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Ignorance of Interaction Programming Is Killing People

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1. details The numbers on the label break many recommendations 1 2mL hr rather than the correct 1 2 mL per hr the space before mL is required to help avoid the m being misread as 00 and showing a number pointlessly to five significant figures and so on Worse in my opinion the numbers were not organized in any way that related to the pump s requirements The bag label appears not to have been designed to help the nurse who has to use it Both nurses incorrectly cal culated 28 8 yet this incorrect number had also been printed on the label which would have provided confirmation bias for the nurses and distracted their attention from relevant detail indeed the cognitive load of compiling a complex calculation would have reduced their error detecting vigilance in general The ISMP report commissioned a small human factors study of the Abbott pump It identified numerous problems 2 Why arent devices made consistent with best clinical practice so that operator training becomes simpler rather than the other way around Why does the report say in its recommenda tion 10A that nurses should be trained that mL on an infusion pump means mL per hour 2 Why does recommendation 10B ask purchasers hospitals to do human factors studies of pumps The same answer to both ques tions is that for the time being manufacturers and national regulatory processes can t be relied on and hospitals therefore have to
2. M 5250 45 57 MRC The buttons AC and MRC must both be pressed at least twice at the start otherwise the nurse risks the wrong answer being calcu lated In computer science terms what the nurse has just done is called compiling the nurse has converted that is compiled a calculation into a sequence of machine code operations but ton presses to do it To compile correctly which is crucial to get the right answer the semantics of the target machine the cal culator must be defined but we know many calculators are very different and worse math ematically wrong despite even looking alike 5 Clearly compil ing is a difficult task for any user and indeed one can imagine it is especially difficult for people FEATURE trained as nurses rather than as computer scientists We do not know from the incident inves tigation whether the nurses got the compiling wrong were using the wrong numbers or simply missed a step in their calcula tion But requiring nurses to do such a complex operation as compiling for such badly speci fied devices as handheld calcula tors is manifestly risky The cog nitive load on the user will not have helped their vigilance and ability to detect errors Whatever the causes we do know they made an unfortunate calculation error they did not detect Although compiling on a calculator is very complex it is still generally easier than doing the calculation w
3. a nurse cannot easily do the wrong calculation whereas on a conventional cal culator it is easy to hit instead of and never notice The iPhone has no operators and therefore the user cannot employ the wrong ones The iPhone also uses correct units mg and so on and checks that they are used con sistently a conventional calcula tor has no idea about units and cannot help the user avoid errors related to them say mixing up milligrams and micrograms To make numbers easier to read the iPhone shows a clear decimal point with the decimal part smaller as in 45e57 see Figures 3 and 4 and large num bers are shown with commas another recommendation the fluorouracil bag ignored as this reduces confusion between num bers like 100000 and 1000000 I don t currently require users to enter commas 1t would be an interesting study to see 1f their use would reduce errors FEATURE If the calculator communicated with the electronic patient record all numbers could be automati cally provided hence correct or they could be confirmed by the nurse rather than entered manually This would avoid transcription errors If protocol requires nurses to be responsible for calculations the iPhone could show a checksum for the correct answer The bag label would say something like if you don t get X5Q the checksum you ve got the wrong answer Conclusions It is astonishing that a life threatening problem that
4. accommodating device design rather than the other way around If a device operates as designed it is often assumed to be designed correctly even if to more perceptive eyes the incl dent is a symptom of bad design a system induced user error A Fatal Overdose In 2006 a patient received a fatal overdose of fluorouracil a chemotherapy drug Here s a summary of how it happened based on the investigation 2 The nurse went to the hospital pharmacy with the drug order and returned with a labeled bag of diluted fluorouracil and a printout of the dose details The nurse s task was then to calcu late how to program an infusion pump to deliver the drug at the appropriate rate The relevant numbers and units are 5 250 mg of fluorouracil diluted to 45 57 mg per mL to be delivered over four days This 1s not an easy problem for anybody to work out even without the many simulta neous jobs that nurses have to juggle The nurse had to calculate the rate to be delivered 5 250 45 57 mL over 24x4 hours he or she should have done this calculation 5 250 45 57 4 x 24 The nurse attempted the cal culation using a calculator and a second nurse double checked the work as a routine precaution It s a simple calculation as things go for instance a calculation for a dose of gentamicin an anti biotic is based on patient weight gender and height and involves powers as well as many con stants and condition
