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Ask George
Ask George In this column, BI&T features questions and answers between AAMI members and George Mills, director of the Department of Engineering at The Joint Commission. Become part of the discussion and ask questions about those subjects that matter to you the most. You can submit your Joint Commission question at this link: www.aami.org/tmcconnect/ askgeorge.html. Or to join AAMI’s Joint Commission e-forum, which is open to all AAMI members, visit www.aami.org/ tmcconnect/discussiongroups. html. Some of the questions and answers may have been edited for space, style, and clarity.
Is there a definition of critical care equipment? Is there a list of types?
Although the unfamiliar terms used by the Centers for Medicare & Medicaid Services “critical equipment” and “non-critical equipment” were chosen by CMS in the recent Survey & Certification (S&C) 14-07-Hospital, we believe them to be equivalent to life support and non-life support equipment as The Joint Commission has defined them. Life support would be equipment that if it failed, a life would be at risk. For example, a heart-lung bypass machine is clearly a life-support equipment; if it fails, a patient will be at extreme risk of injury or death if not for prompt clinical interventions. A suggested list of life support equipment could include anesthesia equipment, circulatory assist equipment, left ventricular assist devices [LVADs] with intra-aortic balloon pumps ]IABPs], and ventilators (adult, infant, magnetic resonance imaging [MRI]-compatible). Does EC02.05.01 EP6 refer to new construction only? What about facilities that have areas that were designed and built before Facility Guidelines Institute’s “Guidelines for Design and Construction of Healthcare Facilities (2010 Edition)” was accepted, and cannot meet these guidelines?
The Joint Commission would survey to the edition of the “Guidelines for Design and Construction of Health Care Facilities” in effect at
the time of design. If the organization built to a different but equivalent document (i.e. the U.S. Department of Defense design documents), we would survey to that as well.
installing an angled plug would certainly make sense. If the risk assessment has not identified any risk, install the high-quality hospitalgrade plug and follow up with an electrical safety test.
Is replacing the power plug on a power cord an acceptable practice in a healthcare facility? During a recent mock survey by an outside consultant, we were told that we should never replace power plugs on medical device power cords. He went on to say the whole power cord assembly should be replaced using one purchased only from the original equipment manufacturer. We have found in some cases an angle plug is a better solution for beds and certain other devices. Currently, we use brandname high-quality hospital-grade plugs to repair damaged plugs (bent grounding pins, etc.) We always follow up with an electrical safety test.
Who would you consider a ‘qualified individual’ with regards to performing maintenance on medical devices, and/or changing maintenance intervals with regards to manufacturer recommendations?
The Joint Commission would expect the organization to define who oversees the organization’s medical equipment management program and what qualifications they require for those who assess equipment for inclusion in their program. Typically, a biomedical engineering technician or clinical engineer would be qualified. For equipment that is unique or specialized, the organization may seek input from staff with appropriate training. n
I am assuming the broken plug is molded into the power cord of the device, so it is not repaired by replacement but by using a different part. I would suggest you have a risk assessment process to evaluate your proposed action of modifying the equipment. Assess whether the plug can be replaced safely without affecting the equipment function. Part of the risk assessment may include contacting the manufacturer and see if it has any issues with the replacement plug. The added justification of
Biomedical Instrumentation & Technology September/October 2014
325
Ask George
Ask George In this column, BI&T features questions and answers between AAMI members and George Mills, director of the Department of Engineering at The Joint Commission. Become part of the discussion and ask questions about those subjects that matter to you the most. You can submit your Joint Commission question at this link: www.aami.org/tmcconnect/ askgeorge.html. Or to join AAMI’s Joint Commission e-forum, which is open to all AAMI members, visit www.aami.org/ tmcconnect/discussiongroups. html. Some of the questions and answers may have been edited for space, style, and clarity.
Is there a definition of critical care equipment? Is there a list of types?
Although the unfamiliar terms used by the Centers for Medicare & Medicaid Services “critical equipment” and “non-critical equipment” were chosen by CMS in the recent Survey & Certification (S&C) 14-07-Hospital, we believe them to be equivalent to life support and non-life support equipment as The Joint Commission has defined them. Life support would be equipment that if it failed, a life would be at risk. For example, a heart-lung bypass machine is clearly a life-support equipment; if it fails, a patient will be at extreme risk of injury or death if not for prompt clinical interventions. A suggested list of life support equipment could include anesthesia equipment, circulatory assist equipment, left ventricular assist devices [LVADs] with intra-aortic balloon pumps ]IABPs], and ventilators (adult, infant, magnetic resonance imaging [MRI]-compatible). Does EC02.05.01 EP6 refer to new construction only? What about facilities that have areas that were designed and built before Facility Guidelines Institute’s “Guidelines for Design and Construction of Healthcare Facilities (2010 Edition)” was accepted, and cannot meet these guidelines?
The Joint Commission would survey to the edition of the “Guidelines for Design and Construction of Health Care Facilities” in effect at
the time of design. If the organization built to a different but equivalent document (i.e. the U.S. Department of Defense design documents), we would survey to that as well.
installing an angled plug would certainly make sense. If the risk assessment has not identified any risk, install the high-quality hospitalgrade plug and follow up with an electrical safety test.
Is replacing the power plug on a power cord an acceptable practice in a healthcare facility? During a recent mock survey by an outside consultant, we were told that we should never replace power plugs on medical device power cords. He went on to say the whole power cord assembly should be replaced using one purchased only from the original equipment manufacturer. We have found in some cases an angle plug is a better solution for beds and certain other devices. Currently, we use brandname high-quality hospital-grade plugs to repair damaged plugs (bent grounding pins, etc.) We always follow up with an electrical safety test.
Who would you consider a ‘qualified individual’ with regards to performing maintenance on medical devices, and/or changing maintenance intervals with regards to manufacturer recommendations?
The Joint Commission would expect the organization to define who oversees the organization’s medical equipment management program and what qualifications they require for those who assess equipment for inclusion in their program. Typically, a biomedical engineering technician or clinical engineer would be qualified. For equipment that is unique or specialized, the organization may seek input from staff with appropriate training. n
I am assuming the broken plug is molded into the power cord of the device, so it is not repaired by replacement but by using a different part. I would suggest you have a risk assessment process to evaluate your proposed action of modifying the equipment. Assess whether the plug can be replaced safely without affecting the equipment function. Part of the risk assessment may include contacting the manufacturer and see if it has any issues with the replacement plug. The added justification of
Biomedical Instrumentation & Technology September/October 2014
325
