Key Challenges to Maintenance Activities in Clinical Engineering

Azman Hamid

Next Level Technologies, Kuala Lumpur, Petaling Jaya 47301, Malaysia

Key Challenges to Maintenance Activities in Clinical Engineering

Azman Hamid

Next Level Technologies, Kuala Lumpur, Petaling Jaya 47301, Malaysia

編者按：2015年10月21日，《中國醫(yī)療設(shè)備》雜志社獨(dú)家承辦了“第一屆國際臨床工程與醫(yī)療技術(shù)管理大會”（ICEHTMC 2015），大會主席由美國FDA醫(yī)療設(shè)備顧問委員會主席、美國臨床醫(yī)學(xué)工程學(xué)會首任主席Yadin David先生和解放軍總醫(yī)院醫(yī)務(wù)部副主任、中國醫(yī)師協(xié)會臨床工程師分會會長周丹共同擔(dān)任。來自14個(gè)國家的臨床醫(yī)學(xué)工程學(xué)會的主席、23個(gè)國家的60多位醫(yī)學(xué)工程的領(lǐng)軍人物、世界衛(wèi)生組織醫(yī)療器械委員會的協(xié)調(diào)員及國內(nèi)580多位醫(yī)工專家與會交流，共同搭建世界臨床醫(yī)學(xué)工程的學(xué)術(shù)平臺。大會共征集了62篇臨床醫(yī)學(xué)工程領(lǐng)域的優(yōu)秀論文，主要包括醫(yī)療技術(shù)創(chuàng)新、醫(yī)療技術(shù)管理、醫(yī)療設(shè)備維修模式、標(biāo)桿管理、醫(yī)療設(shè)備監(jiān)管及風(fēng)險(xiǎn)管理方法、醫(yī)療設(shè)備評估和采購方法、醫(yī)療技術(shù)人員的職業(yè)化發(fā)展、醫(yī)療技術(shù)評估等8個(gè)主題。本刊自2016年第1期起開始刊登大會征集的優(yōu)秀稿件（每期1～2篇），分享醫(yī)學(xué)工程領(lǐng)域的最新動(dòng)態(tài)，以供同行參考。

Objective Maintenance of biomedical equipment has undergone tremendous improvements over the last several decades since the publication of Ralph Nader's fateful article in 1971. The uproar caused by Nader's article had called for stringent electrical safety testing. Clinical engineering fraternities worldwide hurried to provide solutions and addressed the damage. In the process, we saw improvements in many areas of clinical engineering. Yet, despite these improvements, clinical engineering is still grappling with challenges in its maintenance activities that seem to persist. This paper seeks to identify these challenges which have caused difficulties, and to some extent, impede the performance of effective maintenance. The paper also seeks to propose solutions and recommendations for improvements. Methods Over the course of his work, the author has noticed areas that have posed major challenges in clinical engineering. One such challenge is in the area of clinical engineering competency. Non-standardization in maintenance activities is another area where some tough decisions may be needed. Other challenges will be identified, explained and where possible, solutions will be offered. Results In this paper, the author identifies ten major challenges that have affected the provision of clinical engineering services. Most of these challenges, if properly addressed may significantly improve healthcare delivery and/or provide clinical engineering with clear guidelines on the breadth and limits of the discipline. Some have severely affected maintenance performances while several have been left unattended and unresolved. Regardless, the ten challenges are common and normally experienced at clinical engineering department across the globe. Conclusion By pointing out these key challenges, clinical engineering practitioners would be able to identify shortfalls and trends in clinical engineering maintenance and systematically focus their attention towards assisting in problem solving. With the challenges identified, it is hoped that clinical engineering, through its various networks, would be able to incorporate compliance and enforcement.

clinical engineering; clinical engineering practitioners; clinical engineering certification; clinical engineering competency; biomedical equipment; healthcare technology management; medical devices

1 INTRODUCTION

The scope and limits of clinical engineering have seen constant redrawing over the past decades but many agree that by the turn of the century it had become a complete discipline of engineering. In some countries, clinical engineering has gracefully evolved towards technology management realm; yet, in some other countries, it has just seen a beginning. The importance of clinical engineering for the advancement of health care services is beyond question and has been firmly established in the literatures. Healthcare organizations consider clinical engineers as integral part of the health care delivery whose presence ensure the establishment of a safer environment[1]. The area of human factors and human-computer interaction has received considerable attention for the design of medical devices, many of which involve the contribution of clinical engineers[2]. Investigation in medical device-related injuries is lame without the involvement of clinical engineering personnel[3].

