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Riccardo Offredi Thesis - Reduced Version


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Most interesting chapters of my Thesis about Preventive Maintenance protocols (English version).

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Riccardo Offredi Thesis - Reduced Version

  3. 3. Author: Riccardo Offredi - TABLE OF CONTENTSTable of contents .................................................................................................................................. 3Introduction .......................................................................................................................................... 4Chapter 6: Case study: Preventive Maintenance recommendations .................................................... 7 6.1. Introduction ............................................................................................................................... 7 6.2. Anaesthetic machines description ............................................................................................. 7 6.3. Protocol analysis ....................................................................................................................... 8 6.3.1. Equipment “A”: Spanish protocol...................................................................................... 8 6.3.2. Equipment “A”: French protocol ....................................................................................... 8 6.3.3. Equipment “A”: Considerations......................................................................................... 9 6.3.4. Workstation “B”: Spanish protocol.................................................................................... 9 6.3.5. Workstation “B”: French protocol ..................................................................................... 9 6.3.6. Workstation “B”: Considerations..................................................................................... 10 6.4. Different protocols .................................................................................................................. 10 6.5. Considerations ......................................................................................................................... 11 6.6. Conclusion and proposals ....................................................................................................... 12Chapter 7: Proposals .......................................................................................................................... 14 7.1 Introduction .............................................................................................................................. 14 7.2 Operative proposals.................................................................................................................. 14 Preamble..................................................................................................................................... 14 Expedient ................................................................................................................................... 15 Self-criticism .............................................................................................................................. 17 7.3 Systematic proposals ................................................................................................................ 17 7.3.1. Technical Area ................................................................................................................. 17 7.3.2. Legislative Area ............................................................................................................... 19 A. Preventive Maintenance protocols selection ......................................................................... 19 B. Collaborative process for Preventive Maintenance protocols ............................................... 21 C. Maintenance Service Organization ....................................................................................... 25 D. Biomedical Equipment Technician ....................................................................................... 26Conclusions ........................................................................................................................................ 28 Optimistic Scenario ........................................................................................................................ 28 Realistic Scenario ........................................................................................................................... 30 Final considerations ....................................................................................................................... 31 Future developments ...................................................................................................................... 31Appendix A – Notified Bodies........................................................................................................... 32 3
  4. 4. Medical equipment Preventive Maintenance: is a new approach possible? - Reduced version INTRODUCTIONConsidering the current European-wide financial situation, hospitals localized in Member states ofthe European Union, and so clinical engineering department, are going to receive less and lessresources (human, technological, and financial) to cope with increasing healthcare request.Clinical engineer who is responsible for the department, will be asked to contribute to resourcesoptimization, with the principal target to enhance (or at least maintain) care quality level deliveredto patients.One of the historical clinical engineer skills is organizing maintenance and its consequent activities.An Italian law impose on the clinical engineer to follow Preventive Maintenance protocolsrecommended by original equipment manufacturers (in the case those protocols exist) which arebroadly characterized by fixed interval intervention.The resulting activities require a lot of man power and their efficiency is not demonstrated for anincreasing share of medical equipment used in hospitals; in the last 40 years the clinical engineercommunity have been watching a double shift: medical equipment moved from machines typifiedby mechanical friction that brings wearing (in which fixed intervals of maintenance areappropriate), to machines characterized by electronic components (in which few parts have to bereplaced), to medical systems and devices that are interconnected among them for diagnosis andtherapy goal (wide use of Information Technology).The evolution outlined above entails a reduction of usual issues (Preventive Maintenance at fixedintervals), and first appearance of new issues (relating Information Technology), to which clinicalengineers will have to give a quick answer to reduce patients’ uncomfortableness toward theminimum level.In my thesis I am going to consider Preventive Maintenance as “True Preventive Maintenance” thatis restoration or replacement of medical device non-durable parts.According to Malcolm Ridgway, some devices that appear to be very similar in function and designhave manufacturer-recommended intervals that vary by a factor of two or more. So someperplexities rose about the fact that those intervals are based on meaningful test data. If so, wouldmanufacturers share those informations? If there are no test data, nor willingness to share, nor otherrationale is provided, than it is easy to understand the concern about the validity of thoserecommended values.Many clinical engineers are thinking that is given too much emphasis on fixed intervalsmaintenance tasks even if those tasks don’t cause, for much medical equipment, an improvementfor reliability and safety.The goal of my thesis is to understand if it is possible to find and to implement PreventiveMaintenance protocols which are different from OEMs’ Preventive Maintenance protocols toimprove patient quality of care, considering hospital peculiar necessities where medical equipmentis used.The reasons that pushed me to investigate on that topic can be summarized in the curiosity evokedby the following questions:  Why Preventive Maintenance is done in a certain way?  What is the benefit coming from a certain maintenance task for healthcare sector?In the continuation of my thesis I am trying to answer to the following questions:  What are the different maintenance techniques that are alternative to the prevailing ones?  In which condition new techniques find the best application?  What are the involved consequences?  Considering that each healthcare organization has unique features coming from users, patients, environmental stresses, may a hospital have the necessity for a specific protocol for the same make-model of medical equipment?  May a clinical engineer (having a deep knowledge of a certain hospital) modify OEMs’ protocols with better results on patient safety?4
  5. 5. Author: Riccardo Offredi -  What kind of information should be based on the adoption of a certain maintenance strategy?  What is the best source for that information?  What process is necessary to adopt in order to derive from the available information the choice about the best strategy to implement?  Is it possible to learn from other sectors that are involved in maintenance tasks to improve patient safety through the application of a certain maintenance strategy that is different from the prevailing one?  How can a clinical engineer optimize resources, that is where we have to cut resources and where it is better to invest more resources?  What kind of effort will be asked to clinical engineer due to the increasing use of more and more electronic and intercommunicating devices?The instruments used to reach the answers corresponding the questions written above are listed asfollows:  Exchanging e-mails with some clinical engineers that are conducting experiments abroad Italy (U.S.A and South Australia); those experiments cause the application of maintenance strategies which are different from OEMs’ maintenance strategies;  Interviews through e-mail made to an expert clinical engineering working for a third party organization (whose goal is to find new process to improve patient care);  Interviews made to a operant Biomedical Equipment Technician;  Comprehension of clinical engineering conference presentations discussed by innovative leaders about maintenance strategies;  Study of the process through which is determined Preventive Maintenance protocols in European / American civil aeronautics;  Analysis of European Law about medical devices and aircraft safety;  Analysis of Italian Laws about medical technology and public contracts for services and supplies;  Analysis of near event distribution communicated by Public Health Service (UK and Australia);  Reading a handbook about new approaches to maintenance management (Reliability- centered Maintenance).The topic treated by this thesis is particularly up-to-date, because in literature traditionalPreventive Maintenance has been criticized by illustrious members of clinical engineer sector since2009:  Malcolm Ridgway deals with this topic in “Optimizing Our PM Programs” , Biomedical Instrumentation & Technology, May/ June 2009; “Reducing Equipment Downtime: A New Line of Attack”, Journal of clinical engineering, October/December 2009; “Manufacturer- Recommended PM Intervals: Is It Time for a Change?”, Biomedical Instrumentation & Technology, November/December 2009;  Binseng Wang deals with this topic in “Evidence-Based Maintenance - Part I: Measuring Maintenance Effectiveness With Failure Codes”, Journal of clinical engineering, July/September 2010; “Evidence-based Maintenance – Part II: Comparing maintenance Strategies Using Failure Codes”, Journal of clinical engineering, October / December 2010.My thesis is structured in 7 chapters.In the first one I am highlighting exogenous factors that are affecting the healthcare sector evolutionin Europe and particularly in Italy, considering economics, demography and society. This chaptermakes clear the necessity for optimizing available resources for healthcare sector of every Countryin European Community. In the remaining part of the thesis I am trying to understand how a clinicalengineer can contribute to optimize resources.In the second chapter I am showing basic definitions such as clinical engineering, clinical engineer,biomedical equipment technician; I am clarifying the difference between health technology, medical 5
