William (Bill) Jackson Jose,
I feel your frustration and I agree but that does not mean we can do away with IFUs, that being said as they are a mandatory aspect of medical devices and yes they do not work as expected. There are the usability standards in the EU and I believe Draft Versions in the US for FDA purposes, by conducting Usability Testing these will you make your manuals better for all parties. But as we say in the US, "you can lead a horse to water but cannot make them drink".

Training is a great adjunct to the manual and I have consulted with many sophisticated device companies where the product could/would not be sold unless the end user had mandatory training, but that depends upon the complexity of the device, such as software controlled robotics.

Clinical trials can also be used to document whether or not the manual was adequate for the use of the device.

I am sure more will come to mind,best regards,

Bill J

Brent Matthews Well, I just have to jump in here. As the (former) senior technical writer for CHG Hospital Beds, I solely created and maintained the owner/user manual.(a.k.a. device manual as it is referred to in regulatory jargon). Therefore, I feel that I am uniquely qualified to address this issue. It sure was a hard pill to swallow when I was informed that, after the countless hours I spent crafting a thorough and complete device manual, no one reads them. They are either immediately shelved, lost, or forgotten after the delivery and set-up of the new hospital bed, or, worse, they are simply discarded with the packaging.

Let's be further honest here. Sadly, there are many ways that someone can get hurt by the misuse of a hospital bed (or other medical devices). There is simply no way to display all the necessary warnings without littering every square inch of available space with warning labels (I also designed all of these too...and yes, nobody reads them either).

CHG's clever way to address this was the creation of a Quick Reference Guide, which eventually became standard issue on every bed. This laminated, 8-1/2" x 11" sized QRG contained pared down instruction for basic hospital bed functionality. It was physically attached to foot board with a metal clasp ring through a heavy grommet swaged in a top corner. This was done intentionally to ensure that it hung crooked to draw attention to it. When installed (as instructed) it was very hard to NOT notice it. Additionally, it had aesthetically pleasing, yet appropriate, colours and large font size so it was easy, and, as the name suggests, "quick" to read. It was broken up into simply yet clear sections and provided step-by-step instruction on basic bed operation. It was in no way comprehensive but it didn't need to be.

The iconology used on the control points (usually on the foot board and head siderail panels) may not always be intuitive to non-healthcare people so by simply removing the guess work and providing easy to find, understand, and follow instructions, you also remove much of the potential hazards. However, in my opinion, CHG has excellent iconology created by a truly gifted designer with a real knack so they were highly intuitive and the beds are easy to use. A tremendous amount of thought went into iconology, and the consequent human/bed interaction, for this very reason.

It is human nature to fiddle with things, especially fancy hospital beds (with all those buttons and lights!!!) however most people will not be inclined to do so with a loved one in the bed. By providing instruction for safe use of basic bed operation, you may entire avoid misuse of the device by otherwise well intentioned family/visitors whom simply wish to help make Uncle Bob feel more comfortable.

Most hospital beds are also equipped with control point lock-outs which either restrict or entirely disable some/all bed operation thus largely preventing misuse.

RECAP:
Include succinctly written, colourful instructions on a physically attached, laminated Quick Reference Guide. Also ensure that the QRG instructs the user to refer to the device manual for further guidance and also warns non-healthcare professions to NOT use the equipment.

Hope this helps.
Brent

Kiran C Shetty Hi Jose, we've had success with supplemental material such as online videos, DVD's or patient centric pared down versions of IFUs (not replacements for full IFUs).

Sofia Epshtein Elbrus Clearly, first of all the device should be so constructed (among others by conducting a risk analyses and usability process, including analyses of foreseeable misuses) that the misuses, even if occur, will not result in a hazardous situation. If such a design is not possible, a risk vs. benefit analyses is to be performed in order to determine whether the device should still be developed.
If the answer is yes, it is usually enough to put some nice labels and a quick guide and accept the fact that the full UM will be rarely read, just as Brent above mentioned. Of course, this works for the simple user operated devices only. It is still required for these devices to be as inherently safe as possible in order to comply with the international regulations so we need to be really careful here. The risk management is very strict nowadays, no labeling / instructions to be used as a risk mitigation mechanisms.
As for devices that should be operated by a trained personnel, well, training, retraining and training once again. You must make sure that whoever operates you device is capable to do so w/o risking the patient, and proper training is the only way to do so.

All other cases, where the misuse makes the treatment less effective or may result in a device failure, are the reason we still do write the UM and put a "refer to instructions" label on the device. In other words, it actually is the user responsibility to read it and there is not much you can do in order to enforce it, as far as I've seen. Although, it is always helpful to have a readable, may be even interactive SW version of the UM. Just bear in mind it should be in addition to the hardcopy or complying with the relevant requirements.

Best,
Sofy

Make it a requirement that all new users pass a quiz before the device will work.

Jeff Witt Certify by training or program process control, on line program would not allow advancement viewing warnings without first passing test.

José Ramón Alonso Domínguez Thank you all for the good tips. After reading all the comments, from my point of view it seems that there is a technologycal need to provide the user "quick and straightforward" information about the device he is going to use, as an addition to the IFUs.

Andrei Kamandzenka Reduce the number of controls available to the user. Intellectualize all available controls (add special means double-checking user actions). Put a capitalized legal disclaimer of user responsibility for any adverse outcome resulting from improper equipment use.

Bruce Grayson We are in a business where we intervene to make people live better and happier. Few products are without any risk and medical devices tend not to be in that category. Studies show that adding the double check (eg. "Are you sure?") to software creates an operator blindness where the user reflexively checks "OK" and misses the one time in 100 that they should have paused, Unfortunately, psychologically, it is also proven that our mental decision systems are lazy and reflexive, prone to a dozen types of error, especially when rushed and in pressure conditions. The User Interface should, by definition of a good UI, perform in a manner that the user expects it to work. Complexity is going up.
There is no substitute for a trained operator and while written materials are shown to be one or the weakest training methods they are the basis for creating class room, on-line, and video training. They also provide concrete support in time of litigation. I often ask engineers during discussions where they are getting bored with the need for detailed instructions: "How well would you like the clinician trained if your loved one was the patient?". Would any of us be satisfied with a quiz or an 8x10 laminate with big icons that is ignored because it is not part of the flow? Of course not, but they are a start.
Now the good news. The best instruction, well placed on the device, or in the medical software, is that the device/software should not be used without formal training. Clinicians want to do the right thing and do not want to risk their certification. They will and do demand training from employers and vendors who should be prepared to have this well mapped out for the administration. Education should not be an "add-on" post sale product even though it can be a great marketing tool or customer contact opportunity. As Sofia and risk managers point out, written warnings are the weakest mitigation for hazards and good vendors must move well beyond the minimum standard "User Manual", which, incidentally, almost no one ever reads.

Hi , let me first tell that we cannot ignore IFU, we have to add it to our pack.
User study etc can help to get approval but no assurance that there will not be any complain.
So what is alternate ?

Small site for device so that it is easily opened in a mobile and simple animation or pictures to be loaded in the site to address how to use the device.

For persons who doesn't like to all above, the IFU must contain only the instruction , nothing more than that. No big big write ups.

Still will there be guarantee ? Perhaps no, but it can reduce the problem to many extent

Jerry Twomey RTFM? 'People RTFM when they can not figure it out playing with the device. Serious thought needs to go into the user interface for ease of use and simplicity. Having done machines that EMT's use in field urgent care scenarios, simple, simple, simple needs to be the mantra of the product designer. Did I say simple? :)

Andrei Kamandzenka Shyamal, it's rather impossible to avoid IFUs - they are required by industry standards. And most of them cannot be much shorter - their contents is regulated by industry standards. Speaking of small sites and simple animations for smartphones/tablets - it's again a kind of IFU which, I believe, is not going to be popular unless it would provide any entertainment, bonuses, etc.
Bruce, it's not double check makes operator blind, but rather its poor implementation (not taking into account those psychological features of humans).

Maybe, instead of trainings there have to be vendor supplied quizzes on the correct use of equipment and the burden of conducting trainings should be shared between vendors and clinics. Indeed, its volume and price might differ for different users due to a number of reasons and it would be unfair to make vendors alone to carry the weight.

Sofia Epshtein Elbrus We should also remember that we are in a competitive market here, so it should not turn into some complicated big deal with quizzes and games. As far as it simplifies things - great, the users will be grateful and the industry standards and regulations will keep them (and us) safe.
Although I would still treat conceptually differently a home use devices and the ones intended to be operated by clinicians / doctors.

Dave Sheppard, CMAA I agree with Jerry. Product design needs to be intuitive and simple. It's amazing how even the brightest clinicians can try to insert a square peg into a round hole during a patient event. IFU's are required but more important is "easy to use" for a two year old.

