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Is It ‘Maintenance’ If It Serves No Purpose?

By William A. Hyman, ScD

Published on January 4, 2018


The issues of preventive maintenance (PM) have been with us for as long as I have been involved in clinical engineering—which is a long time. The key technical questions are what maintenance tasks to perform and how often, with the sometimes hidden question of: “For what purpose?” There is also the administrative question of “Who if anyone is making us do it?”—an issue that often seems to have little to do with the technical questions.


Part of who is making us is whether the requirement is real or a myth. Thus, the answer to the question of “Why are you doing this?” may often be “because it’s required” without the person answering being able to tell you who it is that requires it, and being otherwise unable to substantiate the claim.

Or, they may cite a non-governmental standard, without being able to tell you an authority having jurisdiction that has adopted that standard as a binding requirement. Or, they might give a grandiose citation—such as “the government”—but no particulars.


Routine electrical safety testing falls into this category; “because it’s required” is often stated, even when this may not be the case. If there is an actual, citable requirement, there still is a potential difference between this and having a sound technical basis.

In addition, there may also be a legal risk management component to levels of maintenance, anticipating a scenario in which a piece of equipment fails and causes an injury and the level of maintenance was less than or different from what the manufacturer recommended.


Then, the plaintiff argument might be that if you had only followed the manufacturer’s recommendations, the event would not have happened. The manufacturer will likely agree because any alleged failure by the equipment owner may offset any liability the manufacturer might have.

Fortunately, device maintenance-related patient injuries are extremely rare. This is why the recent and ongoing hubbub about maintenance has been met in part with the rejoinder that there is no real problem that needs to be solved.


Returning to the issue of “what maintenance and how often,” it is good to review the technical bases for PM. One basis is that the condition of a medical device might deteriorate such that it becomes unsafe and that by checking, changing, and/or adjusting certain things, the path to unsafety can be interrupted.

For this to be true, there must be something that is observable or measurable that is related to the device becoming unsafe—and there must be a time at which the device is still safe, but the deteriorating condition can be detected.


Alternatively, there may be a situation in which a forthcoming failure cannot be measured, but some action can reduce its occurrence. In this case, it is good to actually know how this is the case. Changing consumable parts may fall into this category if it is actually known that certain parts have a limited life and that replacing them in a timely manner can prevent significant field failures.

Proactive changing of consumable batteries is an example here. Note, however, that such actions are related to safety only if there is an actual hazard associated with the failure, as opposed to, for example, inconvenience. Here, risk analysis plays an important role.


When assessing inconvenience, it is also appropriate to remember that a scheduled PM may also be inconvenient for the end user—although, hopefully, it does not come as a surprise. If the failure can be easily corrected, perhaps even by the end user, then preventing the failure may not be necessary. This is the run-to-failure model, which generally sounds worse than it is and perhaps should be called “run-till-service-required.”


Another reason to replace consumable parts that are still working is the efficiency that might arise from sweeping an area, rather than going to that area on an on-call basis. Even so, the efficiency of area sweeps depends, in part, on the true time cost of a service-on-demand event. This is not just the actual time of touching the device, but includes the time to get to the device—time that might be lost in some accounting systems.


In large, far-flung, multi-building mazes, the time from shop to device can be considerable. And that’s not even counting the conversations that might take place along the way, although such conversations may have value.


In determining the what and how, there have been some recent mandates to follow the manufacturer’s instructions—but whether the device manufacturer actually knows how much maintenance is required is an open question. If it is a new device, the manufacturer will not have had any direct field experience when the instructions were written, although some lessons might be learned from previous devices. It is also clear that manufacturers have reason to keep maintenance activities on the high side.


One such reason is that routine maintenance doesn’t cost them anything. Secondly, if the manufacturer is providing the service for a fee, or parts are being replaced, then they’re incentivized to keep the amount of service relatively high. These days, they also seem to be motivated to prevent others from servicing. Depending on who you believe, this is either to protect their service income or to protect patients from bad service providers.


Another non-safety reason for PM may be to control repair costs and to prolong the life of the equipment. For instance, mechanical devices may have serviceable components that, if they were to fail, could cause a high level of damage and associated repair or replacement.