  6. 6. Medical equipment Preventive Maintenance: is a new approach possible? - Reduced versiondevice and electromedical equipment; I am describing Health Technology Assessment concept; Iam treating healthcare aspects of Information Technology and its very probable future impact onorganization and task relative to Clinical Engineer Department; I am examining the reliabilitynotion, the original equipment manufacturer definition, and the concept of Preventive Maintenance.The third chapter is titled “re-think Preventive Maintenance”: firstly I am examining the legislationin force in Italy and in Europe, and the rules emanated by the most important hospital accreditingorganization in the world, set outside European Directives; then I am analysing the incentives thatencourage us to think critically the current way of organizing and managing PreventiveMaintenance; lastly I am registering the obstacles that prevent the adoption of different protocolsfrom the ones indicated by manufacturers.In the fourth chapter I am describing current and future techniques relating Preventive Maintenance;I am dealing with Reliability-centered Maintenance, because it is the process that allowed derivingan evolution compared to traditional maintenance strategies in many industrial sectors, and I amtreating its application in biomedical technology field: Evidence-based Maintenance. At last I amanalysing how experiments conducted by innovative technology managers made concrete theprincipals of Reliability-centered Maintenance in healthcare and what are their outcomes.In the fifth chapter, considering how safety has been growing in civil aviation sector, I aminvestigating the process through which Preventive Maintenance protocols are established in thatsector: I discovered that it is based on Reliability-centered Maintenance principles and it is sharedby stakeholders. Then I am analysing automotive sector, realizing that following some principles ofthat market, it would be possible to reduce Preventive Maintenance cost for healthcareorganizations, increasing competition among maintenance service provider.The sixth chapter is made by a case-study: in two different cases, for a specific make-model ofelectro-medical equipment, which is sold in two different Countries of European Community, thesame manufacturer recommends different Preventive Maintenance protocols. It is impossible thatboth protocols are the best for maximizing patient safety goal and for minimizing resources requestgoal. So I am suggesting to uniform Preventive Maintenance protocols at European-level for thesame make-model.The most original side of my thesis is pinpointed in the seventh chapter, relating to proposals: at thebeginning I am showing a way to get a more appropriate protocol for a specific hospital needing; itis obtained during a single piece of electromedical equipment negotiation, without modifying anyexisting Italian Law and straight spendable by Italian Clinical Engineering Services.Secondly I am putting forward the adoption of the same failure classification, which happen onmedical device; the adoption is made hopefully by as much as possible healthcare organizations.Then I am promoting the choice -made by clinical engineers- to select the more opportunePreventive Maintenance protocols, asking for the modification of Law Decree n. 81 in 2008.Subsequently I am proposing a process to realize an initial Preventive Maintenance protocols formedical devices valuable inside European Community, subject to amendment of EuropeanDirective on Medical Device.Next I am suggesting the certification for medical equipment Preventive Maintenance servicecompanies working inside the European Community; the certification is subject to the promulgationof a specific European Directive.At last I am proposing the constitution of a specific European Directive that imposes a maintenancelicence to the people who wants to do Preventive Maintenance tasks on medical equipment insidethe European Community.In the present work I am just dealing with the following chapters: introduction, chapter 7(proposals) and conclusions.6
  7. 7. Author: Riccardo Offredi - CHAPTER 6: CASE STUDY: PREVENTIVE MAINTENANCE RECOMMENDATIONS6.1. INTRODUCTIONIn brief I was able to examine two pairs of Preventive Maintenance protocols which concern twomodels of the same class of medical device; such class of medical device is used by every advancedhealthcare organization to implement a vital healthcare process, which is anaesthetic therapy.The first pair of protocols are different between them and they regard the same make-model ofmedical device (I will call that model “A” for legal issues) which is currently used in some Frenchand Spanish hospitals.The second pair of protocols are different between them and they concern another make-model ofmedical device (I will call that model “B”): even that one is marketed and it is working in someFrench and Spanish hospitals.Inside each pair of above-mentioned protocols, it is interesting to investigate differences inPreventive Maintenance recommendations set by the same manufacturer for the same make-modelof medical device, which is commercialized in two different Countries of the European Union.6.2. ANAESTHETIC MACHINES DESCRIPTIONBoth “A” and “B” are two anaesthetic machine models, coming from the same Manufacturer and sothey belong to the same make, but they have different features: in a nutshell the first model (“A”) ismore essential in its functionality, while the second (“B”) has all the features that someone mayrequire to an advanced anaesthetic workstation.Anaesthetic machines may be set up whether as modular systems or as integrated machines.In the case of modular approach –device “A”-, anaesthetic system platform is constituted by trolley,with mixers and rotameters, by ventilator, and by monitor for airway pressure, for expired gasvolumes and for inspired oxygen concentration. The benefits coming from modular configurationinclude flexibility in choosing during integration or possible system improvement. Among thedrawbacks there are problems coming from interfacing different modules or the presence ofmultiple alarms and displays.The medical device “B” is an integrated anaesthetic workstation in which it is evident the benefit tohave an integrated system of parameters visualization and a system which control alarm priority.Table 6.1 shows differences between “A” and “B” medical deices in their features, in target patientsand in environment of use. 7
  8. 8. Medical equipment Preventive Maintenance: is a new approach possible? - Reduced version Anaesthetic machine “A” Anaesthetic workstation “B”Principal environment of use Designed for Intensive Care Unit. Designed for Operating Room.Secondary environment of use May be used in Operating Room. May be used in Intensive Care Unit.Price Cheap. Expensive.Feature Essential. Complete.Patient target Newborn, traumatized, routine Newborn, traumatized, routine, patients. pharynx mask, not-tolerating to some anaesthetic gases patients.Anaesthetic system Fundamental parameters Fundamental parameters monitoring. monitoring, hemodynamic parameters monitoring, central nervous system monitoring, ECG, etc.Patient breathing system O2 and N2O supply. O2 and N2O supply. Fewer parts and connections; it reduces the possibility of leakage and connection-mistakes. Improved patient-safety. Reduced maintenance downtime.Ventilator operational modes Default: controlled volume and By default all the ventilation pressure, Positive End-Expiratory modality present in anaesthetic Pressure (PEEP). Optionally: machine “A” by default and synchronized ventilation, support optionally. pressure with apnea ventilation.Table 6.1. Detailed comparison between two models of anaesthetic machine.6.3. PROTOCOL ANALYSISLet’s analyse and compare firstly the pair of Preventive Maintenance protocols regarding medicaldevice “A”, and secondly the pair of Preventive Maintenance protocols concerning medical device“B”, used in Spain and France.6.3.1. EQUIPMENT “A”: SPANISH PROTOCOLThe Spanish Preventive Maintenance protocol relating anaesthetic machine “A” does notdistinguish among different Preventive Maintenance techniques, that is substitution of worn parts,checking of parts subjected to wear and tear, and calibration; instead it distinguishes the onlysubstitution. Consequently it is necessary to substitute yearly the non-durable parts, regardless oftheir state of deterioration.Given the great amount of parts to be substituted and the annual frequency (and so constant) atwhich is requested to substitute the parts, the annual total cost regarding Preventive Maintenanceamount to 2291.44 €. This estimate of cost was realized in 12 October 2007.6.3.2. EQUIPMENT “A”: FRENCH PROTOCOLFrench Preventive Maintenance protocol regarding medical device “A” distinguishes amongdifferent Preventive Maintenance technique, that is substitution, check and calibration. Let’sanalyse only the substitution task recommended as in June 2004.Every 12 months the manufacturer recommends to substitute:  One o-ring to the value of 3.53 €;8
