Instrument Processing

Dry Heat Sterilization Services

Sterilization with mechanical, chemical, and biological verification are available to foot care nurses located on Cape Cod. Those who are interested are welcome to contact me with any questions. The cleaning process includes manual cleaning, ultrasonic cleaning, and dry heat sterilization at 170 degrees Celsius for 2 hours. Tools are placed in a dry heat self-seal sterilizer bag with chemical verification (a sticker that changes color to indicate sterilization). Biological indicator reports are available from weekly testing. Lubrication of movable parts (nipper hinges) is recommended prior to use.

In the United States, you are not required to sterilize your tools, but consider various recommendations to do so, including the CDC.

Three factors influenced my decision to sterilize:

  1. I want to be environmentally/animal friendly.

  2. No one can guarantee there is no risk of cutting live tissue.

  3. Personal preferences.

See below if you are interested in setting up for dry heat sterilization.

High-Level Disinfection versus Sterilization

High-level disinfection and sterilization both eliminate all microorganisms. The difference is that sterilization also eliminates bacterial spores, which aren't eliminated by high-level disinfection. Read more about the differences from the CDC.

What harmful bacteria make spores?

Bacillus anthracis - Anthrax

Clostridium botulinum - Wound botulism

Clostridium tetani - Tetanus

Clostridium perfringens - Gas gangrene

Clostridium difficile - C. diff

Infection Control: Creating Your Policies and Procedures

CDC: Guide to Infection Prevention for Outpatient Podiatry Settings    

CDC: Indications for Sterilization, High-Level Disinfection, and Low-Level Disinfection

APMA: Disinfection and Sterilization Guideline Recommendations for Podiatric Physicians 

Research recommendations in your area. For example: Boston Public Health Commission states that nail salons "must install and use either an autoclave or a US FDA registered dry heat sterilizer to sterilize multi-use tools". Although the Boston Public Health Commission writes about "nail salons", the focus should be about sterilizing multi-use tools.

According to the CDC:

  Sterilization should be used on critical items (e.g. tools that penetrate tissue that has a blood supply).

  High-level disinfectants can be used on semi-critical items (e.g. tools that come into contact with non-intact skin).

  Low-level disinfectants can be used on non-critical patient-care surfaces (e.g. foot stools) and equipment (e.g. tuning fork). 

Following CDC recommendations, the American Podiatric Medical Association (APMA) guidelines (last updated March 2019) recommend:

  High-level disinfectants (at a minimum) should be used on tools for manual debridement (e.g. nippers and curettes).

  High-level disinfectants (at a minimum) should be used on tools for mechanical debridement (e.g. burrs).

  With mechanical debridement you must use dust extraction equipment.

 

The APMA further recommends that heat stable instruments that have the "potential to break intact skin during ordinary use" (e.g. nippers, burrs, and curettes) should not rely on liquid chemicals for sterilization. Regardless of the terminal reprocessing method, APMA states that all tools must be thoroughly cleaned, as inorganic and organic materials that remain on the surface of instruments will decrease the effectiveness of disinfection/sterilization.

Canada has more clearly stated and stricter standards than the US for processing foot care instruments. See the Reprocessing Decision Chart from Ontario Agency for Health Protection and Promotion for all options for cleaning, disinfecting, and sterilizing (full document here). In Canada, foot care equipment is considered critical and requires sterilization.

What does this mean for practice? APMA refers to cleaning methods for manual (e.g. friction (rubbing/scrubbing with a brush) and fluidics (fluids under pressure)), as well as mechanical (e.g. ultrasonic cleaners or washer-disinfectors). The minimum required cleaning method would be using water and detergent with a brush and rinsing well and drying thoroughly before disinfection/sterilization. This may mean that you need multiple sets of tools so clients aren't exposed to improperly disinfected or sterilized tools. 

Not convinced? Read about these unfortunate cases in the US.

Multiple Sets of Tools

A quick guide to CDC’s Guide to Infection Prevention for Outpatient Podiatry Settings states:

"Bring, or have available at the off-site location, an adequate supply of clean and disinfected or sterilized patient-care instruments so that items do not have to be reprocessed on-site to maintain clinical workflow."

See "Reprocessing of Medical Devices with Off-Site Podiatry Care", page 31, of the full guide for more details.

Nippers and reusable burrs need to be cleaned prior to disinfection/sterilization. This means you need multiple sets of tools. Good nippers can cost over $100, but what is a good nipper? The features of a nipper includes the type of stainless steel, the handles, the cutting edges, and springs and hinges. Some of the least expensive nippers (and poorest quality) are available on Alibaba.com (this one is actually $8.50). These can be considered "student grade" nippers after proper refining. It will help you afford the same number of nippers as you see clients in one day and allow for proper reprocessing of your nippers.

 

Type of Stainless Steel. Inexpensive nippers are typically made from 201 stainless steel, which is the least expensive type and not used for surgical tools (but nippers are not surgical tools and it is allowed in the US). 201 stainless steel is said to rust if exposed to the elements (water and salt), so care must be taken to protect it by reducing its contact time with water and salt (clean on the same day of use and dry after getting wet). 

