Human Factors in Healthcare Blog

In my last two postings, I provided some non-traditional advice about how to hire someone for a human factors engineering and design/safety job.  A reminder of the five jobs that contained attributes helpful for an HFE and Medicine specialist:

1. Bartender
2. Bean-packing plant safety manager
3. Lifeguard
4. Set designer
5. Wilderness survival expert

The #3 job, lifeguard, is easy for me to relate to;  I was a lifeguard at a quarry lake for 2.5 summers.  During my time there, two people drowned at this lake – both times I happened to be off.  Nevertheless, we “pulled” many kids and adults out of situations where they were drowning or near drowning (N=30-40 per summer).  It was an old, deep quarry that was very crowded and full of many people who could barely swim – but tried anyway.

What does this have to do with skills and knowledge to be a HFE and device/healthcare expert? 

It all starts with the training.  Nearly 30% of lifeguard training is learning how to use “judo” moves to escape the clutches of a frantic, grab-at-anything drowning person.  This frenzy is not nearly the same as designers and engineers whose prototype is “drowning”, but there are parallels.  We learned some of this at a how-to-be-a-consultant workshop I took at Usability Professional Association (UPA).  The “master” consultant went through several resistance strategies we would encounter from product designers who felt threatened – and how to “wrestle” our way out of their “clutches”.

Secondly, drowning or near-drowning does not look like what you see on TV.  Major human factors engineering design flaws are often not what you think (or just common sense).  There is very little splashing and waving.   Major HFE design flaws are often subtle or hide.  In both cases, you not only need to train yourself about these counterintuitive ways of monitoring the situation, you need to be able to teach others. 

Third, lifeguards very quickly learn that their job is a lot of being tested, being drilled, and regular practice.  Hands-on, lots of feedback, peer input, and building a thick skin.  Its not boot camp or military, but often close.  Applying HFE in the hectic healthcare or device development arena requires you have that thick skin.  You also need to develop it in your design, marketing, engineering, and management colleagues.  HFE is about high contact, hands-on, and lots and lots of testing.  Building thick skin requires repetition, tack yes, but repetition.

Next, we look at  the job of “set designer” (huh?!)

Years ago, the most common question I got was, “where do I go to learn more about human factors engineering?”  The the length and breadth of my answer did evolve as more workshops and books (including our own) came on the scene.  Funny, very few people thought it was funny when I said that they could go back to school and get a masters degree in HFE in just a few short years!  I was only partially kidding, since I knew that some of the design or safety questions they would tackle could easily be major essay questions on graduate level tests – or even research theses.

Many people now ask different questions:  who should I hire?  where can I find them?  [These are harder questions, so I reminisce about the old days of the easier questions above.]  The question arises frequently enough, that we devoted part of a chapter in our recent book to this.

Simply stated, it is only a small problem to find people with masters degrees or PhDs in human factors engineering.  That is not enough.  They need one or more other qualities.  Below, and in the next 4 postings, I will describe and give examples of some of those needed qualities for an HFE and Medicine specialist:

1. Bartender
2. Bean-packing plant safety manager
3. Lifeguard
4. Set designer
5. Wilderness survival expert

Skills of a bartender (or, if you will, ombudsman) are key!  Your HFE will need to be able to listen, and listen, and listen.  Those 40 minutes of seemingly irrelevant stories are the needed lead-in for a patient to reveal the real problem they have with the device or medication delivery system.  The HFE needs to be trusted by the usability test participant clinicians when they see “interesting” usage of devices or medications.  They should have a ready supply of (NON-ALCOHOLIC) drinks and other pleasantries to set the stage for stressful design meetings.  Sometimes, especially during “last call”, they need to summon jaw-dropping honesty about bad things that might happen if the product goes “out” - and be willing to stand up to peer pressure.  Finally, be prepared to help out with lots of jobs, clean up messes, and know how to fix things on “the fly”.

I have been invited, forced into, and willingly sought to be on various committees that create “standards”. 

[ASIDE: For those who don't know or work with "standards", I still think you will find discussion about this topic vaguely interesting.]

In one case, I have worked for days in windowless conference rooms with barely a break.  In another case, I have spent minutes giving my input (testimony) in the hallowed halls of Institute of Medicine.  Never, repeat, never is any of work done in tropical resort hotels like the one depicted on the right.  Sometimes our end-point is clear, but often it’s not.  Example of clear end-point:  create a list of the minimum processes/steps needed to validate a better medication warning label.  Example of less clear end-point: create a summary of all patient safety remedies that are effective, or can be made effective, or have hints that they might be effective (yikes!).

In the 2000’s, I was part of the Association for Advancement of Medical Instrumentation’s Human Factors Engineering Standards committee.  We were assembling a second document (HE-75) to complement the first standard (HE-74).  [Aside #2:  most standards are somewhat costly, but I do not receive any $].  The standard has been in both the medical device and human factors engineering press lately.  A recent webinar was held by co-chair, Ed Israelski, for HFES.  And MD&DI (trade pub) has had nice explanatory pieces.  It is stated that FDA and possibly other stakeholders will take special note of the guidance and standards contained in HE-75.