  9. 9. Author: Riccardo Offredi -  One oxygen-cell to the value of 229.86 €;Every 24 months the manufacturer recommends to substitute:  One lead-acid battery, with a voltage of 12 V to the value of 81.55 €;  One flapper-valve to the value of 7.70 €;  One free-will respiration o-ring to the value of 1.00 €;Every 2 years the total cost of substitution is equal to (3,53 * 2 + 229,86 * 2 + 81,55 +7,70 + 1,00) €= 557,03 €.In conclusion the yearly total cost of substitution is equal to 278,52 € (rounded off to the seconddecimal point).6.3.3. EQUIPMENT “A”: CONSIDERATIONSThe parts which have to be substituted and which are present in the Spanish protocol for anaestheticmachine “A” are all comprised in the French protocol.Comparing the two protocols regarding anaesthetic machine “A”, the Spanish protocol causes anexpense about 8 times greater than the French analogous protocol, regarding to the onlysubstitution.Note that if the checks scheduled in the French protocol for medical device “A” entailed thenecessity to substitute any non-durable parts, yearly cost of substitution would increase compared tothe only substitution expense.6.3.4. WORKSTATION “B”: SPANISH PROTOCOLThe Spanish Preventive Maintenance protocol relating anaesthetic workstation “B” does notdistinguish among different Preventive Maintenance techniques, that is substitution of worn parts,checking of parts subjected to wear and tear, and calibration; instead it distinguishes the onlysubstitution. Every year it is necessary to substitute the parts which are subject to wear. Such partscomprise all the parts which are present in the French protocol of the same medical device and otherparts which the French protocol does not consider for substituting.Given the great amount of parts to substitute, and the fixed frequency (annual) at which it isrecommended to substitute the parts, the total cost of Preventive Maintenance amount to 1390.69 €.This estimate of cost was realized in 12 October 2007.6.3.5. WORKSTATION “B”: FRENCH PROTOCOLThe French Preventive Maintenance protocol distinguishes among different PreventiveMaintenance technique, that is substitution, check and calibration. Let’s analyse only thesubstitution task recommended as in June 2004.The protocol regarding substitution requires the execution of different tasks depending onconsidered range. The intervals are fixed at 12 months, 2 years or 4 years.Every 12 months it is requested to substitute 4 o-rings any of which was worth 3.53 € depending theprice list. The number of the pieces is compatible with the 4 o-rings scheduled in the Spanishprotocol.Every 2 years it is requested to substitute:  Everything that is substituted every 12 months;  One flapper-valve (in the Spanish protocol one flapper-valve is requested to be substituted every 12 months);  One free-will respiration o-ring (in the Spanish protocol one free-will respiration o-ring is requested to be substituted every 12 months);Every 4 years it is requested to substitute:  Everything that is substituted every 2 years; 9
  10. 10. Medical equipment Preventive Maintenance: is a new approach possible? - Reduced version  2 batteries (in the Spanish protocol 2 batteries are required to be substituted every 12 months);The total cost regarding the part to be substituted every 4 years becomes:3.53 € / 1 o-ring * 4 o-rings /years * 4 years +(7.70 € / 1 valve + 1 € / 1 o-ring) * 2 years +(81.55 € / battery * 2 batteries) = (56.48 * 17.4 + 163.1) €= 236.98 €That is equal to 59.25 € / year.6.3.6. WORKSTATION “B”: CONSIDERATIONSThe parts to be substituted, which are present in the Spanish protocol for anaesthetic workstation“B”, coincide with all the part which are present in the French protocol and with other parts that theFrench Protocol does not consider for substitution.Comparing the two protocols about workstation “B”, the Spanish protocol causes an expense about23 times greater than the analogous French protocol regarding to the only substitution.If the scheduled checks in the French protocol for workstation “B” entailed the necessity tosubstitute non-durable parts, the value of yearly substitution would increase compared to theexpense relating to the only substitution.6.4. DIFFERENT PROTOCOLSIn brief in at least one Spanish hospitals is made a sort of “heavy maintenance” where themaintenance organization requires to substitute many parts at fixed intervals; differently in at leastone French hospital is made a sort of “light maintenance”, where maintenance requirements ask toclinical engineering service to  Substitute a lower amount of components compared to the Spanish case and  Verify the wearing condition of other non-durable parts and  Calibrate some components.Note that the manufacturer issues those protocols regardless to local hospital features.Preventive Maintenance is influenced in each hospital at least by the following local factors:  Environment of use: that is in which department the medical device is used;  Which category of caregiver uses it: physician, nurse;  Which kind of maintenance experience the clinical engineering service has in a specific hospital: new service where few and neophyte technical staff is working, versus skilled service where much technical staff is working.  Frequency of use of medical device: it is probable that in an Operating Room, the stress to which medical equipment is undergone is greater compared to other departments.In my opinion, such consideration is important because the Preventive Maintenance request madeby a specific medical equipment manufacturer have to be designed for a standard healthcareorganization; so the recommendations should be the result of considerations which are on averagevalid for every hospital.Making the hypothesis that the feature of Spanish and French hospitals are on the average verysimilar in the above-mentioned points (as it is reasonable to think), the Preventive Maintenanceprotocols for the same make-model of medical device should bring to the same result, that isidentical Preventive Maintenance recommendations for both Countries.Reasoning for absurd, it would be logic to expect that medical equipment manufacturerrecommends Preventive Maintenance protocols that would schedule the only headings ofsubstitution of the components which are subject to wear at fixed interval to every hospital of acertain Country if the large majority of clinical engineering service of the same Country areshowing similar serious technical gap, such as incapacity to verify the wearing condition.10
  11. 11. Author: Riccardo Offredi - riccardooffredi@gmail.comAbility to do maintenance comes from mainly the schooling level in technical field and it is likelyto expect that, where there is a good ability in teaching to physicians, there is at least a basilarability in teaching to BMET’s.I think it is reasonable to expect serious gap in teaching maintenance techniques in a Country which isnot evolved with regard to the effectiveness by which healthcare services are supplied.Using the sentence “effectiveness by which healthcare services are supplied” I mean mainly the capacityof a government to improve the health of their citizen and it is -according to the World HealthOrganization- the only feasible way to compare different healthcare systems belonging to differentCountries.A study made by World Health Organization1 places Spain and France inside the top-ten of theHealthcare Service with the best effectiveness in the World, as table 6.2 shows. Table 6.2. Effectiveness ranking of the top-ten Healthcare Service in the World.By my argument I conclude that there are similar skills in France and in Spain regarding medicalequipment Preventive Maintenance; in my opinion Spanish BMET’s are able to do inspections andcalibration as well as French BMET’s.Spanish protocols are characterized by low efficiency of Preventive Maintenance because, after aninspection task, BMET’s could notice that some tasks are useless, because some parts did not reachtheir respective “useful life” limit.That is the reason why I consider spurious from a manufacturer to recommend PreventiveMaintenance protocols which are based on different parameters for the same make-model, that isfixed interval for Spanish protocol and a combination of fixed interval and metered maintenance forthe French protocol.The true reason of a fixed interval request could lie in the will to increase the invoice coming from alow efficiency Preventive Maintenance tasks.6.5. CONSIDERATIONSConsidering so both French and Spanish protocols, and ignoring which one of the two is the best,necessarily we could be alternately in one of the two situations examined afterwards. Each instancecauses some anomalies which in brief causes a physical risk for the patient and/or a bad allocationof economic resources.Let’s examine the two possible situations: A) Preventive Maintenance protocol which entails to substitute a few parts (“light maintenance”, as in the case of above-mentioned French protocol) is the best one, that is it requires to do all Preventive Maintenance tasks that entail demonstrable benefit to reduce failure onset. Consequently Preventive Maintenance protocol which schedules the substitution of many components (“Heavy maintenance”) is characterized by excessive, so it1 Tandon A., Murray C. JL, Lauer J. A., Evans D. B., “Measuring overall health system performance for 191countries”, - GPE Discussion Paper Series: No. 30 - EIP/GPE/EQC - World Health Organization. Disponibile 11
  12. 12. Medical equipment Preventive Maintenance: is a new approach possible? - Reduced version entails an inefficient Preventive Maintenance (in the sense that it requires to do tasks which don’t entail any demonstrable benefit) and even very expensive for the healthcare organization that is forced for (supposed) safety-related reasons to follow the recommendations issued by manufacturer. Such a practice entails de facto to subtract some resources which could have been invested in more added-value activities for patient. After, we should not undervalue the possibility that “Service-induced Failure” (cf. 3.3.6) could occur which increases the failure probability of medical device to the detriment of patient safety. B) Preventive Maintenance protocol that entails to substitute many components (“heavy maintenance”, as in the case of Spanish protocols) is the best one, that is it requires to follow all the Preventive Maintenance tasks which entail demonstrable benefits to reduce the failure onset. Consequently Preventive Maintenance protocol that schedules to substitute few parts (“light maintenance”) is characterized by insufficient maintenance recommendations, so it involves the execution of an incomplete set of Preventive Maintenance tasks, in the sense that some tasks which would reduce the probability of a failure are not performed. Such a failure could happen during the patient treatment2. Given that we are talking about anaesthetic machine, so it is possible that adverse event happen during the surgical intervention. This situation is absolutely not acceptable for patient safety.Table 6.3. shows how French and Spanish protocols cannot be contemporaneously the best forpatient-safety and Preventive Maintenance efficiency. Instance A Instance B France Best Not best Spain Not best Best Table 6.3: French and Spanish protocols cannot be contemporaneously the best.6.6. CONCLUSION AND PROPOSALSAs summarized in table 6.3. and thinking logically, I can draw the following conclusions:  French and Spanish protocols related to the same make-model of medical device are never contemporaneously the best;  Within a European-wide vision, none of the condition present in the examined protocols is: o Tolerable for patient-safety; o Reasonable, considering the approach to maintenance.The solution in view of the described situation, in my opinion, is just one and more distinctly: everymedical equipment manufacturer which operates in European Community market, should issuePreventive Maintenance protocols which are the exact copy for the same model of medical device,before that the same piece of medical device is put into commerce.Such Preventive Maintenance protocol should be just the “initial” one and after it should be subjectto improving modifications. In fact with passing of time, a particular medical device would be usedby healthcare professionals, allowing to BMET’s and clinical engineers to gather specificknowledge about Preventive Maintenance: some parts are subject to a certain degree of wear, otherparts are subject to a different degree of wear and so they have different expected useful life span.This specific knowledge would allow clinical engineers to modify Preventive Maintenanceprotocols; such modifications would make maintenance contemporaneously safer for the patient andmore efficient for resources allocation.2 The probability of such failure on the patient depends on the share of time in which the machine is working on thepatient compared to the range in which the machine is switched on.12
