Download Each item of medical equipment is assessed in accordance with the

CHERRY STREET HEALTH SERVICES
POLICY AND PROCEDURES
SUBJECT:
Bio-Medical/Dental Equipment Management Plan
POLICY:
All medical/dental equipment used in this organization will be inspected for
safety and proper functioning. This equipment will be used by staff who are
trained and qualified in the use of such equipment.
PROCEDURE(S): The Bio-medical/dental Equipment Management Plan will provide and
maintain a program that promotes the safe and effective use of equipment.
Responsibility
The responsibility for the implementation of the Medical Equipment Management Plan rests with the
Equipment Assessment team under the direction of the Director of Operations. The Facility
Manager is responsible for the supervision and the day-to-day execution of the Bio medical/dental
equipment management plan. All supervisors and department heads are authorized to intervene
whenever conditions pose an immediate threat to life or health, or threaten damage to equipment or
buildings.
Selection & Acquisition of Biomedical Equipment
All requests for clinical equipment shall be reviewed by the Systems Coordinators prior to purchase
to determine if the equipment meets appropriate space requirements, load and phase requirements,
Underwriters Laboratory requirements, OSHA requirements and includes the appropriate warranties
and manufactures reliability information.
Incoming Equipment Inspection Procedure
The Systems Coordinators/Site Managers are responsible for receiving the equipment and notifying
the director of Operations as specified by this policy. The systems coordinators/Site managers shall
perform an equipment approval inspection before use (see Training addendum Steps 1 and 2,
Addendum A). If the equipment is not approved, the facility Manager will be notified immediately
and the item will be returned to the manufacturer /distributor with documentation indicating the
problem. The department requesting the equipment will also be notified. Upon equipment approval,
it will be evaluated for inclusion in the preventative maintenance program using Form EM form 1.
If included, a copy of this form filed with the facilities manager at the site where the equipment is to
be used. A master file of all original Equipment Acceptance/Assessment Forms and any equipment
histories will be kept with the Systems Coordinators respectively. All electrical testing results and
preventative maintenance information are then stored on file in the appropriate system coordinators
office. The risk assessed equipment will be tagged with an inspection label, EM form 2 showing the
13.1
Page 1 of 13
date inspected and will then be sent on to the proper department. Equipment categorized as
excluded will then be sent to the proper department.
Inclusion Criteria
Each item of medical equipment is assessed in accordance with the following criteria prior to being
placed in service. The criteria include:
•
•
•
•
Equipment function
Physical risks associated with use
Maintenance requirements
Equipment incident history.
In order to facilitate the classification of each device type, each primary evaluation category has
been broken down into subgroups and subgroup characteristics. Each subgroup has been assigned a
numerical value for each characteristic. Values from each primary evaluation category are added to
arrive at an overall assessment score that is used to determine which devices are to be included in the
equipment management program. All equipment entering the organization will be evaluated and
assessed by the Equipment Assessment Team using the Equipment Assessment Form that is
included as part of this policy as attachment EM Form .
The Equipment Management Assessment Score (EMAS) is determined by summing the individual
scores for each of the four characteristics according to the following criteria:
EMAS =function + risk + required maintenance + equipment incident/inherent risk
Equipment Function: Therapeutic
 Life Support – Defibulators
 Surgical and Intensive Care– Oxygen Autoclave Nitrous
 Physical Therapy and Treatment – none on site
Diagnostic
 Surgical and Intensive Care Monitoring - EKG
 Additional Physiological Monitoring and Diagnostic
Pulse Oximeter, X-Ray, and Mammography``
Analytical
 Analytical Laboratory
Hgb A1C, Glucometers Thermometers05
Audiometer Titmus Microscopes,
Tympanogram Spirmoter, Hemocue
 Laboratory Accessories
 Computer and Related
Miscellaneous
13.1
Page 2 of 13
10
09
08`````
07
06
04
03


Patient Related and Other –Scales, Blood Pressure Units,
Non-Patient Related
Copiers, Refrigerators, Space Heaters,
Dental Chairs, Electric tables, Amalgamators,
Ultrasound Cleaner Lights
Physical Risk:
 Patient Death
 Patient or Operator Injury
 Inappropriate Therapy or Misdiagnosis
 No Significant Risks
Maintenance Requirement:
 Extensive
 Above Average
 Average
 Below Average
 Minimal
Equipment Incidents and Inherent Risks:
 Very High Inherent Risks
 High Inherent Risks
 Average Inherent Risks
 Minimal Risks
 No Significant Risks
02
01
05
04
03
01
05
04
03
02
01
05
04
03
02
01
Using the EMAS, clinical equipment is categorized into the following categories for testing and
additional management actions.