Joseph Mandell Our company develops eLearning operator and equipment maintenance training courses for the U.S. Army. The Army's intent is that managers will require operators to take and pass the eLearning course prior to using the equipment as part of their competency training.

The main purpose of the operator eLearning training courses is clarify the User's Guide, point out key safety concerns, and to provide tech-tips on overcoming frequent problems (hit reset). The maintenance courses teach the biomedical equipment technicians how to perform calibrations and common repairs. Both courses are designed so that students can use the lessons as a reference, which are quickly and easily accessed at a later date when needed.

With today's accessibly to training material through the use of smart phones and tablets, I am surprises that more companies are not doing this.

If you have a nurse who has to perform a procedure that they rarely perform, such as setting up an invasive arterial blood pressure line, don't you think that nurse would like to see a quick step-by-step instructional video on how to perform this procedure?

Instead that same nurse has to thumb through a phone book sized User's manual to determine which sub - sub menu that they need to get to in order to activate and set-up the parameters for this option. A User's Guide is good for activities that are performed all the time, but if a nurse, or any operator for that matter, has not received training for a particular procedure in the past six months or so, I am sure that they would like to have a quick refresher course; eLearning provides that.

Hi everyone,
As a Surgical Technologist for almost 10 years I have learned that people definitely don't want to read the directions. Assumptions get made and the company gets blamed while the patient suffers the consequences. The Nurse's and Surgical Techs teach the surgeons as to the point of the equipment and how to use it. I teach new surgical techs to listen to the rep from the companies and learn to work without them. That's the only way they can learn to deal with doctor's without the rep always being there

Charles Collier I worked as a healthcare capital equipment vendor for many years and my reality was that during an inservice, which you were expected to give many, many times, people would simply not pay attention. I personally feel that it does not matter how many decals and cards you have, the end user needs to know the equipment and with everyone being expected to cover more and more bases, its almost impossible. There comes a time when the owner of the equipment must simply take ownership and it seems that does not always happen. There should be inservice coordinators in these various departments that must do their job, the education refreshers cannot always fall on the vendor particularily when the life cycle of some types of equipment is 10+ years. You are all correct about people not reading directions and try to even find an operators manual a month after the equipment is placed in service. Unfortunately, people are most familiar with what they have the most problems with.

Marguerite McHenry All very good comments. IFU's are here to say, and users are not readers.
Several years ago a product had 1 fatality, and 2 serious complications.
Procedure was not complicated. Surgeon did not want to take the time to re-scope the patient during the last part of the procedure. Why ? Because he did not understand the rationale or potential complications, regardless if they reviewed the IFU.
Approach was to put a drawing on the outside of the package under the sterile wrap, it illustrated 4 critical steps. If doctor did not read, the nurse often kept it at hand and would look at it. A picture is worth a thousand words, so true. Additionally, we made a video with CEU's for both Doctors and Nurses. Training sales rep is critical, if he is there with the surgeon the first few procedures, better chance it will be done properly. Inservice, Inservice, Inservice.

Ed D. Can't help remembering the well known Scandinavian manufacturer of powered garden tools, who claimed that the user manual for the US had to be 75 pages longer than UM's for any other market, because of all the legalese required. Puzzled why you would want to inform the user of possible misuses of your product. (they are already creative enough!)

Andrei Kamandzenka Ed, reading about the different legal systems of Europe and US might be helpful (http://en.wikipedia.org/wiki/Civil_law_%28legal_system%29 and http://en.wikipedia.org/wiki/Common_law). Essential is that is US law is based on cases and judges' decisions on them. Probably, this is why not considering exhaustive list of misuses might cost dearly.

Alan Barta A quick scan through seems to overlook a couple of facts. Those who care DO READ instructions for use. The author, the legal department, the marketing department and reviewers at regulatory agencies all read them and from there pass the word to doctors, end users, nurses and technicians. There has been a recent change at FDA that attempts to put emphasis on what feature or risk makes the label or IFU important. This follows renewed government administration appreciation of regulation after a series of lapses of public safety and major recalls, for example, closure of the compounding pharmacies that spread fungus and meningitis. Previous conservative administration was content to let greedy pals race to profit no matter who died and suffered. I'm all for regulation when lives depend upon it.

Now, there seems to be some focus on software manuals in this thread. It's an FDA peeve if you don't validate software first. Only after you're absolutely sure it works are you allowed to distribute. The problem with software is it is very easy to alter code, then arrive at a cascade of downstream errors. FMEAs for software are almost not worth producing, so you never fully appreciate risks until people die. The manual becomes the center of attention in training, but any IFU cannot be a risk mitigation. It's really up to the manufacturer to minimize confusion and mistakes through design. As I always say, design should meet expressed needs, not just drive future sales. Software can be highly imaginative because it can, rather than do right and settle into medically sound approaches. Participating in medical forums and standards organizations helps.

Andrei Kamandzenka Alan, I don't see anyone careless here. The problem is not in authors and regulatory agencies who by the way don't have to regularly return to the same(!) UMs. It's in users or in those people, who would have to read it more often and who constantly fail to do so and put someone's health at risk. Many posters here including myself suggested a number of approaches to medical devices design (minimalism, intuitiveness, controls intellectualization and/or simplicity) and their IFUs design (quizzes, videos, web-sites, eLearning).
How do you suggest to help those who are in no time, who don't expect that they have missed something already? Regulation? Please explain how it's different from today! Why so much pressure on 'greedy pals' - you prefer to pay for rebuilding a house instead of replacing a worn carpet?

Alan Barta Andrei, what you don't see can kill you. Instructions serve an important purpose in educating the entire organization who produces, sells and uses a medical device. But they aren't designed to teach such high level actions as surgical practices, only relay necessary information, such as contraindications or limitations.

Not criticizing profit, just de facto deregulation (achieved by cutting funding) that shifted risks onto the unsuspecting. After all, medical devices and pharma are in the top 5 of consumer complaints, mostly for being too expensive. If it's a matter of death or life, you want the best device in the hands of a surgeon well experienced in handling it, so price doesn't matter to patient, yet government who has to pay some of those bills might think otherwise. But this is a minor topic compared automotive fees and services in the billions, and banks gone berserk on trillions deposited without regulatory oversight. You have to pick your fights. This economic war was so well masked millions of homeowners didn't catch on until under wate; tens of thousands die on highways every year.

As far as carpets and houses, analogies are supposedly for further explaining not totally obscuring your point. My suggestion is that technical writers never use them unless very well thought out beforehand.

Andrei Kamandzenka Alan, I believe that something you see every day can kill you more likely than something you don't see at all. I believe your idea that "Instructions ... only relay necessary information, such as contraindications or limitations" is as much wrong as the thought that surgeons are not taught on textbooks. In reality in both cases instructions/textbooks are not sufficient but required.
Further concerning "the best device". As a patient I'm usually quite far from knowing whether the clinic has the best equipment at hand for several reasons: firstly, a patient usually cannot judge which equipment is best and why; secondly, most expensive or newest does not necessarily mean best; thirdly, I prefer to rely on physicians - if they are comfortable and successful with what they have, then I don't care what they don't have (i.e. doctors do the job, not equipment). And your position is similar to discussing a new smartphone (best screen, best processor, etc.), but it does not work in MedDev.
Next, I agree that analogies are not allowed in IFUs, but I don't mind anyone using them consciously in usual conversations. Unfortunately, I don't see a constructive proposition and its efficiency explanation from you.

Alan Barta Well, Andrei, we disagree. If you can see something, you can avoid it. But the invisible issues do kill millions every year. IFU's are specifically written to limit information, because that would expose manufacturer to legal liabilities. Software manuals serve as an IFU, but are quite different, which was what I was addressing. And standards save lives.

I relay a story every so often about anesthesiology devices that was in a prestigious medical journal. There was a statistic that predicted 1 in 500 or so would die because of wrong dosage. A board convened to addressed. Turned out that every operating room had some different piece of equipment with which a visiting technician was unfamiliar, controls that worked in reverse and switches in different places. Once they standardized layouts, mortality rates dropped dramatically, 1 in 100,000 (don't quote me on the actual numbers).

Now that you bring it up, aps for cell phones are a great example of how a need is fulfilled with something simple. MedDev ought to take a cue from such success. But it's not my job to educate you.

