Activities and Updates

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Notes from an email to team members and colleagues:

Not for the faint at heart...

that was a pun.

But seriously. It took me a few hours of searching and reading to find the contraindications notification from this particular manufacturer that the Medical Practitioner must not use this particular smart scale for patients with any implanted devices, nor attached devices, including but not limited to infusion pumps, (along with the implanted cardiac pacemakers and defibrillators), and a wide array of other ordinary devices not at all implanted. P 6 in the physician and staff guide.

And also to find the rest of the important clinical methods applied in the device that might be helpful to a practitioner you must sift through lots of stuff. Some information for example, can be found on Page 46.

I was unaware until Sherri (P2933) brought some articles to my attention. It never occurred to me that it might be so challenging to medical professionals to get to the data they need about clinical applicability of devices sold into the medical device industry. I was thinking companies have specialized materials to help physicians, and certainly the guides I have seen provide everything you ever wanted to know about your 'smart scale' for example.

I had not seriously considered how challenging it is to round up the information and integrate it into a medical practice.

I'm not sure why the manufacturers keep this clinically important information spread out in thick documents for Doctors and Assistants, and in the Administrator's literature. Perhaps they already have quick apps on mobile phones, or they don't see the utility.

I see no evidence of product knowledge in any medical facility I have personally visited, and the persistence and enthusiasm of the articles by medical professionals leads me to believe whatever is provided -- it's not so transparent nor user friendly. And it is likely to lead to injury to people who don't know they are at risk, disabled people and others who cannot speak for themselves.

At the same time, Pacemaker/Defibrillator manufacturers provide very difficult to understand information to patients including directing patients to American Heart Association websites to read about what not to do. Again, not transparent, not easy to use, not very effective in improving health.

In addition to the problems with implants I found information about standard infection protocol in all the related literature including for the Smart Scale. This is an important topic that Sherri also brought to my attention: Sepsis. It is the leading cause of death on the planet. Everywhere on the planet.

WHO has a new report and a plan to reduce Sepsis and associated mortality and morbidity.

There is an opportunity to reduce suffering and offer better healthcare.

It occurs to me from reading the rest of the warnings on the smart scale, and especially in the setting of COVID-19 and Sepsis risks, that manufacturers can be leaders to recommend people have little paper or plastic shoes and gloves when using the smart scale. The manufacturer's guides mention addressing infection. The manufacturer also provides warnings in the documentation not to allow patients who have known infection or any cuts or wounds to use the device. Appropriate PPE should be easy to access in the location where the professional can advise the patient to don them. These PPE can be used as standard precautions to reduce spread of infectious diseases that can occur by the person going on the scale and touching the handles. In particular, since many infectious diseases may go without symptoms for some time, this is an opportunity for leadership.

Especially in low resource communities, where people may have less education or training or skills available, fewer medical resources and medicines, or opportunities to interact with healthcare, it is important to provide excellent user information. We can see how critical it is to have safe and meaningful healthcare devices especially during this challenging time of COVID-19 pandemic with associated high numbers of infections everywhere on the planet and ongoing challenges to the healthcare systems.

This is a great opportunity for the IEEE SA IC Healthcare Showcase or Competition to improve instructions, reduce infection, provide PPE at the point of clinical need, etc. To Connect the Unconnected.

And this is an opportunity to Fight Sepsis, Heart Conditions, and to reduce the spread of COVID-19 at one time, among other health conditions. Smart Scales are used to measure weight in most healthcare interventions and is an important clinical measurement.

If I were a betting person, I would wager not too many people have read these important warnings... or at least nobody recently, or perhaps nobody at point of care.

And they probably don't warn the patient the devices used in healthcare management even a smart scale or sport watch might be harmful to them.

I am wondering if it is necessary to get patient's affirmative consent to use these devices if they have any of the situations mentioned in the manufacturer's warnings. But that's a different matter.

I am also left wondering if there is any analysis of patient data to see if some consequence of the use of incompatible devices has been observed in particular, in cases when the staff is unaware they should be looking for any interaction between the devices. This is an important opportunity to use new AIML methods to conduct analysis of data associated with individuals who have encounters that fit into the use case.

The kinds of issues pacemakers and other devices might suffer could easily be misinterpreted as patient health issues and might therefore be missed if they are not systematically analyzed and for certain, if the staff is unaware of the manufacturers warnings about the contraindications and resulting situation.

And I would wonder if the manufacturer provides branded posters or warning labels or instructions, or quick to find mobile app, for any of these very important matters.

I wonder if they make little branded paper / plastic shoes or gloves for the use to follow their important instructions in their doctors and staff instructions book. And so forth.

Or if the IEEE Standard can require a Feature Off Mode for example, for the BMI feature, that's easy to use by staff and patients. And that they can confirm the state with a calibration sort of test. Or to create a user interface prompt for the medical person to ask the patient if they have any implanted devices or check a list of likely devices, or look in the EHR record and double check with the patient... especially in the pacemaker laboratory.

You know: for example to ask the patient if they have any implanted devices such as a pacemaker... look at the patient and observe if they have an infusion pump. And the like. I would imagine the medical people in my Electrophysiology Doctor's office in Cleveland Clinic should but apparently they don't know they should check. I would not have previously presumed to ask them about their professional business thinking they should know their business. But now that I have read the user guides, I will be asking a lot of questions and nobody is going to enjoy it at all.

If someone can demonstrate to me that doctors know how these devices are fit for duty in a clinic, and in which cases, for which patients, please let me know. If the manufacturers effectively warn their pacemaker defibrillator and other implant patients, please let me know. That has not been my personal experience.

I have been following up on the articles our colleague Sherri (IEEE P2933) brought to my attention about how the so-called medical or clinical devices are not 'working' or they are somehow not fit for duty or do not match clinical needs. I had suggested that reading the company literature should reveal what the professionals need to know.

I have a new impression about the human factors of the situation and risks to health and well-being.

This literature I have seen is not transparent.

Although I have not yet done an exhaustive search of manufacturers, and I have not yet taken any surveys nor spoken with company representatives. But given our upcoming meetings this week with DIITA, there appears to be enough preliminary information to continue to pursue the effort.

I suggest the methods in these and other healthcare devices are not sustainable for communicating important information to professionals and patients even if the information is in actuality, somewhere.

I suggest it is not user friendly, scalable, culturally and linguistically sensible, for improving health, meeting needs of the disabled or those experiencing disparity, and so much more.

It is not connecting the unconnected people with the health care they need.

I suggest that our IEEE SA DIITA can take this on as Accessible, Inclusive, Interoperative, and on the Transparency issues as a Standard. And engage some industry members for example, through IEEE SA IC Telehealth to demonstrate how they can improve matters for people who have to use the devices in clinics and so forth with real doctors, medical staff, and real patients.