Validation of Autoclave Protocols for Successful Decontamination of Category A Medical Waste Generated from Care of Patients with Serious Communicable Diseases

Abstract

In response to the Ebola outbreak in 2014, many hospitals designated specific areas to care for patients with Ebola and other highly infectious diseases. The safe handling of category A infectious substances is a unique challenge in this environment. One solution is on-site waste treatment with a steam sterilizer or autoclave. The Johns Hopkins Hospital (JHH) installed two pass-through autoclaves in its biocontainment unit (BCU). The JHH BCU and The Johns Hopkins biosafety level 3 (BSL-3) clinical microbiology laboratory designed and validated waste-handling protocols with simulated patient trash to ensure adequate sterilization. The results of the validation process revealed that autoclave factory default settings are potentially ineffective for certain types of medical waste and highlighted the critical role of waste packaging in successful sterilization. The lessons learned from the JHH validation process can inform the design of waste management protocols to ensure effective treatment of highly infectious medical waste.KEYWORDS Ebola, sterilization, medical waste, serious communicable diseases, autoclave T he Ebola outbreak in West Africa in 2014 revealed potential gaps in the abilities of U.S. hospitals to safely provide care for patients with highly infectious diseases. Prior to the outbreak, the capacity to care for patients in the United States infected with high-consequence pathogens was limited to a few specialized facilities, or biocontainment units (BCUs) (1-3). In response to the crisis, the Centers for Disease Control and Prevention (CDC) recommended a tiered approach wherein U.S. hospitals serve as frontline health care facilities, Ebola assessment hospitals, or Ebola treatment centers (ETCs) (4). The Office of the Assistant Secretary for Preparedness and Response (ASPR), a federal office in the Department of Health and Human Services (HHS), created a regional response plan, which called for the creation of Regional Ebola and Other Special Pathogen Treatment Centers (RETCs) (5). These RETCs were modeled in part on the U.S. facilities that provided care for Ebola patients, namely the University of Nebraska Medical Center, the National Institutes of Health, Emory University, and Bellevue Hospital Center, and also include design elements based on local capabilities and lessons learned from the outbreak (6).

Evaluation of the Efficiency of Autoclaving Healthcare Waste Using Biological and Chemical Indicators

“…As highlighted by Garibaldi et al (2017), "cycles that evaluate treatment efficiency should contain the biological indicators disposed within the waste load, considering that indicators outside the mass of waste may not reflect actual treatment conditions," a fact that demonstrates the importance of assessment of the mass of waste.…”

“…Some studies have evaluated the application of biological and chemical indicators to monitor autoclaves. These include Garibaldi et al (2017), who evaluated the standard configuration of two autoclaves for the healthcare waste treatment of Ebola-infected patients, considering different exposure times, temperatures, and pressures. The authors found that 16 out of 19 autoclave cycles with the factory default setting were positive for the biological indicators inserted in the center of the load.…”

High-Containment Pathogen Preparation in the Intensive Care Unit

“… 21 The potential high volume of waste, both in the form of patient secretions and disposable products, such as PPE, present additional challenges. 18 , 19 , 21 , 22 The CDC and ASPR recommend that facilities planning to care for patients with EVD consider installing steam sterilizers, or autoclaves, to sterilize waste before transport out of the containment facility. 17 It is critical that facilities using onsite autoclaves validate their protocols using simulated patient waste and biological indicators to ensure successful sterilization.…”

“…17 It is critical that facilities using onsite autoclaves validate their protocols using simulated patient waste and biological indicators to ensure successful sterilization. 21 In a recent survey of 43 ETCs, 10 had onsite autoclave capabilities. The remaining centers had alternative plans that included packaging waste according to Department of Transportation’s guidelines and transporting it to a certified processing facility.…”

Plasma-Sprayed and Sintered Silver-Based Antimicrobial Coatings for Industrial and Biomedical Application

“…Quaternary ammonium and sodium hypochlorite are both frequently used in industrial applications 47 . Joint replacements are most commonly autoclaved immediately before being implanted, as this is the general practice hospitals use with surgical equipment 48 .…”