Milestone-Proposal talk:Pulse Oximeter

Advocates’ Checklist

1. Is proposal for an achievement rather than for a person?
2. Was proposed achievement a significant advance rather than an incremental improvement to an existing technology?
3. Were there prior or contemporary achievements of a similar nature?
4. Has the achievement truly led to a functioning, useful, or marketable technology?
5. Is proposal adequately supported by significant references (minimum of five) such as patents, contemporary newspaper articles, journal articles, or citations to pages in scholarly books? At least one of the references from a peer-reviewed scholarly book or journal article. The full text of the material, not just the references, shall be present. If the supporting texts are copyright-encumbered and cannot be posted on the ETHW for intellectual property reasons, the proposers shall email a copy to the History Center so that it can be forwarded to the advocate. If the advocate does not consider the supporting references sufficient, the advocate may ask the proposer(s) for additional ones.
6. Are the scholarly references sufficiently recent?
7. Is proposed citation readable and understandable by the general public?
8. Does the proposed plaque site fulfill the requirements?
9. Is the proposal quality comparable to that of IEEE publications?
10. Scientific and technical units correct? (e.g. km, mm, hertz, etc.) Are acronyms correct and properly upperercased or lowercased?
11. Date formats correct as specified in Section 6 of Milestones Program Guidelines? https://ieeemilestones.ethw.org/Helpful_Hints_on_Citations,_Plaque_Locations

Reviewers’ Checklist

1. Is suggested wording of the Plaque Citation accurate?
2. Is evidence presented in the proposal of sufficient substance and accuracy to support the Plaque Citation?
3. Does proposed milestone represent a significant technical achievement?

Submission and Approval Log

22 August 2022 -- Submitted 6 September 2023 -- History Committee approval. 19 November 2023 -- BoD approval

Advocate's address to the proposers -- Savini (talk) 12:54, 25 April 2022 (UTC)

Dear proposers I have recently been appointed as the advocate of your Milestone proposal. According to our rules, my duty is to help the reviewing process. I am currently looking forward to receiving reviews from independent experts. Best r. Antonio Savini, IEEE History Committee

Re: Advocate's address to the proposers -- Joe Campbell (talk) 17:59, 29 August 2022 (UTC)

Dear Prof. Antonio Savini,

Let me suggest this independent expert to review the Pulse Oximeter proposal:

Name: Tom Keating Email: tlkeating213@gmail.com Phone: +1-252-455-6318

Hope this helps, Joe (j.campbell@ieee.org) -- Joseph P. Campbell, PhD, LFIEEE MIT Lincoln Laboratory Group Leader, AI Technology & Systems

Re: Re: Advocate's address to the proposers -- Savini (talk) 09:51, 27 September 2022 (UTC)

Replace this text with your reply

Dear proposers I had already appointed two experts and I am looking forward to receiving their replies. In case I do not receive the reply from one of them I will consider your suggestion with pleasure. With best regards

Antonio Savini

Advocate's upload of the review received from Expert 1 -- Savini (talk) 20:16, 5 November 2022 (UTC)

November 4, 2022 Milestone Proposal : Pulse Oximeter As regard the Milestone Proposal on Pulse Oximeter, I am forwarding my POSITIVE judgement. In particular, I would stress the following points: i) The suggested wording of the Plaque Citation is certainly accurate and no main application areas are neglected. ii) The proposal supporting the Citation is well documented and substantiated, with proper references iii) Undoubtedly, the proposed milestone is a fundamental step in non invasive clinical monitoring of oxygen saturation parameters, thus constituting a significant technical achievement of paramount importance.

Sergio Cerutti, IEEE Fellow Emeritus Professor of Biomedical Engineering chair od B3Lab: Biosignals, Bioimaging, Bioinformatics Dept of Electronics, Information and Bioengineering Politecnico di Milano, Italy

Advocate's upload of the review received from Expert 2 -- Savini (talk) 12:39, 30 November 2022 (UTC)

Dear Antonio, Please accept my profuse apologies for my delay I have read through the IEEE Milestone proposal, and the material and claims presented is sufficient and correct.

