AAMI Issues New Standard on Water Quality for Medical Device Processing

Water quality is an important aspect of medical device reprocessing because of the critical role it plays in ensuring the effectiveness of the process. Water can be a source of microorganisms and chemicals that can negatively affect reprocessing and thus device safety.

The Association for the Advancement of Medical Instrumentation (AAMI) provides expert guidance for settings such as hospitals and ambulatory surgery centers (ASCs) on issues including the reprocessing of instruments and devices. In October 2023, in response to what the organization said was an "extraordinary amount of interest," AAMI published a new standard that establishes requirements for the quality of water used to process medical devices. The standard, ANSI/AAMI ST108:2023, "Water for the processing of medical devices." This new standard revises and replaces AAMI TIR34:2014/(R)2021, which provided information and guidance on water quality for device reprocessing.

AAMI states its new standard:

  • identifies the categories of water quality that should be used during each stage of sterile processing;

  • provides a risk analysis and establishes roles and responsibilities for processing facilities;

  • assesses water quality based on factors such as pH, microbial level, conductivity and other properties;

  • establishes maintenance, monitoring and quality improvement procedures for water treatment systems; and

  • addresses emergency circumstances such as service interruptions and boil water advisories.

Infection Control Consulting Services (ICCS) assists central sterile processing departments (CSPDs) in maintaining strict compliance for reprocessing, including following nationally recognized guidelines and standards from the Centers for Medicaid & Medicare Services (CMS); accreditation organizations, including The Joint Commission; and organizations like AAMI. The ICCS team has extensive experience with monitoring the processes for pre-cleaning, high-level disinfection, sterilization, environmental cleaning and much more. ICCS also supports organizations that have undergone a survey that identified deficiencies associated with reprocessing and others in putting together a plan of correction.

Contact ICCS to learn what our team can do for your organization.

Should You Perform Hand Hygiene Before Gloving?

By ICCS Founder Phenelle Segal, RN, CIC, FAPIC

An article recently published in the Journal of the American Medical Association (JAMA) highlights a study intended to assess the value of performing hand hygiene prior to donning non-sterile gloves when compared to donning such gloves without prior hand hygiene.

The Infection Control Consulting Services (ICCS) team visits many facilities in the ambulatory surgery setting, and the most frequent violation of proper practices concerns improper hand hygiene. This violation occurs most frequently prior to healthcare personnel donning gloves.

Performing hand hygiene before donning gloves is a practice that's expected, with the Centers for Disease Control and Prevention (CDC) providing specific guidance in the area. Its guidance includes the expectation that staff will perform hand hygiene immediately before touching a patient, performing an aseptic task (e.g., placing an indwelling device) or handling invasive medical devices.

CDC specifies the need for hand hygiene “before touching a patient.” Hence, the ICCS team expects to observe this practice before gloving. Donning gloves is an activity required prior to touching a patient, thus it should be preceded by use of hand sanitizer or handwashing to perform hand hygiene.

ICCS will continue to endorse hand hygiene prior to donning gloves until standards change. While this report is receiving significant media attention, it is important that providers of care do not make a change in their practice based upon the conclusion from a single study and article. We hope to see many additional studies on the subject so we can better determine whether standards should change.

ICCS services include observing practices and providing a written report of findings and suggestions for improvement. As noted, shortcomings with hand hygiene is the most common deficiency we observe in ambulatory settings. Ongoing hand hygiene education is required by the Centers for Medicare & Medicaid Services (CMS) as well as accreditation agencies. Our consultants are also able to assist with the development and provision of hand hygiene education that helps with patient safety and maintaining compliance.

Reuse of Single-Use Devices: Why Dental Practices Are Coming Up Short

Infection Control Consulting Services (ICCS) continues to provide a range of services to dental practices, including assistance with remediating deficiencies related to non-compliant practices which violate nationally recognized guidelines and standards.

An ICCS client was recently reported to the state department of health (DOH) and dental board by an employee who was concerned about the reuse of a single use item labeled as disposable. Depending on the type of item being reused, the state DOH will discipline the practice based on the level of risk to patients. The consequences of a visit from authorities include a spectrum of penalties from fines to the dentist(s) losing their license to the worst-case scenario of dental practices being required to notify patients that they may have been exposed to a bloodborne pathogen.

Reuse of single use devices remains a significant issue in the dental community. According to observations conducted onsite and via staff interviews, ICCS consultants report the following as the reasons dental practices fail to adhere to the standards:

  • Cost savings

  • Lack of recognizing international symbols (e.g., single-use symbol of a 2 with a slash through it)

  • Misunderstanding product labels (disposable items are also considered one-time use)

  • Unaware of the importance of a manufacturer’s instructions for use (IFU)

  • Overall lack of general infection prevention and control education

ICCS reminds the dental community that the Centers for Disease Control and Prevention (CDC) released Guidelines for Infection Control in Dental Health-Care Settings in 2003 and updated in 2016, with an extensive checklist for offices to follow. The American Dental Association references the CDC guidance and encourages all dental practices to strictly adhere to them. Educating and reeducating staff on the importance of following nationally recognized guidance, following manufacturer's IFUs and considering items as single use if IFUs are absent are vital to patient safety.