Month: May 2020

The theory of mind. A discussion on what we think others think.

September 15, 2020, 7PM, 2185 LBME

• Theory of Mind (Goldman)
• Theory of mind: The state of the art (Wellman)
• Theory of Mind and the Self (Happé)
• Why psychological accounts of personal identity can accept a brain death criterion and biological definition of death (Heshenov)

Artificial intelligence. A discussion on what we know machines know.

September 29, 2020, 7PM, 2185 LBME

• Ethical Issues of Artificial Intelligence in Medicine (Matsuzaki)
• Regulatory responses to medical machine learning (Minssen et al)
• Will artificial intelligence solve the human resource crisis in healthcare? (Meskó et al)
• Medical ethics considerations on artificial intelligence (Keskinbora)

Artificial parts. A discussion on what is replaceable.

October 13, 2020, 7PM, 2185 LBME

• Implant ethics (Hansson)
• Neuro-Prosthetics, the Extended Mind, and Respect for Persons with Disability (Anderson)
• Why Not Artificial Wombs? (Rosen)
• Going Out on a Limb: Prosthetics, Normalcy and Disputing the Therapy/Enhancement Distinction (Karpin & Mykitiuk)

Dia de los Muertos. A discussion on the celebration of the living and the dead.

October 27, 2020, 7PM, 2185 LBME

• Dead Bodies: The Deadly Display of Mexican Border Politics
• Primum Non Nocere Mortuis: Bioethics and the Lives of the Dead (Dees)
• Cultures of Death: Media, Religion, Bioethics (Hirschkind)
• The Day of the Dead, Halloween, and the Quest for Mexican National Identity (Brandes)

Democracy. A discussion we will choose to have.

November 10, 2020, 7PM, 2185 LBME

• Bioethics and Democracy (Jennings)
• Bioethics and Populism: How Should Our Field Respond? (Solomon & Jennings)
• Crowdsourcing in medical research: concepts and applications (Tucker)
• How Democracy Can Inform Consent: Cases of the Internet and Bioethics (Gould)

The coming administration. A discussion on our (new?) government.

November 24, 2020, 7PM, 2185 LBME

• Three Ways to Politicize Bioethics (Brown)
• Affording Obamacare (Buck)
• Confronting Deep Moral Disagreement: The President’s Council on Bioethics, Moral Status, and Human Embryos (Nelson & Meyer)
• The role of party politics in medical malpractice tort reforms (Matter & Stutzer)

Annihilation. A discussion on our obliteration.

December 8, 2020, 7PM, 2185 LBME

• Bioethics and the Metaphysics of Death (Taylor)
• The Ontological Representation of Death: A Scale to Measure the Idea of Annihilation Versus Passage (Testoni et al)
• The Nonidentity Problem and Bioethics: A Natural Law Perspective (Delaney)
• Controversies in the Determination of Death: A White Paper of the President’s Council on Bioethics

The madness of crowds. A discussion on popular delusions.

January 12, 2021, 7PM, 2185 LBME

• The Liverpool Cholera Epidemic of 1 and Anatomical Dissection—Medical Mistrust and Civil Unrest (Burrell & Gill)
• The Wisdom of Crowds, the Madness of Crowds: Rethinking Peer Review in the Web Era (Millard)
• The Hippocratic Thorn in Bioethics’ Hide: Cults, Sects, and Strangeness (Koch)
• The Importance of Complying with Vaccination Protocols in Developed Countries: “Anti-Vax” Hysteria and the Spread of Severe Preventable Diseases (Pandolfi et al)

Population control. A discussion on limiting ourselves.

January 26, 2021, 7PM, 2185 LBME

• Population Control Policies and Fertility Convergence (de Silva & Tenreyro)
• Contraception and its ethical considerations (Morgan & Datta)
• Must Growth Doom the Planet? (Nordhaus)
• The Population Control Holocaust (Zubrin)

Sex. A discussion on what we do.

February 9, 2021, 7PM, 2185 LBME

• Sex Differences in Institutional Support for Junior Biomedical Researchers (Sege et al)
• Sex as an important biological variable in biomedical research (Lee)
• Deciding on Gender in Children with Intersex Conditions: Considerations and Controversies (Thyen et al)
• The Use of Sex Robots: A Bioethical Issue (Nascimento et al)

Artificial life. A discussion on new forms.