5. bear this notice and the full citation on the first page To copy otherwise to republish to post on services or to redistribute to lists requires prior specific permission and or a fee ACM 1072 5220 08 0900 5 00 September October 2008 interactions
6. has been recognized for a century has had such little impact on interaction design Why are basic errors ignored by interactive medical devices As the iPhone showed better interaction pro gramming is easy to explore We could save many lives if we made people aware that poor interaction programming is a significant factor in medi cation incidents Lawyers who represent patients and clinicians need to know more We already have many good recommenda tions to improve design 6 this article has argued that these recommendations should also be applied to the details of interac tive design Investigatory bodies analyzing incidents must include people trained in HCI This has already started and the role of ergonom ics and human factors is increas ing but expertise in interaction programming is essential too It should be normal for manufac turers to employ programmers with appropriate postdoctoral specialist qualifications just as pharmaceutical companies do Regulatory bodies should also be vigilantin preventing problematic designs from being approved Interaction is com plex Program specifications and source code must be checked using formal tools otherwise inconsistencies and other prob lems will not be detected this is a fundamental theorem of computer science This article addressed simple problems with numbers but no usabil ity study can ensure that all numbers both well formed and errone
7. train nurses to cope with bad design That also means that when things go wrong as they do that the nurses or the train ing has failed It s then a very short step to blame the nurses or their management for the conse quences Alternatives Are Possible I spent a day programming an Apple iPhone to explore ways of improving things see Figure 2 With my prototype you can hold in your hands a working system that avoids some of the problems described above It can be down loaded from harold thimbleby net health The iPhone stimulates many ideas For example it has a cam era and could photograph the drug barcode and check that it was what was expected it could require a second nurse to check the calculation and so on On the other hand the Phone is a new approach so it might not work as well as expected without further development Using a conventional calcula tor a dose calculation would report very few errors perhaps an accidental division by zero It would just display E and a wrong number when there is an error Unlike conventional calcu lators the Phone provides a clear explanation and importantly no number that could be misin terpreted is displayed Using the iPhone for the calculation above potentially 52 errors can be detected and some are detected during incomplete steps such as when the nurse is entering 45 57 but has not yet entered the deci mal portion of 57 On the iPhone
8. September October 2008 interactions Factors to No Longer Overlook 1 Thimbleby H Press On Principles of Interaction Programming Cambridge MIT Press 2007 Ignorance of Interaction Programming Is Killing People Harold Thimbleby Future Interaction Technology Lab FIT Lab Swansea University harold thimbleby net Almost a century ago the April 9 1929 issue of the International Herald Tribune reported the death of three young brothers All of them had been given a dose of thallium acetate 10 times what was intended because of a deci mal point error Decimal point errors occur regularly For instance on October 7 1998 The New York Times reported the death of a 10 month old from a decimal point error In May 2001 the Canadian Institute of Safe Medication Practice ISMP reported two deaths caused by decimal point errors In two sep arate cases 5 mg of morphine was misread as 5 mg The ISMP report mentioned that decimal point errors were among the first safety issues the Institute had dealt with when it was founded almost 10 years ago We are still risking such errors every day What Is Interaction Programming The title of this article men tions interaction program ming a term I ve introduced to distinguish the programming aspects of interaction from the more often emphasized human aspects 1 Human factors and design together with user cen tered processes are often taken to be
9. all there 1s to interaction design but the hidden partner is the details of how things work when they are used As they say the devil is in the details and this is a matter of programming This article shows that the programming matters a great deal A crucial point is that good interaction programming has to be engineered into a device s design by good programmers it cannot be established by inspec tion after it is working A very simple example is the Cardinal Health Alaris GP infu sion pump a new model intro duced in 2006 I have one and its firmware failed so the manufac turers replaced it The replace ment has a new user interface quite different from the old but of course the physical ergonom ics are identical Although there are some obvious differences between the old and new user interfaces the exact differences all of which affect users cannot be established by inspecting the device Interactive programs are too complex for unaided human comprehension instead good user interface design require ments must be engineered into programs by rigorous formal processes User centered methods and processes are essential and quite rightly are emphasized by the usability community but they are not sufficient to assure safe interaction For too long user centered methods and pro eramming have lived in different worlds programmers discount human factors and usability people discount programming Us