Is this good?  Does a standard or guidance help to standardize or guide design?  To answer those questions, let me ask a rhetorical question:  when has a standard or guideline helped you do your job? 

My guess is that an effective guideline reminded you what to do, and the context in which you were supposed to do that thing.  It’s a reminder in that you already knew the guidance, or at least knew that the knowledge existed.  The guideline is centered around what to do, or not do.  It is not suggestions on how to feel, or hints about what thoughts or concepts to consider.  Most important the standard provides the context so you know when to act on this purported wisdom.

Some John-Created Examples

GUIDELINE:  Medical devices that will be used in the home shall be designed to be used by novices 95% of the time

NOT GUIDELINE:  Consider the fact that the user of a device may prefer a range of colors depending on many factors.

Last Saturday I emceed and judged a design competition that was organized by an interprofessional student group called Institute for Healthcare Improvement – Open School (IHI-OS) Michigan Chapter.  Five teams of 4-5 students had watched the hemodialysis device in use, interviewed operators, and read about the pros and cons of having people living with kidney failure use this in their home.  Yes, attach their veins and arteries to a blood-pumping and blood-filtering machine for several hours, 3-4 times per week…

The rules of the competition (criteria for judging) were deceptively simple: clearly identify some design-related problems; suggest and prototype a solution, and make it innovative and user-centered.  Get your medical student, public health student, engineering student, and business student team members to do all that in 105 minutes and you win invaluable prizes (glory, fame, Sears gift card!).

I will leave the details of the event to the student group’s Blog.  For my part the 3 hours on a Saturday afternoon was some of the most fun and engaging in a long time.  Sure, I use design exercises when teaching students or educating engineers about HFE and safety.  But, to actually have the groups do 90% of the work without my help or others — and come up with 5 or 6 breakthrough ideas was really cool. 

Lots of people write about the necessity and wonderfulness of multi-professional teams.  Sounds good…but, it’s often a hassle to create and manage these teams.  Device companies AND hospitals have some mixed teams, but they also have lots of homogenous departments (e.g., biomedical, pharmacy, accounting, etc.).  On this day, and for this application, the mixed mental models seemed to cook up some nice designs.  Concrete ideas to address the solitude, scariness, or tedium of having your arterial system mated with a plastic and metal machine for hours.  Cleverness about giving more mobility and efficiency to the person living with kidney failure, as well as the partner who is sharing the triumphs and set-backs of longer term care situations.

If I suffer a steak-induced illness, I want these teams looking into addressing my cardiac, football-watching, and kid-scolding needs.

- John

It happened 5 years ago, but I am always reminded of it when I board a plane.  The PA announcement on my return flight from a conference in Las Vegas was something like this: “there is a medical emergency.  Is there any medical people to help us in the back of the plane?”  I was towards the front of the plane and looked back to see no one standing up.  I reluctantly went to the back to find a semi-conscious middle-aged man and two flight attendants who looked worried.  I had not practiced medicine in 15 years, but had some recurring training and exposure to emergency care.  When we removed the in-flight med kit, we found bandages, aspirin, a small EKG machine, and little else.  I wanted an AED (automated external defibrillator), but none was aboard.  Long story short, I assessed him, spoke by teletype to medical consultants at Mayo Clinic, the plane kept flying, and he eventually did okay and left the plane under his own power.

Because of this encounter, and HFE work I have done with AEDs and defibrillators,  it always catches my eye when I see an AED.  Just last week I took pictures of an AED and surrounding signage in the Atlanta airport.

As I did, you might notice a few design-related things:

1. The AED Sign is one of the largest ones I have seen.  If you think of running around a busy and visually cluttered terminal, there is no way this sign can be too big
2. The AED is below the sign, but having other items so close might warrant a second sign; plus the added bonus that your vision might be blocked from one or the other sign by people.
3. The directions on the AED cabinet are not really clear.  Do you yank it open?  Break the glass?  If the alarm sounds when you open it, why not have “it” call 911?
4. Perhaps it would be ominous, but having a poster on CPR and the main steps for using an AED (like you see in restaurants showing the Heimlich Maneuver steps for choking)

What are your thoughts?

You could find many articles in academia about device safety, usability and human factors engineering (HFE).  From judging the usability of techniques to cool patients after cardiac arrest to assessing insulin pens for the person living with diabetes, there are more and more research reports about applying the HFE technique of usability testing to devices.

What about in the “real world” that most of us live in?  In non-academic resources, it might be a bit harder to detect.  If you search Google for HFE, usability, and medical devices, you can find articles in the medical industry press with increasing frequency.  A pioneer in this area (since at least the 1990s) is Medical Device & Diagnostic Industry (MD&DI).  A very recent article in this trade publication shows the need to HFE in home devices.

In this Blog, we plan to highlight and comment upon HFE and Healthcare in the news.  This can help you in three ways:

1. Support your activities, if you are doing HFE for a living
2. Give you a break from reading our stuff (i.e., other perspectives)
3. Point out to novices the trajectory of thought and work in this area

Have a great weekend…  For many of our USA readers, please enjoy the snow like I will while snowmobiling and skiing in Northern Michigan.