February, 23, 2021, 7PM, 2185 LBME

• Is the creation of artificial life morally significant? (Douglas et al)
• Why Do We Need Artificial Life? (Bonabeau & Theraulaz)
• Artificial Life (Bedau)
• The Bioethicist Who Cried “Synthetic Biology”: An Analysis of the Function of Bioterrorism Predictions in Bioethics (Holm)

Infection. A discussion spreading to others.

March 9, 2021, 7PM, 2186 LBME

• Evidence and Effectiveness in Decision-Making for Quarantine (Bensimon & Upshur)
• The 1918 Influenza Pandemic: Insights for the 21st Century (Morens & Fauci)
• From SARS to Ebola: Legal and Ethical Considerations for Modern Quarantine (Rothstein)
• Responding to the COVID-19 pandemic: Ethical considerations for conducting controlled human infection studies (Shah et al)

Accidents. A discussion we were not meant to have.

March 23, 7PM, 2185 LBME

• Defining Failure: The Language, Meaning and Ethics of Medical Error (Schubert et al)
• Taking the blame: appropriate responses to medical error (Tigard)
• Medical Error and Moral Luck (Allhoff)
• When AIs Outperform Doctors: Confronting the Challenges of a Tort-Induced Over-Reliance on Machine Learning (Froomkin et al)

Virtual reality. A discussion like any other?

April 6, 2021, 7PM, 2185 LBME

• Internet-Delivered Health Interventions That Work: Systematic Review of Meta-Analyses and Evaluation of Website Availability (Rogers et al)
• Ethics of Virtual Reality in Medical Education and Licensure (Iserson)
• Wearables and the medical revolution (Dunn et al)
• Creating Bioethics Distance Learning Through Virtual Reality (Harfouche & Nakhle)

Abdication. A discussion on our renunciation.

April 20, 2021, 7PM, 2185 LBME

• The Idea of Legitimate Authority in the Practice of Medicine (Applebaum)
• Decentralization of health care systems and health outcomes: Evidence from a natural experiment (Jiménez-Rubio & García-Gómez)
• Vox Populi or Abdication of Responsibility?: The Influence of the Irish Citizens’ Assemvly on the Public Discourse Regarding Abortion, 2016-2019 (McNamara)
• Lifeboat Ethics: The Case Against Helping the Poor (Hardin)

An interview conducted by Jolyon Jenkins. Found here: https://www.bbc.co.uk/sounds/play/m000j803. 

At 13:55

“I call up Dr. Barry Belmont, a specialist in medical devices at the University of Michigan.

–There’s something of a gold rush going on, I suppose. People will go rushing for gold and fools will rush in with them. I think there’s very good ventilators out there and there are very bad ventilators. There are things that are already used in hospitals, these are great ventilators and ramping up their production is a great thing. However, on the other hand, you have a lot of people that are developing from scratch all these new ventilators that are meant to squeeze bags and rotate camshafts and they have 3D printed parts and I think the rush to make more of those is not the best use of our time and resources.”

At 16:57

“No sensors. No alarms. No built-in PEEP valve. It wouldn’t meet the UK government’s specifications.

–How something like this gets approved is very disconcerting.

This is Barry Belmont from the University of Michigan again.

–We have not seen any of these working. Even though many of these emergency resuscitators are getting FDA and regulatory approval across the world, you know, they’re not actually conducting any kind of trial or saying ‘here, we’ve put it on a patient and their clinical outcomes have improved.’

But they keep coming. One sector making the most of it is the PR industry. I read in PR Week Magazine that one company began pitching their client’s ventilators the weekend of April the 18th, they say as of Monday it had generated 50 placements – they mean in newspapers – and more that 345 million impressions. And a phrase starts creeping into press reports: bridge ventilator.

–I tried to look up this term and it doesn’t seem to exist really before about April 1 of this year. And this bridge ventilator term, I think, is a branding term more than anything.

Do you think this term’s been invented to cover things that have already been made but which don’t really don’t have a great deal of use in the situation we find ourselves but if you call it a ‘bridge ventilator’ it sounds like it’s a thing rather than a white elephant?

