by Susan Klacik BS, CRCST, ACE, CHL, CIS, FCS

Every medical device has its own instructions for use (IFU). In fact, before a medical device can be sold, the Food and Drug Administration (FDA) requires validation testing to demonstrate that the device can be effectively cleaned and disinfected or sterilized in healthcare facilities by following the IFUs. These IFUs, along with sterilization standards, provide critical information about reprocessing medical devices to render them safe for patient care. With medical devices increasing in complexity in both design and materials, it is vital to process them exactly as prescribed in the manufacturers’ IFU.

Following the instructions for use is so important that The Joint Commission is asking facilities undergoing their survey if they have them readily available for all of their medical devices and may ask to review their process to assure they are following the IFU. Additionally, there have been alerts issued by Government agencies in response to infection control lapses, telling healthcare facilities to review their current reprocessing practices to be sure they are in compliance with IFUs as well as having policies and procedures that are in line with current standards and guidelines.
Without proper cleaning, an instrument cannot be sterilized or disinfected. Cleaning procedures vary depending on the complexity of the device, so IFUs always provide instructions on how to achieve thorough cleaning. Some instruments have areas that are difficult to clean and may need to be disassembled. In these cases, the IFUs typically include diagrams for adequate disassembly and reassembly. Cleaning chemistries are also included since not only can the materials be harmed if the wrong type of cleaning solution is used, but many are only effectively cleaned when using the correct ratio of cleaning chemistry to water.
Medical devices with channels, such as flexible endoscopes, robotic arms and laparoscopic instruments, require channel flushing to clean. Proper channel flushing is important to remove retained soil from inside these devices. IFUs provide flushing instructions along with information about the specific accessories to be used—including the exact size connectors for the flush ports, proper brush sizes, and the type and volume of flushing agent to be used.
Accessories for reprocessing, such as valves, plugs or cleaning implements, are described in detail in most IFUs. Another important part of cleaning is the full removal of chemical residues used during reprocessing, so rinsing steps should be included after cleaning. Biofilm residue left on medical devices has been known to cause instrument pitting, which can lead to poor patient outcomes in addition to preventing sterilization or disinfection. Lastly, the IFUs also include what to look for during the inspection step.
The IFU describes the specific sterilization method to use for each device. For steam sterilization, the IFU specifies the type of sterilization cycle to use. Some medical devices can only be sterilized using a gravity cycle, while others can be sterilized using a dynamic air removal cycle. There are some IFUs that specify an extended steam sterilization cycle and provide the necessary time.
For heat or moisture sensitive items, a low-temperature sterilization method may be required. For these devices, the type of validated low-temperature sterilization methods will also be listed.
Additional Types of IFUs
It is important to note that medical device IFUs are not the only product-level instructions that healthcare workers need to follow. In addition to following device IFUs, it is also important to follow the IFUs for packaging, processing equipment, chemicals and quality monitors. These may have specific requirements for sterilization and their IFUs may outline other special parameters.
Building a system that keeps IFUs readily available to all staff and ensures each device is reprocessed as documented is a hallmark of an effectively managed CS department.

Susan Klacik, BS, CRCST, CIS, ACE, FCS, is president, Klacik Consulting, in Canfield, Ohio, and at St Elizabeth Health Center and the IAHCSMM (International Association of Healthcare Central Service Materiel Management) representative to AAMI (Association for the Advancement of Medical Instrumentation).

Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013.
FDA safety communication: Infections associated with reprocessed flexible bronchoscopes, September 17, 2015.

Immediate need for healthcare facilities to review procedures for cleaning, disinfecting, and sterilizing reusable medical devices. Distributed via the CDC Health Alert Network, September 11, 2015, CDCHAN-00382.

Reprocessing medical devices in health care settings: validation methods and labeling guidance for industry and Food and Drug Administration staff. Document issued March 17, 2015.
Top five most challenging requirements for first half of 2015; Joint Commission Online, August 26, 2015.