Compliance News: TJC Infection Control Standards for Medical Equipment, Devices and Supplies

By Dean Samet, CHS

For 2010, The Joint Commission (TJC) has made several changes to its infection control standard IC.02.02 .01 including a new “rationale” and revisions to elements of performance EP1 and EP2 which clarify requirements to reduce the risks associated with medical equipment, devices and supplies.

According to an October 2009 The Joint Commission Perspectives article, several significant issues have emerged related to the cleaning, disinfecting and sterilizing of medical equipment, devices, and supplies.  TJC cites an example of the proper use of steam sterilizers as discussed in the July 2009 Perspectives.  Medical technology and instrumentation is a rapid and ever-changing field where new devices and new or resistant pathogens are emerging at an unprecedented rate.

2010 rationale for IC.02.02.01 states, “The Centers for Disease Control and Prevention (CDC) estimates that 46.5 million surgical procedures are performed in hospitals and ambulatory settings each year.  Each of these procedures involves contact with a medical device or surgical instrument. A major risk of all such procedures is the introduction of pathogens that can lead to infection.  Additionally, many more  people are at risk of developing an infection from contact with medical equipment, devices, or supplies while seeking other health services.  Failure to properly clean, disinfect, or sterilize, and use or store medical equipment, devices and supplies not only poses risk for the person seeking health services, but also carries the risk for the person-to-person transmission of infections.

“There are numerous steps involved in the cleaning, disinfecting, and sterilizing of medical equipment, devices, and supplies. It is critical that health care workers follow standardized practices to minimize infection risks related to medical equipment, devices, and supplies. In order to maintain a reliable system for controlling this process, organizations pay attention to the following:

•   Orientation, training, and competency of health care workers who are processing medical equipment, devices, and supplies

•   Levels of staffing and supervision of health care workers who are processing medical equipment, devices, and supplies

•   Standardization of process regardless of whether centralized or decentralized

•   Reinforcing the process (for example, the use of placards which lists the steps to be followed,  according to manufacturers’ guidelines)

•   Ongoing quality monitoring”

2010 Elements of Performance 1 & 2 for IC.02.02.01: The hospital implements infection prevention and control activities when doing the following:

1. Cleaning and performing low-level disinfection of medical supplies and devices.*

 

Note: Low-level disinfection is used for items such as stethoscopes and blood glucose meters.   Additional cleaning and disinfecting is required for medical equipment, devices, and supplies used by  patients who are isolated as part of implementing transmission-based precautions.

2. Performing intermediate and high-level disinfection and sterilization of medical equipment, devices, and supplies.* (See also EC.02.04.03, EP 4: The hospital conduct performance testing of and maintains all sterilizers. These activities are documented.)

Note: High-level disinfection is used for items such as respiratory equipment and specula. Sterilization is used for items such as implants and surgical instruments. High-level disinfection may also be used if sterilization is not possible, as in the case with flexible endoscopes.

*  For further information regarding cleaning and performing low-level, intermediate, and high-level disinfection of medical equipment,  devices, and supplies, refer to the web site of the CDC at  http://www.cdc.gov/ncidod/dhqp/sterile.html Sterilization and Disinfection in Healthcare Settings).

As shown above, EP 1 refers to the lower-risk process of cleaning and disinfection while EP 2 refers to sterilization and the higher-risk processes. EP 2 now specifically shows that intermediate and high-level disinfection are included with sterilization!