Andrei Kamandzenka Alan, I agree that standards are important, but I don't see that much difference between MedDev and software IFUs as you do, neither I agree that any IFUs are designed to conceal some terrible truth. Moreover, I don't see an IFU problem in your story. It looks more like a case of an immature (may be even inadequately certified) manufacturer who failed to ship according to specifications and careless customers who did not dare to check/commission the devices (including IFUs supplied). Actually, your story shows that standards alone don't work too. Because (if) standards are imperfect and (if) customers are not sufficiently literate in equipment related areas (both of which was probably the case in your story) then patients are at higher risk.
Strange that you liked smartphone analogy and sunk into it even deeper. Smartphones are relatively simple and inexpensive devices designed to meet much more relaxed requirements than MedDevs (e.g. DR, FFDM, CT, MRI systems). If smartphones were that strictly regulated as MedDevs, then they were 10 times more expensive and 100 times less spread. And while you don't understand that attending your courses is a waist of time even if it is free.
Generally, I think that IFUs fidelity problems are irrelevant in the present topic no matter how bad they are by themselves. What to do when even good IFUs are failing?

Alan Barta Jose, honest would be: User guides done right become a "reference". Users might be totally familiar with product from OTJ or school, but some feature might confuse or surprise, so they seek out that portion of instructions. Instructions serve all sorts of needs beyond just imparting information, like interdisciplinary, historical, legal, and legislative. To summarily dismiss wouldn't be ethical or practical. But, granted, they are only one part of complete method. Powerpoint presentations, small videos, and worldwide websites are what we do to supplement. Unfortunately, most I've seen by others are beyond awful due to poor production values. A studio with excellent animators helps. Problem becomes capturing a moving window of products undergoing continual improvement at a reasonable budget, not impossible but requiring commitment, discipline, organization and priorities. Don't you think those funds would be better spent on design enhancements, R&D, regulatory compliance, and training scenarios?

One of the worst harms a patient faces is surgical delay, which means longer under anesthesia. Devices must be designed to avoid delays, inconvenience, sharps sticks, etc. There is no way to circumvent best practices without risking injuries or lives.

Jeff Witt Colder products is trying to offer connection devices that are intuitive. It's not easy trying make things idiot proof!

Michael McCarthy, MBA, BS, RRT-NPS I have adopted my previous employer's model. Everyone one of our technicians will have an annual requirement to demonstrate to me that they are competent at setting up every piece of equipment we own. I keep records showing who is certified and when they were certified. And I do read the user manual.

As a student of linguistics, I used an IFU for a clinical device and looked specifically at its' Lexical Density (i.e. how difficult is it to read and understand) Brent (second post in the chain) commented on the time taken to generate the documents. Part of the issue is the difficulty in understanding these documents; A typical lexical density for an IFU is 65% - reader's need a very high standard of education to read & understand the contents. A good newspaper will be around 40%.

Joseph Mandell Good point Paul. I think the complexity of the lexical density may be based upon the fact that a lot of the technical manuals have been translated from another language using software and not real people. The placement of verbs and adjectives within the sentence are the biggest indicator that the instructions weren't originally written in English.

I am sure that this goes both ways. Instructions that were originally written in English probably are not translated well into other languages and this likely this leaves the operator confused.

As an example, I was installing a ophthalmology system manufactured by a Japanese company and I remember seeing a warning label on a lamp, which stated, "Be warned: The lamp is hot to touch". A simpler and more direct warning could have said, "Warning; Hot Lamp!"

Brent Matthews To Paul's comment about Lexical Density. While I have actually never heard this term before I was very aware of the audience that I was writing for. A device manual (I'm guessing IFU is also a very common abbreviation for some) is not where you use fancy words necessitating the use of a dictionary for the reader to fully comprehend what is written. I don't want to say that my goal was to write it for the lowest common denominator but EVERYONE must be able to read and understand the instructions to ensure maximum safety for patients, staff (clinician, etc) alike. To this end, when I finished writing, say, instructions for a new feature, I asked people from different departments to perform the task while I observed. If there was even the slightest challenge/hesitation, I rewrote it. This process continued until it was painless to perform. This happened for every aspect of my manual. Simple clear instructions coupled with consistent and logical GUI interaction/feedback made our beds easy to use.

To Joseph's comment about translation (very good point by the way) CHG hired expensive technical translator services to translate the manual into several different languages. We then asked people within the CHG family whom spoke those languages fluently to read both the English and respective translated versions, and compare content to ensure that instructional intention was maintained and that there were no glaring "lost in translation" errors. After this exercise it was easy to see that we had spent money wisely using professional technical translation services.

Alan Barta IFU's are written for users who have doctorates. By law, only a doctor can prescribe a medical device, although we all know that's not how they ultimately get distributed.

The small mention of translations has some merit in this thread in that writing for translation means simplifying sentences and terminology. We used to have every new manual translated into as many as 12 languages, always the basic English, French, Italian and Spanish, sometimes Dutch, Greek, Mandarin, Portuguese, Russian, Swedish, etc. We had an entire protocol for this process. First, we contracted native experts to help develop a glossaries of industry terms. Then we hired translators locally to do the gross conversion using glossaries. Then we sent conversions to our native speaking employees in target countries, who would enjoy picking conversions apart with great mirth. We'd get back a text file with BOP and EOP (beginning and end of page relative to original) indicated for new layouts. German (with all its long compound nouns) usually filled 35% more pages than English. Italian also ran longer. French and Spanish were more comparable in length. Writing for translation and translating itself are art forms. I'm not sure they can even be taught, but, as such, need to be managed carefully.

It is a general failure among manufacturers that they underestimate what it takes to produce manuals. Often they designate an engineer who isn't otherwise busy to gin out a rough explanation that becomes the final one. Done right, they are an amalgam of content producers, editors, legal and psychological teams, graphic artists, layout/proofreaders, marketeers, subject matter experts, tech illustrators, tech writers, translators and whoever else has a vested interest. What made Microsoft great is their manuals. Visited Hewlett Packard's Tech Pubs Department and was impressed with their commitment to staff dozens of direct reports. If all you produce is software, the manual becomes 50% of the product (actually dwarves the disks). Even if your audience is small where people would rather learn by doing than reading about doing, info is important. Robohelp has been badly used by nearly illiterate engineers to document software on many occasions, but the results seem to include an awful lot of definitions that use the word itself being defined and other such faux pas. Good manuals anticipate questions, gather audiences, make loyalties, and provide that last resort so well appreciated. They directly advertise how well a company is run, in fact, often break or make relationships.

Alan Barta Btw: There is a Flesch-Kincaid Readability Test and Lexile Measure. F-K Readability can be driven to teen level by constructing sentences with less than 14 monosyllabic words. For Lexile, 800 is teen level. Truly, even doctors can be brain dead on Monday mornings. These are issues too big to solve in an online thread, but cheap operators want fast results, which is how patients wind up dead.

Antonin Cuc Dear Friends! I have been full depressed when I am a State investigator in Health and Safety and I have experienced designer, I was working on International Standards for Safety of dangerous products, I have organised a State Office for Labour Inspection including Law harmonised between EU/CZ. I have build the State surveillance in processing in the Nuclear Power Stations in Czech Republic - so as I have known in the extremal deep the praxis for Health and Safety in industry - but there are in Health care petrification extremal ignorancy a rational participation in Health+Safety on responsibility for 100 years. You compare the situation - when there are a airplain crash, there must be detect Black Box records and all finding wrecks including Victim bodies by the State Airtransport Surveillance for each case with mortality about 80 peoples in extremal punctualities of time analyses, relations of material tracing, pilot communications, sequential processing loss of managing of parameters pilotage, functional ability mechanical and electrical Devices, infuences of weather, temperature outside airplain, critical speed, late acceleration to change parameters of fallen, personal responsibility, User´s Guides for pilotage, service´s guiedes, testing before starting, reeducation of pilot staff, supervisions to take substitutional element with certification only, protocolling each of repair working, designer´s proof and counting reserve in safety processing in extremal conditions in thunbderstorm, bad visibility over airport, etc., etc. When I am well educated ex crimi expert in Physicx, crimi Biomechanics, crimi Anthropolgy - I have no competent Inputs in my official preliminary Clinical documentation before orthopaedic surgery THA, I have no competency to ask Video_Black:Box recording of procesing on surgery hall, I have no competency to ask a radiological firm mask of used stem in my orthopaedic surgery, I have no competency to exerpt from medical Law and producer instruction user guide in my Court, I have no worth to comment the false medical testimony in Court in mz role plaintiff, I have no competency to protocol my evidences of forensic engineering against a false forensic medical subjective message....There are about 180 thousands of patient dying in US needlessly after medical errors yearly and in Germany about 90 thousand patients needlessly dying and NOBODY COULD SAY IT IS A SCANDAL to tolerate frequence of mistakes in medical decision making 1 : 10, when we have to be in industry routinely with accepting mistakes only 1 : 10x10x10x10x10x10x !!! The Physicians are petrificating constant Internal Citizens war against patients and we are probable ignorants when we could tolerate it in future! I am dying needlessly after concatenation of many fatal orhopaedic mistakes contrary forensic engineering by the implants Law about Medical Devices by rquirements of Directive 93/42EEC! I will be ask a forensic crimi recapitulation all evidences of mistakes by detection of international Crimi forensic evidency from area - Crimi Anthopology, Crimi-iBiomechanics, Crimi-Radiology and I would ask supporting against Czech Republic for enduring of inertia in safe my private Constitution Human Right to be Health and with medical care... keeping of level by the medical Law, with regards to deterministic evidences and mandatory working by the principles Based Evidency Medicine - not by the intuitive nonlegal ways decision making! Each surgery could be described as sequential processing legal steps and each partly decision making must be realised by the Law in rational ordering, in the level of quality by the principles Based Medical Evidency...never without absency selfcontrolling, phase of realisation must be realised by the preliminary processing Plan supervison of controlling, by the prevences all known risks by the Protocol of Conformity Assessment, by producer guides or more better!