Critical:
Equipment with an EMAS from 22 to 25 points, inclusive. This equipment is
given the highest priority for testing, calibration and repair. Equipment in
this priority must have its preventive maintenance completed no later than
one month after its scheduled date. This equipment is noted as "High
Priority". Equipment failure procedures must be implemented by the
equipment users for Priority I equipment.
Facility Managers will be notified of Priority I equipment in their department
and the requirement for failure procedures implementation by written
memorandum from the Systems Coordinators.
High Priority: Equipment with an EMAS from 19 to 21 points, inclusive. Every effort will
be made to test, calibrate and repair this equipment, but only after Priority I
equipment requirements have been completed. This equipment is noted as
"Medium Priority". Equipment failure procedures are not required for this
equipment.
Low Priority: Equipment with an EMAS from 12 to 18 points, inclusive. Every effort will
be made to test, calibrate, and repair this equipment, but only after Priority I
and II equipment requirements have been completed. This equipment is
13.1
Page 3 of 13
noted as “Low Priority”. Equipment failure procedures are not required for
this equipment.
Excluded:
Equipment with an EMAS of 11 or less is not included in the Equipment
Management Program, and is not included on the inventory. This equipment
will still be checked at least annually for hazards by the Equipment
Assessment Team as part of Safety Site Visits through all. Equipment failure
procedures are not required for this equipment.
Unique Inventory
A unique inventory is maintained at each facility of all medical equipment, regardless of ownership,
if it is used in the care of the organization’s patients. The unique medical equipment inventory
identifies equipment by type, serial number, location, ownership, category or level of equipment
management, frequency of maintenance checks, and comments related to equipment failure history.
The unique inventory is maintained by the Director of Operations.
Regular Inspection, Testing, & Maintenance
All mechanical and electrical patient care equipment will be evaluated prior to use. Preventative
Maintenance will be completed on all equipment in the program by the assigned personnel. The
equipment will then be tagged with an inspection label, E M form 2. The equipment assessment
team will annually review for completeness.
Each item of medical/dental equipment identified in the unique inventory is monitored according to
a specific schedule to assure proper calibration, electrical safety, operator competence, and failure
history. In some cases equipment in a lower priority classification maybe provided service before
equipment in a higher priority classification depending on department and patient needs.
Incident history is documented and maintained. Equipment displaying unusual repair history or
unusual incidence of injury to staff or patients will be evaluated for necessary changes or
replacement.
Documentation of Maintenance & Testing
All maintenance and testing of Biomedical/Dental Equipment that is included in the organization’s
Biomedical/Dental Equipment Management Program shall be documented using the attached EM
Form 3.
13.1
Page 4 of 13
Tracking & Trending of Maintenance & Testing
Devices included in the Equipment Management Program are assigned an individual control number
to which all periodic maintenance and corrective work orders can be tracked. Preventative
maintenance for equipment in the program will be regularly scheduled on a frequency not to exceed
an annual period. Devices determined not to meet the requirements to be included in the Equipment
Management Program will not be assigned a tracking number. Patient, clinical and laboratory
environments will be inspected annually at which time these items will receive a general safety
inspection. Documentation of problems with devices not included in the program will be by
exception.
Hazard Notices & Recalls
Medical device recalls and hazard notices received by Cherry Street Health Services must be
forwarded to the Director of Operations for proper handling and action. Recalled equipment shall be
immediately removed from service until certified safe by the appropriate service company or agency.
This notification is for medical equipment only (not to include supplies or medications).
Safe Medical Device Act of 1990 (As Amended in 1996)
The Safe Medical Device Act of 1990 requires that device user facilities report incidents to the
device manufacturer when the facility determines a device has or may have caused or contributed to
the death or serious injury of an individual. The facility must also send a copy of the report to the
FDA in the case of death. Such reports will provide detailed information on medical device failures
that may have caused, or are suspected of causing serious illness, injury or death.
Equipment Failures & User Errors
The following steps will be followed in the event of an equipment failure:
 If equipment fails while in use, appropriate interventions must be taken to ensure employee
and patient safety
 Appropriate interventions must also be taken to ensure appropriate level of care for the
patient until the equipment is repaired.
 Any defective equipment will be removed from service immediately and will remain so until
the equipment is returned to the proper operating condition.
 The malfunctioning equipment will be clearly identified with a DEFECTIVE label - EM
form 5
 The Director of Operations will be notified of the problem
 The Systems Coordinator will arrange to have the problem corrected or fixed.
 Once the problem is corrected, the equipment will be returned to service
Reporting & Investigating Equipment Failures & User Errors
13.1
Page 5 of 13



All equipment failures and user errors will be investigated and reported.
Included in the report will be the error/failure date, location of the equipment, cause or
affected area, resolution and follow-up. The report will be filed on EM Form r.
