Advancing Safety in Health Technology

AAMI Consensus Report

Emergency Use Ventilator

(EUV) Design Guidance
AAMI/CR501:2020
AAMI Consensus Report AAMI CR501:2020
Revision 1.2
8 April 2020

Emergency use ventilator (EUV) design guidance

Revisions are expected to be made to this document as the COVID-19 situation evolves. Please go to
https://www.aami.org/covid_cr to find the most current version as well as past versions. This document is
freely available and may be shared with all interested stakeholders. Contact celliott@aami.org with any
comments or questions.

Approved 8 April 2020 by

AAMI

Abstract: Provides targeted design constraints to enable rapid development of emergency use ventilators
(EUV) to treat patients with COVID-19 respiratory failure. Also intended to guide the review of an
EUV by an authority having jurisdiction.

Keywords: COVID-19
AAMI Consensus Report
A Consensus Report (CR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI)
developed to provide concise, prompt and practical guidance on narrowly focused topics of high importance to the
health technology community. A Consensus Report is intended provide initial consensus guidance in response to an
urgent/immediate need for guidance in the following instances:

• While more robust data/information develops on emergent areas

• When variation in the development, implementation or use of a product or process exists

• When existing standards or other documents require additional context/clarification

A Consensus Report is not subject to the same formal process as a standard and while similar in nature to a technical
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© 2020 by the Association for the Advancement of Medical Instrumentation

All Rights Reserved

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Printed in the United States of America

ISBN 978-1-57020-748-8
Contents Page

Task Group representation ......................................................................................................................iv

Acknowledgments ................................................................................................................................... v
Purpose................................................................................................................................................... 1
Introduction ............................................................................................................................................. 1
Review of the requirements of ISO 80601-2-80 and their applicability to an EUV...................................... 2
Task Group representation

Association for the Advancement of Medical Instrumentation

COVID-19 Response Team Members

This AAMI Consensus Report (CR) was developed by a task group under the auspices of the AAMI COVID-19
Response Team.
The AAMI COVID-19 Response Team had the following members:

Cochairs: Jennifer Danieley

David Feinstein
Julian Goldman

Members: Simona Bancos, FDA/CDRH

Andrew Bath, ResMed Inc.
Brandon Blakely, FDA/CDRH
Brad Bonnette, ECRI Institute
Caitlin Brady, Intertek
David Busch, UT Southwestern Medical Center
Anthony Ciccarello, Philips
Steven Dain, University of Western Ontario
Rakhi Dalal, FDA/CDRH
Jennifer Danieley, FDA/CDRH
Andy Doering, Medtronic
Simon Dunham, Weill Cornell Medicine
David Feinstein, American Society of Anesthesiologists (ASA)
Bruce Friedman, GE Healthcare
Hamed Ghods, FDA/CDRH
Julian Goldman, Partners HealthCare System
Ralf Heesch, Draeger Medical Systems Inc.
Heidi Horn, Nuvolo Technologies
Fernando Isaza, Philips
Michael Jaffe, Cardiorespiratory Consulting LLC
Gardner Kimm, Medtronic Inc Campus
Robert Kopotic, Edwards Lifesciences
Hubertus Lasthaus, VitalAire Germany
Ed Madsen, Avanos Medical
Phoebe Mainland, Alfred Health
Madeleine Manousaridis, Standards Australia
Benoit Marchal, Air Liquide
Thomas Marmet, GE Healthcare
Debra Milamed, Harvard University
Cyndy Miller, Medtronic Inc Campus
Bryant Moeller, ResMed Inc.
Curtis Morgan, 3M Health Care
Akito Ohmura, Teikyo University-Mizonokuchi Hospital
David Osborn, Philips
John Stark, 3M Health Care
Robert Steurer, Steurer Consulting Group
Dongbo Wang, FDA/CDRH
Sandy Weininger, FDA/CDRH

NOTE—Participation by federal agency representatives in the development of this document does not constitute
endorsement by the federal government or any of its agencies.

iv © AAMI 2020 AAMI CR501:2020

Acknowledgments

AAMI gratefully acknowledges the writing team members, Julian Goldman, Dave Osborn, Anthony Ciccarello and
Sandy Weininger for their outstanding and expeditious work in preparing these drafts for committee review and
approval.

© AAMI 2020 AAMI CR501:2020 v

 1 AAMI Consensus Report AAMI CR501:2020

2 Emergency use ventilator (EUV) design guidance

3 Purpose

4 The goals of this document are to provide targeted design constraints to enable rapid development of
5 emergency use ventilators (EUV) to treat patients with COVID-19 respiratory failure. This document is also
6 intended to guide the review of an EUV by an authority having jurisdiction.

