Single-Use Items And Sterilization
In my dental practice, prophy angles are bagged individually, unlike other single-use items. Generally, these items are taken from their bulk storage containers and stored in drawers in the operatories. Is it acceptable from an infection control standpoint to unwrap them when placed in a drawer next to other unwrapped items, or must they stay wrapped in their individual baggies until treatment time?
Infection control guidance related to single-use or disposable devices, such as prophy angles and saliva ejectors, is limited. Single-use items are nonsterile and intended for use on one patient, after which they are discarded, according to the United States Centers for Disease Control and Prevention (CDC).1 Single-use items, such as gauze and cotton rolls, should be bagged and sterilized when used in oral surgical procedures, but this is not necessary for routine nonsurgical procedures.1 The US 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.2Although 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 While there is no specific CDC guidance for storage of singleuse items, manufacturer instructions should be followed. Individually wrapped, disposable prophy angles should be kept in their original wrappers until the point of use to avoid contamination from handling, dust, or debris.1
There is confusion surrounding single-use items and infection control. 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. Reusable semicritical instruments, such as mouth mirrors and impression trays, touch oral tissues but do not penetrate bone or soft tissue. They are required to be heat sterilized between uses.1 Disposable prophy angles also touch oral tissues and do not penetrate bone or soft tissue but they are not required to be sterile according to the FDA classification.2 This begs the question: should disposable items that fall into a similar category as semicritical be sterile?
There are methods such as gamma irradiation to sterilize single-use items. Gamma irradiation for sterilization of single-use disposable items is a safe and reliable method that has been around since the 1960s.3 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 ensure compliance is necessary for safe patient care.
- Kohn WG, Collins AS, Cleveland JL, et al. Guidelines for infection control in dental health-care settings—2003. MMWR Recomm Rep. 2003;52(RR-17):1–61.
- Food and Drug Administration. Product Classification. Available at: access data.fda.gov/ scripts/ cdrh/ cfdocs/ cfpcd/ classification.cfm?ID=DYN. Accessed June 17, 2016.
- Steris. Gamma Irradiation Process. Available at: steris-ast.com/ services/ gamma-irradiation. Accessed June 17, 2016.