Human Factors in Healthcare Blog

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 Wednesday Laura went in to an ambulatory surgery center for a (hopefully) final procedure for a serious illness.  Besides watching the pre-op phases of her surgeries (N=5), I have seen the pre-op phases of both my children.  Fortunately they are now all doing fine.

Some have called the phases prior to skin cutting similar to the various important steps that need to be accomplished before a plane takes off.  Thus, we have seen this big increase in use of so-called checklists to help ensure somewhat important things like starting on time, to somewhat more important things like getting the right patient and doing the right procedure.

Checklists usually go hand in hand with “double-checks” and other attempts at improving reliability.  Just think about the care you take in prepping to drive to work a few miles on a sunny day versus trekking 600 miles during the dead of winter.  We all know that the checklists work, don’t we?  There seems to be a lot of them for pre-op preparation, so the flow of patient and process must be smooth and with few hiccups, right?

As you might guess, that is not always what I see.  A checklist that is well-agreed upon, crucial task-centric, visible, obviously tied to useful outcomes, and USABLE has a chance of working.  These “animals” are hard to make, usually more expensive, but easier to implement and STAY implemented.  It appears that the lists, checklists, whiteboards, and other documents are nice beginnings – with work to be done.

Here is one example in the literature where using HFE principles moved the usage rate by doctors from ~10% to ~75%.  Even the authors could not believe paying attention to seemingly minor details made such a huge difference.  Getting the “paperwork” right will save more time and prevent more injury than you think…