AAMI has released emergency guidance documents to enable the rapid development of safe and effective emergency-use ventilators and resuscitators, which are essential to treating patients with COVID-19 respiratory failure. Published as the first four AAMI Consensus Reports (CRs), this emergency guidance was developed by the AAMI COVID-19 Response Team, consisting of manufacturers, clinicians, and FDA representatives.
“These CRs are an especially valuable roadmap for companies new to the health technology space who are stepping up to build emergency-use ventilators and resuscitators. While they have talented engineers, many do not have the foundational knowledge in this area, particularly when it comes to patient safety,” says Julian M. Goldman, MD, cochair of the AAMI COVID-19 Response Team, anesthesiologist and director of the Program on Medical Device Interoperability and Cybersecurity at Massachusetts General Hospital, and medical director of biomedical engineering for Partners HealthCare System.
In addition to design and safety guidance, the CRs help manufacturers save valuable time by pointing them to the standards documents and clauses that are most relevant to them.
“Once you show them that there are standards that exist, that can really help them rapidly understand what should be considered for safety, it makes the engineers’ lives much easier and speeds product development. They don’t have to ask for the same information over and over again—for example, what level of pressure is acceptable? What range of tidal volumes are typical? What kind of flow is typical? What are the things you worry about for safe and effective clinical use? Those are the questions that should be asked repeatedly, and the CRs contain that information,” Goldman says.
AAMI CRs provide concise, prompt, and practical guidance to respond to an urgent/immediate need for the health technology community. The following documents are available for free download at www.aami.org/COVID_CR.
- AAMI CR501:2020, Emergency Use Ventilator (EUV) Design Guidance
- AAMI CR502:2020, End User Disclosures for Emergency Use Ventilators (EUVs)
- AAMI CR503:2020, Emergency Use Resuscitator Systems Design Guidance
- AAMI CR504:2020, End User Disclosures for Emergency Use Resuscitator Systems
As these documents will continue to evolve, check back frequently for the latest updates. For the latest COVID-19 developments and news from AAMI, visit www.aami.org/Coronavirus.
If you need guidance around standards, FDA’s Emergency Use Authorization (EUA) process, or other quality assurance and regulatory affairs issues, AAMI can connect you with faculty who can provide assistance. For more information, contact Bradley Schoener at [email protected].