Infection Prevention Tip: Determine If Your Enzymatic Detergent Requires a Temperature Test

Do you know that use of enzymatic detergents to clean instruments and devices in preparation for high-level disinfection and/or sterilization may require testing the temperature of water prior to use? The requirement to perform this important step is often missed if the instructions for use (IFUs) are printed on a brochure attached to the lid of the detergent bottle and are discarded by the user without reading. Several products include the instructions printed directly on the plastic bottle.

If a temperature range is noted, using a liquid thermometer is best. and ensure that you document the temperature with each premix. If there is no mention of optimum temperature, omit this step. Some products will note the following: “works in all temperatures” (see image below).

This tip is further support for always reading and following IFUs.


AORN Previews 2019 Guidelines Changes

2019 will bring noteworthy changes to Association of periOperative Registered Nurses (AORN) standards. In a The Periop Life blog, AORN shares a few of the more significant guidelines changes that can be found in the 2019 edition of its Guidelines for Perioperative Practice and provides tips to help meet these new standards.

The changes highlighted in the blog are as follows:

  • Cover the sterile field

  • Identify how traffic is limited in your operating room

  • Assess your air handling system

The blog also notes that look and organization of the guidelines has undergone significant changes. Access the blog here.

Infection Control Consulting Services (ICCS) anticipates additional changes and will share them if they are announced. Follow ICCS on LinkedIn so you don't miss new information and analysis.

Infection Control Lapses at NJ Surgery Center Possibly Expose Thousands to Bloodborne Pathogens

Alleged lapses in proper infection control practices for instrument sterilization and cleaning and medication injections may have exposed nearly 3,800 patients at a New Jersey ambulatory surgery center (ASC) to bloodborne pathogens, according to news reports and a letter sent by the ASC to its patients.

The 3,778 patients who underwent a procedure at the ASC between Jan. 1, 2018 and Sept. 7, 2018, were informed that they may have been exposed to hepatitis B, hepatitis C and human immunodeficiency virus (HIV).

As a statement from the ASC notes, the N.J. Department of Health closed the center for three weeks in September 2018 because "some members of our staff were not following proper sterile processing procedures and failed to comply with other regulations regarding the dispensing and storage of medication, as well as infection control planning and procedures." To date, there have been no reports of any infections or illness related to the poor infection control and prevention practices.

When it was closed, the ASC stated it took several corrective actions, including improving its infection control and medication dispensing procedures, hiring and training new staff, and cleaning and repairing all instruments by an outside resource.

Unfortunately, as Infection Control Consulting Services (ICCS) noted in a recent special report on safe injection practices, such alleged infection control and prevention lapses continue to occur at healthcare facilities throughout the country. ICCS works with organizations, including ASCs, hospitals and outpatient care settings, to develop proper policies and procedures that comply with current rules, regulations and guidelines and help ensure staff follow appropriate processes that help keep patients safe. To learn more about what ICCS can do for your facility, contact us.

Infection Prevention Tip: Be Careful How You Use 'Christmas Trees'

Tree t.png

If your organization uses "Christmas tree" adapters, which connects the oxygen tubing to the flow meter, make sure you are not reusing single-use versions of these devices.

Two t.png

For these and all devices, ensure that if packaging states "single patient use" or "single-use only" or has the number 2 circled with a strike through it, you do not reuse and will discard/change the device between patients.

StainlessSteel t.png

If your facility uses the stainless-steel, reusable version of the Christmas tree adapter, ensure that you have specific disinfection instructions from the manufacturer and accountability for cleaning between patients. This device is difficult to disinfect, hence a more common approach is to use disposables.

FDA Updates Recommendations for Duodenoscope Reprocessing

The U.S. Food and Drug Administration (FDA) has issued a safety communication drawing attention to the ongoing challenge of effective cleaning and disinfection of duodenoscopes between their uses.

The safety communication shares the results of preliminary surveillance studies performed by the three U.S. duodenoscope manufacturers: Olympus, Fujifilm and Pentax. The studies — one to sample and culture reprocessed duodenoscopes in clinical use to characterize contamination rates and learn more about issues that contribute to contamination (sampling study) and one to assess how effectively the trained hospital staff follow the manufacturer reprocessing instructions (human factors study) — are intended to determine whether healthcare facilities are able to properly clean and disinfect the devices.

Concerning the preliminary findings of the sampling studies, FDA states:

"Interim results from these studies indicate higher-than-expected contamination rates after reprocessing, with up to 3% of properly collected samples testing positive for enough low concern organisms to indicate a reprocessing failure and up to 3% of properly collected samples testing positive for high concern organisms. High concern organisms are defined as organisms that are more often associated with disease, such as E. coli, and Pseudomonas aeruginosa. Root cause analyses are currently underway to better understand these culturing results. Some factors that may contribute to device contamination after reprocessing include device damage and errors in reprocessing."

Concerning the preliminary findings of the human factors studies, FDA states:

"… results indicate that reprocessing instructions in current user manuals are difficult for reprocessing staff to comprehend and follow. For example, some reprocessing staff missed one or more steps in the process and needed additional training to complete the process properly. The study revealed that the descriptions of some of the processing steps in the user manuals were unclear. As a result, the FDA is working with the duodenoscope manufacturers to revise and clarify the user materials to improve comprehension and adherence to reprocessing instructions."

Revised Duodenoscope Recommendations

Since the study results revealed unexpectedly higher contamination rates, FDA provided updated recommendations for steps healthcare providers can take to enhance duodenoscope reprocessing. They include the following:

  • Facilities and staff should strictly adhere to the manufacturer's reprocessing and maintenance instructions.

  • Meticulously clean the elevator mechanism and the recesses surrounding the elevator mechanism by hand, even when using an automated endoscope reprocessor. Raise and lower the elevator throughout the manual cleaning process to allow brushing and flushing of both sides. After cleaning, carefully inspect the elevator recess and repeat cleaning if any soil or debris is visible.

  • Implement a comprehensive quality control program for reprocessing duodenoscopes. Include in it written procedures for monitoring training and adherence to the program and documentation of equipment tests, processes and quality monitors used during the reprocessing procedure.

  • Follow the duodenoscope manufacturer's recommendations for inspection, leak testing and maintenance of the duodenoscope.

    • Prior to each use, closely inspect and remove from service for assessment, and repair or replace any duodenoscope that shows visible signs of damage.

    • During each reprocessing cycle, conduct leak testing and remove from service for assessment, and repair or replace any duodenoscope that shows signs of leakage.

    • Follow the duodenoscope manufacturer's leak testing instructions for angulating the bending section and elevator during leak testing.

    • Return the duodenoscope to the duodenoscope manufacturer for inspection, servicing and maintenance of the device at least once per year.

FDA also highlighted its previously issued safety communication that provides a detailed list of supplemental duodenoscope reprocessing measures (e.g., microbiological culturing, sterilization, use of a liquid chemical sterilant processing system, repeat high-level disinfection) that can be implemented to reduce the risk of infection transmission. 

In March, FDA issued warning letters to the duodenoscope manufacturers concerning their failure to fully comply with a federal order to conduct the postmarket surveillance studies.