Blog
News / March 1, 2021
In Part I of this blog (Elmed blog number 41) we discussed the FDA’s mandate that all reusable medical device manufacturers provide instructions for successfully reprocessing their devices (IFUs). “FDA interprets these regulations to require manufacturers to validate the design, including reprocessing instructions, of reusable devices to ensure that the device can be effectively reprocessed and safely reused over its use life, as intended.”1
As part of the requirement for manufacturers to validate their cleaning IFUs, the FDA has established six general criteria for all reprocessing instructions. In Part I of this blog we covered the first two criteria. In Part II we covered the first part of criteria number three (critical and semi-critical devices). This blog will cover the second part of the FDA’s criteria number three, non-critical items.
Non-critical devices are instruments and other devices whose surfaces contact only intact skin and do not penetrate it. Non-critical devices also include devices that do not directly contact the patient but may become contaminated with microorganisms and organic soil during patient care (e.g., blood, body fluids). It is important to remember that such devices may not be visibly contaminated (e.g., biofilm). FDA recommends thorough cleaning, then intermediate or low level disinfection for non-critical devices depending on the nature and extent of contamination.
Examples of devices that contact only intact skin or non-sterile mucosal surfaces include blood pressure cuffs, stethoscopes, nasal endoscopes (without a biopsy or culture port) and skin electrodes. Examples of devices that have no direct patient contact, yet may become contaminated during patient care, include infusion pumps and ventilators.
Patient care equipment should be cleaned according to the equipment manufacturer’s guidelines. In the absence of specific guidelines, CDC guidelines can be followed. CDC guidelines state that if the manufacturer’s cleaning instructions are not available, non-critical items should be cleaned with a commercially available detergent/disinfectant. 2
Visible soil should be removed from patient care equipment as soon as possible to prevent cross contamination. The healthcare worker using the equipment is responsible for ensuring that the cleaning takes place before the equipment is used on another patient.
Non-critical items soiled with blood or other potentially infectious body materials must be thoroughly cleaned to remove blood and then disinfected using the disinfectant manufacturer’s instructions for minimum contact time to achieve viricidal (Hepatitis B and HIV) kill. 3, 4, 5 Alcohol wipes are acceptable for cleaning non-critical items that are not visibly soiled.
Items contaminated with blood or body fluids, which may contain blood-borne pathogens, should be cleaned and then receive intermediate level disinfection with a product having an EPA-registered claim for activity against hepatitis B.4 Blood glucose meters used in healthcare settings are an example of a blood-contaminated device which has been a source of hepatitis B transmission during patient-to-patient use when not properly cleaned and disinfected after use with each patient.
Horizontal and patient contact surfaces are more likely to be contaminated with microorganisms that are more difficult to disinfect and clean. Mechanical action to remove microorganisms is an important step in the cleaning process. The CDC recommends the use of a back and forth or circular motion with moderate pressure covering all surfaces to be cleaned to ensure removal of microorganisms.6
It is important to remember that some disinfectants are fairly effective cleaning agents while others are not. Always consider the worst-case microbes to which the device/equipment may be exposed during clinical use and the likelihood of significant organic soiling of the device during use.
When selecting a disinfectant you need to consider its potential impact or damage to your device/equipment. If a disinfectant or class of disinfectants can damage the materials in your device/equipment, the label should include a warning not to use that disinfectant or class of disinfectants to reprocess your device/equipment. Use of a disinfectant that is contraindicated on the manufacturer’s labeling may harm or permanently damage the device/equipment and potentially invalidate its warranty.
Be aware that in some clinical situations (e.g., patients with Norovirus or Clostridium difficile infections, drug-resistant organisms, etc.), isolation precautions recommended for use by the CDC may include the use of specific disinfectants and should be followed. You should instruct your staff to follow the specific EPA label disinfectant contact times when using the disinfectant as well as the instructions specified in the medical device labeling.7