–Yes. I think we should be focusing more on the public health side of things – on the care side of things – than the mere production of new medical devices. Especially medical devices that are being rapidly approved and whose follow on consequences we are not taking even a moment’s pause to consider. For instance, as of April 30, 2020, Venti-Now got their Model JM-P2020A emergency resuscitator approved by the FDA. Well, what happens if a year, two, three years from now that model is sitting on a shelf and has no manual associated and someone goes to use it. It’s either going to be used poorly or it’s going to end up in the trash heap and we do not need more medical waste.”

Ahmaud Arbery, 25

Tom Bagley, a retired firefighter

Kristen Beaton, a continuing care assistant

Greg Blair &

Jamie Blair, survived by their two children

Joy Bond &

Peter Bond, began their 40+ years of marriage at a sardine plant

Corrie Ellison, a social-services worker

Gina Goulet, a denturist

Dawn Gulenchyn, a wife

Frank Gulenchyn, a husband

Lillian Hyslop,”a quiet and, overall, very nice lady”

Alanna Jenkins, a correctional manager

Lisa McCully, an elementary school teacher

Sean McLeod, a correctional manager

Heather O’Brien, a licensed practical nurse

Jolene Oliver, a hospitality worker

Heidi Stevenson, a mother of two

Elizabeth Joanne Thomas, head of the “Laundry Project”, a nonprofit group that helps people in need have clean laundry

Aaron Tuck, a mechanic

Emily Tuck, a daughter

Joey Webber, a logger at a local pulp mill

John Zahl, “the smartest man I knew”

Test Kits

1. CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel by Centers for Disease Control and Prevention (CDC) (Molecular) on 2/4/20
    
2. New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel by Wadsworth Center, New York State Department of Public Health (Molecular) on 2/29/20
    
3. cobas SARS-CoV-2 by Roche Molecular Systems, Inc. (Molecular) on 3/12/20
    
4. TaqPath COVID-19 Combo Kit by Thermo Fisher Scientific, Inc. (Molecular) on 3/13/20
    
5. COVID-19 RT-PCR Test by Laboratory Corporation of America (Molecular) on 3/16/20
    
6. Panther Fusion SARS-CoV-2 Assay by Hologic, Inc. (Molecular) on 3/16/20
    
7. Quest SARS-CoV-2 rRT-PCR by Quest Diagnostics Infectious Disease, Inc. (Molecular) on 3/17/20
    
8. Lyra SARS-CoV-2 Assay by Quidel Corporation (Molecular) on 3/17/20
    
9. Abbott RealTime SARS-CoV-2 assay by Abbott Molecular (Molecular) on 3/18/20
    
10. ePlex SARS-CoV-2 Test by GenMark Diagnostics, Inc. (Molecular) on 3/19/20
     
11. Simplexa COVID-19 Direct assay by DiaSorin Molecular LLC (Molecular) on 3/19/20
     
12. Xpert Xpress SARS-CoV-2 test by Cepheid (Molecular) on 3/20/20 (CLIA waived)
     
13. Primerdesign Ltd COVID-19 genesig Real-Time PCR assay by Primerdesign Ltd. (Molecular) on 3/20/20
     
14. Accula SARS-Cov-2 Test by Mesa Biotech Inc. (Molecular) 3/23/20 (CLIA waived)
     
15. BioFire COVID-19 Test by BioFire Defense, LLC (Molecular) on 3/23/20
     
16. PerkinElmer New Coronavirus Nucleic Acid Detection Kit by PerkinElmer, Inc. (Molecular) on 3/24/20
     
17. AvellinoCoV2 test by Avellino Lab USA, Inc. (Molecular) on 3/25/20
     
18. Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 by BGI Genomics Co. Ltd (Molecular) on 3/26/20
     
19. NxTAG CoV Extended Panel Assay by Luminex Molecular Diagnostics, Inc. (Molecular) on 3/27/20
     
20. ID NOW COVID-19 by Abbott Diagnostics Scarborough, Inc. (Molecular) on 3/27/20 (CLIA waived)
     
21. QIAstat-Dx Respiratory SARS-CoV-2 Panel by QIAGEN GmbH (Molecular) on 3/30/20
     
22. NeuMoDx SARS-CoV-2 Assay by NeuMoDx Molecular, Inc. (Molecular) on 3/30/20
     
23. COV-19 IDx assay by Ipsum Diagnostics, LLC (Molecular) on 4/1/20
     
24. qSARS-CoV-2 IgG/IgM Rapid Test by Cellex Inc. (Serology IgM and IgG) on 4/1/20
     