A few words from me on the subject. “The discovery made by Aoyagi in the 1970s has set up the advancements of non-invasive oximetry for the next decades. After developing the first pulse oximeter prototype in 1973 (OLV-5100 by Nihon Kohden, and presenting his work at an international conference, Aoyagi moved to a managerial position at Nihon Kohden, without the possibility to work further on his prototype device. In the next ten years, his idea of a pulse oximeter was further developed by Minolta, Ohmeda, and Nellcor, paving the way to the commercialisation of a device that will revolutionise clinical monitoring for decades to come. “ I also wish to add/emphasize something under What obstacles (technical, political, geographic) needed to be overcome? As this will acknowledge the recent advances in pulse oximetry “As conventional pulse oximeters moved out of the operating room and into intensive care units and recovery rooms, their shortcomings became apparent: they false alarmed over 70% of the time. What was causing the false alarms was the failure of one assumption to hold true during patient motion and low perfusion, that the only thing that pulsates is arterial blood. During motion, venous blood, which is at very low pressure, moves with the motion frequency, “confusing” conventional pulse oximeters. Joe Kiani and Mohamed Diab invented the modern measure-through-motion pulse oximeter by devising an algorithm and systemic approach that separated the arterial blood from the venous blood signal. Masimo commercialised this technology as Signal Extraction Technology®, or SET®. SET® pulse oximeters have been shown to reduce the rate of false alarms by over 90% and increase the detection of true alarms. Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry is a new and fundamentally distinct method of acquiring, processing and reporting arterial oxygen saturation and pulse rate. Masimo SET® technology enables the power of adaptive filters to be applied to real-time physiologic monitoring by utilizing proprietary techniques to accurately establish a “noise reference” in the detected physiologic signal, thus enabling the direct calculation of arterial oxygen saturation and pulse rate. Because it is not bound by the conventional pulse oximeter’s assumption that the only thing that pulsates is arterial blood, the Masimo SET® system substantially eliminates the problems of motion artifact, low peripheral perfusion and most low signal-to-noise situations. This greatly extends the utility of SpO2 in high motion, low signal and noise intensive environments.”

Also, the below claim (2) is too strong; (2) Since pulse oximeter devices are calibrated in healthy subjects, the accuracy is poor for critically ill patients and preterm newborns [2]. The new “generation” of pulse oximeters (i.e., Masimo) managed to mitigate some of the challenges of more traditional pulse oximeters and they have proven to be more accurate and robust in critical patients and neonates.

I hope the above are ok.

Please let me know if you require anything else

Once again apologies for the delay

With kindest regards

Panicos

Professor Panicos A Kyriacou BESc MSc PhD FIET FIPEM FIoP FEAMBES SMIEEE CEng CPhys CSci Professor of Biomedical Engineering Adjunct Professor, Yale University, School of Medicine

Director, Biomedical Engineering Research Centre Past President, European Alliance of Medical and Biological Engineering )

City, University of London School of Science and Technology Northampton Square London, EC1V 0HB, UK

Message of the Advocate to the proposer -- Savini (talk) 08:46, 2 December 2022 (UTC)

Dear proposer

Following the comments I received from the two Experts, I suggest the following citation:

The first pulse oximeter prototype, a medical device monitoring blood oxigen saturation of patients non-invasively, was developed in 1972 at Nihon Kohden (Japan). In the following decades pulse oximeters were further developed and provided reliable tools for easy and immediate detection of oxigen saturation values, paving the way to the widespread commercialisation of devices that became a standard of care in most clinical settings and also in home monitoring.

As you will see, I had to limit the lenght of the citation to less than 70 words; moreover, I had to omit the name of the invention, according to our current rules. If you agree with the above improved citation, I will submit the proposal to the consideration of the History Committee. Thanks. I look forward to hearing from you

Antonio Savini

Comments on the Proposal -- Bberg (talk) 00:09, 2 July 2023 (UTC)

This is a well-written proposal, including its 68-word citation. However, per the requirements for a citation that includes names, the paragraph at the start of the “historical significance" section should be moved so that it immediately follows the proposed citation, and it should be labeled as "Justification for Inclusion of Names in the Citation:".

In my opinion, there is enough support in this paragraph for inclusion of "Takuo Aoyagi" in the citation.

tightening up citation -- Amy Bix (talk) 17:55, 4 July 2023 (UTC)

Nice milestone. I just would recommend some rewriting of the citation for flow and conciseness, as follows:

The principle behind a non-invasive way to measure blood oxygen saturation in patients was discovered in 1972 by Takuo Aoyagi of Nihon Kohden Corporation. In 1975, the company created the first pulse oximeters. Later improvements established pulse oximeters as vital devices for monitoring health in hospitals, clinics, and homes.

Re: tightening up citation -- Bberg (talk) 05:14, 5 July 2023 (UTC)

I conferred with Amy about her new citation since I thought that her brief version should be expanded to teach more about the device, particularly its later improvements. I sent her my proposed new wording, which she then tightended up a bit, and which I include below at 62 words. While this version is admittedly redundant by including both "non-invasive" and "without a blood sample," this does provide fuller clarity:

Pulse oximetry, a non-invasive technique to measure blood oxygen saturation continuously and immediately without a blood sample, was discovered in 1972 by Takuo Aoyagi of Nihon Kohden Corporation. The company launched its OLV-5100 as the first ear pulse oximeter in 1975. Improvements including microelectronics, two LEDs, and a photodiode made the device an inexpensive standard of care in hospitals, clinics, and homes.

Re: Re: tightening up citation -- Bberg (talk) 19:57, 5 September 2023 (UTC)

I repeat my support for this citation as it provides much more insight into what is being honored as compared with the current proposed citation.

Re: tightening up citation -- Pichkalov (talk) 14:22, 11 July 2023 (UTC)

I would only add that there should probably be two names in citation: The first pulse oximetry was developed in 1972 by Japanese bioengineers Takuo Aoyagi and Michio Kishi at Japanese medical electronic equipment manufacturer Nihon Kohden (wiki)