7 It is recognized that the surge in COVID-19 is requiring extraordinary measures to provide mechanical
8 ventilatory support to keep pace with clinical need. This global community of clinicians, engineers,
9 manufacturers, regulators, and others are responding to this need by designing and producing, inexpensive,
10 and often open-source, ventilators of varying complexity and capabilities for rapid deployment. This
11 document identifies clinical, engineering and test requirements appropriate to support safe operation. The
12 document identifies requirements that are required for non-EUVs but might not be required for EUVs that
13 have appropriate disclosures. Therefore, ventilators complying with the requirements of this document need
14 not provide a level of performance equivalent to that of critical care ventilators (ISO 80601-2-12 1) or life-
15 supporting homecare ventilators (ISO 80601-2-722).

16 NOTE This document is intended to be used in conjunction with AAMI CR502:2020, End user disclosures for
17 emergency use ventilators (EUVs).

18 Introduction

19 The requirements outlined in this paper are modeled on ISO 80601-2-80:20183 presuming usage in
20 traditional healthcare facilities (e.g. hospitals, assisted living facilities, nursing homes) as well as spaces
21 converted for the care of large numbers of COVID-19 patients (e.g. convention centers, university
22 dormitories, motels). This paper presumes that the operators of the EUV are all trained professional
23 healthcare providers and not lay persons. Hence the requirements of ISO 80601-2-80:2018 specifically for
24 lay operators or the home healthcare environment are considered not applicable to an EUV intended for
25 the treatment of COVID-19 patients.

26 Fundamentally, the EUV needs to provide ventilation at the patient-connection port within the alarm limits
27 set by the operator or inform the operator via an alarm condition that ventilation within the alarm limits is
28 not occurring. Such alarm conditions need to include:

29 • Gas or electricity supply failure.

30 • Ventilator switched off while in mandatory ventilation mode.

1 ISO 80601-2-12, Medical electrical equipment — Part 2-12: Particular requirements for basic safety and
essential performance of critical care ventilators
2 ISO 80601-2-72, Medical electrical equipment — Part 2-72: Particular requirements for basic safety and
essential performance of home healthcare environment ventilators for ventilator-dependent patients
3 ISO 80601-2-80, Medical electrical equipment — Part 2-80: Particular requirements for basic safety and
essential performance of ventilatory support equipment for ventilatory insufficiency

© AAMI 2020 AAMI CR501:2020 1

31 • Inspiratory airway pressure exceeded.

32 • Inspiratory and PEEP pressure not achieved (equivalent to disconnection alarm condition).

33 • Tidal volume not achieved or exceeded.

34 The ventilatory support needs of a COVID-19 patient can range from simple BIPAP (bilevel positive airway
35 pressure) for patients that are breathing spontaneously to mandatory ventilation in either a pressure-support
36 or volume control mode. Additionally, these patients are very likely to require inspired oxygen
37 concentrations (FiO2) in excess of the 21 % contained in room air.

38 To properly manage a COVID-19 patient, the EUV needs to indicate to the operator at a minimum:

39 • The current settings (e.g., inspiratory pressure, tidal volume, frequency, PEEP, FiO2, ventilation
40 mode).

41 • The current delivery (e.g., inspiratory pressure, tidal volume, respiratory rate, PEEP, and FiO2 at
42 the patient-connection port).

43 To properly manage a COVID-19 patient, the operator needs to be able to control the EUV at a minimum:

44 • FiO2 over the range of 21 % (ambient) to 95 % of the source oxygen concentration input to the EUV
45 in no more than 10 % steps

46 NOTE When oxygen is provided by an oxygen concentrator, the input concentration is not 99.5%, but can
47 vary from 90% to 96% in which case the upper limit of FiO2 would be 90 %.

48 • Set PEEP (i.e. BAP) (5 to 20) cmH2O in no more than 5 cmH2O steps

49 • I:E ratio (ratio of inspiratory to expiratory time) of 1:2 preferably adjustable from 1:1 to 1:3

50 • For mandatory modes, respiratory rate from (10 to 30) inflations/min preferably adjustable in steps
51 of no more than 2 inflations/min

52 • Tidal volume (350 to 450) ml ±10 % in no more than steps of 50 ml, preferably a lower range of
53 250 ml and an upper range of 600 ml or 800 ml

54 • Where applicable, inspiratory pressure limit (15 to 40) cmH2O preferably adjustable in steps of no
55 more than 5 cmH2O

56 To help prevent contaminating the environment (and particularly the clinicians), filters need to be placed in
57 the expiratory pathways. Particular attention needs to be placed on the exhaust port.