Still, such an assertion should be based on actual data. In this regard, it seems to be increasingly apparent that repair can cost more than replacement. This is part of planned obsolescence, which seems to have accelerated in recent years. In fact, one could argue that out-of-control obsolescence is at an all-time high as exemplified by certain electronics that many of us have in our pockets.


There may also be value in PM that goes beyond the specific items on the work order—for instance, is there an eyes-on value from being face to face with the device? Such value, if any, would depend on whether anything was likely to be seen, along with the observational skills and effort of the servicer. It would be preferable if servicers did not fail to see or actively ignore observable conditions that might be present. It is also sometimes appropriate to not just fix an observed condition, but to investigate it with questions such as: “How did it get that way?” “Is it likely to happen again?” and “How can it be prevented?”


Unfortunately, this non-specific category also invites speculative second-guessing when adverse events occur. The question that then arises is: “If there had been a PM at an appropriate time before the event, would the servicer have seen the condition and acted on it such that the adverse outcome would not have occurred?”


Of course, anyone seeking to blame the facility or servicer would say “yes” to this question, although it is generally impossible to know the answer. At a minimum, the allegedly missing PM would have to have occurred between when the device was damaged and the harm incurred.


Equally important is the assertion that the servicer would have seen the defective condition that “must” have been present had they been there to conduct the PM, even though that condition was not on their worklist. Another issue with this non-specific “other” category is that there is no definable interval for such inspections to be both practical and effective.


To return to the title, it seems reasonable that “maintenance” should have technical value. If there is no value, then maintenance is as much of a misnomer as “preventive”. After all, a PM that has no value is simply a waste of resources. If we like the acronym “PM” for historical reasons, however, perhaps we should separate the letters “P” and “M” from having any meaning.

There is a precedent for this: ASTM once meant American Society for Testing and Materials, but it now officially has no meaning beyond its name. Some might remember JCAHO, which once was an acronym, but then became a name.


Similarly, I spent most of my academic career at Texas A&M University, where “A&M” once meant “agricultural and mechanical” but later dropped that meaning. We might note that other words could be given to “PM” without using “preventive” or “maintenance.” “Periodic meddling” comes to mind.

So, we are back where we started: Trying to answer the question of: “What procedures should be done, at what intervals, to achieve what specific goals?” Then there’s the question: “How will we measure if those goals are met?” Unless, however, someone with authority is making us do it—in which case, technical questions do not apply.


William A. Hyman, ScD, is professor emeritus, biomedical engineering, at Texas A&M University, College Station, Texas, and adjunct professor of biomedical engineering at The Cooper Union, New York. Questions and comments can be directed to 24×7 Magazine chief editor Keri Forsythe-Stephens at

[email protected].


Source: 24x7 Magazine

ِِAre you Qualified to Carry the Title of Medical Equipment Planner (MEqp)?-Qualifications and Requirements

To carry the title of Medical Equipment Planner (MEqP) you should have the following minimum qualifications & Requirements;I. Main Qualifications;
  1. Hold a University Degree in Biomedical Engineering /Medical Devices or any Engineering filed related to Medical Technology & Devices. 
  2. Have a Min of 10 years’ experience in medical equipment, 5 of which in the field of equipment assessment of the sites needs, technical specifications, purchasing conditions & selection, installation, testing & commissioning, in addition to experience in medical equipment technology management.

II. Basic Requirements
  1. Capable to deal with Auto CAD, Revit CAD drawings.
  2. Well familiar with International Standards, Regulations, and Guidelines related to:
  • Medical devices and equipment
  • Medical Gases
  • Hazards & safety in healthcare facilities
  • Electrical safety
  • Radiation protection
  • Radio-frequency protection
  • Noise and noise protection in medical spaces
  • Lighting in medical spaces
  • Sterilization and infection control
  • Biomedical waste management  


3. Well familiar with international guidelines for ;

  • Health facilities design & planning
  • Space programs
  • Department relationships
  • Medical rooms /areas sizes & plans
  • Medical room occupation
  • Room data sheets (RDS)
  • Medical Equipment & medical furniture distribution
  • Medical rooms & areas environmental conditions requirements; temperature, humidity, air pressure, air flow & air exhaust, lighting level, noise level and special isolation requirements. 