25. BioGX SARS-CoV-2 Reagents for BD MAX System by Becton, Dickinson & Company (Molecular) on 4/2/20
     
26. Logix Smart Coronavirus Disease 2019 (COVID-19) Kit by Co-Diagnostics, Inc. (Molecular) on 4/3/20
     
27. ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit by ScienCell Research Laboratories (Molecular) on 4/3/20
     
28. ARIES SARS-CoV-2 Assay by Luminex Corporation (Molecular) on 4/3/20
     
29. Gnomegen COVID-19 RT-Digital PCR Detection Kit by Gnomegen LLC (Molecular) on 4/6/20
     
30. Smart Detect SARS-CoV-2 rRT-PCR Kit by InBios International, Inc (Molecular) on 4/7/20
     
31. QuantiVirus SARS-CoV-2 Test kit by DiaCarta, IncMolecular4/8/20
     
32. BD SARS-CoV-2Reagents for BD MAX System by Becton, Dickinson & Company (Molecular) on 4/8/20
     
33. iAMP COVID-19 Detection Kit by Atila BioSystems, Inc. (Molecular) on 4/10/20
     
34. DPP COVID-19 IgM/IgG System by Chembio Diagnostic System, Inc (Serology IgM and IgG) on 4/14/20
     
35. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack by Ortho Clinical Diagnostics, Inc. (Serology Total Antibody) on 4/14/20
     
36. SARS-CoV-2 Fluorescent PCR Kit by Maccura Biotechnology (USA) LLC (Molecular) on 4/15/20
     
37. COVID-19 ELISA IgG Antibody Test by Mount Sinai Laboratory (Serology IgG) on 4/15/20
     
38. Curative-Korva SARS-Cov-2 Assay by KorvaLabs Inc. (Molecular) on 4/16/20
     
39. GS™ COVID-19 RT-PCR KIT by GenoSensor, LLC (Molecular) on 4/16/20
     
40. Fosun COVID-19 RT-PCR Detection Kit by Fosun Pharma USA Inc. (Molecular) on 4/17/20
     
41. GeneFinder COVID-19 Plus RealAmp Kit by OSANG Healthcare (Molecular) on 4/18/20
     
42. PhoenixDx 2019-CoV by Trax Management Services Inc. (Molecular) on 4/20/20
     
43. Allplex 2019-nCoV Assay by Seegene, Inc. (Molecular) on 4/21/20
     
44. RealStar SARS-CoV02 RT-PCR Kits U.S. by altona Diagnostics GmbH (Molecular) on 4/22/20
     
45. STANDARD M nCoV Real-Time Detection Kit by SD Biosensor, Inc. (Molecular) on 4/23/20
     
46. LIAISON SARS-CoV-2 S1/S2 IgG by DiaSorin Inc. (Serology IgG only) on 4/24/20
     
47. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack by Ortho-Clinical Diagnostics, Inc. (Serology IgG only) on 4/24/20
     
48. Anti-SARS-CoV-2 Rapid Test by Autobio Diagnostics Co. Ltd. (Serology IgM and IgG) on 4/24/20
     
49. SARS-CoV-2 IgG assay by Abbott Laboratories Inc. (Serology IgG only) on 4/26/20
     
50. U-TOP COVID-19 Detection Kit by SEASUN BIOMATERIALS (Molecular) on 4/27/20
     
51. LabGun COVID-19 RT-PCR Kit by LabGenomics Co., Ltd. (Molecular) on 4/29/20
     
52. Rheonix COVID-19 MDx Assay by Rheonix, Inc.(Molecular) on 4/29/20
     
53. Platelia SARS-CoV-2 Total Ab assay by Bio-Rad Laboratories, Inc (Serology Total Antibody) on 4/29/20
     
54. New York SARS-CoV Microsphere Immunoassay for Antibody Detection by Wadsworth Center, New York State Department of Health (Serology Total Antibody) on 4/30/20
     
55. Bio-Rad SARS-CoV-2 ddPCR Test by Bio-Rad Laboratories, Inc (Molecular) on 5/1/20
     
56. BioFire Respiratory Panel 2.1 (RP2.1) by BioFire Diagnostics, LLC (Molecular) on 5/1/20
     
57. Elecsys Anti-SARS-CoV-2 by Roche Diagnostics (Serology Antibody) on 5/2/20
     
58. Anti-SARS-CoV-2 ELISA (IgG) by EUROIMMUN US Inc. (Serology IgG) on 5/4/20
     
59. Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR Fluorescence Probing) by Sansure BioTech Inc. (Molecular) on 5/4/20
     