Eric Carpenter I think the most important thing is to follow the Wogalter structure of warnings: first design the error out if possible, then take precautions within the workflow to reduce error occurrence, and finally give a warning if no other solution is possible. Also make basic functions as usable as possible without training/reading. If most users won't delve into advanced features (especially if advanced features are hotkey only and not part of a normal GUI) there may be rationale to make advanced features more complicated. Personally, as a medical device user of 20+ years and a human factors practitioner, I have to say people do eventually read the manual. I may only refer to task specific portions as needed, so it is important to make every task such that I could complete it without having to refer to another portion of the manual.

Sofia Epshtein Elbrus The regulators and the tech standards are asking these exact questions - are the IFUs written in a way that whoever it is designed for will be able to easily understand it and are you translating it using a high level professionals. From my experience, both while on the certification body side and while on the various medical devices companies side - strong and dedicated QA RA team does magic also to the documentation & labeling level.

Antonin Cuc I have been evaluating most of participant in discuss are full worry, when there many elementary risk situation which could be with a fatal consequents when the users didn´t known Idea about principles of functional ability of Medical Device. a releative light indisposition or unaccuracy, but the consequents could be fatal, sometimes with superpositional risk. But the users Physicians are sure "to be Gods" and when the patient "has hard luck" they are with a white conscience...they never believe to be culprits. But they feel only overflow of information not only in medical ranks but so as with to many Producer instructions for users, to many explicit risk with explicit dozen recommendation to explicit preclusive activities! Physicians are nearly full resignating on managing patient risks, they would to safe they style of working with limited capacity of Brain with a refuse to change some part of information with substitution other part of most important skills and information. There are 180 thousand patient needlessly dying in US yearly after medical mistakes and about 90 thousands of patient needlessly dying in Germany and today I am writing to Czech Ministry of Justice Czech Republic, why I have been ignored by Court with crimi evidences and by forensic physicians creating the false medical Court message, when I have been giveve as Plaintiff, despite I ´m a State investigator Health and Safety, I was ignored with sending by written a duzend forensic clear evidencies by forensic engineering - I was injured after nonlegal ignorancy of my orthopaed the mandatory legal duties to create a preliminary Plan of processing planning surgery THA, there had to be realised planning postion with a radiological mask of stem the planning of spice stem in femural axis in standard depth, there had to be defined a dysplastic declination of my femoral neck..and then no fausse route stem could be arrised on surgery hall, which was bad and late to diagnose till after 10 days in other hospital...and I never should be dying 5,5 year before the origin average duration rest of my life by median biostatistic hypothesis by slusters of patient with standard successful realisation orthopaedic THA surgery. Just all physicians are just lying, Judge didn´t me possibility to explain medical mistakes by Court contrary my Constitution Human Rights....What are you doing when the physicians didn´t read User´s Guides and yours child could be dying with trivial medical irresponsibility..?

I think that an overlooked instructional tool is Aurasma (http://www.aurasma.com/) which allows you to create a video that is then played when a target image is viewed with a smart-phone loaded with the Aursma app. So for example, a brief video dsecribing the use and contraindications of a product can be displayed by looking at the product package before it is opened in the OR.

In a sea of information it is hard to wade through Instructions for Use.

Since only smart people use advanced medical devices of course they "know" how to use it and if something goes wrong it is because the design was flawed or not "intuitive" with a poor user interface ....

Jerry Twomey Reading the commentary I would also suggest:

Make sure that your documents are clear and concise.
Make sure that the documents are reviewed by native speakers of the target language.

If the content is awkwardly worded, rambling in content, or poorly organized you have failed your audience.

A "Getting Started" guide is read by the majority of users. Using Pareto analysis for health and safety...where 20% of the hazards can account for 80% of the injuries and by categorizing the hazards, safety professionals can target the 20% of the hazards that cause 80% of the injuries or accidents. A "Getting Started" or "Quick Guide" coupled with suitable labeling on the device (if possible) can target the 20% of the hazards. e-Learning can be used for more complex devices used by professionals.

Ryan Raz Before you take off or land a plane you go through a check list. You use a check list not because you don't know how to takeoff or land but because you can't afford a momentary distraction which might cause you to miss a step.

Training is only part of the answer. If you do something too often then the risk is that your executive part of your mind does not take part in the activity so a distraction or some abnormality will cause an "operator" mistake.. If you do the activity infrequently then the chances are that a critical step is missed or is done out of sequence because of your lack of use. In a complex environment it's unrealistic and dangerous to assume training is the full answer.

In a hospital environment everyone is well-trained yet the use of a check list to do something that might be considered as part of the job seems to give the false perception that the person doesn't know their job.

One possible technology solution is to standardize the format of electronic check lists or graphical instructions. Smart tag equipment so these are retrieved to a tablet or maybe in the near future to google glasses so they are automatically on hand. If everyone used the system any negative perception about looking up information would disappear while at the same time safety would be improved.

Eric Carpenter Standardization and best practices are definitely part of the solution, but checklists aren't foolproof. There are incidents where automatizing to a preflight checklist procedure led to confirming that the deicers were off, leading to a crash in cold weather.

Dave Sheppard, CMAA Checklists are best utilized if there are two people involved. It's too easy for one person to be distracted mentally and miss something. That's why pilots use a checklist verbally in the cockpit and check it with each other.

Ryan Raz My use of the word checklist shouldn't be taken too literally. Think about them more as instructional cheat sheets with safety first graphically illustrated procedures pertinent to the task at hand.

Eric and Dave no single solution is fool proof but check lists do work to reduce mistakes maybe especially so when there isn't a co-pilot. In flying there is no stigma attached to opening up a guide when in flight while in medical institutions opening up a manual may have some he or she is not quite fully trained yet stigma attached.

Also IMHO Inattention either due to lack of and reinforcement of the training or because of over familiarity with task at hand are equally serious safety problems.

Jerry Twomey Properly written and followed checklists should be foolproof. The example given above illustrates a faulty checklist, not that the concept of checklists are faulty. NASA went to the moon with them and the Strategic Air Command/NORAD has been using them to keep us out of nuclear war for the last 70 years.

One of the problems I have seen with MD's is that refusal to admit to a lack of knowledge on any topic. Nurses read manuals, doctors not so much. Ego is an amazing thing.

Steve Weisner One way around this is to produce a 'quick-card'. It is a double-sided laminated card that you attach with some sort of loop to your device. It contains the main steps of how to use the device and the critical warnings/gotchas. This does not replace the User's Guide (IFU) but folks actually might read this.

Dave Sheppard, CMAA Hi Steve - hope all goes well ! I agree with you. We've used these "quick-cards" in the past and they are very helpful - if you find a good way to attach it to the device (as you mentioned). Otherwise, they "travel" and it's back to square one.

Jerry Twomey make the quick reference actually part of the machine and can not be removed, thats been done for years in many areas.

