In response to the growing COVID-19 public health crisis, AAMI is releasing three standards and technical information reports (TIRs) at no cost. These resources address the production, selection, and use of personal protective equipment (PPE) and surgical drapes for the healthcare environment and the effective disinfection of medical devices, patient-care equipment, and sterile processing environmental surfaces.
“Right now, our healthcare system is facing unprecedented challenges. Fortunately, the health technology community is rising to meet them,” says Rob Jensen, president and CEO of AAMI. “As companies from various industries work to meet the rising global demand for PPE, and health systems work to make the best use of limited resources, these AAMI documents play an essential role in ensuring that urgently needed products are safe, effective, and available.”
In addition, AAMI and the Health Technology Alliance are hosting an online town hall (open to media and the public) to discuss health technology challenges and solutions related to the Coronavirus at 4:00 p.m. ET on Tuesday, March 24. REGISTER.
The following AAMI documents are now available for free download:
- ANSI/AAMI PB70:2012, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
An American National Standard, ANSI/AAMI PB70 provides manufacturers with a consistent basis for creating device labeling claims regarding barrier efficacy against liquid-borne microorganisms. Through labeling requirements, the standard is also intended to assist end-users in selecting the appropriate protective apparel and drapes to inhibit the transfer of microorganisms associated with blood, body fluids, and other potentially infectious materials. FREE DOWNLOAD
- AAMI TIR11:2005/(R)2015, Selection and use of protective apparel and surgical drapes in healthcare facilities
This technical information report (TIR) covers the selection and use of protective apparel and surgical drapes. It includes information on types of protective materials, safety and performance characteristics of protective materials, product evaluation and selection, levels of barrier performance, and care of protective apparel and drapes. FREE DOWNLOAD
- TIR68:2018, Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
TIR68 provides guidance on the selection and use of low and intermediate-level disinfectants and disinfection processes for safe and effective use. FREE DOWNLOAD
Standards are voluntary consensus documents that provide requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for their purpose. AAMI develops standards documents aimed at enhancing the safety, efficacy, safe use, and management of medical devices and health technologies. A technical information report (TIR) is a review of technical issues relevant to a particular technology and a statement of expert opinion. TIRs can provide additional guidance to a standard or advice on how a standard might be implemented.
As the coronavirus crisis continues, AAMI is providing direct support and guidance, via a Q&A with The Joint Commission’s director of engineering, hosting an online Coronavirus town-hall, and by providing other useful resources.