  13. 13. Author: Riccardo Offredi - riccardooffredi@gmail.comIn order to know how it is possible to implement a couple of conditions by which any medicalequipment manufacturer writes a initial reasonably safe and efficient Preventive Maintenanceprotocol for any piece of medical equipment, I refer you the next chapter (cf. 7.2 and 7.3.2.). 13
  14. 14. Medical equipment Preventive Maintenance: is a new approach possible? - Reduced version CHAPTER 7: PROPOSALS7.1 INTRODUCTIONA doubtless original feature inside my thesis lies in the elaboration of different proposals that arehelpful for clinical engineering field.Particularly it is possible to subdivide my suggestions contained after in two sections:  The first one encompasses pragmatic ideas, which are immediately spendable by clinical engineering services operating today in Italy to improve Preventive Maintenance protocols used by healthcare organizations (cf. 7.2. “Operative Proposals”);  The second one is more subject to external and systemic conditions, and so the ideas lying there could be implemented only in favourable circumstances. However their application would cause structural and lasting improvements in the quality of Preventive Maintenance supply (cf. 7.3 “System Proposal”).As we will see, operative and systematic proposal are interrelated.7.2 OPERATIVE PROPOSALSThere are many operative proposals, but these are all based on the sole following idea: a certainclinical engineering service is able to obtain, by negotiation, a specific Preventive Maintenanceprotocol for a specific make-model of piece of medical equipment that is going to be used in its ownhealthcare organization; such protocol fits better than the previous one to the necessities expressedby the same organization.PREAMBLENot each and every piece of medical equipment put on the European (and Italian) market isfurnished with the relating initial Preventive Maintenance protocol. This fact derives directly by theapplication of European Directive on Medical Devices 93/42 and following.“Where appropriate, the instructions for use must contain the following particulars: […]d) all the information needed to verify whether the device is properly installed and can operatecorrectly and safely, plus details of the nature and frequency of the maintenance and calibrationneeded to ensure that the devices operate properly and safely at all times;”The lack of a initial Preventive Maintenance protocol causes some problems to clinical engineeringservices that must strive to understand what is the best protocol: in Italy the Decree-law called“Testo unico in materia di salute e sicurezza nei luoghi di lavoro” (D. Lgs. 81/2008 and following)indicates to seek among best practice techniques or coming from fine procedure codes.In the case the medical equipment manufacturer communicates Preventive Maintenance protocol,we still don’t know if that is the same for all healthcare organizations spread throughout a certainCountry.The case study presented in the sixth chapter highlights that a specific manufacturer communicatedtwo different protocols for the same make-model of medical device to two different healthcareorganizations located in different Countries of the European Community: for this reason wonderingif the practice to supply different Preventive Maintenance protocols may be implemented eveninside the same Country, could appear legitimate.Let’s consider the hypothesis that the practice described above is conducted inside the Italianterritory: this preamble is necessary to maintain valid both European Directive on Medical Deviceand Italian Decree-law “D. Lgs. /2008 - Testo unico in materia di salute e sicurezza nei luoghi di14
  15. 15. Author: Riccardo Offredi - riccardooffredi@gmail.comlavoro”. In compliance with the latter law the healthcare organizations are imposed to usemanufacturer Preventive Maintenance protocol, if it exists.In my opinion this Decree-law constitutes an important constrain for medical device maintenancemanagers, because it cancels the possibility to adapt the protocol to peculiar necessities ofhealthcare organization in which medical equipment is used.For a specific make-model of piece of medical equipment which contains non-durable parts,different external conditions exist, typical of a specific healthcare organization, that influence thebest maintenance protocol; the conditions are the following:  Intensity of use;  Exposure to different environmental stresses like: o Electricity supply out-of-service; o Medical gas supply out-of-specification; o Environmental temperature out-of-specification; o Contaminant fluid (for example rainwater or trickling drink); o Electromagnetic interference;  Users: o Training; o Experience;  Patients: o Demography; o Epidemiology.A clinical engineer who have experience and who have been working since many years in the samehealthcare organization should deeply know the influence of the elements described above, eachone of them affects on Preventive Maintenance requirements of single piece of medical equipment.Consequently qualified clinical engineers could know suboptimal Preventive Maintenance protocolfor a specific make-model of a piece of medical equipment in his/her own hospital whether in thecase that model is working, or in the case in which a certain technology – that meets similarrequirement compared to the previous one - has been already programmed for being acquired by thehealthcare organization.EXPEDIENTThe core of the operative proposal: during the negotiation done to acquire a piece of medicalequipment, and if needed the relating Preventive Maintenance service, the expert clinical engineerbargains Preventive Maintenance protocol features with medical device manufacturer/distributor.It is necessary to make a distinction between public healthcare company and private healthcarecompany. A) In the case a clinical engineer deals with acquisition for a private healthcare organization, he has the opportunity to call any manufacturer/distributor company, to fix an appointment with a technician of the same company and to know if the company would be willing to communicate/modify Preventive Maintenance protocol to fit with clinical engineer necessities; in short private company can free itself form the competitive tender rules. B) In the case a clinical engineer deals with acquisition for a public healthcare organization, that professional would be a civil servant, and so that person should not favour in any way any competitor during the tender. The request for Preventive Maintenance protocol modification would be done during the negotiation for the medical device acquisition: the negotiation is ruled by “D. Lgs. 163 del 2006”, known as “il Codice dei contratti pubblici relativi a lavori, servizi e forniture” in force in Italy. For this reason the request for collaboration for building the maintenance protocol must fit in one of the mechanism expressed by “D. Lgs. 163 del 2006”: the request for a maintenance protocol must never favour any competitor company compared to any other company. The contracting companies (healthcare organizations) can award a public contract through procedures called 15
  16. 16. Medical equipment Preventive Maintenance: is a new approach possible? - Reduced version “procedura aperta”, “procedura ristretta”, “procedura negoziata” or “dialogo competitivo”. The contracting companies use preferably “procedura ristretta” when the awarding criterion is that of the more economically profitable offer. The “procedure ristrette” are procedures in which any economic operator may ask to be involved in, and in which only economic operator that have been invited by contracting companies may make an offer in the way expressed by “Codice degli appalti”. I am trying to describe how my operative proposal may fit into the public contract negotiation for the acquisition of a medical technology: how must the current procedure be modified into the bureaucracy of “procedura ristretta” to realize my operative proposal?I am describing the “procedura ristretta” that has a request for collaboration amongproducer/distributor technicians and healthcare organization technicians, in order to find an initialPreventive Maintenance protocol of a specific piece of medical equipment.The necessities for public body during the acquisition process are the following:  To verify the market condition in order to pick the more economically profitable one;  To negotiate with many economic operators;  To make sure each competitor has the same opportunities;The “appalti pubblici” are onerous contracts, stipulated in writing between a contracting companyand one or more economic operator, that deal with work-execution, products supply, and servicegiving.The civil servant, as the clinical engineer who is responsible for conducting competitive tenders,must demonstrate a posteriori that:  Acted in the authorization limits;  Was impartial.In order to achieve this aim, the civil servant must stringently follow “D. Lgs. 163 del 2006, Codiceunico degli Appalti”. The “D. Lgs 163 del 2006” considers the award of the competition called“ristretta”: in that procedure the minimum requisitions are communicated to the economicaloperators to participate to the contest in the notice. The companies that think to have the minimumrequisitions send a request for participating to public administration. The awarding organizationverifies which are the companies