Continuing Education Program
Following established protocols for instrument processing is an important aspect of modern health care as it helps to minimize the patient’s risk for infection of the surgical site. This program is intended to provide an “overview” of current recommended practices and is approved for continuing education credit.
6 Steps of instrument reprocessing
1. Transport
2. Cleaning & Inspection
3. Packaging
4. Sterilization
5. Storage & Delivery
6. Quality Assurance
Transport
Contaminated instruments should be handled carefully to prevent exposure using appropriate PPE (personal protection equipment). At point of use, they should be placed in a sealed, leak proof container (displaying a biohazard symbol) to prevent any injuries or cross contamination during transport to the processing area.
Transport
From Treatment Area
• Organization
• Efficiency
• Safety
• Puncture resistant, leak-proof container with lid
Cleaning
Manually or mechanically clean soiled instruments as soon as possible in a designated area, wearing appropriate PPE. Quick cleaning removes blood much easier, and can minimize instrument staining, corrosion and/or pitting. Be sure to use approved cleaning solutions and cleaning brushes as commercial products not intended for use with surgical instruments can cause damage and/or limit cleaning effectiveness. Mechanical cleaning is a safer practice for staff and a more effective process over manual cleaning. Therefore, whenever possible, mechanically clean instruments, using warm water and a neutral pH detergent.
Ultrasonic Cleaner
• Remove gross soil before using
• Use an enzymatic cleaning solution
• Use treated water when needed
• Change solution AT LEAST daily
• Must use lid
• Don’t overload
• Periodically perform ‘foil test’
Instrument Washer
• Increase productivity
• Improve cleaning effectiveness
• Decrease personnel sharps risk
• Accommodate more instruments than ultrasonic units
• Use automated washing cycles
• Eliminate need for manual presoaking, hand scrubbing rinsing, and drying
• Some have high temp cycle - thermal disinfection
Rinsing
After cleaning, thoroughly rinse instruments with tap water and ensure all debris and detergent residue is removed. If the tap water is of poor quality, consider using treated water as a final rinse to avoid instrument staining.
Inspection
Each instrument should be critically inspected after each cleaning for residual debris or damage.Replace instruments as needed and never sterilize a “dirty” instrument. In addition, check each instrument for proper function and lubricate as required by the instrument manufacturer. Hinged instruments with stiff joints may be a sign of inadequate cleaning
Packaging
Instrument packaging should be done in a clean and low contamination area, using approved products:
• Sterilization pouch
• Sterilization wrap
• Sterilization container
Packaging
Sterilization pouches are for packaging loose instruments and small, lightweight items. Paper / plastic pouches allow you to see the contents and come with a build in adhesive strip for seal sealing. It is important to remove all excess air, prior to sealing the sterilization pouch.
Packaging
For quality assurance, be sure to include a chemical indicator inside each pouch. Per CDC guidelines, this will verify sterilization parameters were met inside, as well as outside the pouch (time, temperature and sterilant contact.
Packaging
Special Note: Some new technology pouches come printed with an external and internal chemical indicator. If the internal indicator is a multi-parameter chemical indicator, there is no need to add a separate indicator strip inside.
Packaging
To assist sterilization and aid drying, place pouches facing each other and on edge using a divider. For quality assurance, include a chemical indicator inside to verify the sterilant reached the inside of the package. Wrap in a way that allows sterile presentation and aseptic and delivery of the surgical pack or kit. Sterilization indicator tape should be used to secure the wrapper.
Special Note: Most steam indicator tapes contain latex in the adhesive and lead in the color change ink. Latex and lead- free indicator tape is commercially available.
Sterilization
Heavier wraps should be placed on the lower shelf of the sterilizer and pouches (being lighter) on the top, on edge. This enables moisture to drain out without wetting other items in the load. Sterilizers are Class 2 medical devices requiring clearance.
They are available in a variety of sizes with the following processes most common to medical:
• Steam
• Chemical vapor
• Dry heat / Rapid heat transfer
Saturated steam under pressure is one of the oldest methods used to sterilize surgical instruments. The CDC recommends steam sterilization as the process of choice, because it is efficient, fast, and inexpensive.
Sterilization
By heating distilled water under pressure, moist heat is created and rapidly kills microorganisms. Some common steam sterilizer cycle parameters are:
• 250°F/121°C for 30 min (Gravity)
• 270°F/132°C for 10 min (Gravity)
• 270°F/132°C for 04 min (DAR)
Gravity - Gravity Displacement; DAR - Dynamic Air Removal
There are three (3) different types of steam sterilizers:
1. Gravity Displacement
2. Prevacuum
3. Steam Flush Pressure Pulse (SFPP)
Gravity displacement sterilizers heat the water which converts it to steam and pushes the air out the drain gradually. This is called “passive air removal”. Prevacuum (also called Class B) sterilizers heat water and convert it to steam; however, they use a vacuum pump to quickly remove the air which allows for faster cycles. This is called “dynamic air removal”. Because prevacuum steam sterilizers rely on a pump to remove air, an air removal test called Bowie-Dick test should be performed daily.