58 Review of the requirements of ISO 80601-2-80 and their applicability to an EUV

59 NOTE Any subclause marked with an asterisk (*) means that further guidance for this requirement is available in
60 Annex A of the standard.

2 © AAMI 2020 AAMI CR501:2020

61 Remember that ISO 80601-2-80 is a particular standard so it is written on top of (i.e. it modifies) the GS
62 (the general standard, IEC 60601-1 4) and the collateral standards (i.e. IEC 60601-1-2 5 on EMC, IEC 60601-
63 1-6 6 on usability and IEC 60601-1-8 7 on alarms). There are additional applicable collateral standards (and
64 hence requirements) if the EUV is intended for home use, ambulance use or as part of a physiological
65 closed loop control system. These standards can be purchased from many sources including ANSI 8 and
66 AAMI9.

67 NOTE Words written in SMALL CAPS are not ‘normal English’. They are defined terms and have specific, defined
68 meanings. See Clause 3 in the GS and 201.3 in ISO 80601-2-80 for their definitions.

69 201.4.11.101 Additional requirements for pressurized gas input

70 Fully required.

71 These are the requirements for an EUV intended to connect to either an air or oxygen pipeline.

72 Clause 5 General requirements for testing of ME EQUIPMENT

73 This Clause of the GS is fully required.

74 201.5.101 Additional requirements for the general requirements for testing of ME EQUIPMENT

75 Fully required.

76 This Clause explains how to interpret and perform tests as well as how to indicate specifications.

77 Clause 6 Classification of ME EQUIPMENT and ME SYSTEMS

78 This Clause of the GS is fully required.

79 An EUV may be Class I or Class II or internally powered.

80 Unless there are electrical connections to the PATIENT (e.g. monitoring ACCESSORIES) or heated breathing
81 tubes or electrically powered ACCESSORIES (e.g. expiratory valves located proximal to the PATIENT), the
82 plastic breathing tubes provide adequate floating electrical isolation.

83 Protection from the ingress of water: IP21 is required and IP22 is recommended. Body fluids and IV bags
84 are an expected normal part of the environment of use.

85 Since the EUV is expected to handle gas with an oxygen concentration in excess of the ambient 25 %, the
86 considerations for an OXYGEN RICH ENVIRONMENT (see IEC 60601-1, 11.2.2) are fully applicable.

4 IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
5 IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential
performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
6 IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for basic safety and essential
performance - Collateral standard: Usability
7 IEC 60601-1-8, Medical electrical equipment — Part 1-8: General requirements for basic safety and essential
performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical
equipment and medical electrical systems
8 ANSI, https://webstore.ansi.org/
9 AAMI, https://my.aami.org/store/

© AAMI 2020 AAMI CR501:2020 3

 87 201.6.101 Additional requirements for classification of ME EQUIPMENT and ME SYSTEMS

88 This subclause is recommended but not required. An EUV need not be TRANSIT-OPERABLE.

89 Rationale: For pandemic treatment, a tabletop (i.e. somewhat large) EUV is acceptable.

90 Clause 7 ME EQUIPMENT identification, marking and documents

91 7.1 General

92 This subclause of the GS is recommended but not required.

93 Rationale: Although ensuring that the EUV can be read both over the indicated illumination level and the
94 indicated cone of visibility is recommended, in this pandemic situation it is not considered mandatory. It is
95 noted that operators are likely wearing PPE and will have reduced visual acuity. Consideration should be
96 given to doubling the distance of the observer.

97 7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts

98 This subclause of the GS is required.

99 201.7.2.4.101, 201.7.2.13.101, and 201.7.2.101

100 These subclauses are required.

101 7.3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts

102 This subclause of the GS is required.

103 7.4 Marking of controls and instruments

104 This subclause of the GS is required.

105 201.7.4.2 Control devices

106 This subclause is required.

107 201.7.4.3 Units of measurement

108 This subclause is required.

109 7.5 Safety signs

110 This subclause of the GS is required.

111 7.6 Symbols

112 This subclause of the GS is required.

113 7.7 Colours of the insulation of conductors

114 This subclause of the GS is required.

115 7.8 Indicator lights and controls

116 This subclause of the GS is required.

4 © AAMI 2020 AAMI CR501:2020

117 NOTE The pending amendment to the GS clarifies this requirement.

118 7.9 ACCOMPANYING DOCUMENTS

119 This subclause of the GS is required.

120 201.7.9.1 Additional general requirements

121 This subclause is required.

122 201.7.9.2.1.101, 201.7.9.2.1.102 and 201.7.9.2.9.101

123 These subclauses are required except for the portions of these subclauses relating to LAY OPERATORS that
124 are not required.