that satisfy the Law. The awarding company sends an invitationletter to all deserving companies: in this document any hospital must specify which are thepreferential requisitions, among which I am proposing the collaboration in order to find aPreventive Maintenance protocol.The competitor companies that received the “lettera invito” can send their offer. Any offer that getsto the hospital should be structured in three envelopes: one which keeps various documentation; onewhich contains what the company is offering; and one which embodies the economical offersubscribed by competitor company holder. Inside the envelope which contains what the company isoffering should be the “technical project”, that is a standard description of some elements in acertain order so that it is possible to compare the offers among them. In the case of a technicalproject for a service (such that of supplying Preventive Maintenance tasks) the suggested elementsto insert are the following:  The structure and organization of the service, the base and the representatives;  The number and the qualification of staff that will be available for the service referred above with details relating to professional profile of everyone and details relating the integration in organization with reference to tasks assigned to everyone;  The list of analysis and measurement instruments that will be used during the intervention and of medical device and classes of materials;  If-needed technical-operative ways through which to collaborate to establish initial Preventive Maintenance protocols and the staff qualification that will be made available for contribution;  Informative flow which guarantees successful outcome and quality of tasks both for preventive and corrective maintenance, and for management, and for modification/extension of the system and to guarantee continuous improvement;16
  17. 17. Author: Riccardo Offredi -  Management modalities of different sort of failure and of repair service as a general rule;  If-needed procedures that will be imposed to if-needed subcontractors;After receiving all the offers, those are valued by the professional staff in charge of management ofcontract depending on a certain criterion, in order to award.Such criterion should include a bonus for all those competitors that formulate the willingness tocollaborate in realizing Preventive Maintenance protocols. In fact the following high-qualityprotocol trades-off a reasonably high level of patient safety, coming from a high level of reliabilityof the machine, and a low maintenance tasks cost.This union represent a quality factor for the machine. So such element should be rewarded -in adifferent way depending on algorithm used- in the method which enables to find the moreeconomical profitable offer in a competitive tender. After the awarding, the contracting agreementis stipulated.Let’s consider the case in which the hospital chooses a manufacturer in order to get the piece ofmedical equipment and concerning Preventive Maintenance task; the manufacturer communicatedits agreement in the collaboration: in that case in the specification will be present the detaileddescription of the agreement of the collaboration.In brief, Preventive Maintenance tasks are negotiated with manufacturer/distributor of the piece ofmedical equipment. Next Preventive Maintenance team assess if it is better 6 months fixed intervaltechnique, 12 months fixed interval technique, if it is more clever do metered maintenance, orpredictive maintenance, or else the team could decide not to do any kind of Preventive Maintenance(run-to-failure) on medical device that have no non-durable parts.SELF-CRITICISMAt the end of the description of proposed expedients used to establish Preventive Maintenanceprotocols more suitable for the healthcare organization, I think it is worth to make a self-criticism.Only clinical engineering services operating in a hospital which are experienced (people that wereemployed long time ago) would be able: 1) To communicate the features of the hospital that influence preventive protocol; 2) To understand if the proposal about Preventive Maintenance of the winner competitor were right; 3) If-needed to thwart effectively excessive requests of fixed interval Preventive Maintenance tasks.Consequently not much expert clinical engineering services could hardly negotiate efficientlyPreventive Maintenance initial protocol. To find a systematic and definitive solution to thisproblem, where the solution is not depending on the skills of a single clinical engineering service, Iinvite you to read paragraph SYSTEMATIC PROPOSALSThe applicability of “systematic proposals” is conditioned to decisions accepted by differentlegislative bodies.In order to explain, I decided to subdivide this section in two portions, in which the first one isabout technical area (cf. 7.3.1.), while the second one has a legislative core (cf. 7.3.2).7.3.1. TECHNICAL AREAIn the technical area I am dealing with a proposal that consists in the adoption of the sameclassification of failures that happen on medical devices for as many hospitals as possible.Historically and presently Italy lacks a defined codification for causes of medical equipment failurewhich is shared among different hospitals that use different clinical engineering services.Examples of cause coding have been presented by B. Wang and M. Ridgway. 17
  18. 18. Medical equipment Preventive Maintenance: is a new approach possible? - Reduced versionA classification of failure cause could be implemented in Italy and shared among many hospitals,but just for those healthcare organizations which are using the same independent serviceorganization (ISO) that requires to its technicians to distinguish and to record the cause according tothe same codification.In all those situations the common element is given by the fact that a company which sellsmaintenance services decided in a strategic, autonomous and voluntary way to classify thehappening failures; the necessary condition is that the ISO has a computerized maintenancemanagement system (CMMS). In the case of ARAMARK Healthcare® the unique CMMS allowedto B. Wang to do “lateral comparison”, that is to compare failure data from healthcare organizationsthat used different maintenance techniques.So in Italy, in general terms, it is impossible to collect data coming from different hospitals in justone database. So we cannot analyse failure data and make comparison on different elements amonghospitals.My proposal is the following: as many Italian healthcare organizations as possible adopt the samefailure code classification, and make their biomedical equipment technicians record failure data in astandard way on a database.That discrimination would go down to a make-model level, or alternately, to a certain type ofmedical equipment class using CIVAB class of technology3.In order to get that result, it is necessary the intervention of a Law enacted by Health Department orby any Italian region, considering the power those bodies exercise on healthcare organizations:anyway it is necessary the intervention of a regulatory body.The consequence of the application of this law would consist in obtaining shortly a large databaseabout recorded failures on medical equipment; in addition the hospitals would get reciprocalbenefits sharing that volume of informations.It would become possible for just one centralized entity to analyse data. That analysis would allow : A. For each healthcare organization to know the distribution of the frequency of any failure cause for each model/class. B. To make comparisons among different hospitals, with regard to differences between failure pattern for model/class.The knowledge coming from point A could allow to every healthcare organization to understandwhere should be more appropriate to invest resources in health, choosing in macro-areas like usertraining, communication, Preventive Maintenance, advice on purchasing, etc.M. Ridgway suggested the necessity to pay attention on better user training and purchasing betterdesigned equipment, instead of useless Preventive Maintenance in his PowerPoint presentation“Effective maintenance strategies: Identifying the best practices for your facility” (AAMI 2010Conference, Tampa, June 2010).The knowledge coming from point B could allow to understand what is the more effectivemaintenance technique to adopt for each make-model/technological class: if for two differenthospitals we obtain similar failure patterns (that is patterns in which each category mean values areincluded in the respective standard deviation) using different maintenance technique (e.g. 6 monthsfixed interval or 12 months fixed interval), it would be opportune to adopt the maintenancetechnique that requires less resources, if risk analysis performed on model/technological classwould allow it.3 CIVAB system of classification is about many medical equipment classes which mainly are classified based onclinical speciality of affiliation; even the producer and the model of the piece of medical equipment are codified.18
  19. 19. Author: Riccardo Offredi - Figure 7.1: Annual failure probability distribution for pulse oximeters in 3 groups of hospitals. Gained from Wang B., Fedele J., Pridgen R, et al., “Evidence-Based Maintenance - Part II: Comparing Maintenance Strategies Using Failure Codes”, Journal of clinical engineering, October/December2010; p. 228.Figure 7.1 is about experiment detailed in paper titled “Evidence-Based Maintenance - Part II:Comparing Maintenance Strategies Using Failure Codes”, Journal of clinical engineering,October/December 2010 by Bang W., Fedele J., Pridgen R, et al. Data were collected by 6 hospitalssubdivided into 3 groups: one group were made of a single hospital and adopted statisticalsampling, a second group with 3 hospitals adopted 12 months fixed intervals PreventiveMaintenance; a third group with 2 hospitals that adopted run-to-failure technique.Within each failure class, the height of each bar that derives form the second and third group is themean of the failure probabilities obtained by hospital within the corresponding group, whereas theerror bars represent ±1 standard deviation. The adoption of the best technique (i.e. the mosteconomic technique considering a certain failure pattern for each piece of medical equipmentmodel, pattern that is reasonably safe for patient) would allow saving of resources. The economizedresources would be invested in macro-areas coming from the knowledge of point A.7.3.2. LEGISLATIVE AREAI called this side “legislative area” because the most part of the efforts to implement structuralreforms must be accomplished by European and Italian Public Bodies.In this section I am going to deal with the following themes: A. Chance for clinical engineer to establish more appropriate Preventive Maintenance protocols in Italian healthcare organizations; B. Collaborative process to realize an initial Preventive Maintenance protocol that is effective within European Community; C. Preventive Maintenance service organization certification within European Community; D. Maintenance task licence for biomedical equipment technicians within European Community.A. PREVENTIVE MAINTENANCE PROTOCOLS SELECTIONIn this section I am proposing more freedom of choice and contextually a greater responsibilityassumption for clinical engineer during the selection and the implementation of medical equipmentmaintenance protocols under his/her administration. 19