Antonin Cuc There are very sofisticated processing standardisation: You have to realised for example 12 cases with videorecords classic surgery THA from 8 most experienced hospitals /with number more as 800 cases yearly/, then you realised flow commentariers - not only describing fluently Video, but so as parallely more detailed comments with pointers to medical rank literature on a few parallely screens: - for each professionals from all engaged medical ranks - anesthesy, instrument storing, firm instruments, full emmergency equipments for ad hoc Crashes in surgery hall, IT continualy support.. with list of dangerous sequency activities... choice of best incomming surgery cuts, best way deposition of joint, chirurgical separation a part of femural Head, measurements, creating form of proximal end of femural cavity for stem, drilling of distal form of femoral cavity, controlling integrity of femural bone, preparing of anchoring of distal spice of stem, etc, etc. timing and ways of postoperational radiologic control, archiving similar specific modeling cases, risks of orthopaedy for patient over Age 68 years, Diabetes melitus, limited weakness of Heart, Crash of implants on surgery hall, planning of duration implants), you change and evalueting of all researcher partly outputs to controlling systematic each-other all medical decision making with explicit separation deterministic, statististic, intuitive decision making - namely to regards mandatory activities by the Law and by Producer instruction, then you realised the first version of modular Professional Standards for classic surgery THA of adult patient with extremaly regards to minimize patient risks and summ of increases entropy in processing in Transformal channel. Then you realised about 200 similar cases THA surgeries on 25 different Orthopaedic Clinic...then you all finishing for the international usage in the OECD including a computerized simulator to testing the knowledges and skills of prime Orthopaeds, Radiologist, Student of Anestehsy etc. with best way to perfect reusage speeder and with best skills... Then you could sent me so as a salutation on my cemetery with sincerely THANKS for usage of my patented method S_T_A_R_S-Statistical Retrieval and Search of information to decision making with computer support. I wish you more success as I had got.

Lots of money has been spent for IFU's and training on Medical device from Companies, The R&D team has to design a Medical device product in such a way that it works without training just like consumer buying Mixer from market, and when the new box of Mixer is opened and is plugged in & ready to use by any person.

Systems become more complex and could be difficult for the end user. We have to become aware that there must become a new role for the biomedical engineer in the Hospital. Most of the time he or she is aware of the usage of the equipment but also the technologie behind it.

Antonin Cuc I´m a bit distressed you are thinking with limited subconscious "what to imrpove in the medical style of working", but this must be a full revolucionaire changed style of working. There must be to implanting such organisational and scientic change, more similar in the industrial rational particiaption phases, complementary working from other participants with automatic mesurement, more scientic calibration, more exactly inforced method statistic accuracy finishing partly phases of complicated working, more exactly describing processing with elementary differencial suboperational acts, etc. Maybe you are thinking it is probable to much dream and no realistic view...I don´t agree, I´m sure, it is nonsence, when the Orthopaed could begin with surgery THA, when there are no realised mandatory preliminary Clinic analyses of preliminary X-Ray of hip, there are for me scandal, when some forensic physicians could assert "there Fausse route stem as a normal expecting risk result - maybe unpleasent, but probable accepted as variant in limits LEGE ARTIS". No, there are scandal to begin with such operation without fullfilment mandatory requirements to create preliminary Clinic documentation, there should be diagnostic a natural declination femural neck of patients, there had to be rational change all processing Plan for next surgery THA. When do you studied Logics, there are by legal and Occam´s razor definition: There are all complicated surgeon processing full and absolute nonlegal! when there are before a fatal medical mistakes to ignore a duty taskby the Law in time! I need shoot dead some Orthopaeds, when there are a functional EHRs dialogic system. Please, you contact me, probable we could safe the lives of many patients! When you are a moder designers, you haven´t ignore Logic, new deivision of activities of usage Medical Devices among more number of exact responsible physicians for each elements of realisation, functional testing, measurement, postoperational controling on Orthopaedic screen, more efficiency computer support. There are thousand of Orthopaeds in rank which "there are only intuitive observing the postoperational THA", when I dispute:but there are duty by the Law "to measurement and compare imaging standard Profile of the used stem!" This is probable a infective idiocy??? I find namely in my Court about 40 radiologist and Orthopaeds which said to Judge: We are working such way for 20 years continually - and you are Mr. Cuc a first provocateur who could critise our excelency
experiences!!???

Marguerite McHenry In the ideal world engineers could design a fool proof product. Unfortunately, we are all mere mortals including design engineers. Reality, there is always a new employee that is unfamiliar with a product, or a hectic day and something is forgotten. We do failure analysis on devices, but do not do an adequate job on human failure analysis. Most often would have engineer write IFU, I would "translate" into a user IFU. Then would have the office secretary read and perform according to the IFU. That was only a simple IFU readability test.
It is a major team effort of Marketing, engineering, and regulatory to try and produce a product that has a minimal risks for the "non-reader".

Alan Barta Marguerite: A helpful tool is a process map. Any device that takes a whole lot of steps to use ought to be reengineered to eliminate some. I recall a staging device for arthroscopic knee surgery that had several mating parts. The reengineering eliminated several parts without sacrificing effectiveness and usability.

Antonin Cuc When I have been projecting "Assembling of subsections for the industrial hoisted cars in project 1971" there we are able to describe by the processing elements "MTM methods" each of elementary mooving of right/left hand ....on the lenght 48 cm in the high of breast 35 grads in right direction,,,, in store carton 2x1 dm with content machinary elements AAN, change of yours louding personal weight from left leg on right leg 70%, the touch of 3 fingers the elements XXY with force about 0,5 kp, it must be situated on the shaft in fixture board on working table No. DWD, etc. The describing was with the same accuracy, so as the music score for the pianist.... There never could be forgotten no partly act, so as in the music work J. S. Bach: Preludium C Dur BVW 545 there are never accepting a absency a part on page No 7. I am not recommending such detail describing the phases of THA surgery, but when there are in the Law the requirements to create allways mandatory Preliminary processing Plan of surgery, Then I haven´t accept as lege artis, when I was operated without such piece of Clinic preliminary Health documentation! So as when there are requirements by the producer instruction so as measurement firm instrument to control assembling of coaxiality between stem and femur...Then I never tolerate when a group of forensic physicians could accepting "virtually coaxiality only" when there are "a real uncoaxiality 13,68 grads"! I was convinced - there could be for physicians explained the duty a surgery THA realised exactly by the Standard Model by Videorecord of classic THA surgery with concomitant explanatory detailed medical text and with regards to explanatore annexes of photos and set of X-Ray imaging. But the Physicians are not able to respect such rational document. When I was asked, why the first postoperational X-Ray was realised till 3. days after surgery (when there are clear to know all medical instalation mistakes must be corrected in shortes time after trauma)...The forensic physicans told me - there are not exact definition in the implants Law...what exact time after surgery and what exact reliable ways it must be realised a first postoperacional X-ray. There are usual doing in many hospital in first day, but we could safe a postnarcotic rest for our patient 3 days and we have to economize costs and so we are realising only 1 imaging...and you are a first engineer provocateur who criticised our old aged experiences "intuitive observing X-Ray imaging with number of 2600 surgeries in last 8 years ". I have extremal high blood pressure to hear such stupid speach from gradueted Doctors - when there are on the surgery hall so as Radiological Devices with C automatic hand with scaner, so as there are Orthopaedic big Screen with computer support...SW with accuracy 1 Pixel = 0,2 milimeter - and the mistakes of doctors observing it was 5,8 milimeters and declination of stem from femural axis there were 13,68 grads, e.g. 8x more as accepting tolerance of coaxiality, but "by the view without measurement it was virtually O.K. Since the time, I am sure after such "Doctors arguments", there are explosure of Mass idiocies in medical heads, arn´t you? I´m dying for such stupidities! I wish you more health in springs 2014!

Sofia Epshtein Elbrus Antonin Cuc, I understand your claims and wish you the best of health!

Antonin Cuc There friends! In world literature it is known famous quote from Johann Wolfgang Goethe : "When you started to turn his shirt and the first button to get into the false holes , even with the best of your intentions It can not save the continuation to the correct result ! " Also, each running in athletics " Men 's 110 meter hurdles " can not be legally recognized as the potencial winner rounded the second obstacle in the trace! The same philosophy also says "Ocamm´s razor" in all scientific discussions. For example - If any medical complex operation surgery THA contained only 1 partial mandatory decision-making process , where it was necessary to respect consequent way the Pythagorean theorem in interpreting the image of postoperative alignment coaxiality of the femur shaft ... So the whole process of implantation THA is illegal - when there are 8x overcome angle assembling tolerance! If then forensic doctors said .... it's not intuitive to recognizing at postoperative observation of X-ray imaging....ir was no such clearly to see and we are evaluating as medical working "Lege Arti"s .... so I beg you friends - You could standing not ovations - but a minute of "Protest silencium in memory" of all patients who died unnecessarily or needlessly mutilated orthopedic patients yearly. I was a victim as a State investigator Health and Safety . I never had a possibility to express and take a commentary in Court Protocol, there are such conclusions in the judgment in contrary to my constitutional human right to a fair trial and the judgment and objective argumentation, crimi evidences by the forensic engineering, there were never be tasking regards to my mutilation, worse quality of life and Shortening my life about 5.5 years - in comparing with samples of orthopaedic patients with a right reslisation of THA surgery - and it was only for such aim to take my limited patient agreement in case in the medical working with modern scientic way and with regards to Conformity Assessment CE marking and there were all duties to prevency all known risk by the Protocol of CE. In the Law, there are no accepting "observing by the view X-Ray imaging", but here are fixed principles ..working with regards to all producer´s instruction with respect to medical orthopaedic knowledges Health and Safety with technical requirements by the design perfect anchoring implants centrizing in the hip bones with prediction to take safety usage of implanting in the normal duration of patents usage...without risk to Crash suddenly, etc. Yesterday I wrote on Ministry of Justice Czech Republic my claim for a false medical Court message !