10. als It is easy to take the design of calculators for granted but we already know that calculators ignore many errors So let s look more closely at how one was used though the report does not give details presumably because it assumes calculators just work Calculators Are Mad Bad and Dangerous The nurse would have pressed a sequence of buttons to perform the calculation For example the keystrokes AC AC 5250 45 57 4 x 24 will obtain the cor rect result 1 2 However it 1s likely that the nurse did not have a calculator with brackets and instead had to do AC AC 5250 45 57 4 24 What nurse knows that repeated division is equivalent to dividing by a product Far more likely then the nurse would have calculated 4x24 on paper or used the cal culator to store the result in the calculator s memory He or she would then need to do AC AC 5250 45 57 MRC to get the answer How can one work out 4x24 and store itin the memory A basic calculator has a memory but many calculators do not have a store in memory key instead they have an add to memory key M To store a number to memory then the memory must already be zero otherwise the number stored will be wrong If the nurse starts to calculate 4x24 before zeroing the memory it is almost impossible to store the result correctly To get the drug calculation right the nurse must do the fol lowing AC AC MRC MRC 4 x 24
11. ers do not understand design neither they nor interface design ers can articulate the full intrica cles of computerized problems Yet programmers think their own programs so intuitive so easy to demonstrate need no hard work to become usable But all of us need to work together These ideas will become clear er by exploring interactive medi cal devices Details Matter National agencies make detailed recommendations on how to write drug dosages Always write fractions like 0 2 mg witha leading zero never have a trail ing zero aS in 1 0 mg it might be read as 10 not 1 and so on There are rules for not confusing micrograms and milligrams ug badly written could be confused with mg causing a factor of 1 000 error Write millihters as mL not as ml which might be con fused for m1 Write slash in full as per that is write mL per hr not mL hr so the won t be confused Don t use unnecessary decimal precision 20 4 mg might be read as 204 mg And so on Unfortunately little if any of this basic life saving advice seems to have been picked up by manu facturers of interactive medical devices September October 2008 interactions Factors to No Longer Overlook 2 Canada Institute for Safe Medication Practices Fluorouracil Incident Root Cause Analysis www ismp canada org 2007 3 Thimbleby H Interaction Walkthrough Evaluation of Safety Critical Interactive Syste
12. im ity of the buttons might mean a nurse presses the 10 instead of the 1 Here what is intended as a user interface accelerator has created a hazard analogous to the decimal point problems of conventional numeric keypad user interfaces Overall this may be better or worse one would have to do experiments to find out A potentially worse prob lem is that different approaches increment decrement versus numeric keypad create their own problems Most hospitals have many types of devices and correct operation of one may be deadly 1f transferred to another In short we need very detailed standards for user interfaces so that there are no unneces sary proliferations of interaction styles Decimal point errors are one of the simplest drug calculation errors to understand one of the longest consistently recognized problems in the area and argu ably the easiest to do something about Yet nothing seems to be happening Well one might then ask is it a significant problem Medical errors in hospitals in a given year cause about as many deaths as AIDS car accidents and breast cancer combined 4 Clinicians accept as routine using workarounds such as switching a device off and on to recover from errors often los ing data e g drug dose to date in doing so Indeed many near misses are not reported because they do not lead to adverse clini cal incidents Often hospital pro cedures or training are blamed for not
13. ith pencil and paper One of the main reasons compiling is so complex is that calculators are designed to do any calculation they are more powerful than any nurse or doc tor needs If the nurse makes a mistake perhaps pressing instead of no calculator will complain it has no idea what calculation the nurse is trying to do It will just provide the wrong answer If the design of calculators 1s inappropriate for medical calcu lations it is even more remark able that the infusion pump did not help as it unlike a calcula tor was specialized to medical problems Its design should have been based on a task analysis and potential user errors An infusion pump contains micro processors and one could easily be designed to take concentra tion duration and so on from the nurse and do the sum itself Some are of course but not this one the ones that do so called smart pumps cost much more despite differing only in their programming Interactive Medical Devices Are Bad Too In the 2006 fatality both nurses failed to divide by 24 hours per day so they agreed the dose rate was 28 8 mL per hour instead of the correct 1 2 mL per hour The pump could have told the nurse that at that rate the drug supply which the pump knows would take about four hours to be used This would not have been the four days the nurse expected Instead the infusion pump merely asked the nurse to con firm what they had e