60. FTD SARS-CoV-2 by Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company) (Molecular) on 5/5/20

Laboratory Developed Tests

1. SARS-CoV-2 PCR test by Yale New Haven Hospital, Clinical Virology Laboratory on 3/31/20
    
2. SARS-Cov-2 Assay by Diagnostic Molecular Laboratory – Northwestern Medicine on 4/2/20
    
3. SARS-CoV-2 RT-PCR test by Infectious Disease Diagnostics Laboratory – Children’s Hospital of Philadelphia on 4/2/20
    
4. MGH COVID-19 qPCR assay by Massachusetts General Hospital on 4/3/20
    
5. Viracor SARS-CoV-2 assay by Viracor Eurofins Clinical Diagnostics on 4/6/20
    
6. Stanford SARS-CoV-2 assay by Stanford Health Care Clinical Virology Laboratory on 4/8/20
    
7. Orig3n 2019 Novel Coronavirus (COVID-19) Test by Orig3n, Inc. on 4/10/20
    
8. ThermoFisher – Applied Biosystems TaqPath COVID-19 Combo Kit by Rutgers Clinical Genomics Laboratory-Rutgers University on 4/10/20
    
9. SDI SARS-CoV-2 Assay by Specialty Diagnostic (SDI) Laboratories on 4/10/20
    
10. UNC Health SARS-CoV-2 real-time RT-PCR test by University of North Carolina Medical Center on 4/10/20
     
11. SARS-CoV-2 Assay by Integrity Laboratories on 4/13/20
     
12. COVID-19 RT-PCR Test by Pathology/Laboratory Medicine Lab of Baptist Hospital Miami on 4/13/20
     
13. Childrens-Altona-SARS-CoV-2 Assay by Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children’s Hospital on 4/14/20
     
14. SARS-CoV-2 Test by Exact Sciences Laboratories on 4/14/20
     
15. CDI Enhanced COVID-19 Test by Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory on 4/15/20
     
16. CirrusDx SARS-CoV-2 Assay by CirrusDx Laboratories on 4/15/20
     
17. SARS-CoV-2 Molecular Detection Assay by Mayo Clinic Laboratories, Rochester, MN on 4/20/20
     
18. SARS-CoV-2 PCR Test by Diatherix Eurofins Laboratory on 4/22/20
     
19. COVID-19 Key by Southwest Regional PCR Laboratory LLC. dba MicroGen DX on 4/23/20
     
20. UDX SARS-CoV-2 Molecular Assay by Ultimate Dx Laboratory on 4/24/20
     
21. SARS-CoV-2 Assay by AIT Laboratories on 4/24/20
     
22. SARS-CoV-2 Assay by Nationwide Children’s Hospital on 4/27/20
     
23. SARS-CoV-2 Test by Biocerna on 4/28/20
     
24. Altru Dx SARS-CoV-2 RT-PCR assay by Altru Diagnostics, Inc. on 4/30/20
     
25. UTHSC/UCH SARS-CoV-2-RT-PCR Assay by UTMG Pathology Laboratory on 5/3/20

Pursuant to section 564(d)(1) of the Federal Food, Drug, and Cosmetic Act, the Secretary of the Department of Health and Human Services has thus far authorized the following “ventilators” for use in healthcare settings during the COVID-19 pandemic.

