Instructions for Use

Infection Control

By Katherine Schrubbe

What they are and why they are important to the dental practice

When you purchase a new car, you find the time to read and review every page of the ½-inch-thick owner’s manual to ensure the new vehicle runs at peak performance. When you purchase a new television for the dental reception area, you unfold the thin accordioned sheets of diagrams to review the set-up and ensure that each connection jack has the correct cords plugged in, prior to turning it on for viewing. So why do dental healthcare personnel discount – or even ignore – instructions for use (IFU) that accompany medical/dental devices or products used in the dental practice? In fact, does everyone in the practice even know what IFU stands for and why it’s important? 

IFUs are provided for medical devices and products in accordance with federal Food and Drug Administration (FDA) standards. In October 1982, the FDA merged the Bureau of Medical Devices and the Bureau of Radiological Health to establish the Center for Devices and Radiological Health (CDRH). The Center develops and implements national programs to protect the public’s health in the fields of medical devices and radiological health. These programs are intended to assure the safety, effectiveness and proper labeling of medical devices; control unnecessary human exposure to potentially hazardous ionizing and nonionizing radiation; and ensure the safe, efficacious use of such radiation.¹

In an ever-increasing society of litigation, dental healthcare personnel must be aware of, educated and accountable for the proper use and maintenance of medical/dental devices utilized in the dental practice. In large group practices and DSOs, where there are greater numbers of staff, calibration and team members to be trained, it is vital that the IFU are a key component of patient care and staff safety. Everything from sterilizers to hand-held x-ray equipment, chemical indicators and more contain IFU, which must be explicitly followed for peak performance of the device.

Part of the FDA’s mission is to protect the public’s health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics and products that emit radiation.² In the daily routine of dental practice, most dental team members are primarily focused on CDC and OSHA compliance and may not realize how great an impact the FDA makes.

On March 17, 2015, the FDA released “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff.” The document not only superseded the April 1996 guidance titled, “Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance”, but included an appendix (E) that was updated June 9, 2017.³ Let’s take a brief review of the highpoints of this document as it relates to reprocessing reusable devices in the dental practice.

For starters, the 2015 FDA guidance focuses on the importance of stated methods for reprocessing reusable/reprocessable devices, sterilization parameters and labeling requirements for manufacturers submitting devices for 510(k) clearance. A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device; substantial equivalence means that the new device is at least as safe and effective as the predicate. The guidance document applies not only to new devices, and exemption from 510(k) does not mean a device is exempt from compliance with labeling or quality system requirements.⁴ The updated 2015 guidance states that for reusable medical devices, validated reprocessing instructions are expected from the manufacturer.³

Section 6 of the 2015 guidance document lists six criteria manufacturers should include in their IFU to ensure users – in this case, dental team members or dental healthcare personnel – understand, implement and facilitate the IFU correctly:

• Criterion 1: Labeling should reflect the intended use of the device. This includes how and where the device is used. For instance, is it only used on skin? Mucosal surfaces? Sterile tissues of the oral cavity? The label should state the reprocessing method that reflects the physical design of the device, its intended use and the soiling and contamination to which the device will be subject during clinical use.³ This provides the DHCP with the information needed to use the device as intended; it is not acceptable to make a subjective decision on device usage once the manufacturer and FDA have made this determination.
• Criterion 2: Reprocessing instructions for reusable devices should advise users to thoroughly clean the device. Cleaning is the most important step in the instrument processing cycle.⁵ The criterion here states that instructions to the user should clearly communicate how to achieve thorough cleaning and that details of the cleaning procedure will vary depending on the complexity of the device.³ From the user perspective, the CDC recommends that dental team members assigned to sterile processing areas be trained and understand the importance of cleaning instruments prior to disinfection or sterilization.⁶

CDC Key recommendations for sterilization and disinfection of patient-centered devices for dental setting.⁶

• Criterion 3: Reprocessing instructions should indicate the appropriate microbicidal process for the device. In this section, the guidance states that the method for reprocessing should be consistent with current infection control protocols and that whichever reprocessing method(s) is recommended, the compatibility of the device with the method(s) and the ability of the method(s) to successfully reprocess the device features should be validated and then stated in the instructions for use.³ Dental team members must read and understand the IFU for sterilizer cycle times and temperatures.
• Criterion 4: Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed. This criterion, which was intended as a recommendation for manufacturers to provide the dental team with streamlined, understandable IFU, can actually be quite confusing. It’s intended to ensure that the method for reprocessing the device includes the equipment and accessories needed to implement the instructions, which should be clearly defined. In short, manufacturers should not come up with unreasonable methods or obscure devices needed for the reprocessing of their device. “The FDA recommends that the instructions specify sterilization methods and parameters that are technically feasible for the user. That is, sterilization cycle parameters specified in the labeling for reprocessing a device should be consistent with validated sterilization cycle parameters for commonly available, legally marketed sterilizers.”³ This is demonstrated in the sterilizer manufacturer market, where manufacturers are required to meet AAMI standard cycles to ensure IFU for sterile packaging systems don’t conflict with IFU for sterilization indicators used to monitor their cycles.⁷

