TRIMEDX-2542 Regulatory Article

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Understanding the
Regulatory Requirements
for Documenting Medical
Maintenance
How Accreditation Standards and
Regulatory Compliance Influence
your business
In today’s hospital, there’s a
significant gap between hospital
risk management and clinical
engineering. Clinical engineers (CE) are hired to
accepted practice today, especially with more rigorous
maintain, repair and fix equipment but many times are also
requirements (TJC, HFAP, DNV), state department of
expected to oversee hospital risk management related to this
health compliance, not to mention equipment recalls
equipment. In a typical hospital, there aren’t enough engineers
and alerts you must respond to from the Food and
and techs to adequately cover the risk management role
Drug Administration (FDA) and original equipment
leaving many CEs left to rely on previous experience and gut
manufacturers (OEM). On average, between the major
instincts acquired from years of experience in the field rather
federal and state governing bodies mentioned above, there are
than following state and federal regulations precisely.
numerous requirements that hospitals are fully expected to be
But working off of industry experience alone is not an
aware of on an annual basis.
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regulatory requirements like the Centers for Medicaid &
Medicare Services – where a hospital’s reimbursement
depends on its compliance with the most recent regulations.
In addition to the CMS regulations, you have Accreditation
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As you can see, today’s effective risk management
of this job, many are not given the time required to effectively
requires a full-time professional to fully understand and
engaging with each regulatory body or to stay up to date with
be up-to-date on accreditation standards and state and
every device in the hospital. In this article, we’ll talk about
federal regulations for every device in the hospital as well
whose responsibility it is in the hospital as well as cover best
as have a plan in place to keep each device compliant at any
practices for staying compliant.
given moment. Although experienced CEs are very capable
Medical Equipment Management Plan
Compliance starts with a medical equipment management plan (MEMP). Consider The Joint
Commission EC01.01.01, EP7 (A) – “The hospital has a written plan for managing medical
equipment.” Best practices for MEMP include several key components including:
The written plan and it’s supporting policies
and procedures
Maintenance strategies and intervals
Process of selecting, planning, acquiring
equipment
Alerts and recalls
Process of addressing equipment use errors
and medical device patient risks
Safe Medical Device Act (SMDA) requirements
Preventive Maintenance of life and non-life
support equipment and documentation
Process for evaluating effectiveness of MEMP
and compliance
Inventory
Consider these two important compliance requirements:
The MEMP starts with accurate inventory management.
The biggest (and sometimes most costly) mistake hospitals
make has to do with physical inventory – knowing what you
have, its preventive maintenance schedule, how you utilize it,
etc. Many times we find equipment listed in inventory that no
longer exists, we see duplication of equipment, and the most
dangerous is equipment still in use but not accounted for.
Not knowing critical information about your inventory puts you
and the facility at risk with regulatory compliance.
1 CMS Regulations 482.53 “An equipment inventory and
incident history is maintained.”
2 The Joint Commission, EC02.04.01, EP2 “The
hospital maintains either a written inventory of all
medical equipment or a written inventory of selected
equipment categorized by physical risk associated with
use (including all life-support equipment) and equipment
incident history. The hospital evaluates new types of
equipment before initial use to determine whether they
should be included in inventory.”
2
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Not knowing critical information
about your inventory puts you
and the facility at risk with
regulatory compliance.
Together the regulatory bodies require hospitals to establish a
inventory based on criteria such as manufacturers
current and precise inventory of all medical equipment and to
recommendations, risk levels or current hospital experience.
document maintenance and preventive maintenance regardless
of ownership (lease, rented, physician owned, hospital owned,
or a loaner/demo). Although regulatory bodies do not specify
how the inventory is documented (in a single database, multiple
databases, etc.), the best practice for storing inventory data is
through a computerized maintenance management system
(CMMS) that stores information in one location and allows you
to have the complete list of inventory and its history on file and
it’s easily accessible at any given moment.
These regulations (and many others) are vague and left to
the interpretation of the beholder, but as we mentioned in the
beginning of this article, interpretation is risky. For instance,
recent changes with the CMS preventive maintenance
directive now make the interpretation of whether a device
is considered life support, critical care or general based on
where that device is located in the hospital and how it’s used.
Let’s look at this scenario:
AED defibrillators in a medsurg unit: some OEMs don’t
Preventive Maintenance Frequencies
Now that you have taken inventory, the next important
step to staying compliant is the management of preventive
maintenance frequencies. Let’s start with the regulations:
1 The Joint Commission, EC02.04.01, EP3 “The hospital
identifies the activities, in writing, for maintaining, inspecting,
and testing for all medical equipment on the inventory.
2 The Joint Commissions, EC02.04.01, EP4 “The
have a designed PM or frequency and some CEs decide
to not put it on schedule because there isn’t a requirement.
However, it’s now considered a life support device – if a
patient crashes and it’s not operable it’s life and death
therefore you should conduct a PM twice a year otherwise
you risk a citation (or request for improvement) with The
Joint Commission and your state department of health.
In other words, life support and critical devices are no longer
limited to ventilators and anesthesia; it can include other
hospital identifies in writing, frequencies for inspecting,
less obvious devices like radiographic imaging and patient
testing, and maintaining medical equipment on the
monitoring.
Understanding the Regulatory Requirements for Documenting Medical Maintenance
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Whether it’s life support or critical care equipment, now both
This is a significant change for the industry that places a huge
have to follow OEM recommended PM frequency– regardless
strain on the CE department because a PM that used to take
of which state you are operating within. Non-life support
two hours can now take up to six!
equipment PM frequencies can be based upon risk, as
The key to maintaining compliance with PM frequencies
long as the hospital is not located in a Non-Risk state.
is not only understanding the current regulations, but
AL, CA, GA, IN, LA, NY must follow the OEM recommended
also having a plan and schedule. Best practices for PM
PM frequencies unless a waiver has been executed and
frequencies include developing a plan, documenting the plan,
approved by the state department of health. Additionally,
working the plan and updating it based on federal and state
all PM procedures must follow manufacturer documented
changes.
procedures regardless of equipment type, per CMS.
The bottom-line
As you can see, the roles and responsibilities of documenting
your risk manager or safety officer understand
medical maintenance requires more than asking a seasoned
the timing, process and requirements for each
CE to “help out” when time permits. It requires a full time risk
governing body.
manager or safety officer that works in tandem with CE to
If hiring a full time professional for this
develop an MEMP plan, document inventory, and create a PM
frequency plan for every device in the hospital. And further for
this professional to know when the surveys will take place so
role is not in the budget, consider
partnering with a service provider
who can help you prepare for the
surveys and stay compliant yearround. Because we have nearly 1
million devices across the country,
TriMedx has been able to develop PM
frequency plans that meet or exceed
the minimum regulatory requirements
and we are able to adequately prepare
hospitals for the impending surveys each
year through a regulatory readiness survey.
Regardless of how you approach the
challenge, it’s critical for your facility to fully
that you are prepared and not scrambling to find data. While
state surveys occur every year, the Joint Commission surveys
understand the regulatory requirements
and how it impacts your business.
occur within 18 months to three years and CMS happens
For more information visit
about every 15 months. The process and requirements for
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each state and each regulatory body vary so it’s imperative
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