Assessing the risk of disease transmission to patients when there is a failure to follow recommended disinfection and sterilization guidelines

doi:10.1016/j.ajic.2012.10.031

American Journal of Infection Control

Volume 41, Issue 5, Supplement, May 2013, Pages S67-S71

https://doi.org/10.1016/j.ajic.2012.10.031 Get rights and content

Medical devices that enter body tissues should be sterile, whereas devices that contact mucous membranes should be high-level disinfected between patients. Failure to ensure proper cleaning and sterilization or disinfection may lead to patient-to-patient transmission of pathogens. This paper describes a protocol that can guide an institution in managing potential disinfection and sterilization failures.

Section snippets

Risks of endoscopy

Endoscopes represent the medical devices most commonly linked to health care-associated outbreaks and pseudo-outbreaks.6, 7, 8, 9, 10, 12, 13, 14, 15 Flexible endoscopes represent high-risk devices because they often have high levels of bacterial contamination, require low-temperature sterilization or disinfection methods, and their design poses substantial challenges to adequate cleaning and disinfection. Because of the body cavities they enter, flexible endoscopes often acquire high levels of

Protocol for evaluating and managing potential failures of adequate sterilization or disinfection

Although exposure events because of possible failures of disinfection or sterilization are often unique, one should approach evaluation of potential failure using a standardized approach. As with evaluation of microbial outbreaks, one must be prepared to assess the unique aspects of each possible disinfection or sterilization failure by adapting the following recommended approach.

We propose an expanded sequence of 15 steps that form a general approach to the evaluation of a possible failure of

Assessing and interpreting risk

Assessing the probable risk to a patient following a potential exposure is crucial to deciding whether disclosure is warranted. Furthermore, if patient disclosure is warranted, the proper counseling of the patient requires assessing the risk. In many cases, the probable risk may be determined by a careful review of the literature and construction of an algorithm that determines the independent probabilities of disease transmission.¹¹ Disease transmission resulting in infection requires a chain

Example of a risk analysis

A recent paper by Holodniy et al demonstrates the use of our protocol for managing exposures after sterilization/disinfection failures and assessing risk.²⁰ This paper describes 4 specific events that led to possible patient-to-patient transmission of pathogens. Calculation of risk using the method described above resulted in risks ranging from 8 in 10 million to 2.4 in 1 billion, depending on the event and the bloodborne virus. Despite these very low risks, patients were notified of the

Summary

We have provided a blueprint for evaluating and correcting potential failures of disinfection or sterilization. The key aspects of the evaluation are that it be done in an organized fashion and in a rapid and timely manner. Maintaining communication among key stakeholders is crucial to the process. Although we have described the evaluation in a linear fashion, multiple steps are usually done simultaneously (eg, evaluation of mechanism of sterilization failure and evaluation of patients for

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Cited by (29)

