Revised Joint Commission Standards for

Medical Equipment
Published on October 17, 2014
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By Arif Subhan, MS, CCE, FACCE

On March 31, 2014, the Joint Commission added a new

element of performance (EP 24) to the primary medical equipment standard
EC.02.04.03 for deemed status hospitals. This requirement was intended to
go into effect on July 1, 2014.1 This additional requirement was in response to
the Centers for Medicare and Medicaid Services (CMS) memo dated
December 20, 2013 (S&C 14-07-Hospitals), which had relaxed some of the
restrictive policies on preventive maintenance of medical equipment.2-4 The
term deemed status is described in a previous CCE prep article.4
According to the Joint Commission, however, the CMS was of the opinion that
this additional EP did not bring the Joint Commission standards in line with the
CMS requirements for deemed status hospitals. Consequently, the Joint
Commission has expanded and added EPs in the two main Joint Commission
standards EC.02.04.01 and EC.02.04.03. The previously approved

EC.02.04.03, EP 24, has been removed. These updated requirements went

into effect on July 2, 2014.5
EC.02.04.01 EP 1
This EP is unchanged. It requires the hospital to seek input from individuals
who operate equipment (clinicians and nurses) and those who service
equipment (biomedical/clinical engineering) when the hospital chooses and
purchases medical equipment.6
EC.02.04.01 EP 2
Key Joint Commission Definitions
Medical equipment: Fixed and portable equipment used for the diagnosis,
treatment, monitoring, and direct care of individuals.
High-risk equipment: Any device or components of building utility systems
for which there is a risk of serious injury or death to a patient or staff member
if the device or component fails. High-risk equipment includes life-support
equipment.
This EP was changed. It formerly required the hospital to maintain either a
written inventory of all medical equipment or a written inventory of selected
equipment which would be classified by physical risk associated with its use
and equipment incident history. This requirement was retained for the
hospitals that do not use Joint Commission accreditation for deemed status
purposes.
However, deemed status hospitals must now include all medical equipment
in their inventory. This new rule will require these hospitals to reassess their
current medical equipment inventory based on the definitions of the
term medical equipment, which can be found in the glossary of the Joint
Commission standards.5,6 (See box for a summary of the definitions.)
EC.02.04.01 EP 3
This is a new EP. It requires the hospital to identify high-risk medical
equipment in the inventory. This category of equipment includes items for
which there is a risk of serious injury or death to a patient or staff if the
equipment fails. The high-risk medical equipment encompasses life-support
equipment, including items such as a robotic surgical system. The term highrisk is new to Joint Commission medical equipment standards and is

considered comparable to the CMS term critical equipment. The term highrisk is defined in the glossary of the Joint Commission standards.5,6
EC.02.04.01 EP 4
This new, revised EP combines the concepts of maintenance activities and
frequencies of the earlier EP 3 and EP 4. It now requires the hospital to
identify the activities and associated frequencies, in writing, for maintaining,
inspecting, and testing all medical equipment in the inventory.
In order to determine the frequencies of maintenance and testing, hospitals
must follow manufacturers recommendations or develop strategies of an
alternative equipment maintenance (AEM) program. This AEM program must
not reduce the safety of equipment, and must be based on accepted
standards of practice. For medical equipment, suggested accepted standards
are the American National Standards Institute/Association for the
Advancement of Medical Instrumentation handbook, ANSI/AAMI EQ56: 2013,
Recommended Practice for a Medical Equipment Management Program.5,6
EC.02.04.01, EP 5
This is a new EP for deemed status hospitals. It requires the hospital to use
manufacturers recommendations for maintenance activities and frequencies
for the following types of equipment:
Medical laser devices;
Imaging and radiologic equipment (whether used for diagnostic or
therapeutic purposes);
Medical equipment that is subject to federal or state law or Medicare
Conditions of Participation. It should be tested and maintained according to
manufacturers recommendations or an approach that establishes more
stringent maintenance requirements;
New medical equipment that usually does not have adequate
maintenance history to support the use of AEM strategies. The maintenance
history must include records provided by the hospitals contractors, information
made public by nationally recognized sources, and records of the hospitals
experience over time.5,6
The next CCE Prep column will discuss other changes to the Joint
Commission medical equipment standards.

