由 Sean Ruck
, Contributing Editor | June 12, 2020
From the May 2020 issue of HealthCare Business News magazine
Like so many other industry events, the 2020 AAMI Exchange has been cancelled in light of the ongoing coronavirus pandemic.
While that means the HTM community will not be converging on New Orleans as planned, it also means that Robert Jensen, president and CEO of AAMI, has his hands full with making sure clinical engineers have access to the resources that will keep them safe and healthy during this time when their services are more critical than ever. HealthCare Business News spoke to him about the role of AAMI members, and leadership, in getting through these difficult times.
HCB News: Concerns about a pandemic have been discussed for years, but largely a “back burner” topic. Where did that stand on AAMI’s radar?
Crises like this pandemic are the exact reason why consensus standards are so critical to begin with, as they help establish rigorous and thorough procedures and guidelines designed to protect patient safety. We’ve seen particular interest in standards related to personal protective equipment (PPE) and sterilization procedures, which is why we’ve made many of those resources freely available, and worked with ANSI to make sure that critical ISO and IEC Standards for medical equipment like ventilators and protective equipment are also freely available.
HCB News: What were the first steps AAMI took in regard to COVID-19 and when did those efforts begin?
We’ve taken several steps to help the health technology and sterilization communities fight the coronavirus pandemic.
One of the first steps we’ve taken is to make one standard and two technical information reports available at no cost. These resources address the production, selection, and use of PPE and surgical drapes for the healthcare environment and the effective disinfection of medical devices, patient-care equipment, and sterile processing environmental surfaces.
• ANSI/AAMI PB70:2012, Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities
• AAMI TIR11:2005/(R)2015, Selection and use of protective apparel and surgical drapes in healthcare facilities
• TIR68:2018, Low and intermediate-level disinfection in healthcare settings for medical devices and patient care equipment and sterile processing environmental surfaces
We also set up a task group of industry, clinical, and regulatory leaders to develop consensus around requirements for emergency-use equipment. That group has already produced Consensus Reports (CRs) that detail the safety and performance requirements for emergency-use ventilators. They will be of great help to manufacturers who are producing this equipment, to those who are testing it, and to the regulators who need to approve this equipment for immediate use. The group is also preparing design guides for emergency-use resuscitators and CPAP/BiPAP equipment. Our CRs can be downloaded for free at www.aami.org/COVID_CR.