Air Removal Test
Test Procedure: Place a Bowie-Dick test pack on the lowest shelf, over the drain in an empty chamber at 273°F for 3.5 or 4 minutes exposure time. After processing, the color change indicator inside the test pack should show a uniform color to pass. Retain the indicator as part of your Infection Control records
Sterilization
Steam-flush-pressure-pulse (SFPP) sterilizers are also considered dynamic air removal, but use steam flushes and pressure pulses to remove the trapped air from the chamber and load. As with prevacuum sterilizers, air removal is more efficient than gravity displacement sterilizers and permits shorter cycle times. Because SFPP air removal occurs through atmospheric pressure pulses rather than the vacuum pulses used in prevacuum sterilizers, a daily air removal test is not necessary.
Storage & Delivery
Sterile items should be stored in a manner that reduces the potential for contamination. The shelf-life of sterile items is event related and depends on the quality of the packaging material, storage conditions and amount of handling. Sterile packages should always be handled with care. Avoid dragging, crushing, bending, compressing or puncturing, as this can compromise sterility. Be sure to inspect sterile packages before distributing. Do not use any package that is damaged, wet or opened.
Quality Assurance
Sterility assurance of processed instruments should be routinely verified using three (3) types of indicators:
1. Physical
2. Chemical
3. Biological
1. Physical indicators are the time, temperature and pressure gauges built into sterilizers.These readings should be recorded for every cycle and verified prior to unloading the sterilizer. Hospital sterilizers are required to have a chart or printout, whereas this is optional for sterilizers located in private offices or clinics.
2. Chemical indicators should be on the outside and inside of all packages to verify they have been processed. The outside can be a single parameter indicator, i.e. change with heat alone; however, the internal should be multi-parameter requiring more than just heat to make it pass. We mentioned that some newer pouches now offer external and internal indicators printed with every pouch. Be sure the supplier has validated the internal indicator as a multi-parameter indicator, per CDC guidelines.
3. Biological indicators provide users the highest level of sterility assurance and contain bacterial spores available in plastic vial or paper strip format. The CDC says sterilizers should be tested at least weekly, and every load that contains an implant. An unprocessed Control test, from the same lot must be included. In-office biological monitors are processed along with a normal load. After processing, the plastic vial is activated by crushing the side and then incubated.
Sterilizer failure is noted if the test vial changes color from purple to yellow. An unprocessed vial should be incubated each time to verify test results. A BI inside a Test Pack should be used to monitor large sterilizers when processing packaged instruments.
Steam - place on the bottom shelf, directly above the drain with a load. The SPS medical Steam BI test pack includes a BI, along with a Class 5 integrator for immediate release of load, and is FDA cleared for use with standard or extended sterilization cycles. Paper strip biological indicators can be sent to an outside lab for 3rd party verification.
After processing a spore strip along with a normal load, the strip(s) are sent to a lab for incubation. Test results are returned via mail or fax, with some services offering internet record keeping via password. What’s New? The FDA has approved the SPS STEAM Plus integrator as equal in performance to the spore test. This does not mean it replaces the weekly spore test; however, we do recommend it be used with each steam cycle to protect against the release of non-sterile items. While sterilizers can and do mechanically fail, operator error is the leading cause of sterilizer failure, e.g.
• Cold start
• Wrong cycle
• Overloading
• Improper packaging
Now Let's test your knowledge on instruments reprecessin
Get’s test your knowledge on Instrument Reprocessing
1. Transport
2. Cleaning & Inspection
3. Packaging
4. Sterilization
5. Storage & Delivery
6. Quality Assurance
Test Questions
01. You should wear PPE when handling soiled instruments. True - False
02. Manual cleaning is preferred over mechanical cleaning. True - False
03. All instruments should be inspected after cleaning. True - False
04. Peel pouches are ideal for packaging loose instruments. True - False
05. The CDC says steam sterilization is the process of choice. True - False
06. All sterilizers have the same setting for time and temperature. True - False
07. Packages should be dry when removing from the sterilizer. True - False
08. The shelf-life of sterilized packages is event-related. True - False
09. Each package should have an external and internal indicator. True - False
10. Steam sterilizers should be spore tested at least weekly. True - False