How can you determine whether the contents of a sterile pack are still sterile

Ensuring surgical instruments have been reprocessed correctly is the cornerstone of infection prevention. Endoscopes and arthroscopes have different requirements from your typical wrapped packs, while "reposable" single-use devices (SUDs) have rules of their own. This 6-question quiz will test your knowledge of central sterile processing.

1. Which of the following is true about your SUDs?

1. They may be reprocessed according to manufacturers' guidelines.
2. They are intended for one-time use only and must be disposed of after use.
3. They may be reprocessed, but only by entities that have complied with FDA regulatory requirements.
4. both a and c

c. They may be reprocessed, but only by entities that have complied with FDA regulatory requirements.
There has been much controversy in this area, and the CDC says more studies are required to determine the extent of the risks and benefits of reprocessing, then using, SUDs.1 However, FDA guidance issued in 2000 allows the practice, so long as firms can reprocess SUDs and document the process in such a way that they could meet original manufacturing requirements.2

The FDA has increasingly required 510(k) regulatory submissions and supplemental validation data,2 so any SUD reprocessing must be outsourced to a third-party firm, if you choose that route. If you do, be sure your third-party reprocessor complies with all FDA regulations — for example, reprocessing only devices on the FDA-approved list and devices for which it holds 510(k)s. It's also in your interest to keep abreast of developments at www.fda.gov.

2. After sterilization, wrapped instrument packs are placed into storage. For how long are the instruments inside these packs considered sterile?

1. The items remain sterile indefinitely.
2. The sterility depends on package integrity and storage conditions, or the occurrence of an event that could compromise integrity.
3. The items are sterile for a maximum of 30 days.
4. both b and c

b. The sterility depends on package integrity and storage conditions.
The old rule of thumb was 30 days, but recent evidence shows that, if wrapped packs are stored properly after sterilization, and nothing happens to compromise their integrity, the items inside will remain sterile. This is the principle of event-related sterility.

Events that could compromise sterility include a tear in the packaging, a wet package or a broken seal.1 Other factors are air movement, foot traffic, location, humidity, open/closed shelving, temperature and wrap material properties.1 Studies show that, to ensure integrity, you should

• use covered storage;
• minimize handling while in storage;
• handle using only aseptic technique;
• store 8 to 10 inches from the floor, 5 inches from the ceiling (or 18 inches from a sprinkler head), and 2 inches from walls; and
• avoid storing packs in cabinets under sinks or anywhere else they could become wet.1,3,4

If a pack falls or is dropped, inspect for damage and determine whether the contents may have been broken. The Guideline for Disinfection and Sterilization in Healthcare Facilities notes that, if a package has been "heat-sealed in impervious plastic and the seal is still intact, the package should be considered not contaminated. If undamaged, items packaged in plastic need not be reprocessed."1

3. External indicator tape on wrapped packs changes color to indicate appropriate temperatures have been achieved inside the sterilizer chamber. Attaching this type of chemical indicator to each pack ensures sterilization.

a. trueb. false

b. false
Indicator tape is commonly used, but it can't signal sterility inside a pack. Therefore, your central sterile department should be placing multi-parameter chemical indicators inside every sealed pack. Preferably, these should be Class 4 or 5 indicators (indicator tapes or labels are considered Class 1).5,6

Class 4 indicators react to 2 or more sterilization thresholds, such as temperature, time or steam saturation. Class 5s react to all critical parameters by employing a spore strip that indicates the sterilizer's ability to have killed all the organisms in a given cycle.

Class 5 indicators are preferred because experts consider them more complete, but you may also consider Class 6 indicators, also called emulating indicators, which allow for immediate release of sterilizer loads after processing, compared to an hour-plus with other indicators.5,6

4. For reprocessing purposes, items such as colonoscopes and laryngoscopes are considered which of the following?

1. critical items
2. semi-critical items
3. non-critical items
4. unmentionable items

b.semi-critical items
Semi-critical items include endoscopes, laryngoscopes and anesthesia equipment. Reprocessing this equipment has been demonstrated to have a "narrow margin of safety" due to high microbial load; complex, lumen-containing instruments; intricate reprocessing protocols, deviation from which leads to risk of infection; and the potential for improper cleaning.6

Prominent infection control expert and co-author of CDC sterilization and disinfection guidelines William Rutala, MD, PhD, recommends a 5-step process, preferably performed by an automatic endoscope reprocessor (although initial cleaning remains manual), for flexible scope reprocessing:

1. Manually clean with water and enzymatic cleaner.
2. Immerse and perfuse all channels with high-level disinfectant/sterilant for at least 12 minutes.
3. Rinse all channels with sterile water, filtered water or tap water followed by an alcohol flush.
4. Use forced air to dry all channels.
5. Hang to store with insertion tubes down to prevent recontamination.6

Keep in mind that chemical sterilants in automatic reprocessors become diluted, so you must test the minimal effective concentration (MEC) regularly, at minimum each day of use. Adhere to manufacturer instructions and don't use MEC strips that have gone out of date.

5. Retesting of a sterilizer should be performed in all of the following cases except

1. as part of routine testing
2. after a failed biological load
3. after relocation of the sterilizer
4. after repairs

a. as part of routine testing
Any time you're putting a sterilizer back into service — after a failed load, after relocation or after repairs — you must verify the efficacy of its operations. Routine testing isn't necessary, so long as chemical or biological indicators in packs show that sterilization is occurring.1 Test by running 3 consecutive empty steam cycles with a biological or chemical indicator in a test package or tray, and test each type of cycle separately. Don't recommission the sterilizer "until all biological indicators are negative and all chemical indicators show a correct end-point response."1

6. Recent reports of instrument-related SSIs after orthopedic procedures have put the spotlight on reprocessing arthroscopes and shaver blades. Your sterile processing department suggests changing from high-level disinfection to sterilization for these instruments. Will this ensure a lower risk of infection rates?

a. yesb. no

b. no
Although there is debate on the issue, and sterilization is preferred and provides a greater degree of assurance, high-level disinfection may be necessary for manually removing bioburden and isn't sub-standard when performed according to strict protocols. According to the CDC, this "equipment is simple to clean and disinfect; surgical sterility is relative; the natural bioburden on rigid lumened devices is low; and no evidence exists that high-level disinfection instead of sterilization increases the risk for infection."1 But recent headlines have raised concerns, and there's no reason to not brush up your arthroscope and shaver protocols.

Researchers who looked at a 2009 Texas outbreak detailed the 6 adjustments the hospital now takes in its reprocessing routines:

1. Routinely perform endoscopic evaluation of shaver handpieces to determine whether suction channels contain residual bioburden.
2. Use a non-bristled brush to clean the lumen of the arthroscopic inflow/outflow cannulae.
3. Cap the distal end of the arthroscope camera and shaver handpiece power cord.
4. Submerge shaver handpiece in enzymatic solution for 10-15 minutes during gross decontamination.
5. Cease storing surgical instruments in areas outside the designated storage room.
6. Vigilantly enforce limits on flash sterilization.7

In this case study, no more SSIs occurred after the protocol was instituted. It's a good reminder that you should regularly review your policies and procedures, reinforce staff training and examine workflow.

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