4. Well familiar with Hospital/healthcare facilities Medical and Non-Medical Systems and its relation to the medical equipment such as;

  • Medical Integration Systems
  • IT Healthcare Systems ( HIS, LIS, RIS & PACs)  
  • Nurse Call Systems
  • Traceability automated systems for patients staff and materials
  • Building Management System (BMS), Material Tractability System
  • AV & Alarm Systems
  • Material Management and Inventory Control System   


5. Well familiar with a wide range of medical equipment and medical furniture such as (but not limited to): 

  • Imaging Radiology equipment and Systems ( MRI, CT, CATH LAB, Angiography, C-ARM, X-RAY (Dental, Panorama, Radiography, Fluoroscopy, Mammography), and Ultrasound Scanners
  • Nuclear Medicine and Radio Therapy equipment and Systems (Accelerators, PETs, SPECT, Gamma Camera… etc.)
  • Operating Theater (OT) Medical Equipment and furniture and OT Integration Systems
  • Medical Navigation equipment & systems 
  • Endoscopy equipment and systems
  • Clinical Laboratory, Blood Bank, Clinical Research Lab Equipment and Lab furniture
  • Outpatient clinics equipment (ENT, OPTH, EEG, EKG, EMG, ORTH, Dental,
  • Medical Refrigerators & Freezers  
  • Medical Bio-Safety cabinets and Hoods
  • Pendants ceiling / Wall mounted systems, Bed Head units, and wall consoles  
  • Surgical and Exam Lights
  • Patient lifting and transporting devices
  • CSSD Equipment 
  • Morgue & Forensic Medicine equipment.
  • Rehabilitation and Physiotherapy Equipment and Furniture 
  • Maternity, Delivery, NICU Equipment 
  • Intensive care (ICU, CCU, and SICU) equipment  
  • Anesthesia Machines and Ventilators 
  • Electro-Physiological monitoring systems and equipment  
  • Pharmacy Equipment and systems, including Pharmacy Robotic System 
  • Dialyses and water treatment systems
  • Supporting medical equipment used in diagnostic and treatments     


6. Well familiar with a wide range of medical equipment and furniture Manufacturers  


III. More Specific Requirements.

Should be capable to;

  1. Share & participate in all phases of the hospital/healthcare facilities design, planning, construction, equipment delivery, installation, testing, and commissioning, handing over and follow-up of equipment during the warranty period.
  2. Coordinate and support other Engineering disciplines (Architects, Electrical, Mechanical, Structurer, Internal Design ... etc.) in all related issues to medical equipment & Furniture allocation, Architectural, Structural & MEPs requirements.
  3. Provide full support the client/end-user staff and representatives in all related issued to Medical Equipment to take the right decision in all stages of the project. 
  4. Understand the client/end-user functional requirement and reflecting these to recommendation and decisions via continues meetings, workshops, and connections.
  5. Advise the client/end-user and take the perfect decisions about the following:
  • Assess the needs of the client/end-user needs for all type of medical equipment required.
  • Set schedule plans in coordination with the client/end-user and the engineering team for the purchasing, supply, delivery, installation, testing, commissioning and acceptance processes for medical equipment. 
  • Prepare a comprehensive BOQ (Bill of Quantities) lists for all medical equipment within the project.
  • Prepare a draft estimation of the equipment budgets/cost required
  • Prepare/Review of the technical specification and Technical Terms and Conditions needed for each type of medical equipment within the project.
  • Prepare/Review the Room Data Sheets (RDS) and equipment MEP, IT, Environmental  and Equipment Plans distributions 
  • Prepare the Room-By-Room Equipment Lists.
  • Prepare all types of forms required for the progress of activities related to medical equipment and medical furniture, including inspections forms for delivery, installation, testing & commissioning, acceptance, handing over certificates, equipment services, follow-up, and others.
  • Prepare of medical equipment handing over documents
  • Provide technical advice in equipment/vendor selection and tender evaluations.
  • Advise the client/end-user about the equipment accessories and consumables. 
  • Advise and inform the client/end-user about all recalls related to purchased, installed, running equipment under his responsibility.


6. Conduct a regular/when required meetings with the client/end-user for reporting the progress, current status, next steps in regard to medical equipment and taking the necessary action regarding the feedback from the meeting.


