Changing Standards for Sterilization
Apr 01th, 2011
From the beginning of our involvement with infection control in the 1980’s, Dentronix saw a need to provide FDA-cleared asepsis options for a profession using primarily moisture-sensitive instruments. Today, the orthodontist has a number of instrument choices that have improved corrosion resistance over the tool steels used in the past. Unfortunately, these rust-resistant materials lack a number of properties that are essential for optimum function and longevity - attributes like shock resistance, ductility, and grip. The result is that many orthodontists still rely on tool-steel inserted pliers for performing clinical tasks, and thereby depend upon Dry Heat sterilization as a methodology that is compatible with their pliers. The trade-off in using this inert sterilization process is that barriers cannot be placed between the instruments and airflow without affecting device efficacy. Bagging is simply not possible in the latest generation of convective dry heat systems. Old-style conductive dry heat units will work, however the 2+ hour time cycle required to sterilize a load of packaged orthodontic pliers is impractical when considering of the turnover requirements of the busy orthodontic office.
Though the Centers for Disease Control have historically recognized the special needs of dental specialists, the most recent interpretations of CDC guidelines by state dental boards and insurance companies show little sensitivity to those needs, nor to the generally non-invasive nature of orthodontic procedures. In an apparent effort to simplify field audits, there has been a trend toward grouping all specialties under the General Dental umbrella and mandating bagging of all instruments being processed through sterilization, in spite of the fact that the CDC has made allowances for both unwrapped sterilization and high level disinfection of heat sensitive semi-critical items. Along with a coordinated system of PPE’s, barriers, and surface disinfection, these guidelines have succeeded in keeping the orthodontic patient population safe from communicable diseases for decades.
There are some of our customers who insist that maintaining the sterility of an orthodontic instrument until the point of delivery creates a safer environment for their patients and staff, while others cite the practical implications of maintaining instrument sterility while working in an unsterile environment, wearing unsterile gloves, masks, and garments and breathing unsterile air. Sterilization of instruments is recognized by all as a core function of an effective infection control system, however there can be a legitimate debate over using a sterile instrument versus a sterilized instrument. The important dialogue needs to be about implementation of a comprehensive system that breaks the chain of cross-contamination and cross-infection, consistent with standard-of-care protocols. Mandating rules that have questionable basis in federal regulatory guidelines at the expense of forcing the orthodontic community to completely transition from an FDA-cleared method of sterilization is an unfortunate trend. This lack of sensitivity to a group of dental specialists dependent on moisture-sensitive instruments puts an unfair burden on orthodontists as the directive will not only force purchase of new sterilizing equipment but create a severely negative impact on expensive instrument inventories.
This more stringent regulatory trend started in California, as the State Board of Dental Examiners streamlined a reasonable standard and mandated no exceptions to the bagging-during-sterilization rule as of August 2011. Nevada is following, with local interpretations of CDC standards that ignore existing allowances for unwrapped sterilization. In Massachusetts, the State Dental Board has contracted with a dental insurance company to perform compliance audits, and there are deductions issued on a points scale for offices not bagging instruments. At Dentronix, we believe in safety for patients and staff and in no way condone processes that leave anyone at risk. We simply urge orthodontic professionals to get involved at the state level so that standards that affect your practice are reasonable and assess the practical needs and circumstances of the clinical process.
Category: Dentronix Quarterly