In the medical equipment manufacturing and healthcare provider industries, sanitation is an ever-present concern. Any contaminants, such as dirt, bacteria, or residues that are allowed to remain on medical parts following their manufacture (or, in the case for reusable medical equipment, use) can pose an incredible health risk to healthcare service recipients.
So, both healthcare providers and medical equipment manufacturers need stringent sanitation controls for medical equipment. The question is: “How can healthcare providers and manufacturers create an optimal medical parts cleaning process? One that will minimize costs while maximizing cleanliness and sterility?”
Here are a few steps to follow for optimizing your own medical equipment cleaning process:
Step #1: Consider the Materials Your Medical Equipment is Made from
One of the easiest mistakes to make when establishing a medical equipment cleaning process is to assume that there’s a “one size fits all” approach to cleaning and sterilization. While most medical parts and equipment are made from stainless steel, there are many different types of stainless steel—and each has different properties for chemical and temperature resistance.
A cleaning process or chemical that leaves one formulation of stainless steel clean and ready for use might cause pitting corrosion in another type of steel. So, when creating a sanitation process for your medical equipment, it’s vital to consider the specific type of stainless steel (or other metal) that the equipment uses.
It may even help to specify that your medical equipment is all made from the same type of stainless steel alloy to simplify your medical parts cleaning processes in the future. Of course, not all medical equipment can be made entirely of metal, so it’s often necessary to prepare specific processes for cleaning and sterilizing different kinds of polymers as well.
Step #2: Define Which Contaminants/Soils You Need to Clean
Different pieces of medical equipment will come into contact with different soils and contaminants, so they may need different cleaning agents and sterilization processes to fully eliminate them. For example, a scalpel may frequently come into contact with blood when making incisions, so chemicals that can destroy blood, such as hydrogen peroxide, may be helpful for cleaning—though that alone may not be enough to remove other soils and sterilize the scalpel.
On the other hand, invasive tools such as endoscopes for gastrointestinal examinations may come into contact with many bodily fluids and waste products, such as feces, stomach acid, or blood. As noted by the Center for Disease Control (CDC) in their infection control guidelines document, “Flexible endoscopes are particularly difficult to disinfect and easy to damage… Failure to perform good cleaning can result in sterilization or disinfection failure, and outbreaks of infection can occur.”
Knowing the kinds of soils you need to remove from a medical device or tool can be crucial for optimizing your cleaning and sterilization processes.
Step #3: Ensure Your Cleaning Process Accounts for Complicated Shapes
Does your medical equipment have complicated internal shapes where contaminants may hide? Ensuring that your cleaning process can get into these hard-to-reach spots (and that runoff from the cleaning process can drain away) is crucial for effective medical equipment cleaning.
A basic cleaning process for complicated equipment such as an endoscope is outlined by the CDC in their infection control guidelines*:
- Clean: mechanically clean internal and external surface, including brushing internal channels and flushing each internal channel with water and a detergent or enzymatic cleaners (leak testing is recommended for endoscopes before immersion).
- Disinfect: immerse endoscope in high-level disinfectant (or chemical sterilant) and perfuse (eliminates air pockets and ensures contact of the germicide with the internal channels) disinfectant into all accessible channels, such as the suction/biopsy channel and air/water channel, and expose for a time recommended for specific products.
- Rinse: rinse the endoscope and all channels with sterile water, filtered water (commonly used with AERs), or tap water (i.e., high-quality potable water that meets federal clean water standards at the point of use).
- Dry: rinse the insertion tube and inner channels with alcohol, and dry with forced air after disinfection and before storage.
- Store: store the endoscope in a way that prevents recontamination and promotes drying (e.g., hung vertically).
*This bullet list is recreated verbatim from the CDC’s page on disinfection healthcare equipment, accessed 07/31/19.
This multi-step process is necessary to ensure that medical equipment cleaning is consistently thorough and effective.
Step 4: Choose Between Temperature or Chemical-Based Medical Parts Sterilization
Another consideration when creating your medical parts cleaning process is how your sterilization process will work. The two primary choices are chemical-based and temperature-based sterilization.
Both of these processes can neutralize microscopic contaminants such as bacteria or viruses. However, each process also has limitations.
For example, not all medical parts can withstand a temperature-based sterilization process. In particular, plastics tend to have a fairly low melting point—rarely being able to withstand temperatures in excess of 350˚F for long without melting. To ensure complete sterilization, high temperatures and long process times are a necessity.
On the other hand, chemical-based sterilization alone may not kill 100% of all microbial agents, especially if the chemicals used are not applied evenly to the entire surface of the parts being sterilized. Also, some chemical cleaners may damage certain medical equipment materials.
Many medical parts cleaning processes employ a mixture of both high temperatures (at least as high as the parts can take) and sterilizing agents to ensure the highest possible level of sterility. Extending the duration of the sterilization process can also improve its efficacy—though that does come with the risk of wasting time and resources.
Step 5: Set Your Validation Process for Medical Parts Cleaning
After you’re done cleaning and sterilizing your medical equipment, how will you verify that it meets the required level of sanitation? Here, the manufacturer of your cleaning solution should be able to help. Most, if not all, manufacturers specializing in making chemical cleaners for medical industry sanitation should be able to provide a validation process specific to their cleaning agents.
With a set process for validating that your parts are clean and sterile, you can minimize the risk of infection from your medical equipment.
Need help with creating a custom solution for washing and sterilizing your medical parts and equipment? Reach out to the team at Marlin Steel to learn more.