Ed D. Curious. Medical devices are generally intended to be used by trained personnel. This is not the same as a consumer buying a car (a dangerous weapon) or a food processor. Yet if memory serves, the 2 (among the top 5) highest risks for medical patients in the US today are infection from reusable medical devices and overdose of medical radiation. Before you next have a procedure with a reusable device, ask your doctor for a copy of the cleaning log for that device. Most likely he/she will not know what you are talking about and the clinical staff will give you a vague answer. I know a person who was told by a well known medical center in Texas that the dose for given body mass was x units (rads or whatever). Yet when actual dose was provided/printed out by the machine, person was actually exposed to several times that number. Was the radiologist asleep, or did not read the manual? These are people with strings of alphabet soup after their names....not someone with an 8th grade education!

Alan Barta Ed, funny you should make that analogy. Power tools maim and murder way more people than medical devices, which are often a godsend when accident do occur. Yet litigation dogs industrial machine and medical device makers, since end user expectations are so much higher, but not necessarily the relative prices. Why is that? Car collisions are the 3rd most frequent cause of death in America, but they let anyone drive motorcycles and passenger vehicles despite gross incompetence. Yet victims hardly ever sue carmakers. It all boils down to what people accept and value despite unacceptable risks. Hazards can be mitigated by design. In the case of cars, the easiest way to reduce risks is simply revoke licenses to those who abuse privilege and make entry tests harder. I'm amazed every day by motorists hopping lanes at high speeds and passing carelessly on right in thick traffic, especially when there has already been an accident ahead slowing flow.

I have nothing more to add to this thread, not that anything said so far was even read.

Sofia Epshtein Elbrus Rudolph, it's arguable. Its correct that the user will rarely understand - compiles with class A radiated emissions - but by adding a note stating "not for use in residential environment" you have the issue solved. Same for the additional tests.

Antonin Cuc I took my case injuring by implantation THA to supervison from State Institut for Medicaments and Medical Devices of Czech Republic /SUKL Praha/ as "Undrsirable cases of Medical Devices". It was very comic results "Your Case - Fausse route stem THA - we cannot classified as legal Undersible cases....because we were conatcting both partners so as Deliever firm B. Braun Medical Czech Republic and user of set implants Bicontact S Noncemented - Regional Hospital Mladá Boleslav and we have been resulting...in the moment of beginning surgery THA, there were in perfect standard quality product by conditions CE, well storing, infectiousless...we haven´t legal competency to defined circumstances to arise your injuring, we accept as Lege Artis and we haven´t no competency to take you a product instructions guide - it will be as nonlegal hepling to You, as a third participant! we wish you perfect Health in future, Bye! Then I was asking at least to Director of B. Braun Medical Czech Republic to express - If it could be arrisen Fausse route stem - so as by exactly respecting the producer´s guide for user and when he is graduated Medical Doctor if could be able from 2 postoperational X-Rays of coaxiality stem and femur to recognize Crash and what way and what time - 1. imaging is from November16, 2007, 2. imaging is froem November 28, 2007...He said "I have no competency to exression!" and the Judge said - Mr. A. Cuc have no legal competency to asking this question and answering to MUDr. L. Klepáč, it protocled "Refused Question", it could be answering till from Orthopaedic Court Expert. When I was asking this same next to Court orthopaedic expert "You are not able to recognise Crash of femur from the 1. Imaging since November 16, 2007?" He said it is nearly perfect "by the view"! I have exclaimed WHY BY THE VIEW ONLY!!!??? The Judge took me word away immediately and he protocoled....there were not possible to recognize with sure the real position, maybe it was O.K. and maybe the crash was arrisen till later after surgery by the happend fallen of patient in postnarcotic bad selfreflection...BUT I accept, there are NO relevancy, because we couldnt find the fault from a physicians, but there are such complex responsibility of hospital. Then I exclaimed next question to the Orthopaed - Court expert: You have no able to recognize "a punctuare mooving of spice stem through the femural bone" or "happend breaking of the spice stem from femural axis with radial mooving out???" There must be allways the lengtwise fissure, but by the reoperation of joint, there were only PUNCTUARE HOLE THROUGH FEMURAL BONE ub surgery protocol from November 30, 2007 with 2 signs of Orthopaeds in surgery hall. The judge took me word away again! I never could asking, what about my preliminary declination of femur and whot about coordinates Xi,Yi.Zi of spice stem odn the Preliminary Plan???? There are none of preliminary mandatory documentation, no measurement of my hip bones, no processing planning of centrification implants in bones, no planning of Phases realisation and next controlling best anchoring of implants in bones before assembling of set THA. There are no interess from Judge to know Directive 93/42/EEC Medical Devices, no information about radiological firm mask os used stem and no about best timing of radiological controlling, etc., etc. Dear friends! With my patented method S_T_S_R_S I am able to eliminate 85% all medical mistakes in contrary requirements of forensic engineering! I am able to safe yearly: many thousands of needlessly dying orthopaedic patients and other thousands injured needlessly orthopaedic patient in each of State from OECD. I have no to much time for it! I am exhorting you to continue in my Ideas to medical working with minimize incereases entropy in repeated standards Orthopaedic surgeon and treatment procedures in the States OECD. I would inspired you with all enthusiasm to Human Rights and with regards to scientic level.

Jerry Twomey Lets be honest: Nobody is reading the comments unless they are clear, simple and to the point.

Ryan Raz I found this recent article which might help continue with my previous thought of setting up an industry wide standard for smart tagging physical equipment so relevant operating instructions and checklists will come up automatically on a tablet or monitor. The article does seem to indicate that it should work once some cultural barriers to compliance are overcome.

http://theincidentaleconomist.com/wordpress/when-checklists-work-and-when-they-dont/

"When checklists work and when they don’t

The following is a guest post by Atul Gawande, a surgeon at Brigham and Women’s Hospital, Professor at Harvard School of Public Health and Harvard Medical School, and Director of Ariadne Labs, in Boston.

David Urbach and colleagues have recently published in the New England Journal of Medicine a study of what happened in Ontario after the government there mandated that hospitals adopt a surgical checklist that my research team at Harvard School of Public Health and the Brigham and Women’s Hospital had helped develop with the World Health Organization. ..."

Sofia Epshtein Elbrus Rudolph.
I did not say to add a note that Class 2A devices cannot be used in residential environment (which would have been ridiculous actually), so your sarcasm could be easily spared in this case.
What I wrote is - medical device that passed Class A limits for radiated emissions according to the IEC 60601-1-2 standard (EMC standard for medical devices) cannot be used in a residential area as this is the restriction this emission class puts on the device. What I wanted to show by this example and what is usually done is - the EMC conditions are written as they are supposed to be written and then interpreted to a language the user will understand, in a way that allows him to perform the relevant actions in order to comply with these restrictions. I have no doubt your UK notified body won't mind if you do so :)
The environmental is even more simple - if you are manufacturing home use devices you must comply with the 60601-1-11. This standard sets strict environmental conditions in order to cover a broad range of potential uses and environments. So you are required to write the temperature, humidity and atmospheric pressure limits that your client will RARELY violate even if they won't read the UM, and I'm sure that the vast majority of them will know what temperature, humidity and atmospheric pressure is.

Best,
Sofy

Sofia Epshtein Elbrus Rudolph,
Annex C speaks both about emissions and immunity tests and all of them are referred as electromagnetic environment. Annex C gives an example of how the info should be presented and it also contains the guidance column in which you can help your reader to interpret the results.
By the way, every device that MIGHT be used in home environment must comply with the 1-11 according to the MDD. It was harmonized a couple of years ago. This surely it applicable to over the counter devices.
Have a great day
Sofy

Sofia Epshtein Elbrus I think its only us :)

Thanks, have a good day Ru.

P.S. Though I would still recommend you to look a bit more into this -1-11.

Feel free to msg me if you would like to discuss it further.

Bye.

they do :-)

Marguerite McHenry Yes, when the first get the product, (hopefully) or the sales rep reviews it with the, and them most often when all else fails when trying to troubleshoot the go to IFU. Reality meets Regulatory in the OR or any other place in the medical device world. Started my career as a nurse, real world. Then went into the medical devices. Two different worlds. We can regulate all we want, but getting compliance from the users is the challenge.

