PATIENT SAFETY & RISK SOLUTIONS

GUIDELINE
Medical Equipment Management
Purchase, Use, Maintenance, Repair, and Other Considerations
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CONTENTS

I NTRODUCTION ........................................................................... 1

O BJECTIVES ............................................................................... 1

E QUIPMENT S ELECTION AND P URCHASE /A CQUISITION .......................... 1

E QUIPMENT M ANAGEMENT .............................................................. 3

Inventory Management and Documentation ........................... 3

Evaluation of Equipment........................................................ 4

Testing ................................................................................. 4

Maintenance and Usage ......................................................... 5

Education and Training .......................................................... 5

I NCIDENT R ESPONSE P ROCEDURE .................................................... 6

E QUIPMENT R ECALLS .................................................................... 6

D OCUMENTATION ......................................................................... 7

O NSITE L ABORATORY , A NESTHESIA , S TERILIZATION , D IALYSIS OR

R ADIOLOGY S ERVICES ................................................................... 8

C ONCLUSION .............................................................................. 8

R ESOURCES ................................................................................ 9

E NDNOTES ................................................................................. 9

A PPENDIX A. S AMPLE E QUIPMENT I NVENTORY /T RACKING L OG .............. 10

A PPENDIX B. S AMPLE L OG OF P REVENTIVE M AINTENANCE AND R EPAIRS .. 11

Guideline: Medical Equipment Management 1

INTRODUCTION
Medical equipment plays a vital role in healthcare; however, when it’s not properly used
or maintained, it also can cause harm. In many instances, patient injuries occur
because of assumptions about who may use, calibrate, modify, or repair equipment.
Injuries also might arise from training gaps that don’t address pre-use testing,
preventive maintenance, malfunction reports (and incident reports), and repair
procedures.

A commitment to safety is an essential element of any process related to the use of

medical equipment — whether the medical equipment is purchased, rented, borrowed,
or leased.

OBJECTIVES
The objectives of this guideline are to:

• Review due diligence considerations for selecting and purchasing/acquiring

medical devices and equipment
• Define key aspects of an equipment management program and offer risk
strategies to consider when developing such a program
• Discuss the necessary components of a well-defined incident response procedure
• Offer guidance related to responding to equipment recalls and documenting
essential information about medical devices and equipment
• Provide general recommendations for managing risks associated with the
operation of onsite laboratory and radiology equipment

EQUIPMENT SELECTION AND PURCHASE/ACQUISITION

The selection of medical equipment should not be based on hasty or insufficient
decision-making. Each healthcare organization should formally establish a team that is
responsible for researching and recommending medical equipment.

Once recommendations are made, prospective equipment should be thoroughly

reviewed in a collaborative effort by all end users — especially if it will be used in the
direct diagnosis, treatment, or care of patients. Due diligence when selecting medical
equipment might include:

• A literature review
• Consultation with experts
• Consideration of whether to contract the services of a biomedical engineering
company
• Requests for data and research results from clinical trials
Guideline: Medical Equipment Management 2

• Discussions with other healthcare providers who use the same equipment
(follow-up of references)
• A review of the history and fiscal standing of potential vendors

The medical equipment selection process also should include a formal assessment of
the anticipated risks and benefits associated with the equipment. For example, consider
the following questions:

• Is the use of the equipment consistent with your healthcare organization’s

mission and ethical policies and procedures?
• Does the equipment or new technology reduce the risk of injury to patients or
staff members who may be required to use it (e.g., exposure to lower levels of
radiation, latex, or mercury)?
• Do health benefits and/or time-savings for patients, healthcare providers, and
staff outweigh the cost associated with the equipment?
• Will charges to the patient that are associated with this equipment remain
consistent with similar community pricing?
• Are the procedures for which the equipment is used billable? Does your
electronic health record (EHR) system or billing system need to be modified to
bill for this service?
• What is the community standard? Are market pressures influencing the decision
to purchase new equipment (e.g., “our competition offers it” or “we don’t want
to be left behind”)?
• Do staff and providers need to be aware of any regulatory requirements related
to the equipment (e.g., only licensed independent practitioners can operate the
equipment, environmental safety requirements, etc.)?
• Are you able to integrate direct patient care equipment (e.g., blood pressure
monitors, laboratory equipment, etc.) with your EHR (if appropriate)? If not,
what additional resources would be required to do so?
• Does the new equipment require additional supplies or materials to use or
maintain it? If so, what are the availability and costs of these items?
• Is vendor support or other technical support for maintenance available?
• Have you considered the purchase/lease requirements and options (e.g.,
warranties, volume purchasing, trade-in programs, upgrades, indemnification for
injuries/failures, contract terms, new versus used/refurbished equipment, etc.)?
• What are the training and ongoing competency considerations?