  20. 20. Medical equipment Preventive Maintenance: is a new approach possible? - Reduced versionIn the previous proposal I described the importance of collecting failure data to allow a maintenancestrategy change: this is absolutely useless if a Law forbids the clinical engineer’s choice about theprotocol to use, which is considered the most appropriate.The Decree-law called “D. Lgs. N. 81 del 2008” (“Testo unico in materia di salute e sicurezza neiluoghi di lavoro”) imposes de facto to clinical engineers to adopt, whenever it is possible, the onlyprotocol that was recommended by the manufacturer.Nevertheless manufacturer recommended protocol may not be efficient for a set of reasons listed in3.3.4. and 3.3.6.Thinking valid the considerations that I produced in the previous chapters, it becomes obvious thatresources used in useless Preventive Maintenance entail a bad allocation of resources at disposal ofclinical engineering department. Resources are de facto stolen from other activities that have agreater added value for patient care quality.At the present time many clinical engineers are showing their willingness to have more decisionalcapacity, i.e. they think that they should be allowed to decide if Preventive Maintenance task isnecessary, and if so, what is the frequency and what kind of tasks they must do (consider AmericanSociety for Healthcare Engineering4 and Stiefel5).In B. Wang opinion it is necessary to call into question Preventive Maintenance strategy that hasbeen adopted, in the case new evidences collected on failure data indicate that opportunity.The Decree-law called “Testo unico in materia di salute e sicurezza nei luoghi di lavoro” ispresently in force in Italy: consequently my proposal about giving the possibility to choosePreventive Maintenance protocols requests to modify such Decree-law in article n. 71 paragraph n.8. Particularly I am proposing to place at the same level of validity the manufacturerrecommendations and another protocol that has been obtained by clinical engineer (as medicalequipment manager): such protocol derives from reliable scientific considerations based on realfailure data coming from the same medical equipment managed by the clinical engineer.In my opinion the consequences of this amendment are the following: a) A new clinical engineering service would limit itself in following manufacturer recommendation; b) An expert clinical engineering service, basing on data collected from its own equipment, could elaborate Preventive Maintenance protocols and verify any consequent change in failure pattern.Personally I am against the fact that any novice clinical engineering service modifies their protocolswithout scientific evidence basis.The implementation of the “technical proposal” (cf. 7.3.1.) could allow obtaining a homogeneousclassification of the failures that happen on medical equipment in Italian healthcare organizations.Such information could allow comparing different failure patterns for specific make-models/CIVAB technology classes.The skilled clinical engineer will be able to compare failure patterns coming from theimplementation of different techniques with techniques that the same manager have alreadyimplemented to modify possibly his/her own protocols.Implementing a Preventive Maintenance technique that is cheaper and reasonably safe for thepatients, could allow optimizing resources at clinical engineering department disposal.Fig. 7.2 shows the synergy that happens through (a) failure data collection, (b) PreventiveMaintenance protocols modification and (c) resources optimization.4 American Society for Healthcare Engineering (ASHE). The appendix - clinical equipment risk classification. In:Maintenance Management for Medical Equipment. Chicago, IL: American Hospital Association; 1996: App-1-15.5 Stiefel RH. Medical Equipment Management Manual. 2001 ed. Arlington, VA: Association for the Advancement ofMedical Instrumentation; 2001.20
  21. 21. Author: Riccardo Offredi - Figure 7.2: Synergic action of my proposalsB. COLLABORATIVE PROCESS FOR PREVENTIVE MAINTENANCE PROTOCOLSIn this section I am proposing to build an original process to realize an initial PreventiveMaintenance protocol for medical device that would be valid within the European Community, afterthe amendment of European Directive on Medical Device in force.Current ScenarioEuropean Directive on Medical Device (n. 93/42 and following amendments) in force does not dealwith electromedical equipment management after that medical equipment is acquired by thehealthcare organization, but it deals with necessary conditions so that medical device may be putonto the market. (cf. 3.2.2.).Nevertheless in order to keep high the reliability level of a medical device, and so to guarantee highpatient safety level, it is necessary to carry out an appropriate Preventive Maintenance. It followsthe necessity for the hospitals to know -at least for the more dangerous devices for patient safety-the relative Preventive Maintenance protocols when medical devices are put onto the market.So I am proposing that European Parliament assess the possibility to introduce an amendment toEuropean Directive on Medical Device, in a way that every manufacturer -that want to put onto themarket dangerous medical devices- must issue a certified Preventive Maintenance protocol.In my opinion two important gaps exist in current reality: 1) Manufacturer is not constrained to issue any Preventive Maintenance protocol. In annex I (“essential requirements”) of European Directive 93/42 (and following amendments), in “requirements regarding design and construction”, paragraph 13.6 it is written that: “Where appropriate, the instructions for use must contain the following particulars: details of the nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all times;” 2) The process through which the manufacturer establish Preventive Maintenance protocol of a medical device in unknown. So the protocol may not be the consequence of logical consideration nor based on real evidences. This argument was suggested by M. Ridgway in 21
  22. 22. Medical equipment Preventive Maintenance: is a new approach possible? - Reduced version “Manufacturer-Recommended PM Intervals: Is It Time for a Change?”, Biomedical Instrumentation & Technology, November/December 2009; pp. 498-500. In addition the manufacturer has not any economical benefit in sharing data and information about technical features and intrinsic reliability of the components.So if a Preventive Maintenance protocol is not issued by the manufacturer when the medical deviceis put onto the market, probably it will never be communicated by the same manufacturer.ProposalSo my proposal is twofold: from one side I ask an amendment to impose the existence of aPreventive Maintenance protocol for every dangerous medical device, and on the other side anyprotocol must be certified through a process that involves an independent body compared tomanufacturer interests.In this case the independent body is the Notified Body that any manufacturer chooses in order to getthe “Declaration of Conformity” of medical devices.The Preventive Maintenance protocol would have the following features:  It would have been established through the collaboration between manufacturer and Notified Body (chosen by manufacturer);  Through a defined process;  Valid anywhere in European Community;  Established before that any medical device is put onto the market;  Only for medical devices that are more dangerous (classes IIa, IIb and III).Notified Body is characterized even today by a set of features that in my opinion make itappropriate for being involved in the proposed process.I am listing a set of features originated from annex XI of European Directive on Medical Devicesthat specifies the essential criteria for designating Notified Bodies:  The Notified Body, its director and the assessment and verification staff shall not be the designer, manufacturer, supplier, installer or user of the devices which they inspect, nor the authorized representative of any of these persons. They may not be directly involved in the design, construction, marketing or maintenance of the devices, nor represent the parties engaged in these activities. This in no way precludes the possibility of exchanges of technical information between the manufacturer and the body.  The Notified Body and its staff must carry out the assessment and verification operations with the highest degree of professional integrity and the requisite competence in the field of medical devices and must be free from all pressures and inducements, particularly financial, which might influence their judgment or the results of the inspection, especially from persons or groups of persons with an interest in the results of the verifications.  The Notified Body must have: - sound vocational training covering all the assessment and verification operations for which the body has been designated, - satisfactory knowledge of the rules on the inspections which they carry out and adequate experience of such inspections, - the ability required to draw up the certificates, records and reports to demonstrate that the inspections have been carried out.  The impartiality of the Notified Body must be guaranteed. Their remuneration must not depend on the number of inspections carried out, nor on the results of the inspections.  The staff of the notified body are bound to observe professional secrecy with regard to all information gained in the course of their duties (except vis-à-vis the competent administrative authorities of the State in which their activities are carried out) pursuant to this Directive or any provision of national law putting it into effect.In brief, the staff is qualified, the Notified Body is free from conflict of interests with anymanufacturer.22