14. ms DSVIS 2006 The XIII International Workshop on Design Specification and Verification of Interactive Systems Springer Lecture Notes in Computer Science edited by G Doherty and A Blandford 4323 52 66 2007 4 Kohn L T J M Corrigan and M S Donaldson eds To Err is Human National Academy of Sciences 2000 A typical interactive medi cal device allows users to enter numbers in almost any format with or without decimals mis leading zeros and all without any warnings whatsoever A human factors study of one pump 2 found that three out of five registered nurses were par tially or completely confused over using the decimal point key the user interface doubles up the decimal point with an arrow key that is used for menu selection A paper on another pump noted that its user manual says that it works like a calculator when in fact it does not 3 If a user enters 0 0 5 on the pump 1t is taken as 0 5 whereas on a typl cal calculator the same button presses would be taken as 0 05 a very different value This differ ence could clearly lead to serious problems Neither pump nor cal culator reports any error when more than one decimal point is entered The Alaris pump mentioned in the introduction has no numeric keys so 1t cannot suffer from decimal point errors as such Instead it has four buttons to increase and decrease the current number by 1 or by 10 Unfortunately the close prox
15. ntered They had entered 28 8 in error so the pump asked 1f they had meant to enter 28 8 Unfortunately having made the error that was what they thought they wanted to enter Since the pump was in use exclusively on a chemotherapy Figure 1 The infusion pump used in the fluorouracil incident The pump is small and gives the patient full mobility during the treatment Here the nurse needs to enter mL per hour but has to use Option 3 which is apparently asking for mL Note that the up arrow key doubles as the decimal point 5 Thimbleby H Calculators are Needlessly Bad International Journal of Human Computer Studies 52 no 6 2000 1031 1069 September October 2008 interactions September October 2008 interactions Factors to No Longer Overlook Figure 2 The proto type dose calcula tor running on the iPhone it also works on desktop Web browsers The open ing screen is red and shows that a dose and drug concentra tion have not yet been provided The tabs at the bottom of the screen allow the user to choose which numbers to enter they allow users to enter numbers in any order unlike an ordinary calculator where changing order would create errors Figure 3 Entering the drug concen tration using the keypad The screen scrolls up and the numeric keyboard appears when a number field is tapped The Rate tab is red indicating outstanding errors at thi
16. ous are handled correctly And number entry isn t the only design feature that needs check ing In short a usability study can help check that a design is appropriate for users and their tasks but the entire design must also be checked by formal meth ods Quality assurance has to be done in the beginning using rig orous manufacturing processes not later by regulatory bodies or by hospitals or by users finding the bugs There are many more ideas changing culture is never easy and it will require many approaches Lives depend on us For more information I ve begun to put some resources together at http harold thimble by net health ABOUT THE AUTHOR Harold Thimbleby wrote Press On Principles of Interaction Programming which won the American Publishers Association best book award in Computer and Information Sciences in 2007 Press On has more design recommendations for interactive devices not just medical devices Harold is a Royal Society Leverhulme Trust Senior Research Fellow and the work here was also supported by EPSRC Grant EP F020031 See harold thimbleby net DOI 10 1145 1390085 1390098 6 United Kingdom Department of Health Design for Patient Safety 2003 Permission to make digital or hard copies of all or part of this work for personal or classroom use is granted without the fee provided that copies are not made or distributed for profit or commercial advantage and that copies
17. s point one of the errors is that the user has not finished entering the concen tration Figure 4 Once all numbers are entered correctly the main screen goes green and summarizes the dose details It also confirms how long standard sizes of drug will last and what the daily dose is all Carrier gt 9 47 PM mL hr calculator nts to ei Comme See e Dose needed e Concentration needed Dose Conc beaa E ull Carrier gt 9 44 PM 557 TT A UNKNOWN Dose Conc ll Carrier 9 40 PM mL hr calculator Comments to Rate Dose Conc ward it could have checked that dose rates were appropriate for standard drugs more than 30 grams per day for fluorouracil should have raised warnings 1 gram a day is a high adult dose for fluorouracil Unfortunately the pump provided no such checking The infusion pump was an Abbott AIM Plus In the mode where the nurse should enter mL per hour the display option is mL without the per hour which 1s incorrect see Figure 1 Moreover the HELP button provides information on only two of the three options and does not give help for the incorrectly labeled option The pharmacy computer print ed the label on the fluorouracil bag which the nurse used to get the numbers for the calculation The label confusingly included many numbers 1 2mL hr 28 8mL 24h 1312 5mg 24h 15 numbers in all not counting the date and patient identification

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