Don’t Reuse Single-Use Dental Supplies

Compromising Patient Safety by Reusing Single-Use Dental Items is an Unacceptable Practice!

There have been reports of infection control breaches in dentistry that include allegations that single-use disposable items were being reused in dental offices. It has been reported that dental offices were cleaning items in high level disinfecting solutions (“cold sterile”) prior to reuse even though these items were labeled for one-time patient use. After further investigation, it seems that this is a relatively common practice in dentistry. So, you may be asking what’s the big deal?

There are several issues to consider here and yes, it is a big deal. First, let’s look at what exactly is a single-use or disposable device.

By definition, a disposable device is one that that is designed to be used on only one patient and then disposed of. The device may be one that is not heat tolerant, such as disposable mouth mirrors, plastic evacuation tips or air/water syringe tips. Since the device is designed for only one use, it is not tested for safety and efficacy for multiple uses and exposure to chemicals or heat during reprocessing and sterilization. The device may also be very difficult to clean, which renders disinfection by immersion in a high-level disinfecting solution or heat sterilization ineffective; creating the risk of patient-to-patient cross contamination.

 

FDA REGULATIONS

Product Labeling

Many dental professionals are not fully aware of the authority of the U.S. Food and Drug Administration (FDA) regarding dental and medical devices, which could be a major, factor in the persistent practice of reusing disposable dental devices. The FDA has very specific labeling recommendations for single-use devices¹. On the package of these items, the manufacturer is required to indicate that the items or devices are disposable or single-use. In the above-mentioned breach, it was reported that the devices in question were clearly labeled as single-use.

Reprocessing Instructions

The FDA requires manufacturers to submit instructions for reprocessing of dental and medical devices, if applicable. If a manufacturer does not submit such instructions for FDA approval, a device is classified as disposable or single-use².  These devices, such as disposable mouth mirrors, suction tips, impression trays, air/water syringe tips, burs, prophy angles may be difficult to clean; which may interfere with heat sterilizations or high-level disinfection. Some items are heat sensitive; any may be damaged by heat sterilization, and therefore would need to be reprocessed in a high-level disinfectant.

It is important to note that the use of immersion disinfectants as a limitation. It cannot be monitored for effectiveness, for example a heat sterilizer can be spore tested to verify sterilization parameters have been captured. In addition, items immersed in these solutions must be rinsed upon removal from the solution, and exposure to tap water and the room air results that the items are no longer sterile.

Reprocessing Certifications

The third factor to consider is when a facility reprocesses and reuses a disposable device; the FDA requires that the facility be able to prove that the device is not altered in any way by reprocessing. It must also show that is safe to use as when the manufacturer submitted its data to the FDA for approval or clearance to sell the device. This would not be possible in a dental practice.

 

CDC INFECTION CONTROL GUIDELINES

The Centers for Disease Control and Prevention (CDC) also addresses the reuse of disposable devices in several of its guidelines for infection control/prevention in dentistry as well as health care in general³. The CDC states that a single-use device, also called a disposable device, is designed to be used on one patient and then discarded, not reprocessed for use on another patient (e.g., cleaned, disinfected or sterilized).

The FDA regulations and CDC guidelines clearly preclude the reuse of disposable items. Yet the practice persists, primarily to save money on supply costs. The reality is, however, that if a cost analysis was performed regarding the time and materials needed to clean, disinfect, package and sterilize a disposable item or device compared to the cost of the device itself, a practice would most likely save money and times by using the device and throwing it away. The bigger picture being the ultimate cost of the negative publicity from an infection control breach or outbreak in a dental practice would far outweigh any perceived cost savings by reusing disposable devices.

Patient Safety

There is nothing that can justify knowingly putting patients at risk.  Patient safety must always come first. If items cannot be adequately cleaned and sterilized for reuse, patients may be at risk of infectious disease transmission. Compromising patient safety to save money by reusing single-use items is an unacceptable practice and perhaps a signal you are paying too much for yours. Why don't you spend some time browsing and compare ours to yours.

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Special thanks to Mary Govoni, CDA, RDH, MBA

Mary Govoni is a dental assistant and hygienist with over 40 years of experience in dentistry, including practice administration, clinical assisting and hygiene, dental assisting and hygiene education, consulting and seminar presentations. Her consulting and speaking areas of specialization include infection prevention and OSHA compliance, HIPAA compliance, ergonomics and dental practice efficiency and team development. Mary is a past president of the American Dental Assistants Association, a member of the American Dental Hygienists Association, the Organization for Safety Asepsis and Prevention, the Speaking and Consulting Network, the Academy of Dental Management Consultants, American Association of Dental Office Managers, the American Academy for Oral and Systemic Health and the National Speakers Association.

1. Food and Drug Administration. Labeling recommendations for single-use devices reprocessed by third parties and hospitals; final guidance for industry and FDA. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration;
2. Food and Drug Administration.  Reprocessing Medical Devices in Health Care Settings:  Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff, 2015;  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reprocessing-medical-devices-health-care-settings-validation-methods-and-labeling
3. CDC. Guidelines for infection control in dental health-care settings –2003.MMWR2003; 52(No. RR-17):1–66. Available at: https://www.cdc.gov/mmwr/PDF/rr/rr5217.pdf