 

Handles. The handles may be loose. You can tighten the screw(s), add lock tight if it doesn't stay tightened, or treat it like a rivet. Clipper Shack explains with a video for how to fix the handles.

Cutting edges. Inexpensive nippers have gone through the first process of manufacturing. They have not been refined through proper sharpening. Find a blade sharpening business in your area to see if they sharpen nippers. Excellent quality nippers are made with surgical grade, softer stainless steel. They dull sooner and need occasional sharpening. Nipper sharpening services are likely in an area where there are podiatrists. If you would like to sharpen your own nippers and offer services in your area, consider a Nipper Sharpening System. Uneven edges can be corrected with sharpening as seen in a Clipper Shack video. Or, you can hand sharpen nippers as shown in this video.

Springs and Hinges. These are moving parts that need to be lubricated regularly.

Multiple Sets of Burrs. Start out with disposable sanding caps/bands/disks until you can afford high quality burrs with a high quality drill. Using high speed rotary burrs causes vibration and friction (heat), which can cause discomfort and pain for clients. Vibration can be reduced with use of balanced, reusable burrs and low vibration drills. Sanding caps/bands may have varying thicknesses, which can add to vibration. Friction can be reduced by keeping burrs at the recommended speed (usually 10,000 rotations per minute) and touching down lightly and moving to new areas frequently.

Your hands will also benefit from low vibration debridement (protect your nerves) and well lubricated nippers on pre-debrided nails (protect your joints).

Liquid Chemical Disinfection

Please be environmentally responsible. If you use liquid chemical disinfection, please follow the Safety Data Sheet (SDS) for appropriate use (section 1), first aid measures (section 4), and disposal (section 13). MetriCide 28 is a high-level disinfectant and requires following Federal, State, and local regulations for disposal. EnviroCide is an intermediate-level surface disinfectant and is used as a "hard surface cleaner and disinfectant". CaviCide is also an intermediate-level surface disinfectant and the manufacturer's instructions state it is not to be used as a "terminal sterilant/high level disinfectant". EnviroCide and CaviCide also require verification with Federal, State, and local authorities for disposal. Consider your choices for sterilization/high-level disinfection, the environment, and efficacy.

Please note that SDS information changes and you must have the most recent SDS. Simply searching the internet for "CaviCide SDS" will bring up an outdated SDS from 7/14/2015 stating that CaviCide can be poured down the drain - wait! You must go to the manufacturer's full website for the updated SDS (CaviCide has one dated 12/4/19). Very often liquid chemical disinfectant disposal instructions (found in section 13) will direct you to follow Federal, State, and local regulations. I was informed that any liquid chemical disposal had to be removed by a professional disposal company and I would need a hazardous waste generator ID. Long story short, for me, it's too expensive to discard properly. This does not mean pour it down the drain! Keep searching for an environmentally friendly way to sterilize/disinfect your tools and get verification from Federal, State, and local authorities for how to discard liquid chemicals. Refer to the SDS for disposal of the container, as some state that they cannot be recycled.

 

Some chemicals (like MetriCide 28) additionally need an activator and solution testing strips. Only use chemicals as directed by the manufacturer and document on a Solution Testing Log Sheet.

Know Your Chemicals

In addition to understanding the SDS, knowing the chemical you're working with is also important.

These chemicals have been tested on animals.

FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices. This content is current as of 09/25/2019; however, manufacturers may have made changes.

Search for chemicals on the EPA website.

Common Sterilants and High Level Disinfectants include:

 

Glutaraldehyde/Glutaral

US EPA - Pesticides - Reregistration Eligibility Decision (RED) for Glutaraldehyde Reregistration Eligibility Decision (RED) for Glutaraldehyde
https://www3.epa.gov/pesticides/chem_search/reg_actions/reregistration/red_PC-043901_28-Sep-07.pdf

 

CDC Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) Glutaraldehyde

Peracetic Acid

Peracetic Acid Results - AEGL Program
Peracetic Final AEGL Document

Peracetic acid AEGL Technical Support Document (PDF)
https://www.epa.gov/aegl/peracetic-acid-results-aegl-program

https://www.nap.edu/read/12770/chapter/12

 

CDC Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) Peracetic Acid
 

Ortho-phthalaldehyde

Evaluation of Ortho-phthalaldehyde in Eight Healthcare Facilities 

https://www.cdc.gov/niosh/hhe/reports/pdfs/2006-0238-3239.pdf
 

CDC Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) OPA

Isopropanol/Isopropyl Alcohol

U.S. EPA. Provisional Peer-Reviewed Toxicity Values for Isopropanol (Isobutyl Alcohol). U.S. Environmental Protection Agency, Washington, DC, EPA/690/R-14/009F, 2014.
 

2-Butoxyethanol

Toxicological Review of Ethylene Glycol Monobutyl Ether (EGBE)

(CAS No. 111-76-2) in Support of Summary Information on the Integrated Risk Information System (IRIS)
https://nepis.epa.gov/Exe/ZyPURL.cgi?Dockey=P100SKXV.txt

Dry Heat Sterilization Set Up

Contact me with any questions about setting up!