7. Issue/ Submit regular medical equipment planning report to client/end-user.


8. Keep a strong interface with the medical staff, doctors, and consultants


9.Keep and manage a well-organized filing document (hardware &software) for all related to medical equipment subjects, processes, and actions


IV. Requirments related to relationships with supplier & Manufacturers

MEqp should;

  1. Keep a strong interface and business relations with the suppliers & manufacturers of medical equipment.
  2. Conduct regular / when required meetings with selected local suppliers & Manufacturers representatives for the benefit of positive progress of the project and solving all issues that could impact such progress.
  3. Conduct technical workshop & meeting for the local suppliers & Manufacturers with the Client/End User - Medical Staff, Doctors, and Management representatives. All the out-come from such meeting to be used in the benefit of the project progress and development.
  4. Keep the Client/End User updated about all activities carried by the selected local suppliers & Manufacturers.
  5. Provide the Client/End User with all documentation, Brochures, Manual, Upgrading memos that are related to Medical equipment subject to the project.
  6. Keep updated records of the modification and upgrading of equipment under his responsibility.

V. Ranking of qualifications and experience based on the mentioned requirements

This depends on who is evaluating, the engineer himself, employee company or training center/college. In general, the total mark can be estimated 100%, regardless the party doing the evaluation. Based on the recent and rapid development in the fields of medical equipment and medical equipment planning on one hand, and the importance of selecting the qualified individuals, who are able to carry out the required work and responsibility in the field of medical equipment planning on the other hand, in addition to the satisfaction of the clients/end-users, the minimum mark should not be less than of 75%.

The distribution of percentages should mainly take into consideration ;

  1. University qualification (recognized university, college)
  2. Years of experience (officially accredited preferably with recommendations)
  3. Training and certification (Certified Training)
  4. Healthcare Projects experience ( capacity, type, duration ... etc), and project management recommendations
  5. The types of medical equipment that are pointed in the experience (for some project this may have critical impact)
  6. The mark from the Technical interview/test
  7. Any others

The max weight of each requirement is also subject to the party performing the evaluation. All suggestions in this regard is highly appreciated


Dr.Eng. Walid Tarawneh

Medical Equipment Consultant & Senior Medical Equipment Planner at KEO International Consultants.

Handy Land: A Day in the Life of a Biomed

This article will appear with 24×7’s June 2016 anniversary coverage.


Do your workdays often feel like a children’s board game? Grab a wrench and see if you can make it through all the work orders by 5 o’clock!

Published on May 31, 2016 

Start 


Good Day Sunshine
Start your day off right by getting out of the basement and checking in with other departments. Help yourself to a bagel, and move forward one space.

Morning Mayhem

The CT machine in the ER is down, and you’re stuck waiting for the OEM’s service tech. Lose 2 hours.


Coffee Collaboration
Meet with IT to plan the rollout of a new EHR system. Congratulate yourself for being a team player, and move ahead three spaces.

Service Setbacks
An anesthesia machine breaks…and the page you need in the repair manual is missing. Swap out machines to resume surgery.


Tech Talk
Take 10 minutes to show a frustrated nurse how to use that new IV pump and make a friend for life—or at least until next week. Take another turn!

Afternoon Blues
A senior biomed with 40 years’ experience is retiring next month, but the hospital is in a hiring freeze. Notify HR and plan to reallocate workloads.


Vendor Victory
By getting a quote from a second vendor, you save your facility $15,000 on a service contract. Move ahead four spaces!


Repair Resolution
You track down a hard-to-find replacement part online—and the company even offers same-day shipping! Proceed to checkout.

Jump Start

Take 5 minutes to schedule a test date for the fall CHTM exam. Almost there!


Reset Button
A promising student from a local biomed program wants to intern at your facility. Start over tomorrow!


End 


Source: 24x7 Magazine

The Electronic and Biomedical Engineering (EBME) department should ensure processes are in place for acceptance testing. These processes will check that equipment meets safety standards, meets clinical requirements, and the procurement requirements of the Hospital from the day it arrives. (This advice may be used in conjunction with this acceptance form.)
 

Biomedical Engineering Video

Why recreate the wheel? On this page you'll find sample copies of service plans, policies, safety and marketing brochures, and more. Borrow some ideas and submit your own. To contribute your documents to this page, refer to AAMI site

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