revised joint commission standards for medical equipment

7/23/2019 Revised Joint Commission Standards for Medical Equipment

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Revised Joint Commission Standards forMedical Equipment

Published on October 17, 20140

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By Arif Subhan, MS, CCE, FACCE

On March 31, 2014, the Joint Commission added a newelement 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, 2014.1This 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.2-4The

termdeemed statusis 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
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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 donotuse Joint Commission accreditation for deemed statuspurposes.

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

termmedical 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 medicalequipment 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 termhigh-

riskis new to Joint Commission medical equipment standards and is


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considered comparable to the CMS termcritical equipment. The termhigh-

riskis 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 maintenancehistory 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.


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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 fails4. According to the Joint Commission, the accepted standard for

medical equipment is _______.

a) NFPA 99, 2015 Edition

b) ANSI/AAMI EQ56: 2013


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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 of247s 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 [email protected].

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-cms-

change-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/Provider-

Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-

and-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:


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

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There is1commentPost New Comment

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 SheppardFeruary !"# !$%" &'() amReply

- See more at: http://www.24x7mag.com/2014/10/revised-joint-commission-

standards-medical-equipment/#sthash.iBoze0Cj.dpuf
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revised joint commission standards for medical equipment

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