The advent of Patient Safety Initiatives with its flurry of global activities has made the discipline ever more important. With the renewed attention given to the new discipline, the traditional scope of clinical engineering that focuses on preventive and corrective maintenance is no longer tolerated by many hospitals. Established hospitals now require a safe and cost effective maintenance management program for their medical equipment, often assigning key performance indicators to the services.

Despite being a well-respected discipline in engineering, there have been many recurring and unresolved issues associated with clinical engineering services. Customarily, these issues are encountered by clinical engineers during various phases of clinical engineering implementation. They have caused constant irritations and considerable distractions to the provision of an effective clinical engineering program at hospitals.

This paper is an attempt to enumerate these challenges and identify the extent of the problems they have caused with the hope that the issues highlighted and various solutions suggested will provide guidance for clinical engineers not only to seriously look at these drawbacks and shortfalls but also to help in finding permanent solutions for the benefit of newer generation of clinical engineering professionals.

2 CHALLENGES

Clinical engineering deals mainly with the management of medical equipment at hospitals. From complex medical equipment such as PET scanners and robotic gait systems to the simplest portable items such as nebulizers and fetal dopplers, clinical engineers contribute immensely to health care delivery by the design and implementation of a structured and costeffective maintenance program for hospitals.

During the course of their work, clinical engineers are faced with many issues and challenges. Many of these issues are simple to overcome; others are a bit complex, yet others are recurring and perennial, causing much difficulties and anguish. Over the course of the author's work in clinical engineering spanning well over two decades, it has been noted that these challenges are often associated with key clinical engineering concepts, decisions, consensus or compliances of which as a whole impedes or causes difficulties to clinical engineering personnel in maintaining an effective clinical engineering program. The paper discusses ten of these challenges below.

2.1 Competency and certification

Foremost amongst these challenges is the issue of competency and certification of clinical engineering professionals. In the United States and Canada, Healthcare Technology Certification Commission (HTCC) certifies Clinical Engineers[4]. Supported by American College of Clinical Engineering (ACCE), HTCC has been certifying many clinical engineers from Latin America, the Middle-East, India, Hong Kong and China, in addition to those from the United States. It is the most successful clinical engineering certification program known so far. In Germany, clinical engineers are certified by German Biomedical Engineering Society (DGBMT) since 1980s[5]. In addition, European BIOMEDEA project is also taking shape detailing clinical engineering education and certification with the collaboration and support from International Federation of Medical and Biological Engineering (IFMBE) and World Health Organization (WHO)[6]. Brazilian Board of Examiners for Clinical Engineering Certification handles certification in Brazil[7]. In Asia, especially ASEAN countries, the Commission for the Advancement of Healthcare Technology Management in Asia (CAHTMA) offers similar clinical engineering certification.

Undoubtedly, certification is important as it provides competency assurances to health care facilities that avail clinical engineering services[8]. It formally endorses individual attainment of specified body of knowledge that reflects competency. At present, however, competency assessments and certifications are still largely regional as elaborated above, and individual countries are left to pursue and design theirown competency and certification programs. Such autonomy in certification creates clinical engineering professionals whose competency credentials are considerably ‘localized' and less relevant internationally. Certification bodies may embark on mutual recognition arrangement (MRA) among them to gain internationally recognized reputation but such effort requires a common competency platform. Without this common ‘understanding', the certification bodies run the risk of producing clinical engineering professionals whose competency level is regionally confined and substandard, rendering the certification non-transferable. In other words, while the certification is accepted by the host country or region, the acceptance of this very same certification by other countries remains doubtful.

With the above-mentioned arguments it is essential that clinical engineering fraternities worldwide seek to address this shared setback by seriously relooking at this competency‘misalignment'. One possible solution is to place all existing competency certification programs under a common umbrella, governed by a committee of experienced, well-tested clinical engineering professionals with country or regional representations as members. Such initiative is yet to be seen happening.

2.2 Equipment life expectancy

The objectives of medical equipment management program are to ensure that the equipment remain safe, its lifespan maximized and the total cost of ownership is minimized[9]. Lifespan or life expectancy projection is an important reference for clinical engineers since it provides information on temporal characteristics of equipment reliability and the predicted onset of technical obsolescence. Using the life expectancy chart as a basis of reference, clinical engineers often devise appropriate‘preventive' mechanisms with activities geared towards the above-mentioned objectives.