• AirCurve ST by RESMED
• AirCurve 10 ST-A by RESMED
• Apogee by Incoba LLC
• Atlan A350 and Atlan A350 XL by Drägerwerk AG & Co. KGaA
• Babylog VN800 and VN600 by Drägerwerk AG & Co. KGaA
• Conventor Adult Manual Resuscitator Compressor by University of Minnesota Medical School and Boston Scientific Corporation
• COVID Ventor by CoLabs
• CP101/CP101S Series by SLS Medical Technology Corp. Ltd.
• DM28- 20A-W and DM28- 20A-WP by Shenzhen Yamind Medical Tech
• DM28-20C-G by Shenzhen Yamind Medical Tech
• DM28-20S-G, DM28-20SA-G, DM28-20ST-G, DM28-25S-B, DM28-25SA-BP, DM28-25ST-BP, DM28-30ST-B, DM28-30ST-BP, and DM28-30STA-BP by Shenzhen Yamind Medical Tech
• E30 ventilator by Philips Respironics
• Evita V800 and Evita V600 by Drägerwerk AG & Co. KGaA
• Flexo Bi-Level ST by RESMED
• GA ST by RESMED
• iBreeze 30STA device by Resvent Medical Technology Co. Ltd.
• JIXI H-100 by Jiuxin Medical
• LA Series Ventilators LA20C, LA20A, LA20B, LA25B by Zhejiang LifeMed Technology Co. Ltd.
• LTV2 model 2200 and LTV model 2150 by Vyaire Medical Inc.
• Lumis 150 VPAP ST by RESMED
• Luna G3 B30VT by 3B Medical Inc.
• Luna G3 BPAP 25A-LG3700 by BMC Medical Co. Ltd.
• Luna G3 BPAP S/T-LG3800-G3 B30VT by BMC Medical Co. Ltd.
• Mechanical Ventilator Milano by Elemaster S.p.A. Tecnologie Elettroniche
• MetaNeb 4 by Hillrom
• Mindray SV300/SV60/SV800 ventilators by Shenzen Mindray Biomedical Electronics
• Models 6000S, T5, T7 by AMBULANC TECH Co. Ltd.
• MTV1000 ventilator by MEKICS Co. Ltd.
• Pneumatic Resuscitator device by SecondBreath LLC
• pNeuton Model A-E Ventilator by GE Healthcare
• PREVENT by PVA
• Puritan Bennett 560 Ventilator System by Covidien LLC
• SaVe II Series Ventilator by AutoMedX Inc.
• Spiro Wave by Spiro Devices LLC
• Stellar 150 by RESMED
• UMC-001 EUA by Umbulizer
• V+Pro Emergency Ventilator by VenTec Life Systems
• Vayu bubble Continuous Positive Airway Pressure Circuit by Vayu Global Health Innovations
• Venti-Now Resuscitator Model JM-P2020A by Venti-Now
• Ventway Sparrow by Innovytec
• VG70 ventilator by Beijing Aeonmed Co. Ltd.
• Virgin Orbit Resuscitator by Virgin Orbit
• VITAL ventilator by NASA Jet Propulsion Laboratory
• VX850 Ventilator by Philips Respironics
• Y-30T by BMC Medical Co. Ltd.
• YUWELL® YH-730 Bi-level PAP and YH-830 Bi-level PAP by Amsino
• YUWELL® YH-725 BiPAP by Amsino International Inc.
• Wilcox PATRIOT SAVR by Wilcox Industries Corp.
• ZXH-550 by Zibo Zhongxun Medical Equipment Co. Ltd.

The following tubing connectors and accessories have also been approved.

• 3B Hi-Flow H80 by 3B Medical, Inc.
• DAR Adult Dual Patient Breathing Circuit 301P14429 by Covidien LLC
• Formlabs 3D Printer BiPAP Adapter by Formlabs Inc.
• Janisys CPAP Flow Generator by Janisys
• Northwell 3D Printed BiPAP Adapter by Northwell Health, Inc.
• ReddyPort Mini NIV Access Elbow by SMD Manufacturing, LLC
• Vent Multiplexor by Vent Multiplexor LLC
• Ventilation Expansion Splitter (VESper) by Prisma Health
• VentMI by MakeMedical

Classification Regulations: Device Type(s) (Product Code)

Ventilators

• 21 CFR 868 5160: Gas machine, anesthesia (BSZ)
• 21 CFR 868.5454: High flow/high velocity humidified oxygen delivery device (QAV)
• 21 CFR 868.5895: Ventilator, Continuous, Facility Use (CBK); Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (MNT); Continuous, ventilator, home use (NOU); Ventilator, continuous, minimal ventilatory support, home use (NQY); Ventilator, continuous, non-life-supporting (MNS); Mechanical Ventilator (ONZ)
• 21 CFR 868.5905: Ventilator, non-continuous (respirator) including masks and interfaces under the same product code (BZD); Conserver, Oxygen (NFB); Device, Positive Pressure Breathing Intermitten (NHJ); Resuscitator, Manual Non Self-Inflating (NHK)
• 21 CFR 868.5925: Ventilator, Emergency, Powered (Resuscitator) (BTL)