Keith Kretchmer There are many thoughtful comments in this discussion. It is very challenging to write clear and understandable instruction manuals. We have all seen manuals for various products, both consumer and professional, that are terrible--difficult to follow and understand--that were produced by large companies with abundant resources. One of the challenges of my job over the years has been to work on the final versions of instruction manuals for our products.

With some of the more complex products we provide a quick start guide that is laminated. This has been very helpful and well received.

We try our best with our manuals to make the order of information presented to be logical, concise, and clear. Of course we must include a number of warnings and cautions. We attempt to make the finished product easy to read for those (like me) who do actually read manuals before using a new product, and make them easy to use as a reference when necessary for those who do not.

We cannot avoid providing instruction manuals with our products. Our products are always used by people who know how to take x-rays, but may not know how to use our equipment to do so. Despite the assumption of a basic level of education and training by the operator, we still have to be careful with the style of writing to make these fully and easily understandable.

Writing instruction manuals is a challenging task, and an important skill.

Marguerite McHenry Quick Start laminated guide is a very good idea. I have found pictures are worth a thousand words. After we wrote out guides we would give it to one of the secretaries, or non-technical people. Put them in front of the equipment and see if they could follow the instructions, if they could follow without a problem, it was considered easy to follow.

I think the mindset has to change completely to acknowledge what is real and what is imagined to be real. Regulatory professionals want to be certain that they cover every potential misuse, every detail necessary to completely cover their bases and protect the physician and patient. That is not an unreasonable concept. It is also their legal responsibility. But in reality that protective concept falls into the "what is imagined to be real" category. What is real is that there are very few professionals be it surgeons, practitioner, or nursing professional that have the time or eyesight to completely read the IFU's I know this for a fact, as we have worked on all types of pharmaceutical packaging, surgical instruments, IFU's and over the counter products. We have observed surgeons as they go through their learning curves with new instruments and procedures. To ensure knowledgeable use you have to KISS. Keep it simple. And so, in addition to the IFU, which is required for regulatory purposes, it is more important and rational to provide a well done user hit list. The compact cheat sheet with large type, simple diagrams and intuitive instruction. That is the proper approach to human factors and that is a realistic expectation for an end user. How many of you out there have read the entire user manual for your automobile? What is real? The army has been able to have someone with no mechanical inclination and 12th grade education take a complicated automatic weapon apart and put it back together in less that 10 minutes. They use a cartoon based instruction format. Perhaps that is too drastic but remember working with DOS on the PC and then along came Apple. KISS

Marguerite McHenry You are right on target !

Antonin Cuc Dear Friends! I have been frustred, when we are working as engineers more under our knowledges, because "the Physicians have no sense for cooperating with temporary subordinations under managing of forensic engineers!" I am sure there are useful the same graphic relations with frequency of monitoring of mistakes derived by the functional ability of Medical Devices in duaration of developement of products - so as of monitoring of frequential mistakes of medical usage of complicated Medical Devices in beginning of running in teh medical parxis. There are clear...this critical time must be covered by supervisions of more experienced elderly Doctor...to be rescue Health of patients in standard level of risk. It is probable in Orthopaedic surgery with a new Orthopaed to estimate for cca 100 surgeries in duration of 1,5 years...and not until the new Orthopaed could realised with a adecuated responsibility next surgeries as a Head of processing realisation on the surgery hall with continual passive supervisions "by the view" elderly experienced Orthopaed. Mybe you are a designer of the new type of Orthopaedic implants and you have many clousely friends among the colleagues Orthopaeds in phase of developement of product, you are very integrated creative team, you are understanding each to other...but who will be guaranted "running in of a new Orthopaed with a new type of Orthopaedic Implants??? There are lack of basic education of students of Orthopaedy in "running in a new dangerous working", they have bad informed so as by eldere Head of Orthopaedic Clinics, "they all physicians believe common hardly - have to be running in with personal motivations of a new Orthopaeds in shortest time" ...and this true...it has got a bitter results as many dying of some orthopaedic patients deep under knowledges of organisation projecting in machinary in similar styles safety " working dangerous places in medical users surgery hall". None of Physicians could be pride to accept such professional critics - "How many patients were dying in context running in of a new Orthopaed?". Have you a courage for such next discuss with Orthopaeds??? I am courageous extremally: because I have been dying for such elementary details ...there were namely no surveillance for controlling of mandatory beeing of Preliminary processing Plan of my surgery THR with actual controlling my individual Dimesions, Profiles, Positions of my hip bones in my skeletal preliminary X-Ray imaging - thatsfor my Orthopaed caused Crash "Fausse route stem" without diagnostic ability to detect mistakes in time.

Users are more likely to view a quick start first that highlights high level / most important info supported with visual explanations that gives access to more detailed instructions.

If I look at most of the help pages on MSDN about managed or unmanaged programming, I am surprised to find one which states that the majority of readers rate that page helpful. That goes for most manuals, so people give up on them.

David Karchem The problem is that most user guides are written from the viewpoint of the developer. My most successful guides have been written starting with a list of questions and pictures or screen displays with arrow pointers directing the reader where to look in the picture.
How to do x?
How to get started?

The guides must be confirmed word for word, being very explicit or exacting.

Marguerite McHenry Many companies provide on-line training. To access the training an access code is provide, and changed often. Nothing like a quick visual, or short clip video to show how to problem solve. Also, availability to Skype with someone that thoroughly knows the product.

Tom Mariner Yeah, you need an Operator Manual that is clear and contains the requisite certifications, characteristics, and warnings and cautions. Sure a Quick Reference works.

But 14971:2012 no longer allows a quick reference to a Warning as a total mitigation for a hazard / risk. (and forces as low as POSSIBLE, not as "REASONABLY possible.)

What gives us confidence (in addtion to a great design and commercialization process) is adherence to the guidance in 60601-1-6, which now relies a lot on 62366 for the usability. Throw in 60601-1-8 for Alarms and warnings and you will come close to an interface that is inherently usable by operators, patients, service techs, manufacturing, etc. When you come to something that your risk analyis (or common sense) tells you might be problematic, a local label may well help.

Then we get to our international market, and that has another level of complexity -- but in many cases follows the same (very useful) rules.

interestingly, someone at the site will read the Operator Manual -- normally the youngest, least time on the job and the one that wants to make a great impression. I sure wish we could count on those folks to be our "on site" help desk, but obviously we and you have to consider the least interested, most distracted, most tired who have to operate or fix the amazing medical products you produce.

Antonin Cuc Could you imagine to used the industrial principles in the Medicine praxis? In the industrial processing planning, there are typical very differential describing worker activites, there are in the mass productions typical describing not only preparation of the workplaces, but including a preparation of trackpoint equipment, measure equipments, schema of position of workpiece in the active zone of the machine with strong fixing, all safety instructions, lately machinary fucntional controlling... there are code for adequted certification of professional ability of craftsman, the duty to let allways the first and the each 5. piece to controlling of independent supervisor - controllor, there must be "stop rescue controller", there must be perfect hygiene on the workplace, there are fixed Plan to realisation each step and immediately controlling on the workplace, there are nonsense to skip the defined sequential elementary processing, there are a Videorecords so as in the functions prescriptions each next step, so as Videorecords with guarancy perfect realisation each elementary activites, there are allways posible to reconstruct the arrising of a abortion...there are allways to recognize the causual involving - human mistakes? material colapsing? Third person in the workplaces? It would be perfect each 5. surgery THR as set of Health documentation including Videorecords after each week to set on Independent forensic engineering testing ...to detect each forensic engineering mistakes contrary Standards...Directive 93/42/EEC Medical Devices, Directive Machinary, etc. There are hundered risk situation which the Physicians are not able understand as fatal medical mistakes. When there are is a mistakes in identification of patient and he was needlessly operiert, there are clear to understand, but: when there are mandatory row of physicians activities with alternations some mandatory row of technician requirements and then some physicians activites and the processing is not perfect separated....then the Physicians are not able understand :..."ALL WORKING MEDICAL PROCESSING IS NONLEGAL" when there are at least only one activites or mandatory structure of Health documentation..it was ignored or with false quality? This is a Occam´s Razor principles of transitivities of mistakes influenced the finished results. When the Physicians don´t read the products instructions as the mandatory technician requirements...they are the potential murders of their patients. I had to give the Claims against the forensic Physicians, when they were not able to understand...there are in Law mandatory duties to control TRUE coaxiality between component stem and femur...there are full mistakes "observing intuitive only by the way the first postoperational 1 imaging after surgery THR", there are easy to ignore semantic differences between "coaxiality true" and "coaxiality virtually only", there must be used measurement of Profile and Dimension of stem allways - because in the case declination in the sagittal Direction imaging..there are about 3% with shorten Lenght of stem....there are sure, it is full crooked and without functional ability of assembling set THA. Forensic enginners must be full respcted, because our evidences are exact scientic definitely...forensic physicians could have a true only - when it is not in contradiction against forensic engineering evidences. This is a reason, why many patients are dying needlessly and most of them as crimi medical working....I hope, after my Prague Court there are more Physicians more educated including more Judges! The statistics could study the EHRs contents many years - but I am able to send tomorow thousands claims against crimi medical working - when I would competent to used data in the EHRs, are you smiling? I couldn´t, I am dying for such medical concatenations of stupidities too. I hope you will be continue in the fullfilment of education of yours Physicians regulrally!