125 Rationale: OPERATORS of an EUV are trained professional healthcare providers.

126 201.7.9.2.2.101 Additional requirements for warnings and safety notices

127 Elements e) and g) are not required as they are not relevant in this situation.

128 201.7.9.2.8.101, 201.7.9.2.12, 201.7.9.2.13.101 and 201.7.9.2.14.101

129 These subclauses are required.

130 201.7.9.3.1.101 and 201.7.9.3.101

131 These subclauses are required.

132 Clause 8 Protection against electrical HAZARDS from ME EQUIPMENT

133 This Clause of the GS is generally required.

134 NOTE 1 Unless there are electrical connections to the PATIENT (e.g. monitoring ACCESSORIES) or heated breathing tubes
135 or electrically powered ACCESSORIES (e.g. expiratory valves located proximal to the PATIENT), the plastic breathing tubes
136 provide adequate floating electrical isolation for PATIENT LEAKAGE CURRENT.

137 NOTE 2 Commercially available ITC (information technology communications) power supplies can be used, but
138 electrical safety criteria (e.g. ENCLOSURE TOUCH CURRENTS and dielectric withstand) are likely to exceed IEC 60601-1
139 limits. This can be mitigated in several ways such as:

140 • use of a low leakage SEPARATION DEVICE (isolation transformer) (see 16.5 of the GS);

141 • a second PERMANENTLY INSTALLED PROTECTIVE EARTH CONNECTION (see 16.6 of the GS);

142 • instructing the OPERATOR to not touch the EUV and the PATIENT at the same time.

143 Clause 9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS

144 This Clause of the GS is recommended but not required, expect for 9.3 that is required.

145 201.9.4.3.101 Additional requirements for instability from unwanted lateral movement

146 This subclause is not required.

147 Rationale: This requirement is for equipment intended to be used while moving in e.g. a car.

© AAMI 2020 AAMI CR501:2020 5

148 201.9.4.4 Grips and other handling devices

149 This subclause is recommended but not required.

150 Rationale: This requirement is intended to make it easy to move the equipment around between uses. That
151 is not crucial for use during a pandemic.

152 201.9.6.2.1.101 Additional requirements for audible acoustic energy

153 This subclause is not required.

154 Rationale: This test is hard to perform and takes expensive equipment to perform. It only provides
155 information for disclosure that is not crucial for use during a pandemic.

156 Clause 10 Protection against unwanted and excessive radiation HAZARDS

157 This Clause of the GS is required.

158 Clause 11 Protection against excessive temperatures and other HAZARDS

159 This Clause of the GS is required.

160 201.11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT

161 This subclause is only applicable if a heated humidifier is utilized. See ISO 80601-2-74.

162 201.11.6.6 CLEANING and DISINFECTION of ME EQUIPMENT or ME SYSTEM

163 This subclause is required.

164 201.11.7 BIOCOMPATIBILITY of ME EQUIPMENT and ME SYSTEMS

165 This subclause is recommended but not required.

166 The chosen materials for the GAS PATHWAYS need to be reasonably pure and simple in nature (minimize the
167 use of additives where possible). Avoid Polyvinyl chloride (PVC) in the GAS PATHWAYS. When possible,
168 efforts should be taken to use materials which have a long history of safe use in currently marketed medical
169 devices. Care is needed to ensure that gas pathways are free of foreign material (e.g. oil, particles, volatile
170 organic compounds, mold release agents should be avoided in the GAS PATHWAYS). Care is needed to
171 ensure that gas pathways do not contain toxic compounds (e.g., formaldehyde), and do not release noxious
172 gases (e.g., ozone, carbon monoxide) and fumes. The ACCOMPANYING DOCUMENTS should include
173 cautionary statement for any BIOCOMPATIBILITY identified RISK.

174 Rationale: The tests of ISO 18562 (series)10 are very expensive, time consuming to perform and require
175 very specialized test equipment. Requiring these tests for an EUV would so delay their availability such that
176 new designs would not be available when needed.

177 201.11.8.101 Additional requirements for interruption of the power supply/SUPPLY MAINS to ME
178 EQUIPMENT ALARM CONDITION

179 This subclause is required.

10 ISO 18562 (series), Biocompatibility evaluation of breathing gas pathways in healthcare applications

6 © AAMI 2020 AAMI CR501:2020

180 An external UPS (uninterruptable power supply) may be used to fulfill this requirement.

181 Rationale: The power back up and appropriate notification of power loss is what is important. It need not
182 be integrated into the EUV.

