In recognition of the need for additional guidance on the reprocessing of flexible and semi-rigid endoscopes, AAMI has unveiled a new standard that brings together information from various sources into a single resource.
The standard, titled “ANSI/AAMI ST91:2015, Comprehensive guide to flexible and semi-rigid endoscope processing in health care facilities,” comes at a time of heightened public concern about the cleanliness and decontamination of these devices.
Difficult-to-treat infections caused by the carbapenem-resistant Enterobacteriaceae (CRE) have been reported in North Carolina, Pittsburgh, Los Angeles, Chicago and Seattle. These infections have been linked to a complex type of endoscope.
“Health care personnel are constantly facing challenges with the new, sophisticated devices being developed for patient care,” said Nancy Chobin, vice president for Sterile Processing Services, Barnabas Health, West Orange, N.J. Cleaning, sterilizing and disinfecting flexible endoscopes are particularly challenging due to their numerous lumens and channels, she added. There was no single document to turn to for guidance, and existing resources sometimes contradicted one another.
“ST91 compiles all the information practitioners need for processing flexible and semi-rigid endoscopes, and for the first time, serves as a national standard of practice,” Chobin added. “This should lead to less confusion and to set a standard for patient safety.”
This standard gives guidance on precleaning, leak-testing, cleaning, packaging, storage, high-level disinfecting and sterilizing of flexible endoscopes used in a range of procedures. Initially, the document was going to be a technical information report; however, the working group determined there was a need for more extensive guidance and revised it into a standard.
“I believe ST91 will be one of those ‘must have’ documents for hospitals,” said Sue Klacik, the International Association of Healthcare Central Service Material Management representative on AAMI committees dealing with sterilization standards. “It will be like ST79 and ST58 — highly sought after because of an ongoing need. Furthermore, it will contain all of this great information in one location.”
ST79 and ST58 are two popular and highly regarded standards, the first dealing with steam sterilization and the second dealing with chemical sterilization.
ST91 is available for purchase at www.aami.org/store.
Revised Guide Covers Electrical Safety Standards in Health Care Facilities
A manual intended for those responsible for electrical safety in health care facilities — including health care technology management (HTM) and facilities engineering professionals — has been updated.
Authored by consultant Matt Baretich, president of Baretich Engineering Inc., in Fort Collins, Colorado, the “Electrical Safety Manual, 2015” outlines the key components of an electrical safety program for medical devices and how to implement such a program. It also provides an overview of important codes, standards and regulations that affect medical devices.
“A key objective of this manual is to provide a single publication that pulls together critical material from the full range of applicable codes and standards,” Baretich writes in the introduction.
As it has before, the manual emphasizes that health care facilities must ensure that electrically powered devices are as free as possible from hazards. The manual notes that electrical safety in general has been enhanced over the years with improvements to the design of medical devices and stronger maintenance programs. At the same time, there are more rules dealing with electrical safety testing than ever before, underscoring the need for a comprehensive resource.
To that end, the manual covers a lot of ground. For example, one entire chapter provides a rundown on all the applicable codes, standards and regulations. And there are separate chapters on equipment-related safety requirements versus facility-related safety requirements. Additionally, it provides guidance for a number of challenges, such as how to manage medical device-related incidents and how to handle device recalls.
Two major changes from the 2008 edition are the inclusion of material regarding facility-related electrical safety — particularly information on isolated power systems — and the 2012 update to the National Fire Protection Association 99 Health Care Facilities Code.
The updated resource is available at www.aami.org/store.
Join the AAMI A List
AAMI is launching a new service to help facilitate communications between medical device manufacturers and the HTM professionals who purchase and maintain such equipment in hospitals.
The AAMI A List will enable technicians, engineers and other HTM professionals to provide feedback to manufacturers about medical device products and services — and learn about new products and services.
Several times through the year, device manufacturers and service providers approach AAMI about wanting to get in touch with clinical engineers, biomedical equipment technicians, and other HTM professionals. In many cases, the companies and service providers want to get input from HTM professionals about a particular issue or publicize a new product or service. But as a matter of policy, AAMI does not sell or rent its email or mailing list.
By joining the AAMI A List, HTM professionals can opt to receive one or two emails each month about a manufacturer, service provider, product or service. The emails are sent by AAMI, so email addresses will not be distributed to others. To sign up for the AAMI A List, visit www.surveymonkey.com/s/B82T9ZW.
Companies interested in distributing information through the AAMI A List should contact Jane Richardson, AAMI’s advertising manager, at jrichardson@aami.org.