By AAMI
The Association for the Advancement of Medical Instrumentation (AAMI) is happy to announce the adoption of a new tranche of ISO guidance documents. Adopted periodically over the past fiscal year, the guidance documents listed below bring valuable international guidance on medical devices to the American market. The guidance documents address a range of issues, primarily hospital sterilization, industrial sterilization and cardiovascular devices.
According to Matthew Williams, vice president of standards, AAMI, the adoption of these ISO documents will benefit the American health care system.
“AAMI’s adoption of these ISO standards provides clarity for U.S. medical device manufacturers and healthcare delivery organizations and promotes the harmonization of best practices around the world,” he explained. “Standards are conformance-based documents that serve to assist health care industry by outlining efficacy and safety requirements for a medical device or process. Being a primary source of consensus standards for the medical device industry, AAMI’s members and advisory groups help shape the discussions that create these international standards. Patient safety is everyone’s North Star, so collaborating on the world stage for these important documents is par for the course.”
Guidance on Industrial and Hospital Sterilization
ANSI/AAMI/ISO 11138-8:2023, Sterilization of health care products – Biological indicators – Part 8: Method for validation of a reduced incubation item for a biological indicator, provides guidance on test methods used to confirm reduced incubation times of less than seven days for biological indicators used in monitoring sterilization processes.
ANSI/AAMI/ISO 18472:2022, Sterilization of health care products – Biological and chemical indicators – Test equipment, relates to equipment sterilization. This revised standard provides requirements for test equipment used to assess biological indicators and test chemical indicators for various sterilization modalities.
Guidance on Industrial Sterilization
AAMI/ISO TIR21387:2023, Sterilization of health care products – Guidance on the requirements for the validation and routine processing of ethylene oxide sterilization processes using parametric release, is a technical information report (TIR) on industrial sterilization that provides clarity on ethylene oxide sterilization that relies on parametric release for verification.
AAMI/ISO TIR16775:2023, Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2, was recently revised to reflect new scientific understanding and industry knowledge. This TIR indicates how to comply with prior ISO guidance related to best practices for packaging devices subject to sterilization modalities like ethylene oxide or gamma radiation.
ANSI/AAMI/ISO 11137-3:2017/(R)2023, Sterilization of health care products – Radiation – Part 3: Guidance on dosimetric aspects, is a reaffirmation of the requirements for the use of dosimetry found in guidance documents like ISO 1137-1 and ISO 11137-2.
ANSI/AAMI/ISO 17664-1:2022, Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices, is another newly adopted industrial sterilization standard that specifies what information medical device manufacturers should provide regarding devices that require sterilization or disinfection.
ANSI/AAMI/ISO 17664-2:2022, Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2: Non-critical medical devices, addresses information manufacturers should provide for non-critical medical devices that are intended to undergo sterilization.
AAMI/ISO TIR22456:2022, Sterilization of health care products – Microbiological methods – Guidance on conducting bioburden determinations and tests of sterility for biologics and tissue-based products, is a newly adopted TIR related to industrial sterilization that provides guidance on specific bioburden determinations and sterility tests.
Guidance on Cardiovascular Implants
Three related revised standards on cardiovascular implants will also provide for the verification and validation of the design of surgical heart valve substitutes using risk management based on a variety of different tests. These include:
ANSI/AAMI/ISO 5840-1:2021, Cardiovascular implants – Cardiac valve prostheses – Part 1: General requirements.
ANSI/AAMI/ISO 5840-2:2022, Cardiovascular implants – Cardiac valve prostheses – Part 2: Surgically implanted heart valve substitutes.
ANSI/AAMI/ISO 5840-3:2022, Cardiovascular implants – Cardiac valve prostheses – Part 3: Heart valve substitutes implanted by transcatheter techniques.
Guidance on Medical Symbols
ANSI/AAMI/ISO 15223-1:2022, Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements, is a revised standard related to the symbols used for a broad range of medical devices, whether on the device itself, its packaging, or accompanying information. The standard makes changes such as adding new symbols that were validated by guidance documents like ISO 15223-2.
House Calls for HTM? Seeking to Survey Home Healthcare Practices
Is your local health system meeting a growing demand for home healthcare? Is your healthcare technology management (HTM) department suddenly doing house calls? AAMI wants to hear all about it and more for a unique survey of the HTM field.
“It really is important that we hear from all sectors of the industry,” said Mike Busdicker, an enterprise director for Intermountain Health and chair of AAMI’s Technology Management Council (TMC). “So, we’re looking at maintenance management systems, independent organizations, in-house programs and manufacturers. The more information we can collect from the field, the better clarity we’ll be able to provide” for future resources and guidance.
The TMC is seeking to survey HTM professionals regarding if and how they are approaching home healthcare and the maintenance of devices intended for a patient’s home. Relevant organizations and professionals are welcome to participate in the ongoing survey.
“One of the things we’re really looking at now, as the technology continues to advance, is home healthcare. And that’s different than telehealth,” Busdicker explained.
As an example, Busdicker shared that Intermountain Health, an early adopter of home health capabilities located in Salt Lake City, Utah, has an inventory of 35,000 pieces of medical equipment intended for the care of a patient in their home. And while these devices don’t always facilitate remote patient monitoring or remote doctor-to-patient communication – as would be seen with telehealth devices – they do remain a constant fixture in patient’s treatment.
“We’re now installing things like dialysis machines, O2 concentrators, etcetera … So, now our frontline caregivers and HTM technicians have to go into patients’ homes” to care for those patients and maintain their devices, Busdicker said. He added that the demand for at-home healthcare is only increasing as technological advances in medical devices enable new levels of at-home care.
The main question he and his peers are seeking to answer is, “What is the involvement of HTM departments in home health?” Once Busdicker and his peers have a better understanding of how your average HTM department is approaching the subject, they’ll better be able to identify common challenges the TMC may address by creating guidance documents and curating helpful resources for the greater HTM community.
“How many organizations are involved with home health? How many have home health facilities located throughout a state or region where equipment is going out to patients and coming back? And when a patient goes home and equipment goes with them, how involved is HTM with that process?” he asked. “We want to learn as much as we can.”
