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PATIENT HARM CAUSED BY IMPROPER/INADEQUATE INTRUMENT REPROCESSING

Improper or inadequate decontamination, cleaning and sterilization of surgical instruments continues to be a major source of patient harm that is preventable through proper practice and adherence to manufacturers’ instructions for use (IFUs). The problem of contaminated instruments being returned to the O.R. and causing patient harm was first addressed by the CDC in their September 11, 2015 Health Alert Advisory that stated:

“The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices. Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety.”1

Regretfully, even after this major Health Alert Advisory from the CDC, we have continued to see reports of contaminated instruments causing canceled surgeries, patient harm and even patient deaths. A tragic example of this occurred when thousands of patients were potentially exposed to HIV and hepatitis in an ambulatory surgery center in New Jersey due to inadequate decontamination, cleaning and sterilization of surgical instruments according to the state’s Department of Health.

“More than 3,700 patients who had procedures at HealthPlus Surgery Center in Saddle Brook, New Jersey, may have been exposed to blood-borne illnesses such as HIV, hepatitis B, and hepatitis C, according to a statement from the center. The patients at risk were treated at the surgery center between Jan. 1 and Sept. 7, 2018.”2

The New Jersey Department of Health found that members of HealthPlus’ staff were not following proper sterilization procedures. The state closed the surgery center on Sept. 7, 2018 and allowed it to reopen on Sept. 28. 2018. During that time, HealthPlus said it hired new staff members, improved infection control, conducted training for its new sterile-processing staff, and cleaned and repaired all medical equipment.3

Another tragic example occurred when Porter Adventist Hospital in Denver, Colorado had to cancel all surgeries for a week due to contaminated surgical instruments being found in the O.R. after reprocessing.4

Given the tremendous patient harm that can be caused by inadequately or improperly reprocessed instruments, it is imperative that you, your staff and your facility do everything in your power to ensure clean, sterile, moisture-free instruments on every reprocessing cycle. The best way to start to achieve this goal is to review the following basics of instrument cleaning with your staff.

The cleaning of surgical instruments is defined as the process of removing foreign material (e.g., bioburden, biofilm) from the instruments and is usually accomplished using water with detergents or enzymatic products that are suitable for use. Surgical instruments must be thoroughly cleaned before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes (“If it’s not clean, it can’t be safe!).

The proper cleaning of surgical instruments starts in the O.R. by placing the contaminated instruments into sterile water or an approved enzymatic detergent. This first step in the cleaning process is vital because if soiled organic materials dry or bake onto the instruments, the removal process becomes much more difficult. Even worse, it can render the disinfection or sterilization process less effective, or even ineffective. This is why it is so important that surgical instruments be presoaked or rinsed in neutral pH (7 or lower) water immediately after use and prior to transport to prevent blood from drying and to soften or remove blood from the instruments.

Manual cleaning is required in those areas that do not have mechanical cleaning units (e.g., ultrasonic cleaners or washer disinfectors). Manual cleaning is also required for fragile or difficult-to-clean instruments (e.g., Kerrison Rongeurs, laparoscopic instruments, etc.).

There are two essential components of manual cleaning, friction and fluidics. Friction (e.g., rubbing/scrubbing the soiled area with a brush) is a time-honored and dependable method. Fluidics (i.e., fluids under pressure) is used to remove soil and debris from internal channels, sharp internal corners and dead-spaces. This step is necessary when the instrument’s design does not allow a brush access through a channel or contact with an internal surface(s).5

The use of a washer-disinfector requires additional care when loading surgical instruments into the unit. Specifically, hinged instruments must be fully opened to allow thorough and complete contact with the detergent solution. Do not stack instruments in washers to ensure proper contact with the detergent solution on all of the surfaces. Finally, all modular/take-apart instruments should be disassembled as per the manufacturer’s IFUs.

The first step in reducing patient risk from an instrument that is difficult, if not impossible to decontaminate and clean begins when purchasing new surgical instrumentation. To reduce your patients’ risk of a surgical infection caused by a contaminated instrument, your healthcare facility should demand validated cleaning IFUs from ALL of your instrument suppliers, including take-apart suppliers. According to a recent ECRI Institute report, failure to demand validated cleaning IFUs from your instrument manufacturers is a tremendous patient safety issue.6

Healthcare facilities have a legal, ethical, financial and moral obligation to only use instruments whose cleaning and sterilization IFUs have been validated by independent laboratory testing using AAMI and FDA validation protocols.

1 Centers for Disease Control and Prevention Health Alert Advisory HAN00323, September 11, 2015.

2 NBC News report, New York, Dec. 25, 2018, reported by Kalhan Rosenblatt

3 Op. Cite.

4 NBC News 9, Denver, Colorado.

5 Reichert M., Preparation of supplies for terminal sterilization. In: Reichert M, Young JH, eds. Sterilization technology for the health care facility. Gaithersburg, MD: Aspen Publication, 1997:36-50

6 ECRI Institute website https://www.ecri.org/Pages/2017-Hazards.aspx

 

 

 

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