Review Questions
(Answers at end of article)
1. The following element of performance (EP), which requires the
hospital to solicit input from individuals who use and service equipment
when it chooses and purchases medical equipment, was not part of the
recent revision of the Joint Commission medical equipment standards.
a) EC.02.04.01 EP 1
b) EC.02.04.01 EP 2
c) EC.02.04.01 EP 3
d) EC.02.04.01 EP 4
2. The Joint Commission defines medical equipment as ________.
a) Fixed and portable equipment used for the diagnosis, treatment, and
monitoring of individuals
b) Fixed and portable equipment used for the diagnosis, treatment, and direct
care of individuals
c) Fixed and portable equipment used for the diagnosis, treatment, monitoring,
and direct care of individuals
d) Fixed and portable equipment used for the treatment, monitoring, and direct
care of individuals
3. The Joint Commission defines high-risk equipment as _________.
a) Any device for which there is a risk of serious injury or death to a patient or
staff member if the device fails
b)Any device for which there is a risk of serious injury to a patient or staff
member if the device fails
c) Any device for which there is a risk of death to a patient or staff member if
the device fails
d) Any device for which there is a risk of serious injury or death to a patient if
the device fails
4. According to the Joint Commission, the accepted standard for
medical equipment is _______.
a) NFPA 99, 2015 Edition
b) ANSI/AAMI EQ56: 2013

c) NFPA 70, 2014 Edition

d) January 1, 2015
5. According to the Joint Commission high-risk equipment includes
_____.
a) life-support equipment
b) non-life support equipment
c) all devices that are included in the Preventive Maintenance program
d) none of the above
Arif Subhan, MS, CCE, FACCE, is the chief biomedical engineer at VA
Greater Los Angeles Healthcare System and a member of 247s editorial
advisory board. The suggestions and views expressed in this article are of the
author. They do not represent the views of the Department of Veterans Affairs.
For more information, contact jbethune@allied360.com.
References
1. Revised Requirements for the Environment of Care (EC) Chapter. Available
at:
http://www.jointcommission.org/assets/1/18/EC_PrepubReport_HAPandCAH_
July2014release_20140304.pdf. Accessed October 11, 2014.
2. Biomeds Cheer CMS Change of Mind on Maintenance, December 27,
2013. Available at: http://www.24x7mag.com/2013/12/biomeds-cheer-cmschange-of-mind-on-maintenance/. Accessed October 11, 2014.
3. Hospital Equipment Maintenance Requirements, CMS Memo dated
December 20, 2013. Available at: http://www.cms.gov/Medicare/ProviderEnrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Surveyand-Cert-Letter-14-07.pdf. Accessed October 11, 2014.
4. Subhan A. New Joint Commission requirement for medical
equipment. 247. 2014;19(5):26.
5. Joint Commission. EC News. 2014;17(9).
6. 2014 Joint Commission Comprehensive Accreditation Manual. Available at:
http://www.jcrinc.com/2014-comprehensive-accreditation-manuals. Accessed
October 17, 2014.
Answers:

1A; 2C; 3A; 4B; 5A

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In an unstable health care environment where hospitals are experiencing financial cuts
in operations and capital purchases, to add more administrative work on an inventory
that will now include items that do not risk high enough for anything higher than a
hazard surveilance inspection or performance verification on items like otoscopes, items
that are really not economically reparable and those that are on an exchange basis will
be a nightmare to manage.
Larry Sheppard
February 25, 2015 9:48 am
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- See more at: http://www.24x7mag.com/2014/10/revised-joint-commissionstandards-medical-equipment/#sthash.iBoze0Cj.dpuf