Since obsolescence could also be due to many other deciding factors (other than age alone), a well-structured equipment maintenance management program, if effectively implemented, could prolong equipment lifespan many folds. Such ‘extension' in lifespan is used as a target/parameter in goalsetting and a performance yardstick of clinical engineering programs at the hospitals. Additionally, lifespan chart facilitates accounting processes as it enables accountants to assign depreciation curve over equipment lifespan. Many organizations such as American Hospital Association (AHA), American Society for Healthcare Engineering (ASHE), U.S. Military, Biomedical Engineering Advisory Group (BEAG) as well as tax departments produce their own equipment lifespan chart to facilitate their affairs.

One would expect that since the object of focus is similar namely, medical equipment, the assigned lifespans by these various organizations should be almost identical to each other. Unfortunately, they vary and at times quite significantly. Lifespan expectancy projections taken from several sources are depicted in Table 1 below which shows contrasting projections for several groups of medical equipment.

Table 1 Life expectancy projection (yr)

The divergence of life expectancy projections as illustrated above indicates the absence of consensus even among groups of experts. Unless a health care organization has mandated or endorsed a particular lifespan projection for its use, differing views, in this instance, creates considerable difficulties for clinical engineers to confidently assign ‘useful life' to medical equipment without encountering dissention from other stakeholders. Other areas of difficulties faced by clinical engineers resulting from the above-mentioned issue include assigning depreciated value to medical equipment, obsolescence recommendations, and equipment replacement planning.

Considering the above repercussions, there is a need to streamline and combine these various projections into one coherent reference. Such initiative requires discussions, consultations and concessions among stakeholders and may prove to be painfully strenuous. An easier alternative would be to seek endorsement of one of the projections mentioned above, preferably the one from a reputable organization with considerable influence. Whatsoever method one chooses to resolve the above issue, the resultant life expectancy projection should be globally recognized and endorsed by reputable organization for it to remain highly relevant to clinical engineering activities worldwide.

2.3 Planned preventive maintenance frequency

Planned preventive maintenance (PPM) is an integral component of clinical engineering program and is performedon most medical equipment at the hospitals. A schedule of PPM to be conducted for the year is usually made known to the equipment users well in advance, usually decided, compiled and distributed before the beginning of the year so that disruption to clinical services could be minimized. When scheduling PPM, clinical engineers will decide on the frequency of PPM for a particular device type before proceeding to schedule PPM dates for the devices for the entire year.

Ideally, PPM frequency is decided by the level of its importance to clinical services and whether it is connected directly to patient[10]. PPM frequency is also influenced by maintenance requirements and incident history, inclusive of prior issuance of alerts and recalls[11]. In normal practice, however, PPM frequency is decided by following the recommendation of device manufacturers. While this seems to be a logical step to take, PPM frequency is sometimes altered to reflect current maintenance requirements, economic necessities or when an objective study suggests a frequency revision.

Complications may arise when medical equipment of similar device type produced by different manufacturers are assigned with different PPM frequencies. While this could be easily resolved by assigning a different PPM frequency to each, the matter becomes problematic when conducting analyses of asset performance. As most inventory deals with large CMMS databases which emphasize asset groupings, handling asset information and its related activities will now be relatively more difficult. Performance comparison will also requires additional understanding of unequally assigned parameters.

As an illustration, consider PPM frequency for a defibrillator. Three possible PPM frequencies recommended by the manufacturers are quarterly, semi-annually, and annually as illustrated in Table 2 below.

Table 2 Planned preventive maintenance frequency for defibrillators recommended by manufacturers

If all three different frequencies are accepted and included in the preventive maintenance plan, consider its impact on planning and maintenance analysis:① PPM cost; ② Equipment uptime; ③Time spent on maintenance.

The ensuing analysis of equipment performance (in this instance, a defibrillator group) usually carried out by clinical engineering team may be strenuous as the basis of comparison is now uneven as a result of having different maintenance protocols. Consequently, the cost of maintaining Physio-Control's Lifepak 9 defibrillator would be higher than the rest as more PPMs need to be carried out. A relatively higher maintenance cost of Lifepak 9, however, does not mean the device is problematic. Conversely, a lower cost to maintain GE's Responder 2000 and Marquette's CardioservVF does not suggest that they are better products.

Asymmetrical analysis as discussed above could be avoided if the PPM frequency is uniform for all devices under the same category (group). Assuming other things equal, a lower maintenance cost incurred by any particular medical equipment in device group analysis could now be associated with product superiority, simplifying the analysis considerably.

