Sterile Processing

Q:  We reprocess vaginal specs for some local doctors' offices. I recently learned that once the office staff receives the instruments, they are then opening up the individual sterile peel pouches and then place the “unprotected” vaginal speculums into the exam table to be ready for use by the provider. Is there anything we can purchase to use for transportation purposes that will save us time and money and skip the sterilization process of these items?A:  This is an excellent question, especially with many sterile processing departments (SPDs) now processing devices for offsite clinics and doctors' offices.  Vaginal speculums fall under the semi-critical devices category (Spaulding).

ICT spoke with Karen Swanson LPN, CSPM, CFER, manager of the central sterile department at Connecticut Children's Medical Center and chairman of the board of directors of the Certification Board for Sterile Processing (CBSPD), regarding the challenges that face sterile processing professionals and the importance of building key skill sets.

In healthcare facilities, Clostridium difficile infections spread by transmission of bacterial spores. Appropriate sporicidal disinfectants are needed to prevent development of clusters and outbreaks. In this study by Kenters, et al. (2017), different cleaning/disinfecting wipes and sprays were tested for their efficacy against spores of distinctive C. difficile PCR ribotypes.

The sterile processing department (SPD) can be one of the more challenging environments in which to uphold infection prevention and control principles. As an example, the decontamination area of the SPD can pose a significant threat to its technicians "because of the numerous and unknown microorganisms that pass through," confirms Nancy Chobin, RN, AAS, ACSP, CSPM, a sterile processing educator and consultant. "In addition, there is the potential for a sharps injury due to sharps that are handled in this area as well such a towel clips, etc.," she says.

Q:  I have been using steam tape to place indicator on paper i.e., count sheets, and instrument bags inside of surgical trays before sterilization. I have been doing this for a number of years. My manager informs me that you cannot use steam tape to hold an indicator in place, be-cause "there is no way to validate that the tape is sterile after sterilization." Please clarify or give justification for this statement.

Several years following a widely publicized series of outbreaks related to contaminated and improperly reprocessed duodenoscopes, re-searchers are reporting that current techniques used to clean endoscopes for reuse are not consistently effective. However, some experts say that slow progress is underway.

Some central service (CS) professionals find comfort in knowing their chosen discipline provides them with a secure “job.” The fact is, though, that the dynamic, fast-paced and ever-evolving realm of CS/sterile processing delivers a challenging, yet rewarding career filled with rich opportunities for growth and advancement.

As an infection prevention consultant with 25-plus years of experience, I frequently audited healthcare facilities regarding proper reprocessing of their surgical, dental and/or endoscopic equipment. With each audit, I found healthcare professionals who had a strong desire to learn and adhere to best practices. This is important, as best practices should be adhered to in any profession because they reflect the values of that profession. In healthcare, adherence to sterilization and disinfection best practices ensures patient safety, as one of our greatest threats is healthcare-associated infections (HAIs). That said, I sometimes found it difficult to get everyone on board with compliance with national standards and guidelines, such as the Association for the Advancement of Medical Instrumentation (AAMI), the Association of periOperative Registered Nurses (AORN) and/or the Society of Gastroenterology Nurses and Associates (SGNA).  In recent years, my efforts were reinforced with help from two very important organizations, the Joint Commission and the Centers for Disease Control and Prevention (CDC).

Reprocessing endoscopes, particularly flexible endoscopes, requires numerous steps for proper cleaning and high-level disinfection. Studies have demonstrated that not all of these steps are followed by sterile processing personnel, leading to potential transmission of infectious organisms to patients during invasive procedures using contaminated scopes.

This year's state of the industry report on sterile processing, with data provided through an online survey of ICT readers who work in sterile processing departments (SPDs) and central sterile supply departments (CSSDs), is designed to offer a snapshot of the key issues and challenges relating to budgets, resourcing and workloads, as well as human factor-related issues.

Q: In reviewing our manual high-level disinfection (HLD) records, I noted that on several occasions, the temperature of the solution did not reach the manufacturer’s recommended temperature. The technician did not notify the supervisor of this problem and the following technicians never noted this error on the log. What should we do?

Device-associated infections due to biofilm-producing methicillin-resistant Staphylococcus aureus (MRSA) have been recently associated with the failure of antibiotic treatment and decolonization measures. The goal of the study by Günther, et al. (2017) was to evaluate the extent to which the formation of biofilms influenced the efficacy of topical decolonization agents or disinfectants such as mupirocin (MUP), octenidine (OCT), chlorhexidine (CHG), polyhexanide (POL), and chloroxylenol (CLO).Bacterial killing in biofilms by the disinfectants and MUP was determined as the reduction [%] in metabolic activity determined by a biofilm viability assay that uses kinetic analysis of metabolic activity. The test substances were diluted in water with standardized hardness (WSH) at 25 °C at the standard concentration as well as half the standard concentration to demonstrate the dilution effects in a practical setting. The tested concentrations were: CHG 1%, 2%; OCT 0.1%, 0.05%; PH 0.04%, 0.02%; and CLO 0.12%, 0.24%. A test organism suspension, 1 mL containing ~1 × 109 bacterial cells/mL, and 1 mL of sterile WSH were mixed and incubated for six different exposure times (15 s, 1, 3, 5, 10 and 20 min) after the test substance was added.Additionally, the bactericidal effects of all substances were tested on planktonic bacteria and measured as the log10 reduction.The disinfectants OCT and CHG showed good efficacy in inhibiting MRSA in biofilms with reduction rates of 94 ± 1% and 91 ± 1%, respectively. POL, on the other hand, had a maximum efficacy of only 81 ± 7%. Compared to the tested disinfectants, MUP showed a significantly lower efficacy with <20% inhibition (p < .05). Bactericidal effects were the greatest for CHG (log10 reduction of 9.0), followed by OCT (7.7), POL (5.1), and CLO (6.8). MUP, however, showed a very low bactericidal effect of only 2.1. Even when the exposure time was increased to 24 h, 2% MUP did not show sufficient bactericidal effect.The researchers say their data provide evidence that OCT and CHG are effective components for disinfection of MRSA-biofilms. On the other hand, exposure to MUP at the standard concentrations in topical preparations did not effectively inhibit MRSA-biofilms and also did not show adequate bactericidal effects. Combining an MUP-based decolonization regimen with a disinfectant such as OCT or CHG could decrease decolonization failure.Reference: Günther F, et al. MRSA decolonization failure-are biofilms the missing link? Antimicrobial Resistance & Infection Control. 2017;6:32

Q:  Recently, I refused to process a device based on the following manufacturer’s instructions provided: “The xxx parts are made of durable aluminum and can be cleaned with ultrasound and any cleaning agents. Any standard sterilization technique is acceptable. There are no moving parts to maintain.” I contacted the company to alert them the instructions for use (IFUs) were insufficient. The company replied that “reprocessing is a different concept from cleaning and sterilizing a simple instrument for reuse.” They stated that the particular instrument in question “is a simple "instrument" like a retractor or a mallet. These instruments are reused; do not have critical "parts" that need to be retested between uses. They need to be cleaned and sterilized. It is a simple device with no moving parts or cavities or other complicating factors. How does one handle this?