Association for the Advancement of Medical Instrumentation.⁸

• Criterion 5: Reprocessing instructions should be comprehensive. This lengthy criterion outlines each segment of the reprocessing steps in detail. It states that the instructions should describe any accessories that are needed for safe reprocessing, and notes whether personnel need any special protection for personnel during reprocessing.³ When the dental practice obtains new equipment or devices, it is critically important to review the IFU and follow the detailed steps for reprocessing without shortcuts. Since the IFU have been validated, compliance will provide the intended and expected results.
• Criterion 6: Reprocessing instructions should be understandable. Simply stated, the IFU should “be clear, legible (i.e., reasonable font size) and provided in sequential order from the initial processing step through the terminal processing step.”³ The criterion also states that IFU should be written in “simple” language and that charts, diagrams and pictures can be helpful to end users working to comply with them. If the practice obtains new a sterilizer with an accompanying cycle chart, it is a great idea to post this information in the sterilization area for dental healthcare personnel to refer to. This way, all team members have access and there is no question or confusion about how to use the sterilizer.

Older, legally-marketed reusable devices with IFU prior to the 2015 guidance may not be consistent with state-of-the-art science, according to sources such as the FDA and Andrew Steen, CDRC Senior Lead Reviewer, Dental Devices Branch. Labeling alone is not sufficient to ensure these devices are clean, disinfected or sterile, and the purity or quality of the device may fall below that which it purports or is represented to possess.⁹ In addition, the device may be misbranded such that labeling does not bear adequate IFU and the device is dangerous to health.⁹

The CDC and FDA agree that devices absent of IFU should be considered single-use – used on a single patient and then disposed of appropriately. This includes dental burs and endodontic files.^6,9 For current practice, these devices should be considered single-use, notes Steen. In the future, if the manufacturer has IFU that meet the 2015 guidance, it should be followed. If there are no IFU, or if they are incomplete, clinicians should continue to consider them single-use.⁹

Given the constant stream of new and emerging technology today, and the numerous medical/dental devices currently used in dental practices, IFU should continue to play an important role. The FDA 2015 guidance has set strong recommendations, including clear expectations, for manufacturers. Dental healthcare professionals must be aware of the devices in their practice, and understand and carry out the appropriate IFU. All dental team members – especially those assigned to instrument reprocessing – must take their role in this process very seriously.

Editor’s Note: Katherine Schrubbe, RDH, BS, M.Ed, PhD, is an independent consultant and invited speaker for continuing education and training programs on OSHA and dental infection control for local and national dental organizations, schools of dentistry and private dental groups. She has held positions in corporate as well as academic dentistry and continues to contribute to the scientific literature.

References:

1. US Department of Health and Human Services. Public Health Service Food and Drug Administration. Labeling – regulatory requirements for medical devices. HHS Publication FDA 89-4203. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm095308.pdf. Accessed September 27, 2017.
2. US Department of Health and Human Services. Public Health Service Food and Drug Administration.  FDA Mission Statement. https://www.fda.gov/downloads/aboutfda/reportsmanualsforms/reports/budgetreports/ucm298331.pdf. Accessed September 27, 2017.
3. US Department of Health and Human Services. Public Health Service Food and Drug Administration.  Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff. March 17, 2015. https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm253010.pdf.  Accessed September 27, 2017.
4. US Department of Health and Human Services. Public Health Service Food and Drug Administration.  https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm#when. Accessed September 27, 2017.
5. Molinari JA, Harte JA. Cottone’s Practical Infection Control in Dentistry. 3^rd ed. Philadelphia: Lippincott Williams and Wilkins; 2010; 223.
6. Centers for Disease Control and Prevention. Summary of Infection Prevention Practices in Dental Settings: Basic Expectations for Safe Care. Atlanta, GA: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Division of Oral Health, March 2016.
7. Hughes C. Manufacturer’s IFU. What are they and why they are so important? OSAP Annual Symposium; Baltimore, 2015.
8. Association for the Advancement of Medical Instrumentation. AAMI. http://www.aami.org/productspublications/ProductDetail.aspx?ItemNumber=1077.September 27, 2017.
9. Steen AI. FDA Regulations and infection control in the dental setting.  OSAP Annual Conference; Atlanta, 2017.