IP Introducing Technology into Healthcare

several factors. Let’s dive into what an IP’s role can be when assessing new technologies and how to ensure a successful implementation.

APPROVAL

Identifying if an item is approved/cleared by the Food and Drug Administration is one of the first steps in assessing products. While this is done for a variety of reasons, the IP is looking to ensure that the proper documentation will be provided with the device. In addition, the IP will be looking to determine whether the methodology for cleaning/disinfection is approved by the Environmental Protection Agency.

INSTRUCTIONS FOR USE

One of the most critical pieces of information that an IP requires are the Instructions for Use (IFUs). Not only do we need to ensure that we are using the device properly, but we also need to ensure it is being cleaned appropriately. It is a regulatory requirement that organizations accredited by The Joint Commission are expected to follow IFUs. But if an IFU is not sufficient in its cleaning instructions, the product may not make it past the initial review. All patient care equipment must be cleaned (the removal of visible soil) and then disinfected (the elimination of many or all pathogenic microorganisms) in accordance with the Spaulding Classification. 

How an item is cleaned and disinfected is dependent on how it is being used. An item can be a non-critical item (only used on intact skin), a semi-critical item (contact with non-intact skin or mucous membranes), or a critical item (enters soft tissue or vascular systems). Regardless of the Spaulding Classification, all items must be cleaned and disinfected before being used on another patient. IFUs that give instructions like ‘wipe with a moist, lint-free cloth' or 'clean with soap and water' are not sufficient disinfecting methods in healthcare settings. Additionally, when manufacturers are testing chemicals for effectiveness in disinfecting, IFUs would ideally list the chemicals approved, not specific, name brand products.

PROTECTIVE COVERINGS

Some technologies that are ubiquitous in healthcare cannot be cleaned or disinfected by their nature. Smartphones, tablets, interpreting devices, and other seemingly harmless items can carry hundreds of different pathogens and put our patients and staff members at risk of healthcare acquired infections if they are unable to be cleaned appropriately. As these continue to be integrated into our healthcare settings, future work with these manufacturers is needed to create healthcare friendly smart devices. In the meantime, IPs and other healthcare workers should consider protective cases that fully encase the device and can withstand the chemicals used for disinfection.

HUMAN FACTORS:

As healthcare evolves, learning from other industries has introduced the idea of human factors into the equation. How a device is used, in accordance with following the manufacturer’s IFUs, is critical from an ergonomic perspective, an occupational health perspective, and a patient safety perspective. Identifying how a healthcare worker moves about in a patient room with new technologies can lead to conversations around when to perform hand hygiene while using the equipment, keeping both healthcare worker and patient infection free.

Closer partnerships between IPs and manufacturers will lead to the addition of even more advanced and ambitious devices that will benefit our patients. Infection Prevention and Control are critical members in any assessment of new technologies being introduced to healthcare settings. By ensuring Infection Prevention and Control is at the table at the time of introduction, healthcare settings can avoid delays and possible cancellations of implementations of devices over questions that could have been answered previously. Integration of Infection Prevention and Control experts into the development of manufacturers' IFUs will be extremely important as we work together to keep our patients safe from harm.