disposable option.

In private practice we have found that when a sterilizer is used, it is only used once a day or infrequently at best.  In addition, unless the parts are scrubbed prior to sterilization, then the contaminants are merely baked on and not removed.

#5 – disposing of the valve and using a new DOVE Saliva Ejector or HVE valve for each patient

A DOVE Disposable Valve guarantees each patient a safe, clean valve.  DOVE Saliva Ejector Valves eliminate backflow.  Performance is consistent, time is negligible and cost (approx. $2) is less than frequent cleaning through a sterilizer, making this a superior choice.

While all the above cleaning methods do meet CDC minimum guidelines, only #4 (maintaining the valve frequently) and #5 (offering a disposable version) are truly worthy of our dental patient’s expectations.

Guaranteeing a clean, safe visit for your dental patients is easier and more affordable today than ever. It’s more than an option. In today’s environment, with busy offices and discriminating patients – it’s an imperative.

References:

http://www.osap.org/news/328694/OSAP-Issues-Boot-Camp-Exhibitor-Awards.htm

http://www.dentaleconomics.com/articles/print/volume-103/issue-3/practice/cleaning-or-disinfection-whats-right-for-the-suction-lines.html

https://www.cdc.gov/oralhealth/infectioncontrol/questions/saliva.html

https://www.oralhealthgroup.com/features/does-your-evacuation-suck/

 

 

 

Uncategorized

Your Everyday Decisions Are More Important Than You Realize, by Mrs. Pat Pine RDH

Swab Test Case Study

I was asked to perform an informal case study on dental office evacuation valves. This was a challenge in many ways. Several offices I contacted were leery to allow swab testing in their offices even though they said they felt confident of their disinfection process. My infection control flag went up many times in those practices. If they felt confident, why are they leery of doing a simple swab test? What was the risk to them? One office wanted to check with his lawyer, wanted my license, and much more seeming ridiculous information. The offices that were welcoming wanted to know how they could improve their infection prevention protocol. A big benefit was they received bags of disposable valves for allowing testing of their disinfected valves.

Testing was done to determine if the valves were contaminated even after disinfection. What are the consequences of the unknown invisible organic matter? What pathogens are nesting here? When disinfected what pathogens are being reduced or present?

As an experienced infection prevention and safety specialist, I performed the swab-testing. After reviewing the results, I was glad I had donned the appropriate PPE. Yet maybe I should have worn a hazmat suit!

The Down and Dirty Results

I processed 212 valve surfaces and determined they were YES contaminated after a routine disinfecting protocol. Discovering the bacterial load on dental unit vacuum valves left me with an uneasy feeling. Are we creating a healthy environment for our patients? Occupational Safety, Asepsis and Prevention (OSAP) has repeatedly stated that dental patients should be in a safe dental environment which includes the entire dental facility and all the processes.

Just to begin to discover where problems happen, the first question should be if the valves were disinfected according to manufacturer’s instructions? Metal valve companies recommend routine disassembly, scrubbing and reprocessing of the surfaces between patients. Minimal industry standard between patient protocol should be to:

  • Wipe once to clean
  • Wipe a second time to disinfect

Saliva Ejector and Backflow Risks

It’s not new information that back flow from low-volume saliva ejectors is happening. Research has shown that when a patient seals their lips around the tip of the saliva ejector, backflow can occur via the pressure created in the patient’s mouth. Studies report that gravity pulls fluid back toward patient’s mouth when tube positioning is above the patient’s mouth or when both high or low suction is used at the same time. Unfortunately, like not going in the water for 30 minutes after eating myth, we have taught our patients to close their lips around the saliva ejector.

The CDC recommends that the dental community advise their patients not to close their lips around the saliva ejector. CDC concluded that research confirms the significant risk in backflow with microbial cross contamination between patients.

Is your office using old, outdated operating procedures that are as myth based as watermelon seeds germinating in your stomach? Updated written policies and procedures are a must for any dental setting. Standard Operating Procedures (SOP) can be used for training and OSHA safety purposes. These policies should be reviewed on an annual basis. Check lists are powerful reminders of what might be forgotten in daily routines. (Go to http://www.oshatrainingbootcamp.com/ to find checklists and more.)

Replace the Old with the New

Replacing an old car with a new car increases safety with airbags, hands free phone connection and camera’s in the rear panel to prevent from hitting a child or running over a bicycle. The prevention is worth every penny. Valves are now available to keep patient’s safe in any dental facility. New disposable versions are clean and offer backflow prevention. We need to protect our patients from microbial bio-hazardous debris and possible transmission of disease via backwash. The Hippocratic Oath and professional ethics standards demand that we first, do no harm.

About the Author

Mrs. Pat Pine, RDH is a national and international speaker specializing in OSHA, infection control, lasers and orofacial myology. She brings thirty years of experience in dentistry to provide exciting and evidenced based programs. Pat believes that safety, infection control, and whole health are important to providers and patients alike. Her philosophy is an empowered team is a healthy team, which in turn creates an unstoppable referral formula. Ms. Pine conducts in-office training’s, boot camps, online seminars, and dental/dental hygiene conventions. She is a member of OSAP speaker’s/consultant’s bureau and publishes regularly in several dental magazines. Pat reminds others that education doesn’t stop at clinical treatment. It is an on-going process to enrich ones-self and bring the highest quality of care to patients. Pat can be reached at info@oshatrainingbootcamp.com