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.