The answers to these questions and the rationale for purchasing the equipment should
be documented and saved for future reference.
Guideline: Medical Equipment Management 3

EQUIPMENT MANAGEMENT
A patient injury caused by medical device or piece of medical equipment may trigger a
claim against a practitioner, healthcare organization, and/or an equipment
manufacturer.

To reduce patient safety and liability risks Risk Tip

associated with medical devices and
equipment, healthcare organizations should If an organization opts to use a
have effective programs for managing biomedical engineering contractor’s
equipment used in patient care. equipment management plan,
designated personnel at the facility
Considerations when developing an equipment should review and adopt that plan.
management program include inventory Language in the plan should
management and documentation; evaluation specifically refer to the organization;
of equipment; testing; maintenance and it should not be a boilerplate plan
usage; and education and training. that fails to integrate services and
responsibilities between the
Inventory Management and organization and the contractor.
Documentation
A first step in designing an effective equipment management program is documenting
what equipment you have. Each healthcare organization should:

• Maintain an inventory of all medical equipment, whether it is leased or owned

and whether it is maintained according to manufacturer recommendations or an
alternative equipment maintenance (AEM) program. 1
• Include as part of the inventory a record of maintenance activities. (See
Appendixes A and B for sample tracking and maintenance/repair logs.)
• Ensure that equipment managed through an AEM program is clearly identifiable
as subject to AEM. Further, critical equipment, whether subject to AEM or not,
must be readily identified as such.
• Document the following information for all equipment included in the inventory:
o Unique identification number
o The equipment manufacturer
o Model number and serial number
o Description of the equipment
o Location of the equipment (for equipment generally kept in a fixed
location)
o Identity of the department considered to “own” the equipment
Guideline: Medical Equipment Management 4

Evaluation of Equipment
In addition to having a written inventory of medical equipment, healthcare providers
and staff should understand the purpose of each piece of equipment. As part of the
equipment management program, each organization should:

• Evaluate each piece of equipment to determine:

o Function and clinical application
o Preventive maintenance requirements and expected lifespan
o Likelihood of equipment failure; check U.S. Food and Drug Administration
(FDA) reports (www.fda.gov/MedicalDevices/), consumer reviews,
literature reviews, etc.
o Compatibility with other equipment used at the facility
o Space allocation for equipment and supplies
• Once the equipment has been evaluated, assign each item a tier level (1, 2, or 3)
based on how critical its function is to the practice or patient.
o Tier 1 is for the most critical equipment, such as life support and
emergency devices (e.g., an automatic external defibrillator).
o Tier 2 is for common use equipment, such as blood pressure monitors and
heat therapy units.
o Tier 3 is for equipment that has little to no risk, such as a patient scale.

Testing
Testing medical equipment is an essential element of an equipment management
program and vital for patient and staff safety. Each organization should:

• Test the equipment based upon the tier level assigned:

o Equipment in Tier 1 should be tested on at least a semi-annual basis.
o Equipment in Tier 2 should be tested on at least an annual basis.
o Equipment in Tier 3 may only need to be visually inspected on an annual
basis.
• Ensure that qualified personnel inspect, test, and maintain all medical equipment
(diagnostic, therapeutic, life support, and monitoring).
• Consider contracting the services of an approved biomedical engineering
company to assist with equipment testing and maintenance.
Guideline: Medical Equipment Management 5

Maintenance and Usage

Each organization’s equipment management program should include guidance related
to maintaining and using medical equipment. For example:

• Maintain and use all equipment according to manufacturers’ recommendations or

a specified AEM program. Document all inspections, testing, preventive
maintenance, and repairs — and include telephone numbers for the equipment
vendors.
• Ensure maintenance processes include specific accountability and schedules for
preventive maintenance and testing.
• As part of maintenance guidance, include specific information about
(a) disinfecting all reusable equipment according to FDA guidelines, and
(b) documenting equipment disinfection processes (www.fda.gov/
downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/
ucm253010.pdf).
• Develop a competency process for using equipment. Make sure the process takes
into account job description and training (external and in-service).
• Determine the healthcare organization’s point of contact for reporting any
equipment malfunctions or incidents that could cause patient injury.
• Never use a piece of medical equipment that shows signs of damage or has been
partially repaired or otherwise altered from its original condition by nonqualified
staff members.