Tubing connectors and accessories

• 21 CFR 868.5240: Anesthesia breathing circuit (OFP); Anesthesia breathing circuit (CAI)
• 21 CFR 868.5260: Filter, Bacterial, Breathing-Circuit (CAH)
• 21 CFR 868.5270: Heated breathing circuit (BZE)
• 21 CFR 868.5340: Cannula, Nasal, Oxygen (CAT)
• 21 CFR 868.5440: Generator, oxygen, portable (CAW)
• 21 CFR 868.5450: Humidifier, Respiratory Gas, (Direct Patient Interface) (BTT)
• 21 CFR 868.5580: Mask, Oxygen (BYG)
• 21 CFR 868.5730: Tube, Tracheal (W/Wo Connector) (BTR); Airway Monitoring System (OQU)
• 21 CFR 868.5895: Accessory to Continuous Ventilator (Respirator) (MOD)
• 21 CFR 868.5965: Attachment, Breathing, Positive End Expiratory Pressure (BYE)
• 21 CFR 868.5975: Set, Tubing and Support, Ventilator (BZO)

Declarations of Conformity

• IEC 60601-1: 2012: Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
• IEC 60601-1-2: 2014: Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic Disturbances – Requirements and Tests
• IEC 60601-1-11: 2015: Medical Electrical Equipment Part 1-11: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
• Any other applicable collateral/particular standards in the IEC 60601-1: 2012 family
• IEC 62304: 2015: Medical Device Software – Software Life Cycle Processes
• AAMI TIR69: 2017: Technical Information Report Risk Management of Radio-
  Frequency Wireless Coexistence for Medical Devices and Systems
• ANSI/IEEE C63.27: 2017: American National Standard for Evaluation of Wireless
  Coexistence
• AAMI TIR69: 2017: Technical Information Report Risk Management of Radio-
  Frequency Wireless Coexistence for Medical Devices and Systems
• ISO 10993: Fifth Edition 2018-08: Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
• ISO 18562-1 First Edition 2017-03: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications – Part 1: Evaluation and Testing Within a Risk Management Process
• ISO 18562-2 First Edition 2017-03: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications – Part 2: Tests for Emissions of Particulate Matter
• ISO 18562-3 First Edition 2017: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications – Part 3: Tests for Emissions of Volatile Organic Compounds
• ISO 18562-4 First Edition 2017-03: Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications – Part 4: Tests for Leachables in Condensate
• ISO 10651-5 First Edition 2006-02-01: Lung Ventilators for Medical Use – Particular Requirements for Basic Safety and Essential Performance – Part 5: Gas-Powered Emergency Resuscitators
• ISO 17510 First Edition 2015-08-01: Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
• ISO 80601-2-12 First Edition 2011-04-15: Medical Electrical Equipment – Part 2-12: Particular Requirements for the Safety of Lung Ventilators – Critical Care Ventilators [Including: Technical Corrigendum 1 (2011)]
• ISO 80601-2-13 First Edition 2011-08-11: Medical Electrical Equipment — Part 2-13: Particular Requirements for Basic Safety and Essential Performance of an Anaesthetic Workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
• ISO 80601-2-69 First Edition 2014-07-15: Medical Electrical Equipment – Part 2-69: Particular Requirements for Basic Safety and Essential Performance of Oxygen Concentrator Equipment
• ISO 80601-2-70 First Edition 2015-01-15: Medical Electrical Equipment – Part 2-70: Particular Requirements for Basic Safety and Essential Performance of Sleep Apnoea Breathing Therapy Equipment
• ISO 80601-2-74 First Edition 2017-05: Medical Electrical Equipment – Part 2-74: Particular Requirements for Basic Safety and Essential Performance of Respiratory Humidifying Equipment
• ISO 80601-2-79 First Edition 2018-07: Medical electrical equipment – Part 2-79: Particular Requirements for Basic Safety and Essential Performance of Ventilatory Support Equipment for Ventilatory Impairment
• ISO 80601-2-80 First Edition 2018-07: Medical Electrical Equipment – Part 2-80: Particular Requirements for Basic Safety and Essential Performance of Ventilatory Support Equipment for Ventilatory Insufficiency

When asked, in as much detail as they could muster, describe what “You, as a person” means to them, students of BIOMEDE 211, Winter 2020 provided the following answers on or around April 24, 2020.