  23. 23. Author: Riccardo Offredi - riccardooffredi@gmail.comNotified Bodies is reliable in order to guarantee the safety deriving from medical device because:  Notified Bodies are designated by Competent Authority in member States;  In order to be designated, the Notified Bodies must meet strict criteria contained in Directives and Regulation of European Union;  Notified Bodies have the safety as a founding value.Consequently I am proposing that Notified Body chosen by the manufacturer, beyond carrying outtasks requested currently by European Directive on Medical Device, would deal with manufacturerPreventive Maintenance protocol certification.I am outlining in figure 7.3 the collaborative process in order to obtain the Preventive Maintenanceprotocol.Figure 7.3: Process flowchart in order to obtain Preventive Maintenance protocol.In my opinion, the manufacturer should define the rationale through which each non-durable partcontained in the medical device should be substituted/restored (fixed intervals, meteredmaintenance, predictive maintenance, other) to the chosen Notified Body; such rationale shouldderive from technical analysis or testing on non-durable parts.Implementing my proposal to obtain Preventive Maintenance protocol certified by a Notified Bodywould become a necessary condition in order to put any dangerous medical device into theEuropean market.I am explaining briefly the reasons for which, in my opinion, it is so important to know a PreventiveMaintenance protocol associated to any quite dangerous medical device.The lack of a Preventive Maintenance protocol causes problem to clinical engineering service thatmust do its best to understand what may be the most appropriate protocol: in Italy, the Decree-lawcalled “Testo Unico in Materia di Salute e Sicurezza nei luoghi di lavoro” (D. Lgs. 81/2008)recommends to seek among good techniques rules, or in absence of the latter, that may be deducedfrom best practice codes. Probably the alternative consequences may be the following:  If the technology is quite simple, clinical engineering service will elaborate a protocol without having data coming from the device and so that protocol could be approximate;  If the technology is complex, clinical engineering service may turn to the manufacturer that may impose high price.Let’s consider the proposal that is about involving Notified Bodies for establishing a sharedPreventive Maintenance protocol: in my opinion the proposal is feasible because, even if thequantity of the brand-new class IIa, IIb, and III medical device models put onto the market is high,even the number of Notified Bodies is considerable. In particular in November 2010 the total ofNotified Bodies6 approved under the European Directive on Medical Device is 73.Consequences of hoped proposalThe application of the two described above proposals would cause to obtain the following benefits:  At least one Preventive Maintenance protocol exists for each dangerous class (IIa / IIb / III) of medical devices;6 Notified Bodies list is present in appendix A. 23
  24. 24. Medical equipment Preventive Maintenance: is a new approach possible? - Reduced version  Protocol validation made by an independent body, whose mission is safety;  Probably the effectiveness of the protocol is improved: particularly Preventive Maintenance tasks considered useless by the Notified Body are reduced/deleted; such tasks could have increased the possibility of service-induced failure or simply could have reduced the possibility to supply health care services, because of downtime;  Probably “infant mortality” event of non-durable part would reduce (cf. 3.3.6.): consequently medium reliability levels should increase for each medical device;  Expected patient safety improvement;  Expected reduction of Preventive Maintenance management cost in hospital: the healthcare organization, if it has got the technical skills within, is able to accomplish Preventive Maintenance task autonomously, following the protocol recommendation (that would be known) and save. I remind that, for the same financing received by the hospital, the money saved in medical device management could be invested in other activities, that have a greater added value for patient healthcare quality.  Reduction of clinical engineering service manager responsibility, because the manager should not risk any more through the adoption of an approximate protocol, that could be dangerous for patients or, in the opposite case, expensive.  Appreciation in brand value of manufacturer: considering the globalization in existence, the manufacturer that put its products onto European market would be well-known all over the world for its care for patient-safety, demonstrated by the effort for establishing a Preventive Maintenance protocol, that is offshoot of a collaborative process.I must point out that there could be negative consequences for the manufacturer, that is thereduction of the profit coming from:  Raising of safety cost deriving from the process of protocol determination;  If the fixed interval technique is maintained, probable reduction of the frequency of intervention, and so reduction of total number of technicians’ task;  Possible introduction of maintenance techniques that are different compared to the interval fixed one (metered maintenance, run-to-failure, predictive maintenance);Considering that currently the manufacturer can resort to an auto-certification in order to put its notvery dangerous medical devices (that is class I) onto the market, my proposal in accordance is notapplicable to the same medical devices.Figure 7.4. shows how hopefully the interaction process between manufacturer and Notified Bodyallows to obtain a better Preventive Maintenance protocol than the one established autonomously bythe manufacturer.24
  25. 25. Author: Riccardo Offredi - riccardooffredi@gmail.comFigure 7.4: Interaction between manufacturer and Notified Body allows to obtain a PreventiveMaintenance protocol that is shared and probably better than the one established autonomously by themanufacturer.Considering still valid at the same time both the proposal A (“Preventive Maintenance protocolsselection”) in which I describe the chance for clinical engineers to establish which PreventiveMaintenance protocol to use, and the proposal B, in which I describe the possibility to establishPreventive Maintenance protocols offshoot of a collaborative process between manufacturer andNotified Body, I hope that clinical engineering service initially adopts the manufacturer protocoland only in a second step the clinical engineering service modifies such protocol, in order to apply atechnique judged more in compliance with the necessities of the hospital in which the medicaldevice is working.C. MAINTENANCE SERVICE ORGANIZATIONThe companies that deal with Preventive Maintenance tasks and their staff which is authorized tothat job are fundamental in healthcare sector to hold a high level of reliability of medical equipmentand so they help to maintain high level of safety.Nevertheless it does not exist any prescription -which demand specific quality standards- in thehealthcare sector valid for all the independent companies that sell Preventive Maintenance service.Considering the Commission Regulation (EC) No 2042/2003 of 20 November 2003 (cf. 5.2.5.), Iam suggesting that European Commission imposes to any company that sells PreventiveMaintenance service for medical technology, to satisfy the following requirements:  The maintenance service company must supply a handbook that contains a declaration signed by the responsible manager, in which it is declared that the company is going to accomplish all the necessary tasks.  The maintenance service company must designate a responsible manager invested with the authority that needs to make sure that all the maintenance tasks requested by medical device manager could be financed and performed according to prescribed standards.  All the employees in the company that are dealing with maintenance tasks must demonstrate to have skills, background, or experience in medical device maintenance sector.  The maintenance service company must have the necessary equipment and tools in order to accomplish maintenance tasks established.  The maintenance service company must hold maintenance data and use them in the execution of its assignments, comprising preventive and corrective maintenance; 25
  26. 26. Medical equipment Preventive Maintenance: is a new approach possible? - Reduced version  Each maintenance service company will have be subject to a complete audit at least once in 24 months;  The competent authority must record all non-conformities, the corrective interventions to compensate, and the recommendations.Implementing this law in European Community, a higher general degree of quality would beguaranteed in medical equipment maintenance service organizations. That consequence wouldcause a higher level of medical device reliability and so a probable improvement in patient & staffsafety (cf. figure 7.5.).Figure 7.5: Consequences coming from the modification of European directive on reliability of medicaldevice.D. BIOMEDICAL EQUIPMENT TECHNICIANConsidering the Commission Regulation (EC) No 2042/2003 of 20 November 2003 (cf. 5.2.5.), Iam suggesting that European Commission would bind the technicians who desire to perform anykind of maintenance task on a medical device to obtain the following requirements.People must be more that 18 years old in order to make a request of licence of maintenance.They who require a medical equipment maintenance licence have to demonstrate throughexamination to have an appropriate level of knowledge of pertinent modules of subjects.In addiction they have to possess certain requirements of matured experiences.According to the kind of licence that the technician possesses (for example specialized inbioimaging medical equipment), this person will be allowed to accomplish specific maintenancetasks and to release specific certification to readmit in service the piece of equipment, following upan appropriate maintenance task.The practice of certification privileges is subordinated to some conditions, among the followingones:  Six month experience in maintenance sector, matured in the last two previous years, according to privileges granted by maintenance licence;  Ability to read, write and to communicate at a comprehensible level in a language in which the documentation is drawn up.Achieving a medical equipment maintenance licence would supply to the hospital managers a morehomogeneous and standardized way to select the professionals that are working in the healthcareorganization, compared to current practice in which the hospital managers require technician’scurriculum vitae and on this basis the manager valuates the professionalism of the same technician.26
  27. 27. Author: Riccardo Offredi - Figure 7.6: Biomedical Equipment Technician’s certified professionalism.Figure 7.6 outlines how through the constitution of European Community Law, it would be possibleto impose to technicians, who want to deal with Preventive Maintenance, the achievement of amaintenance licence: the Law described above would allow to healthcare organization managers tolay up for technicians with certified skills. 27