Altering PPM frequency for a device type is not new as even JCAHO had modified its PPM frequency recommendations from quarterly to semi-annually during the times of economic difficulties[12]. Notwithstanding, the reason for changes in PPM frequency need to be fully documented and concurred by a committee who are well-versed in the maintenance of the particular device.

2.4 Device nomenclature

Assigning a code to a medical device seems like a stressfree activity. However, when the same device qualifies for several possible codes, the matter could escalate into an energysapping activity. As an example, let's try to code a diagnostic ultrasound system, Toshiba's Aplio Artida. Using ECRI's nomenclature system UMDNS, possible codes for Aplio Artida are shown in Table 3 below.

Table 3 Possible codes for diagnostic ultrasound Toshiba's Aplio Artida

Toshiba's Aplio Artida was designed and developed with cardiovascular application in mind. With that background information, appropriate UMDNS codes for Toshiba's Aplio Artida are therefore 15-957 and 17-422. But other codes on the list are also equally qualified to be selected. Thus, we will have at least 5 different codes for a Toshiba's Aplio Artida ultrasound system. One may choose any of these codes without being accused of being ignorant. Aplio Artida could be used in many other applications too and it will not be surprising if a hospital employs all of the variants while treating its patients.

The above is just one example of many where properassignment of UMDNS codes is crucial to avoid disinformation. Imagine the scenario when a director of engineering requested to know the number of cardiac ultrasound system available in the country if codes were not properly assigned! It is therefore essential that clinical engineers assign the most appropriate code for medical equipment. Otherwise, statistics on inventory of hospital's capital assets will be inaccurately presented which in turn may result in costly disinformation to the stakeholders.

2.5 Calibration or verification?

Do medical equipment require calibration during PPM? If by ‘calibration' we mean regular verification of measured readings, yes indeed, they do. It is a well-known fact that the accuracy of electronic components drifts over time and failures, though fairly rare, should be expected[13]. Environmental parameters such as humidity, temperature and moisture have been known to have negative influence on the functions of electronic and electromedical systems[14]. Equipment such as defibrillators, electrocardiographs, balances and sphygmomanometers need to be ‘calibrated' to ensure the displayed measurements agree with actual readings. Centrifuges too need regular ‘calibration' of its RPM and many others.

Often, equipment user raises request to the clinical engineering team to ‘calibrate' their equipment during the next PPM. The matter worsens when the user demanded a calibration certificate from an ISO/IEC 17025 accredited laboratory as a proof that the equipment has been ‘properly' calibrated!

There has been widespread misunderstanding of the role played by preventive maintenance. Although calibration requests are sometimes entertained by sending the equipment for calibration to accredited laboratories, most PPM measurements are however ‘verification activities' performed using calibrated test equipment. While actual calibration may be required at times, it is the verification of measured readings that is often sought during PPM. Only after the measured readings deviates and exceeds the tolerance limits does a calibration (or corrective maintenance) is required.

It is necessary that an awareness program on calibration and verification is carried out regularly to educate the end-users of these differences. Such activities could be carried out as a part of routine user training given to end-users each month.

2.6 Delineation of services

Hospital support services normally consist of facility engineering, clinical engineering, cleansing services, linen and laundry services, and clinical waste management. While the scopes of these services are apparently mutually exclusive, a clear delineation of allotted assets between two of the engineering services, namely, facility and clinical engineering is often necessary. Does a medical gas system fall under the purview of facility or clinical engineering? Similarly, under the scope of which service does a portable power supply/stabilizer that often accompany some medical equipment fall into? Which service provider is to maintain a reverse osmosis system?

In the absence of an experienced engineering manager, healthcare organizations sometimes are ill-advised on the scope and battery limits of hospital support services. Misguided decisions often create unnecessary misunderstanding between the two above-mentioned services. A clear demarcation of services and allotted assets is important as training could be geared towards grooming specialists and experts within the particular service's battery limits. Furthermore, related test tools need to be budgeted and associated standards need to be purchased and learned, not to mention various other requirements on spares and maintenance kits.

A solution to the above problem is to maintain a list of items and/or equipment that clearly demarcates the two services. However, the selection of items and/or equipment to be included in the list (either clinical engineering or facility engineering) is itself a challenging task. In the absence of clear guidelines on the scope of work (especially on overlapping claims) of the two services serious misunderstanding may result between the two service providers especially if asset inclusion implies financial rewards.