Reprocessing semicritical items: An overview and an update on the shift from HLD to sterilization for endoscopes
2023, American Journal of Infection Control
Semicritical medical devices are defined as items that come into contact with mucous membranes or nonintact skin (e.g., gastrointestinal endoscopes, endocavitary probes). Such medical devices require minimally high-level disinfection.
Analyze the methods used to reprocess semicritical medical devices and identify methods and new technologies to reduce the risk of infection.
The reprocessing methods for semicritical medical devices is described as well as a shift from high-level disinfection to sterilization for lumened endoscopes.
Strict adherence to current guidelines and transition to sterilization for endoscopes is required as more outbreaks have been linked to inadequately disinfected endoscopes and other semicritical items than any other reusable medical devices.
Risk of disease transmission to patients from “contaminated” surgical instruments and immediate use steam sterilization
2023, American Journal of Infection Control
There are several sources of pathogens that cause surgical site infections (SSI) to include the patients endogenous microflora and exogenous sources (e.g., air, surfaces, staff, surgical equipment).
We searched the published English literature (Google, Google Scholar, PubMed) for articles on reprocessing surgical instruments, effectiveness of sterilization methods, microbial load on surgical instruments, frequency of “contaminated” instruments, and the infection risk associated with “contaminated” surgical instruments and immediate use steam sterilization.
There is substantial redundancy in instrument reprocessing to include: even if a patient was exposed to a “contaminated” instrument, the decontamination and sterilization process would have removed and/or inactivated the contaminating pathogens due to the exceptional effectiveness of the manual and mechanical cleaning (i.e., washer-disinfector) and the remarkable robustness of sterilization technology; and the low-level of microorganisms on surgical instruments after use and before cleaning.
A critical review of the literature suggests that the risk of acquiring an SSI from instruments used in surgery is essentially zero if the sterilization cycle is validated.
Do formal education or certification opportunities in sterile processing enhance career advancement?
2023, Perioperative Care and Operating Room Management
Sterile processing is an essential, yet often overlooked, aspect of surgical operations. An efficient and precise sterile processing department is critical for providing clean, functional instruments without disrupting operating room workflow. Despite the importance of sterile processing in the day-to-day function of operating rooms, little is known about the educational background, opportunities, or incentives for career advancement for individuals working in sterile processing. We conducted a comprehensive online national survey of sterile processing employees to define the role of education in this space.
Following IRB approval, surveys were sent via email to 50,000+ sterile processing employees querying them about their work role, education background, and certification history. Data was collected and maintained on the Qualtrics platform and analyzed for descriptive statistics using built-in tools.
In total, there were 958 respondents. The average age was 47 years, 67% were women and 86% reported working as hospital employees. The average length of employment was 13.5 years. Half (50.52%) reported working as technicians, 16.76% were supervisors, 16.18% were managers, 5.01% were Directors and 3.49% were educators (Table 1). The minority of respondents held a 2-year (19%) or 4-year (21%) college degree Table 2). Approximately half of respondents (427 of 857) had enrolled in a post-high school education program in sterile processing, with an average of 7.2 months of training. Nearly all respondents (92%) held some form of sterile processing certification. Formal training or certification in sterile processing did not correlate with a higher-ranking position of employment. The majority of employees engaged in self-directed learning at least on a monthly basis. On average, directors and managers worked in sterile processing longer than supervisors and technicians and were more likely to have 4-year, master, or doctoral degrees when compared with technicians. Although higher-ranking employees were more likely than technicians to have completed leadership courses, employees overall were significantly less likely to complete leadership courses if they were not provided or reimbursed by their institution (P<0.001).
There exists wide variation in formal training and certification backgrounds among sterile processing employees. In most states, a standardized pathway to employment does not exist; rather, individual employers assume responsibility for SPD employee training. Employment requirements are variable, and certifications specific to this space do not correlate significantly with workplace roles or positions of leadership. Managers and Directors are more likely to hold an advanced degree. There is little financial or career incentive to obtain formal training or additional certifications that may improve the quality of sterile processing. Nonetheless, the majority of respondents appear actively engage in self-directed learning consistent with a highly motivated, resourceful workforce. Our data suggest that sterile processing employees would optimize opportunities generated through the creation of formal, incentivized education pathways.
A review of Spaulding's classification system for effective cleaning, disinfection and sterilization of reusable medical devices: Viewed through a modern-day lens that will inform and enable future sustainability
2023, Science of the Total Environment
Despite advances in medicine and innovations in many underpinning fields including disease prevention and control, the Spaulding classification system, originally proposed in 1957, remains widely used for defining the disinfection and sterilization of contaminated re-usable medical devices and surgical instruments. Screening PubMed and Scopus databases using a PRISMA guiding framework generated 272 relevant publications that were used in this review. Findings revealed that there is a need to evolve how medical devices are designed, and processed by cleaning, disinfection (and/or sterilization) to mitigate patient risks, including acquiring an infection. This Spaulding Classification remains in use as it is logical, easily applied and understood by users (microbiologists, epidemiologists, manufacturers, industry) and by regulators. However, substantial changes have occurred over the past 65 years that challenge interpretation and application of this system that includes inter alia emergence of new pathogens (viruses, mycobacteria, protozoa, fungi), a greater understanding of innate and adaptive microbial tolerance to disinfection, toxicity risks, increased number of vulnerable patients and associated patient procedures, and greater complexity in design and use of medical devices. Common cited examples include endoscopes that enable non- or minimal invasive procedures but are highly sophisticated with various types of materials (polymers, electronic components etc), long narrow channels, right angle and heat-sensitive components and various accessories (e.g., values) that can be contaminated with high levels of microbial bioburden and patient tissues after use. Contaminated flexible duodenoscopes have been a source of several significant infection outbreaks, where at least 9 reported cases were caused by multidrug resistant organisms [MDROs] with no obvious breach in processing detected. Despite this, there is evidence of the lack of attention to cleaning and maintenance of these devices and associated equipment. Over the last few decades there is increasing genomic evidence of innate and adaptive resistance to chemical disinfectant methods along with adaptive tolerance to environmental stresses. To reduce these risks, it has been proposed to elevate classification of higher-risk flexible endoscopes (such as duodenoscopes) from semi-critical [contact with mucous membrane and intact skin] to critical use [contact with sterile tissue and blood] that entails a transition to using low-temperature sterilization modalities instead of routinely using high-level disinfection; thus, increasing the margin of safety for endoscope processing. This timely review addresses important issues surrounding use of the Spaulding classification system to meet modern-day needs. It specifically addresses the need for automated, robust cleaning and drying methods combined with using real-time monitoring of device processing. There is a need to understand entire end-to-end processing of devices instead of adopting silo approaches that in the future will be informed by artificial intelligence and deep-learning/machine learning. For example, combinational solutions that address the formation of complex biofilms that harbour pathogenic and opportunistic microorganisms on the surfaces of processed devices. Emerging trends are addressed including future sustainability for the medical devices sector that can be enabled via a new Quintuple Helix Hub approach that combines academia, industry, healthcare, regulators, and society to unlock real world solutions.
Disinfection and Sterilization in Health Care Facilities: An Overview and Current Issues
2021, Infectious Disease Clinics of North America
Citation Excerpt :
Disinfection strategies for some semicritical items (eg, applanation tonometers and rectal/vaginal probes) are highly variable.88 Because semicritical equipment has been associated with reprocessing errors that result in patient lookback and patient notifications, it is essential that control measures be instituted to prevent patient exposures.67,68 Before new equipment (especially semicritical equipment, because the margin of safety is significantly less than that for sterilization)89 is used for patient care on more than 1 patient, reprocessing procedures for that equipment should be developed.
Reprocessing of flexible endoscopes: Scientific rationales and patient safety implications
2019, Techniques in Gastrointestinal Endoscopy
Citation Excerpt :
Both inpatient and outpatient healthcare facilities should carefully adhere to the CDC's recommendations and also review relevant clinical guidance from professional associates and industry standards. Careful adherence to these standards and best practices will improve patient safety and reduce potential device contamination risks [4]. The FDA has also identified several design challenges associated with flexible endoscopes that can increase the risk for cross-contamination and associated device risk [5]:
Proper reprocessing of flexible endoscopes in gastroenterology practice is a critical element of a comprehensive patient safety and infection control strategy in both the inpatient and outpatient healthcare setting. This effort requires an interprofessional approach consisting of collaboration between the endoscopist and multiple other facility stakeholders including reprocessing professionals, nursing, infection prevention and control, biomedical engineering, and patient safety professionals. Recent advancements in human factors engineering has demonstrated a high reliability in validated and standardized reprocessing efforts for flexible endoscopes with properly trained reprocessing personnel and appropriate resources to execute the overall reprocessing process. A continued and concerted effort must be paid to maintaining the safety of these devices through focus on personnel, processes, and a continued innovative engineering of the devices themselves. While flexible endoscopes play a pivotal role in delivering diagnostic and therapeutic medical capabilities to endoscopists, their use is not without risk and require a comprehensive approach to medical device hygiene and integrated infection prevention and control.

