Decontamination and reprocessing of medical devices for health-care facilities – WHO

Globally, hundreds of millions of people are affected every year by avoidable infections in health care (health care-associated infections, HAIs). The determinants of HAI are influenced by a complex combination of gaps in policies, infrastructure, organization and knowledge, defects in health care workers’ behavior, and patientrelated factors. Through knowledge, best practices and infrastructures improvement, infection prevention and control (IPC) aims to prevent harm due to HAI to patients and health workers.

Sterilization and decontamination of instruments and medical devices play a very important role in the prevention of HAIs. Indeed, defective sterilization of surgical instruments and disinfection of reusable objects including endoscopic devices, respiratory care devices, and reusable hemodialysis devices still occur in many settings and lead to HAIs. In addition, in many low-resource settings inappropriate reuse of disposable medical devices is common practice and the procedures to clean and decontaminate these devices are inadequate and not standardized. The processes of sterilization and decontamination are complex, require specific infrastructure and equipment and involve several steps that need to be correct, from devices collection, receipt by the unit, processing, storage and distribution them throughout the facility. Of utmost importance are also quality control procedures to assess the correct functioning of the equipment.

Most common HAIs caused by harmful device reuse practices or inadequate sterilization/decontamination procedures are surgical site infections (SSI), hepatitis B and C, HIV infection, urinary and vascular catheter associated infections, and ventilator-associated infection.
Following recent threats caused by widespread epidemics and increasing awareness about the spread of antimicrobial resistance, several countries are paying more attention and investing resources to strengthening IPC infrastructures and improving practices. In this context, this manual is a very important instrument to provide guidance to health managers and health workers on required infrastructures and standard procedures for effective sterilization, and decontamination reprocessing of medical devices. This edition of the manual represents a thorough revision and update of the Sterilization Manual for Health Centers issued by the Pan American Health Organization in 2009 and it is the result of a close collaboration between the IPC Global Unit at the Headquarters of the World Health Organization, the Pan American Health Organization, and a group on international experts.

WHO Decontamination and Sterilization Working Group

In response to the lack of guidance in sterile services, particularly for low- and middle-income countries, the current Pan American Health Organization (PAHO) manual was written by two very knowledgeable colleagues, Drs Silvia I Acosta-Gnass and Valeska de Andrade Stempliuk, who worked tirelessly to produce a working document for PAHO/WHO. The manual has been revised in close collaboration with the Infection Prevention and Control Global Unit of the World Health Organization (WHO) Headquarters to expand its scope to a global context in recognition of countries where sterile services departments (SSD) either do not exist or are inadequately run. The aim of this manual is to provide guidance in improving standards in sterile services across health-care facilities worldwide.

The Working Group comprises international experts in the sector of reprocessing of medical devices with a vast experience and knowledge related to the legislation, processes and outcomes of well-established sterile services.