2.7 Applicable standards

A competent clinical engineer should possess a reasonable body of knowledge of basic engineering subjects such as basic electronics, bioinstrumentation, biosensors, biosignals, digital circuits, electronic troubleshooting, anatomy and physiology, electrical safety, etc. He or she need not only able to demonstrate proficiency in these areas but also need to be in a position to advice others, especially the BMETs, on issues concerning medical equipment, technology management, IT solutions, quality systems, safety and health, risk management, etc. Such diverse areas of coverage albeit extensive are manageable and the depth of the subjects expected of clinical engineers generally increases with time and experience. Incidentally, an expected body of knowledge that seems insurmountable to clinical engineers is on standards (including regulations) concerning medical equipment or clinical services.

There are so many standards developed for virtually every type of medical equipment. Either they are technical orclinical, vertical or horizontal, local or international, standards are developed by a consensus of experts in a particular area of interest. Although standards are voluntary, they nevertheless provide pertinent guidelines on the limits, tolerances, safety aspects, best practices, suggested dimensions, symbols and labels, and other matters considered important for successful implementation of healthcare delivery.

Throughout their academic years, clinical engineers were exposed only to the requirements of basic standards and regulations such as standards on electrical safety, code of practice, quality management system, hospital accreditation, Medical Device Directives and maybe a few others. Despite having a significant number of standards to acquaint, a structured acquisition of knowledge on standards has been minimal or absence especially during employment. Mainly, clinical engineers are left with their own initiatives to obtain related information on the requirements of governing standards.

The above discussion reveals the need for a concerted effort by clinical engineering fraternities worldwide to specify commonly relevant standards required for clinical engineering education in the course of their work. Such effort should also include suggestions on hierarchy, priority and revisions among chosen standards since standards are dynamic and sometimes undergo changes and revisions. To facilitate global adoption and acceptance, knowledge on this minimum list of standards should be endorsed by an international clinical engineering society and if possible, supported by World Health Organization.

2.8 Equipment utilization

Degree of utilization of medical equipment during service delivery provides important information on the performance of capital assets at the hospitals. Philips, for example, uses its assessment of equipment utilization to observe patient workflow at the hospitals. It then makes recommendations on areas where utilization could be improved[15]. Healthcare organizations often use information derived from utilization trends in a variety of ways. To some, underutilized assets signal that the equipment is due for replacement. Others argue that medical equipment is underutilized because of reduced level of demand from patients[16].

Utilization is defined as a function of average usage and the number of patients served per unit time[17]. A detailed study of utilization patterns of medical equipment may be prohibitive and time consuming for clinical engineers. An easier alternative may be to just identify the actual period when equipment is in operation, i.e., when electrical power is supplied. Even here, data gathering might prove difficult as not many equipment provide readily available data. Imaging equipment, such as X-ray systems and CT scanners provide slice count information, which could be used towards enhancing results on equipment utilization.

Adding a counter or timer to each medical equipment may provide a solution, although the exercise may be expensive to implement. Alternatively, manufacturers could be persuaded to incorporate timing mechanism in future designs of their medical equipment. Additional production cost incurred and other legal issues that may arise are some of the obstacles towards this implementation.

Utilization issue is difficult to crack. At present, equipment utilization information is normally obtained using equipment utilization survey completed by end users or departmental heads which are subjective in nature. Such loose data may not be able to stand scrutiny and not suitable for ascertaining equipment utilization pattern.

2.9 Electrical safety: moving from IEC 60601-1 to IEC 62353

The introduction of a new electrical safety standard IEC 62353 in 2007 for in-service and after-repair testing of medical equipment was expected to witness sharp changes in the practice of electrical safety testing of medical equipment. The new standard complements IEC 60601-1 which is a type test and considered potentially destructive for routine testing of medical equipment at hospitals[18]. The new standard is preferable as it provides uniform testing, simpler, faster, and relatively safer to perform. Yet with these new advantages, we have seen only a marginal transition to the new standard. Although there have been rigorous publicity and publications of the new standard in Europe, similar take-up by many developing and under-developed countries has yet to take shape. These countries continue to use IEC 60601-1 standard as references as they have doing decades earlier.

The reason for the slow adoption could be traced to the unwillingness of the industry players to invest in new test equipment and the lack of incentives accorded to the adoption of the new standard. Furthermore, awareness of the new standard has been sluggish with very few exception and changes of regulatory enforcement urging for the new standard has also been slow to catch up.

We will continue to see this slow-moving trend in the adoption of the new standard as industry players gradually replace their test equipment with IEC 62353-compliant testerwhen the existing one became obsolete. Meanwhile, we hope to see aggressive regulatory enforcement in implementing the new standard in countries around the world.