View all citing articles on Scopus

: Publication of this article was supported by Advanced Sterilization Products (ASP).

: Conflicts of interest: W.A.R. reports income from ASP and Clorox, and D.J.W. reports income from Clorox.

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Original research articleAssessing the risk of disease transmission to patients when there is a failure to follow recommended disinfection and sterilization guidelines

Section snippets

Risks of endoscopy

Protocol for evaluating and managing potential failures of adequate sterilization or disinfection

Assessing and interpreting risk

Example of a risk analysis

Summary

Infect Dis Clin N Am

J Hosp Infect

Managing and preventing exposure event from inappropriately reprocessed endoscopes

Infect Control Hosp Epidemiol

Disinfection and sterilization in health care facilities: what clinicians need to know

Clin Infect Dis

Transmission of infection by gastrointestinal endoscopy and bronchoscopy

Ann Int Med

Infection control in the bronchoscopy suite: a review of outbreaks and guidelines for prevention

Am J Respir Crit Care Med

Endoscopy-related infections and toxic reactions: an international comparison

Endoscopy

Lessons learned from outbreaks and pseudo-outbreaks associated with bronchoscopy

Infect Control Hosp Epidemiol

Original research article
Assessing the risk of disease transmission to patients when there is a failure to follow recommended disinfection and sterilization guidelines