Global Sterilization Standards Support Infection Prevention Better Patient Outcomes

In the words of poet Maya Angelou, “We are more alike, my friends, than we are unalike.” That is true of all people, and it is especially true of healthcare organizations and providers around the world. Though practices and protocols may vary from country to country, professionals in clinics and hospitals are dedicated to delivering the best care and patient safety possible. That includes ensuring that the environment is safe and critical instruments are sterile.

We know that effective sterilization helps lead to better patient outcomes. Best practices, standards and guidelines help drive us toward those better outcomes that we all seek. While resources for sterilization may vary from facility to facility and from country to country, having global guidelines in place will help us have a positive impact on patient health.

What areas are included in sterilization and disinfection related infection prevention protocols?

There is a hierarchy for what equipment and instruments are of most concern in a care setting. Bed rails, patient care equipment, surgical instruments and many things in between can be sources of contamination and subject to guidelines.

  • Environmental services (EVS), which focus on the surfaces throughout a facility, including countertops, bed rails and the TV remote control
  • Devices that are designated single-use because of risk of cross-contamination if reprocessed
  • Instruments that are reusable that enter an existing patient orifice, like a flexible endoscope
  • Surgical equipment and instruments – anything that comes in contact with the patient incision during surgery

Who drives standards and guidelines?

Globally: The International Organization for Standardization (ISO) is a worldwide standards setting body. It has set standards for many areas including medical devices. These standards describe performance requirements that may include how to manufacture devices (i.e. the type of metal to use in medical instruments). Compliance with ISO is not always mandatory, but some individual countries have recognized the standards and set regulations with which health care facilities must comply. ISO has many standards in development or updated processes that impact how devices are tested and sterilized.

The World Health Organization provides guidelines related to infection presentation and also sterilization practices. Countries that don’t have national regulations or guidelines can use standards set by the World Health Organization (WHO).

Regionally and nationally:

The European Committee for Standardization (CEN) develops sterilization standards for medical devices. These and some additional standards are part of regulations in European Union countries. There is a focus to align CEN sterilization standards to ISO sterilization standards.

The Association for the Advancement of Medical Instrumentation (AAMI) develops consensus standards for the U.S. medical device industry and health care facilities. The American National Standards Institute (ANSI) reviews and approves these standards and guidelines. ANSI is the US national standards representative to ISO.

The recommendations for these three groups are in alignment for the most part. There is a recognized goal that they are all in general alignment to avoid confusion and global medical device manufacturers can more readily comply with all of the standards.

What’s next?

In the U.S., compliance with sterilization standards are driven heavily by accreditation. This practice has been replicated in multiple countries already and will most likely be the norm soon in those countries who have not yet adopted this accreditation approach. Every country that I work with tells me that their practice is different from other countries, so they should have their own guidelines. It is true that there are some differences. For example, in most of the U.S. and Western Europe, sterilization services are not performed by clinicians but by sterilization specialists in the facility. In much of the rest of the world, sterilization is performed by people with different levels of clinical practices, like nurses and pharmacists; in some others they are biomedical engineers.

Another difference is in how they process specific instruments, like flexible endoscopes, where low temperatures are needed and sometimes required. In the U.S., we use vaporized hydrogen peroxide and ethylene oxide as low temperature sterilization methods, but other countries use different technologies, disinfectants or sterilants. For flexible endoscope reprocessing, there is a wide variation in practices. I believe standards will try to address the challenges of reprocessing and reusing flexible endoscopes, which have been related to several outbreaks of multi drug-resistant organisms. In the next several years, the way medical devices are designed and manufactured will advance and use newly engineered materials that can be sterilized using mostly saturated steam or that are disposable.

Standards are changing even as we speak – and these changes are intended to have a positive impact on patient safety around the world. Healthcare professionals, regardless of their country or job title, are driven by patient safety and have a strong connection with their patients. They will continue to regard preventing infections as an important part of their job.

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