Medical Device Cleaning and Disinfection FAQs from The Joint Commission

The Joint Commission adds three new FAQs related to cleaning and disinfecting medical equipment in its Interpretation Standards

Situation

The Joint Commission recently added three new FAQs to its Standards Interpretation webpage. The three new FAQs relate to cleaning and disinfecting medical equipment and should be very helpful to healthcare facilities that need to regularly clean and disinfect medical devices and equipment to ensure patient safety.

Background Information on The Joint Commission

Joint Commission standard IC.02.02.01 requires that the hospital reduces risk of infection associated with medical equipment, devices, and supplies. It is expected that a facility will follow instructions for use (IFUs) for cleaning and disinfection standards provided by medical device and equipment manufacturers.

However, in many situations, manufacturers’ IFUs for cleaning and disinfection are unclear, insufficient to enable correct cleaning and disinfection necessary to reduce the risk from infection, or do not permit/include the use of cleaning and disinfecting products that a particular facility currently uses.

The Joint Commission FAQs provide clarification regarding the responsibilities of manufacturers and facility leadership, as it relates to provision and availability of IFUs for cleaning and disinfecting medical devices and equipment. They also provide guidance on what actions to take when currently used cleaning and disinfecting products may not be compatible with manufacturers’ device and equipment cleaning and care IFUs.   

What Each of the FAQs Say

FAQ #1: Manufacturers Instructions for Use — Expectations Regarding Access To IFUs for Medical Instruments and Devices

This FAQ confirms the FDA requirement that manufacturers of medical devices and equipment provide instructions on how to clean, disinfect and if necessary, sterilize their products. The IFUs should include the steps required, the level of disinfection (low/intermediate-, high-level or sterilization), frequency and which products are compatible.

• The FAQ also confirms that cleaning, disinfection and sterilization products should contain IFUs, which must be followed. For low-level disinfection IFUs, these will primarily apply to correct dilution, contact time and, if applicable, application method.

FAQ #2: Manufacturers Instructions for Use — Responsibility for Ensuring Availability

This FAQ clarifies that facility leadership is responsible for ensuring that IFUs for medical devices and equipment are available for use by staff, and that compliance with IFUs is an integral part of facility policies, protocols, staff education, and training and competency assessments. It also describes actions that leadership can take to support this, which include:

• Using IFUs provided by equipment and device manufacturers and ensuring that staff are trained on how and where to access electronic copies, for example, subscribing to web-based resources that maintain IFUs
• Training staff on how to read and implement IFUs, incorporating them into policies, protocols and/or standard operating procedures
• Alerting staff when the disinfectant used in the hospital cannot be used to clean equipment or devices

FAQ #3: Manufacturers Instructions for Use — Addressing Conflicts Amongst IFUs for Different Equipment and Products

This FAQ describes what organizations should do when they “identify a conflict amongst the IFUs for different equipment and products.” Although the term “conflict” is not described, interpretations include a situation where a disinfectant the facility wants to use is not compatible with the medical device or equipment IFU, or a specific disinfectant product is not listed. The FAQ provides actions to take, and illustrates these actions in descriptions of two scenarios:

• Contacting the device/equipment manufacturer’s technical services
• Contact the manufacturer of the “alternative” product to see if they can provide additional information on compatibility – including biological, chemical and functional compatibility (Note: Clorox interprets the “alternative” product as the disinfectant the facility is using)
• Identifying the risks, strategies to mitigate risks and implanting those strategies in situations where clear compatibility information cannot be obtained
• Considering the implications of their decision on liability, warranty and long-term life of the medical device or equipment

Recommendations for Cleaning & Disinfection 

The FAQ clarifies the position of The Joint Commission with regards to cleaning and disinfection of medical devices and equipment.  Inclusion of this FAQ in the Standards Interpretation section suggests that the development and implementation of cleaning and disinfecting standards and procedures for medical devices and equipment will be a focus of The Joint Commission in the future.

This clarification of responsibilities and guidance on how to balance the benefits of cleaning and disinfection against the risk of potential damage to equipment acknowledges the fact that this has been a challenging part of infection prevention protocols for many years.

To avoid a survey finding, Clorox Healthcare suggests several steps in line with The Joint Commission’s FAQs on cleaning and disinfection of medical devices and equipment:

• Facility leadership should carefully read these FAQs and consider how to implement the recommendations in their facilities. 
• If a medical device or equipment IFU states that a Clorox Healthcare product used in the facility is not approved, we encourage facilities to first contact device and equipment manufacturer technical services department to ask for more information about compatibility.
• Consult the Clorox Healthcare Surface Compatibility hub for high-level guidance on compatibility of disinfectants with common healthcare materials and resources to help determine how best to clean and disinfect medical devices and equipment.
• Form collaborative teams to assess the benefits of cleaning and disinfection against the risks of potential equipment damage. Develop protocols that include steps to mitigate the risk of damage, such as wiping down surfaces with a clean, damp cloth after the disinfectant contact time has been reached.  
• Consider alerting Biomedical Engineering that more frequent preventative maintenance on certain equipment may be needed.

^{Note: The FAQ are included in manuals for the different types of healthcare settings; the first two FAQs are included in the “Infection Prevention & Control” chapter while all three appear in the “Leadership” chapter.}