Education and Training

Providers and staff cannot be expected to properly use and maintain medical equipment
unless they receive appropriate education and training. Each organization should:

• Provide all staff members (including temporary staff) with initial training and
ongoing annual training on medical equipment procedures. Training should
address:
o How to report a piece of medical equipment that is not functioning
properly, which can include visual clues like smoking, sparking, or display
errors.
o How to remove the piece of medical equipment from service, tag-out the
device, and notify the appropriate repair service or biomedical engineering
contractor for repairs.
• Train appropriate staff on how to properly setup, use, calibrate, and clean
equipment. If a staff person has not been trained, or is not appropriately
licensed/certified, he or she should not be allowed to use the equipment.
• Educate staff about back-up plans for when a piece of equipment needs to be
serviced or repaired.
Guideline: Medical Equipment Management 6

• Provide timely training and education for any new or updated equipment prior to
putting the equipment into use.
• Document all equipment training and competency for both providers and staff in
each individual’s personnel file.

INCIDENT RESPONSE PROCEDURE

In the event that a piece of equipment or medical device causes patient injury or harm,
each healthcare organization should have a well-defined incident response procedure.
As part of this procedure, appropriate staff members should:

• Stabilize the patient.

Risk Tip
• Remove from service and secure any
equipment involved in the incident. Equipment that has caused an injury
• Complete an incident report per should never be returned to the
organizational policy. manufacturer. Additionally, a
manufacturer’s representative should
• Report the incident as required by the not be allowed to examine or attempt
Safe Medical Devices Act (SMDA). to repair the equipment. The
o A designated staff member equipment should be sequestered,
should complete the required rendered inoperable (locked, etc.),
form and forward it (or an and examined by a company that
electronic equivalent) to the specializes in independent testing of
appropriate party as required equipment.
by law.
o Deaths should be reported to the FDA (www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverse
Events/ucm2005737.htm) and the equipment/device manufacturer.
o Serious injuries/illnesses should be reported directly to the manufacturer.
If the manufacturer is not known, the user organization should report
directly to the FDA.
• Notify the organization’s professional liability claims specialist immediately (he or
she will advise you if/when you should release the equipment).

EQUIPMENT RECALLS
If a healthcare organization or a biomedical engineering contractor receives a recall or
hazard notice from a manufacturer or distributor, the organization is responsible for
taking appropriate action, as outlined in the notification.

If the notification does not clearly state what steps to take, a designated staff member
should contact the entity that issued the recall/hazard notification for guidance. Until
the process is clarified, cease use of the equipment.
Guideline: Medical Equipment Management 7

If the organization fails to take appropriate action in

the face of such notice and the defective device Risk Tip
injures a patient, the organization might be found
negligent. Additionally, the organization might bear To ensure accountability,
legal responsibility for improper revisions or healthcare organizations should
modifications made to medical devices as a result of consider assigning one person
a recall notice. within the organization the
responsibility of receiving and
Manufacturers may specify how they will conduct a managing equipment recalls and
recall of equipment. Some contracts, especially alerts.
those addressing the purchase of equipment with
high potential for patient or user injury, may specify how and within what timeframe a
manufacturer will notify users of possible risks that have precipitated a recall.

DOCUMENTATION
Documentation related to medical equipment use and management should include
written policies and procedures for:

• Procurement of equipment (purchase, acquire, lease, borrow)

• Disposal of equipment (sale, recycle, destroy)
• Pre-use testing, calibration, and use
• Development and implementation of training programs, as well as periodic
training updates
• Responses to, and reporting of, equipment-related incidents

Additional documentation might be required and should be considered with the

purchase of new equipment. For example, contracts related to the lease of equipment
or maintenance agreements should be kept in a central location. The appropriate
individuals should assume responsibility for reviewing and asking questions about the
agreements before they are signed (including legal counsel as needed). Vendors may
not be accountable for “assumptions” that weren’t included in a contract.

Preventive maintenance and repair records should be available for all procured
equipment (leased, borrowed, used, etc.). Further, documentation related to who
insures the equipment should be maintained.

If necessary for proper pre-use testing or calibration, information from the

manufacturer should be used to develop training and in-service staff updates. These
materials should also be available for reference, and originals of these documents
should be filed with contractual arrangements.