Andrew Clay Good design, onboard cues or even an onboard checklist, and good training.

Edward (Ted) Reesor Tom,

I was quickly going through all the comments on this topic, looking for references to EN ISO 14971:2012 and finally found reference to it on the last comment above (thank you)! As you mentioned, the intent of the new language is that the manufacturer has to move from ALARP to ALAP but without relying solely on instructions or warnings. Meaning that we as manufacturers are no longer allowed to rely on IFU's as safety mechanisms for the very reason that people don't read them (for all the reasons and anecdotes stated above). It places the onus on us to address potential hazards and risks by other means.

As a designer and manufacturer, our company aims for the worst possible scenario when being used (distractions, dark environment, tired staff, hurried situation - the more common factors that can lead to product failure and patient danger). Or, as a colleague states, "Whenever you build something "idiot proof", they'll always find a way to build a better idiot".

I understand what you mean but FDA watch on it !!

Edward (Ted) Reesor Mike,

I have to agree that the subjective statement that reads "NOBODY" is flawed because that's too great a generalization, but there are far too many people who choose not the read them, even when they are supplied with each and every device. When I was a clinician in a hospital, I was often called upon as the "expert" on a device that I never used. The first course of action upon responding was to show the staff where the instruction booklet was and where the answers to their questions where located. This was to teach them that they could find the answers faster than putting out a call and hoping that I could respond in a timely manner. Today, I receive calls almost daily from end users asking questions that are clearly spelled out in the IFU's.

I know people who would read instructions for a pencil or a piece of string and that's far safer than those who ignore IFU's on highly technical devices. The reality is that far too many people gravitate away from using IFU's because they seem to get bigger and longer in a manufacturer's attempt to prevent litigation. We had one auditor try to convince us that we had to warn against every possible off-label application of our devices, meaning we could have placed a warning that you couldn't take a piece of standard disposable oxygen tubing and use it for rock climbing rope or a goat tether.

This is why the newest version of EN ISO 14971: 2012 discusses the limited role of IFU's in mitigating risk for medical devices.

Antonin Cuc Many Medical Devices as the products of engineering thinking so as formulation of Technician requirements of Law "Medical Devices" are building on the bases combination expressions of Legal and Technician contextual describing....when there are mandatory duties to processing planning by the Product instruction of implants...there are explicit sure, each Orthopaed must be processing planning the centrification position in the bones, well anchoring with exact defined finish coaxiality of implant femural bone with usage of radiological mask of used stem in preliminary X-Ray of hip patient....This is for forensic engineers definitely clear...but for Orthopaeds there were no mandatory duties to realise preliminary processing planning...when the same orthopaed was realised the same of surgery on the other link legs...but thatsfor he was not able to diagnostic my declination of femoral neck on the right leg....He said...you had a false day! I realised all with the same way...but it wasn´t fitted.....Yes, I had a pitch, but he had crimi activity contrary explicit mandatory duties. Such ways many patients are dying needlessly yearly...they had a mass pitch but more clever and to pride the Physicians!

Just like user instructions for house hold appliances people are more likely to read instructions manuals when something has gone wrong rather than before they start using something.
I also think it is a huge generalisation to say no one reads them.
However how to make them more easy to read and use is a different question - if you go back to house hold appliances the better manufacturers give you an "essential to know " or "before using "sheet of some description and maybe this is a way forward. Depending on the devise I would support not selling them to customers who have not had training - but this is then a commercial as well as regulatory issue. I am very interested in this discussion so keep posting everyone ........

I would love to know the answer. We sell a machine and train the users on site, our user manual explains in detail everything they are taught at the induction, plus going through the fault finding section should they encounter a problem. We never leave until we are sure they are competent with the procedure and happy with how the machine functions. Occassionally we get a call about a machine not working correctly, the first thing we ask is have you got your manual at hand. Most say I have checked and everything is correct, we ask them to take the manual to the machine and go through each stage with them. After the check they are asked to turn the machine on and it works instantly. One owner confessed she just reached for the phone because it saved her reading the manual, others claim they have never had one.Our system is simple to opperate and maintain, and the manual was approved by the FDA. One can only assume they won't read it because the manufacturer can do it quicker or send a service engineer out at their expense.

Antonin Cuc I have been attending the Spa Rehabilitation in City Trebon CZ, there were installed very clever /probable adequate expesiv and in Developement testing/ technician Medical Devices, like as "Magic Bed" for the Masage for spinal musculn, etc. There very many alternatives for very individual usage for the individual patient Diagnose, Dimension of body, Intensity and location of variant strong Forces, etc. But there were a "Service - nurse", which after 15 Minutes changed the patients on the bed as a stream with perfect derived the insurance costs for a modern massage. I had very intensive touching my Kidneys, but no the spinal musculn. There were a perfect product to used in the bad lines services for the stream of patients. I am sure, there are about 6 minutes taking for the individual re-build for individual informed patient from very educated (after 3 hours educated by delievers) nurse, but the more better services dor targets reahabilitation...was neve such financial profiting, when the case is solving "as blend supervisor and rehabilitation expert" + lack informed a nurse, which she has standard Task "5 Patients/ 1 Hour"...the coins in Cash sang well for somebody only. The insurance organisation paid regularly, with formal supervision, the patient keep a secret silent admiring to a nice nurse in RHB Ambulancy. But a rational thinking has the place here only - among the discussed people - about needless used the many rational products by idiotic ways and despite to public well used knowledges about "workflow analyses with defined places... where the cost are "Lossed?" and by increases of entropy without a influences on rehabilitation Health effects". I am a international expert in Health and Safety, but I have a very little quantum friends...sharing my understanding in main group of participants managing Health care, Many surgries are realised contrary to taking more efficiency alternative nonchirurgical treatments, but you have as a patient no chance to stay in the right queues... Who will be with me in the same group of experts and forensic Physicians to evidence it by samplings of patients???

Richard Oberreiter Having been in the area of OTC and home-use medical devices, I can tell you that it is not a generalization that people do not read the user manual. In fact, on the consumer end it is the rule.

Consequently, we end up putting a large effort into usability testing. Perhaps that is something that should be done much more for clinical devices. After watching dozens of people actually use a device, even after reading the instructions is very enlightening.

Device "misuse" (which I interpret to mean: when a device is used for something other than its intended use) is often a function some other workplace constraint such as: knowledge, personal conduct, corporate culture, limitations of time, budget or resources (human and otherwise). A pressing issue for most manufacturers is liability exposure. IFU's and training are valuable because, as well as being a regulatory requirement and educating users, they afford the company some measure of legal protection from litigation. I think an interesting question to ask is: does the "misuse" of our product open up any potential new application or present an opportunity for innovation that we hadn't previously anticipated? Is it possible that, in the long run at least, device misuse could actually be a good thing?

Marguerite McHenry Nigel, correct on "intended use". IFU's and training very important. Once small problem that happens occasionally, is the over enthusiastic sales rep trying to make the sale and say yes to the doctor on "off-lable" use. We all of read about those incidents. Your point is on new application: If doctor has an idea for product use that is not covered in the indications, he should be contacting the company to discuss, this protects the doctor and the company.

Brent Matthews I believe that a statement of "Intended Use" is a regulatory requirement and needs to be part of every device manual.

I remember originally thinking that this statement was odd when I first learned that it was required...really...how else are your going to use a hospital bed?!? Isn't it obvious.

Apparently not. It would surprize you to learn how "your" medical devices are being used in various healthcare facilities in other than intended use applications.

For example, we were shocked to learn how our bed was being used in one particular healthcare facility. While performing admirably, providing safe and reliable service as a hospital bed for patients to rest upon, it was, in fact, leading a double life. On occasion, it was being used by the service personnel as an elevating platform to stand on while changing light bulbs.

José Ramón Alonso Domínguez Thank you everybody for your comments. A Quick Reference Guide seems to be the best alternative. With this I also learnt how important is nowadays to summarize the content to read and how difficult is to be good at it, without loosing the most relevant facts.

Antonio C....what?