  28. 28. Medical equipment Preventive Maintenance: is a new approach possible? - Reduced version CONCLUSIONSThe initial goal of my thesis was to understand if it is possible to find and to implement PreventiveMaintenance protocols which are different from OEMs’ Preventive Maintenance protocols toimprove patient quality of care, considering hospital peculiar necessities where medical equipmentis used.Through the evidence collection and my thinking, I noticed that the current maintenance strategiesrecommended by medical equipment manufacturers written on paper very probably are not feasibleby any Italian hospital with a degree of completion equal to 100% for all the pieces of equipment:the principal reason lies in the scarcity of resources at disposal of clinical engineer department.The Italian Law imposes to use manufacturers’ protocols (if they have been communicated) whichoften schedule fixed interval technique. Currently Preventive Maintenance techniques that are moreappropriate to the necessities exist, but those techniques cannot be implemented because technologymanagers are not allowed to select arbitrarily Preventive Maintenance protocol considered moreappropriate for any piece of equipment.If we do not want to see the concrete, even when it is evident, we are not doing our best for overallpatient safety: in a situation of shortage of resources, rough choices would be made on how toinvest the same resources, that is probably it would be done Preventive Maintenance tasks on acertain number of medical device operating in quite critical areas, which are operating room,intensive-care unit and emergency department, excluding other medical equipment, which isimportant for patient safety, working in other departments.Consequently it would be appropriate to focus on prevention of the failures that cause the greaterdamage on patient (or on hospital mission) and that happen with a greater frequency: in brief a riskanalysis should be done on medical equipment which is operating in each hospital. Such riskanalysis would prefigure the necessity to exclude a set of medical equipment from PreventiveMaintenance task.Considering that overall manufacturers’ recommendations are not feasible contextually, it would beopportune to revise accordingly the “rules of the game”, that is to modify the Decree-law “D. Lgs.81 / 2008” in order to allow the responsible choice of more appropriate maintenance techniquemade by clinical engineering service managers: we could take example from state of the artaccrediting organization (for example “The Joint Commission”).Waiting for those amendments to come, I proposed an expedient to obtain Preventive Maintenanceprotocols quite appropriate for necessities of the Italian public hospital companies (that can beextended to Italian private hospital companies): in the negotiation of contracting agreement it isinserted a bonus coming from the will of collaboration between manufacturer and hospital; thecollaboration is apt to determine the Preventive Maintenance protocol to apply on the piece ofmedical equipment which is negotiated.How can a clinical engineer, as a technology manager, improve the patient healthcare quality,considering all the activities that this person presides?To answer to this question, let’s examine two differing scenarios according to available resources.OPTIMISTIC SCENARIOIn the first scenario, the least probable one, I am supposing that the healthcare sector funding in acertain Country of the European Union, is going to increase proportionally to the evolution of thegrowing requirements of healthcare sector.In my opinion, in such a case the perspective to improve patient healthcare quality would befeasible. Such goal, from the technology manager point of view, consists mainly in the bestallocation of available resources.28
  29. 29. Author: Riccardo Offredi - riccardooffredi@gmail.comTranslating theory into practice, the allocation consists in investing fewer resources in uselessPreventive Maintenance, and conversely in investing more resources in user training, and topromote the quality of communication among professionals.7In order to allocate the resources in a better way, it is necessary to know the main failure causes thathappen on medical devices used in each hospital and to associate the main failure causes to specificareas of intervention.Necessary condition so that the association occurs, is that a healthcare organization decide to groupfailure of medical equipment under main failure cause and accordingly to record such failures,coding them in their respective failure cause.Every hospital would obtain a failure pattern for each model/technology class (for example seefigure 8.1.); the failure pattern is a histogram that represents probability of failure cause of amodel/technology class in a certain hospital in a year. Model "A" 60% 50% 40% 30% 20% 10% 0% cause #1 cause #2 cause #3 cause #4 cause #5 cause #6 cause #7 Figure 8.1: Example of failure pattern for the model “A” of medical device in a certain hospital.So that the greatest number of healthcare organizations could compare failure patterns (which eachhospital would obtain) among one another, I proposed that the hospital of a whole Country adoptthe same failure causes classification, and I invited the Normative Agency to interveneaccordingly.The knowledge of failure pattern of a certain model/CIVAB technology class 8 would allow todeterminate which maintenance technique to adopt for that specific model / CIVAB technologyclass in a certain hospital. If two different Preventive Maintenance techniques applied on the samemodel of medical device in different healthcare organizations supply the same failure pattern (or avery similar one), pattern that offers a reasonably high level of patient safety, it is convenient toadopt the maintenance technique which is more economical, if the risk analysis executed beforeallows it.Possible maintenance techniques are, for example, the 6 or 12 months fixed interval, meteredmaintenance, run-to-failure or statistical sampling.Once the clinical engineer will have the faculty to select and to implement the PreventiveMaintenance technique, being based on failure data of his/her own medical equipment, the clinical7 Hypothesis confirmed by B. Wang in “Evidence-based Maintenance – Part II: Comparing Maintenence StrategiesUsing Failure Codes”, Journal of Clinical Engineering, October/December 2020 and by statistics on sentinel event inAustralian public hospitals: “Sentinel events in Australian public hospitals 2004–05” available on-line: Two examples of CIVAB technology class are defibrillator and centrifugal analyser. 29
  30. 30. Medical equipment Preventive Maintenance: is a new approach possible? - Reduced versionengineer will improve the effectiveness of his/her job, reducing costs and maintaining unaltered thereliability levels of the responsibly selected portion of medical equipment.The knowledge of the most important failure cause is useful for different equipment classes. Let’sconsider the department “A”, in which a significant portion of medical equipment is subjected tofailures relating to “user related” reason: it is probable that in such department the users’ care forthe medical equipment is poor, maybe due to new workers. In such a case, the area in which toinvest more resources would be staff training. The knowledge of failure pattern and failure causescontributes to improve patient healthcare quality (see figure 8.2.). Figure 8.2: Proposal to improve patient healthcare quality.REALISTIC SCENARIOIn the most probable scenario technology manager’s goal is to maintain unaltered the high level ofpatient healthcare quality and to cope with a growth in financing that is less than proportional to theincreasing necessities of Healthcare sector of Member Countries in the European Union: de factothe technology manager is going to support a reduction in available resources.It results that clinical engineering department must optimize the resources, and, differently from theprevious case, it is not posed the problem that is about where to invest the resources obtained fromthe optimization.The main proposed way to get this result is that of the selection of the best technique to adopt,basing on the comparison of failure patterns of each model/CIVAB technology class, if risk analysisallows it.30
  31. 31. Author: Riccardo Offredi - riccardooffredi@gmail.comFINAL CONSIDERATIONSBoth scenarios converge on the necessity to code the failures that happen on technology manager’smedical equipment in respective failure cause, within a homogeneous classification that is sharedamong healthcare organizations.The more healthcare organization will share the same classification, the more quickly it will bepossible to benchmark different Preventive Maintenance techniques.It will be possible to classify at a more general level (CIVAB technology classes) or more specificlevel (make-model of medical equipment): in the former case the timetable would be quite short inorder to obtain a great amount of data and to make comparisons among different techniques; in thelatter case the classification would give orienting results with a higher degree of confidence in termsof which technique to adopt.The collection of data coming from technology manager’s medical equipment influencesmaintenance techniques that will be adopted on the same set of medical devices, following a criticalreconsideration of methods and results: consequently the organization of Preventive Maintenancemodels itself on the necessities of a single hospital. In brief this process is the teaching of Evidence-based Maintenance which is Reliability-centered Maintenance applied in the healthcare sector.Remembering this thesis title, changing the approach to Preventive Maintenance is not just possible,but even hoped. Through risk analysis and the knowledge of failure pattern, it is possible to deducewhat is the best maintenance technique to apply to each model/technological class. Such techniqueentails the adoption of a certain maintenance protocol –and so even Preventive Maintenanceprotocol- for each model of medical equipment.The Preventive Maintenance protocol recommended by manufacturer could differ from the oneresulting from the process described above, because the former aims at minimizing the number offailures on a specific piece of medical equipment, while the latter has the goal to improve overallpatient healthcare quality.FUTURE DEVELOPMENTSConsidering that medical equipment manufacturers tendentially don’t disclose the rationale bywhich the manufacturers establish Preventive Maintenance protocols, and that such behaviour couldbe less and less tolerable by the buyers (i.e. healthcare organizations), I am proposing thedevelopment of a Preventive Maintenance protocol to be defined through rational criteria and goalsin cooperation with a healthcare organization.The manufacturer would obtain the following advantages:  The producer could benefits from the hospital collaboration to receive a feedback about the protocol quality and to improve medical device user interface;  The manufacturer could show the image of open-mindedness and listening to the customer.The healthcare organizations would obtain the benefit of enjoying in usufruct a piece of medicalequipment not-so-expensive in terms of invested resources in Preventive Maintenance andcontemporaneously more reliable in order to improve patient safety. 31