183 201.11.8.101.2 Alternative power supply/SUPPLY MAINS

184 This subclause is only required if the EUV is TRANSIT-OPERABLE.

185 Rationale: For pandemic treatment, an EUV is not required to be TRANSIT-OPERABLE.

186 Clause 12 Accuracy of controls and instruments and protection against hazardous outputs

187 This Clause of the GS is required.

188 201.12.1 Accuracy of controls and instruments

189 This subclause is not required.

190 Rationale: These requirements are intended for home use by LAY OPERATORS.

191 201.12.1.101, 201.12.1.102 and 201.12.1.103 (breath types)

192 These subclauses are required.

193 201.12.2.101 USABILITY of ME EQUIPMENT

194 This subclause is required except for d) that is not applicable.

195 Rationale: Requirement d) is related to home use by LAY OPERATORS.

196 201.12.4 Protection against hazardous output

197 All subclauses of 201.12.4 are required.

198 201.12.101 Protection against accidental adjustments

199 This subclause is required.

200 Clause 13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT

201 This Clause of the GS is required.

202 201.13.2.101 * Additional specific SINGLE FAULT CONDITIONS

203 This subclause is required.

204 201.13.2.102 * Independence of ventilation control function and related RISK CONTROL measures

205 This subclause is required.

206 Clause 14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)

207 This Clause of the GS is recommended but not required.

© AAMI 2020 AAMI CR501:2020 7

208 Clause 15 Construction of ME EQUIPMENT

209 This Clause of the GS is required.

210 201.15.102 Pre-use check

211 This subclause does not apply.

212 Rationale: These requirements are directed to the needs of a LAY OPERATOR.

213 Clause 16 ME SYSTEMS

214 This Clause of the GS is required.

215 201.16.1.101 Additional general requirements for ME SYSTEMS

216 This subclause is required.

217 Clause 17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS

218 See Clause 202.

219 201.101 Gas connections

220 This subclause is required.

221 201.102 Requirements for the VBS and ACCESSORIES

222 This subclause is required.

223 201.103 Spontaneous breathing during loss of power supply

224 This subclause is required.

225 201.104 Training

226 This subclause is required.

227 201.105 Indication of duration of operation

228 This subclause is recommended but not required.

229 Rationale: These early warning maintenance-related requirements are not absolutely necessary in a
230 pandemic situation.

231 201.106 Functional connection

232 This subclause is required.

233 201.107 Display loops

234 This subclause is required.

235 201.108 Power supply cords

236 This subclause is required.

8 © AAMI 2020 AAMI CR501:2020

237 201.109 VENTILATORY SUPPORT EQUIPMENT security

238 This subclause is not required.

239 Rationale: These requirements are needed when there are LAY OPERATORS.

240 202 Electromagnetic disturbances — Requirements and tests

241 This Clause is recommended but not required.

242 Rationale: The tests of IEC 60601-1-2 are time consuming and expensive set of tests that take very
243 specialized equipment. Requiring these tests for an EUV would delay availability such that new designs
244 might not be available when needed. Disclosure that these tests have not been performed and that other
245 equipment must be kept at a distance should be considered sufficient.

246 206 USABILITY

247 This Clause is recommended but not required.

248 Rationale: USABILITY as described in IEC 60601-1-6 ensures safety by proscribing a design PROCESS. A
249 proper USABILITY evaluation is extremely time consuming and requires subject matter experts. A hard to use
250 EUV can be better than no EUV.

251 208 General requirements, tests and guidance for alarm systems in medical electrical equipment
252 and medical electrical systems

253 This Clause is recommended but not required.

254 Rationale: Full compliance with IEC 60601-1-8 would be helpful to the OPERATORS as they would more
255 readily understand the operation of the EUV ALARM SYSTEM. Care needs to be taken with auditory ALARM
256 SIGNALS to ensure that they are not too obtrusive, appropriately priority encoded (so that more urgent
257 problems are more highlighted) and there must be a means to inactivate any auditory ALARM SIGNAL. The
258 ALARM SYSTEM, ALARM LIMITS, and ALARM CONDITION priorities are complex areas to optimize for USABILITY.
259 Annex A of IEC 60601-1-8 provides a great deal of guidance.

260 211 Requirements for medical electrical equipment and medical electrical systems used in the
261 home healthcare environment

262 This Clause is not required.

263 Rationale: These requirements relate to home use.

© AAMI 2020 AAMI CR501:2020 9