2.10 Service passwords

With the advent of new and complex technologies that are vulnerable to cybersecurity breaches, medical equipment manufacturers have been tasked by Food and Drug Administration (FDA) to prevent unauthorized access or modification to their products[19]. Even without this recent directive, medical equipment manufacturers have long been known to employ security passwords to safeguard their products and services. This practice has been widely employed especially by manufacturers of imaging devices, laboratory equipment, dialysis equipment, syringe devices, stress test systems, etc. By controlling access to maintenance diagnostics, these manufacturers have indirectly prevented maintenance of their products by in-house maintenance personnel and third party service providers thus eliminating competition completely.

While the practice of assigning service passwords is acceptable to prevent unauthorized access to system software and to ward off unskilled technical personnel from meddling with equipment maintenance diagnostics, such action has also prevented many good clinical engineers and BMETs from providing prompt maintenance support to equipment breakdown. In areas where the manufacturers or their appointed representatives are unable to provide prompt maintenance support such as in remote localities, the presence of such protective mechanism should not even be activated. Truthfully, upon completion of equipment installation and commissioning, it should be the prerogative of the equipment owner to decide who should be in control of these passwords.

The restrictions posed by security password to access equipment maintenance diagnostics create unnecessary hindrance to clinical engineering personnel to provide fast and cost effective maintenance support. Preventing cybersecurity breaches and intrusions to medical equipment software require implementation of strict security protocols. However, such procedure if enforced should not be used as a means to deprive customers of the advantages of market forces of which customers could readily tap to improve equipment uptime as well as reduction in the total costof ownership.

3 OTHER CHALLENGES

Clinical engineers are continuously challenged to provide the best service to patients. Apart from the ten challenges listed above, there are others that could equally affect the effective provision of clinical engineering services. These include cases of ‘a(chǎn)sset not found', incongruent medical device classes, unrealistic PPM hours, competency matrix shortfalls, access to equipment manuals, currency exchange rate fluctuations, unverified maintenance capacity per person, etc.

These challenges exist in varying degree and some may require total revisit of clinical engineering protocols to address the issues.

4 Discussion

Although the challenges listed above are obvious and simple to overcome to some, they are nevertheless real and universal. Clinical engineering teams around the world would have encountered some if not all of these issues during the provision of clinical engineering services. Due to some obvious constraints, some of the suggestions presented may be superficial and selfish and may require further detailed study and analysis.

The ten challenges discussed above are by no means static. Some may have been resolved at hospital, country or regional level but generally, these challenges at some point had caused constraints and inconveniences to clinical engineers preventing them to clearly and effectively represent the discipline within their organizations. As a result, clinical engineering team at times seems to have been indecisive in their thinking and actions vis-à-vis issues that impeded effective delivery of clinical engineering services.

Some challenges could only be resolved at international level, such as certification issues, PPM frequency, and life expectancy of medical equipment. Other challenges may depend on the proactive-ness of the team at the hospital level such as issues on IEC 62353 adoption and service password. Yet others may require deep assessment and rethinking of the way to overcome such as in equipment utilization and service delineation issues.

It should be noted that some of these challenges spring to existence as a result of various audits conducted at sites which require compliances with best practices and/or local and international guidelines. Auditors often require references or justifications for action taken or decision reached. Their demands for some documentary evidence may be difficult for clinical engineers to provide or guidelines, if provided, may have lacked endorsement from local authority for acceptance.

5 CONCLUSION

The existence of the above challenges at the hospital signals inadequate guidelines and/or lack of consensus and support from clinical engineering communities and medicalequipment manufacturers. It is important to note that even if‘a(chǎn)cceptable' references were made available at international level, local acceptance might be an issue, hence the rationale of seeking international endorsement from reputable organizations.

Internationally referred organizations that produce guidelines and references may assist in this regard by holding frequent meeting with stakeholders and revising their recommendations in the presence of new consensus and evidences. Equipment manufacturers, on the other hand, may need to be constantly guided on the importance of clinical engineering work to get their understanding and support when such challenges, as presented, arise.

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R318 [Document code] A

10.3969/j.issn.1674-1633.2016.11.001

1674-1633(2016)11-0001-08

Conflict-of-interest statement: No potential conflicts of interest.

Azman Hamid, Next Level Technologies, No.137-2, Jalan PJU 1A/41B, Pusat Dagangan NZX, Kuala Lumpur, Petaling Jaya 47301, Malaysia. azman@nextleveltechnologies.org