Manufacturers’ specifications, schematics, testing, and calibration directions — and any

other user instructions — should be retained in a master file. Copies should be
Guideline: Medical Equipment Management 8

available, as needed, for users of the equipment. Manufacturers’ warranties (and

information about actions that might void warranties) also should be retained.

Codes or stickers placed on equipment for the purposes of identification, inventory

management, and preventive maintenance should be consistently color-coded
throughout the organization and should comply with state regulations.

All communications regarding damaged or nonfunctional equipment should be

maintained, including logs of telephone conversations. Upon disposal of equipment, all
protected health information should be wiped from the equipment memory.

ONSITE LABORATORY, ANESTHESIA, STERILIZATION, DIALYSIS

OR RADIOLOGY SERVICES
If your healthcare organization performs laboratory, anesthesia, sterilization, dialysis or
radiology services, constant vigilance to ensure the safety and accuracy of equipment is
necessary.

All radiological testing and services must be in compliance with Nuclear Regulatory
Commission (NRC) rules and regulations, as well as state and private licensing and
certification requirements. Similarly, all laboratory, anesthesia, sterilization, and dialysis
equipment must be maintained based on federal, state, and private licensing and
certifications requirements.

Therefore, each organization’s personnel should be knowledgeable about the laws and
ensure that onsite equipment operates in compliance with all of the applicable rules and
regulations.

The following general recommendations are intended to help manage risks associated
with the operation of onsite diagnostics:

• Retain licensing documents within your organization’s permanent files.

• Train, supervise, and periodically test the proficiency of all personnel performing
laboratory or radiology services.
• Maintain an inventory log of all diagnostic equipment and use it to monitor
equipment maintenance, recalibration, and servicing (as recommended by the
manufacturer).
• Maintain and revise written instructions and procedures, including maintenance
and reporting results, on an annual basis.

CONCLUSION
Medical equipment provides many valuable services to support and enhance patient
care, but its use is never without risk. While appreciating the benefits that medical
equipment can provide, healthcare providers and staff also should remain cognizant of
potential safety issues.
Guideline: Medical Equipment Management 9

Risk management strategies can help healthcare personnel proactively manage medical
equipment. When equipment is properly tested, used, and maintained, it is more likely
to work properly, which can help avoid delays in care, reduce the risk of patient and
staff injuries, and optimize patient outcomes.

RESOURCES
• Centers for Disease Control and Prevention: Guide to Infection Prevention for
Outpatient Settings — www.cdc.gov/HAI/settings/outpatient/outpatient-care-
guidelines.html
• FDA: Enforcement Reports — www.fda.gov/opacom/Enforce.html (information
about product recalls and other enforcement actions)
• FDA: Recalls, Market Withdrawals, and Safety Alerts — www.fda.gov/Safety/
Recalls/default.htm
• FDA: Medical Device Reporting — www.fda.gov/MedicalDevices/Safety/
ReportaProblem/default.htm
• Centers for Medicare & Medicaid Services: Clinical Laboratory Improvement
Amendments (CLIA) — www.cms.gov/Regulations-and-Guidance/Legislation/
CLIA/index.html
• Nuclear Regulatory Commission — www.nrc.gov/

ENDNOTES

1
Centers for Medicare & Medicaid Services, Center for Clinical Standards and Quality/Survey &
Certification Group. (2013, December 20). Hospital equipment maintenance requirements [Memorandum,
CMS S&C 14-07]. Retrieved from www.cms.gov/Medicare/Provider-Enrollment-and-Certification/
SurveyCertificationGenInfo/Policy-and-Memos-to-States-and-Regions-Items/Survey-and-Cert-Letter-14-
07.html
Guideline: Medical Equipment Management 10

APPENDIX A. SAMPLE EQUIPMENT INVENTORY/TRACKING LOG

Name/Type of Equipment:

Model #: Serial #: Tier Level:

Tier 1 — Critical Equipment
Tier 2 — Moderate Risk Equipment
Tier 3 — Low Risk Equipment

Own Lease

Rationale for Choosing Equipment:

Location of Equipment Within Office:

Warranty (Length of Time and What Is Included):

Names of Staff/Users Trained on Equipment and Date Trained:

Preventive Maintenance Requirements:

Person/Vendor Responsible for Preventive Maintenance:

Address: Phone Number:

Guideline: Medical Equipment Management 11

APPENDIX B. SAMPLE LOG OF PREVENTIVE MAINTENANCE AND

REPAIRS

Date PM/Repair Description

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