You, as a person

• “Not really sure…”
• “I’d like to think, sitting here now, that I can describe and analyze circuits and systems!”
• “I learned a great deal in this course and hopefully it shows.”
• “Hopefully I am good enough to use what I learned in this class to change lives.”
• “I hope to apply the knowledge I gained in this class and others throughout my life to work to help bring about good in the world.”
• “Someday I hope to make a difference in the world through engineering, and will do my best to achieve that.”
• “I am building myself up to someone who prospers in the field.”
• “a learner, who is always curious to learn more about the world and how the world works around me.”
• “a college student who is stuck in quarantine”
• “a student at the University of Michigan, hoping to understand the fundamentals of electrical circuits and systems so that I am able to make a positive impact on the world once I enter the workforce.”
• “a student […] studying biomedical engineering to eventually apply my studies/knowledge to real world problems!”
• “a biomedical engineering student,”
• “a Biomedical Engineering student.”
• “a biomedical engineering student and citizen of the world”
• “an undergraduate Biomedical Engineering Student”  
• “A sophomore studying BME at UM”
• “a BME student at Michigan who struggled a lot in this class, but kind of enjoyed the content.”
• “a struggling now online biomedical engineering student who is upset to be home all day”
• “just trying to keep my focus pass all of my exams.”
• “Motivation has definitely been harder at home.”
• “kinda freaked out […] right now, to be honest!”
• “sweating”
• “feels awkward taking this test in her bedroom.”
• “relieved to have finished another semester”
• “This entire school year has been very transformative to me”
• “I moved away from home”
• “I am seeing how I personally deal with a pandemic.”
• “I decided how I wanted to be perceived”
• “determined, but anxious all the time”
• “I am aware of when it is healthier for me to worry less about school and more about myself.”
• “but I also understand myself at least better than I used to”
• “I learned that my heart’s contractions are caused by changes in potential.”
• “I have learned that I am a living and breathing circuit.”
• “a combination of circuit elements”
• “all of the cells in my body can be approximated with a circuit of capacitors and resistors.”
• “my body has electricity that can be measured”
• “one giant, extremely complex system made up of trillions of subsystems.”
• “a large collection of cells and atoms, whose main drive is to live and have offspring live.”
• “the giant system holding all of these things together”
• “full of electricity from the ion gradient within my cells.”
• “the sum of numerous biochemical reactions”
• “a being made up of all of these components and more.”
• “a combination of many systems and my actions and thoughts are the response of my systems.”
• “biological systems, systems of my environment and family, and many more that make up how I respond to any input I am given.”
• “The systems of my body respond then by doing the task that is required.”
• “I am many things.”
• “a biomedical engineering major”
• “a dancer”,
• “a daughter,”
• “a freshman,”
• “a friend.”
• “a hard-working and smart individual”
• “a highly stressed individual trying not to bomb this exam”.
• “a listener”
• “a rapidly maturing guy with high hopes for myself.”
• “a sailor,”
• “a sister,”
• “a student striving to learn as much as I can”
• “a student learning about circuits so I can be the best engineer possible, and hopefully provide some useful things to this world to help people. I’m also like any other person with their own interests personal lives as well as feeling emotions etc.”
• “a creative, loyal, hardworking, and reliable person.”
• “pretty hard to define”
• “Passionate, caring, and hopeful.”
• “defined by my actions, beliefs, and aspirations.”
• “taking in everything I possibly can”
• “bringing in a different perspective and a creative way of thinking that comes from an open-minded, curious point of view.”
• “I feel extremely grateful during this time in the world.”
• “because I’m still learning all this stuff”
• “trying to consistently push to become better everyday”
• “trying to figure out who they are”
• “usually self-conscious […], but I am determined to find something that makes me happy.”
• “looking forward to better days ahead.”
• “it drives me to try to do what is right versus wrong”
• “I did learn a lot”
• “I have learned about circuits, but I have also learned about myself.”
• “I have no idea what I mean.”
• “The possibilities are endless for what I mean”
• “There’s still a long ways to go before I figure that out.”
• “I mean a lot to myself”
• “I, as a person, mean quite a bit to myself because I’m me.”