Proper Storage of Prophy Angles in the Operatory
My question is regarding the proper storage of prophy angles in the operatory. These items are bagged individually, unlike other one-use items (saliva ejectors, prophy paste). Generally these items are taken from their bulk storage containers and stored in a drawer in our operatories. Is it acceptable from an infection control standpoint to unwrap them when placed in a drawer next to the other unwrapped items, or must they stay wrapped in their individual baggies until patient time? Thanks for your help!
Many dental hygienists are probably wondering the same question. Infection control guidance related to single-use or disposable devices, such as prophy angles and saliva ejectors, is brief. Single-use items are intended to be used for one patient and then discarded after one use according to the Centers for Disease Control and Prevention (CDC) and are nonsterile.1 Single use items such as gauze and cotton rolls should be bagged and sterilized for use in oral surgical procedures according to the CDC, but is not necessary for routine nonsurgical procedures.1 The Food and Drug Administration (FDA) classifies disposable prophy angles as class I medical devices, which are nonsterile.2 Class I devices are not intended to penetrate sterile areas of the body (ie, bone or soft tissue) so they are considered low risk to patients.2 Although disposable prophy angles are individually wrapped, they are not sterile, nor are they required to be according to the FDA.2 The individual wrapping helps to keep the product safe from multiple handling, contamination, and exposure to dust and debris until it is opened.1,3 Although there is no specific CDC guidance for storage of single use items, it is wise to follow the manufacturer’s directions and keep individually wrapped disposable prophy angles in their original wrapper until the point of use to avoid any kind of contamination from handling, dust, and debris.1,3 From an infection prevention standpoint, there is confusion for practitioners when it comes to guidance related to single-use items. It is interesting that semicritical items and single use disposable items are treated differently when in reality they are quite similar in the tissues that they touch. It begs the question as to why. Reusable semi-critical instruments, such as mouth mirrors and impression trays, touch oral tissues but do not penetrate bone or soft tissue and are required to be heat sterilized between uses.1 Disposable prophy angles also touch oral tissues and also do not penetrate bone or soft tissue but are not required to be sterile according to the FDA classification.2 Should disposable items that fall into a similar category as semi-critical be sterile? There are methods to sterilize single-use items such as gamma irradiation. Gamma irradiation for sterilization of single-use disposable items is a safe and reliable method that has been around since the 1960’s.4 As an infection preventionist, I hope to see a move toward this type of technology in the manufacturing process. Anything that makes infection control easier for the practitioner to understand and to be compliant is what is necessary for safe patient care.
1. Centers for Disease Control and Prevention. Guidelines for Infection Control in Dental Health-Care Settings— 2003. MMWR 2003;52(No. RR-17).
2. Food and Drug Administration. Product Classification. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=DYN
3. Hu Friedy. Disposable Prophy Angle Question and Answers: https://www.hu-friedy.com/NewDPA
4. Steris. Gamma Irradiation Process: http://www.steris-ast.com/services/gamma-irradiation/