In the event the equipment problem was caused by user error, the user(s) will be retrained on
the operation and use of the equipment by the appropriate personnel.
Orientation & Education
As a part of initial employee orientation, periodic continuing education, as required, staff will be
provided with training which addresses:
•
•
•
•
•
Capabilities, limitations and special applications of equipment,
Basic operating and safety procedures for equipment use,
Emergency procedures in the event of equipment failure,
Information/skills necessary to perform assigned maintenance responsibilities, and
Processes for reporting equipment problems, failures and user errors.
Additionally, staff will be periodically undergo a competency assessment (usually annually but
never more than every two years), to determine if competency levels have been maintained. Staff
should never utilize an item of equipment for which they do not have a documented current and
completed competency.
Performance Standards
Performance Standards for the medical equipment management plan include:
•
•
•
Documentation of observed competence by medical equipment users, and
Tracking of any equipment related incident reports
Tracking of any reportable equipment failures in accordance with the Safe Medical
Devices Tracking Act.
Thorough training will be provided regarding the capabilities, limitations and special applications of
equipment included in the program by the department directors or designee in involved departments.
All user/maintainers of equipment shall be trained according to the components of their job
specifications.
Emergency Procedures
Equipment which meets the organization's criteria for critical to patient safety shall have emergency
procedures in the event of a malfunction or failure. Equipment considered critical to patient safety
includes life support, life sustaining or other such equipment whose malfunction or failure may
result in an adverse patient outcome.
13.1
Page 6 of 13
The organization will develop and follow specific procedures in the event of an equipment failure:



Equipment will be removed from service and tagged immediately (EM Form 5).
An occurrence report will be completed describing the failure.
If replacement equipment is necessary, Systems Coordinator should be notified to check in a
replacement.
Annual Evaluation
The Director of Operations will prepare an annual summary evaluation of the Medical Equipment
Management Plan, addressing the objectives, scope, performance and effectiveness of the plan. The
annual report will be presented to the Governing Body for their review and adoption.
4/04
4/06
13.1
Page 7 of 13
ATTACHMENTS
13.1
Page 8 of 13
EM FORM 1
EQUIPMENT ACCEPTANCE/ASSESSMENT FORM
Name/Type of Equipment:
Manufacturer:
Model:
Department:
NOTE: This form is to be utilized for medical/dental equipment ONLY!
Equipment Management Assessment Score (EMAS) Calculation:
[FUNCTION] +
[
]
+
[RISK]
[
+
]
[MAINTENANCE] + [INCIDENTS/RISKS]
+
[
]
+
[
]
=
=
EMAS
[
]
Priority Classification:
Critical ( 22 - 25 points)
[
]
Low Priority ( 12 - 17 points)
[
]
High Priority ( 18 - 21 points)
[
]
Excluded ( 11 points or less)
[
]
[
[
] Bi-Weekly
] Semi Annual
Operator Manual Location:
PM Cycle:
[
[
] Weekly
] Quarterly
[
[
Purchase Date:
Outside Service Contract:
Inspection Conducted By:
Reports Noted:
Date:
Director of Operations
Tracking Number _______________________________
PM will be done by _____________________________
13.1
Page 9 of 13
] Monthly
] Annual
SAFETY INSPECTION
Serial No ____________________________________
Test Date ______________ By __________________
Pass _____________ Fail ______________________
EM Form 2
TRACKING NUMBER _______________________________
EM Form 2
13.1
Page 10 of 13
EM Form 3
EQUIPMENT INSPECTION CHECKLIST
(Inspection may vary per piece of equipment)
FACILITY __________________________________________________________________
DEVICE(Equipment)__________________________________________________________
MANUFACTURER ___________________________________________________________
MODEL NUMBER ____________________________________________________________
SERIAL NUMBER ____________________________________________________________
Date of Inspection
Next Inspection Due
Visual Inspection (Broken knobs, etc.)
Power Cord (frayed wires, etc.)
Power Cord Plug (Missing/damaged prongs)
Equipment Function (Running properly/to capacity)
Inspection Results (Passed, Failed or Repair)
Tracking Number __________________________________
13.1
Page 11 of 13
SUMMARY/HISTORY OF EQUIPMENT MALFUNCTION & MAINTENANCE
DATE
DESCRIPTION OF MALFUNCTION
SUMMARY OF RELATED REPAIR
COMMENTS:
______
Tracking Number ____________________
13.1
Page 12 of 13
Addendum A
TRAINING ADDENDUM
Instructions for acceptance and risk assessing equipment.
1. Visually inspect equipment. Check for damage caused in shipping or anything that
will affect the safe operation of the equipment. Insure that all parts are present.
2. Read operators manual. Follow instructions for putting equipment into safe operation.
Complete any warranty and registration forms and send to manufacturer. A copy of
any warranty or registration form and the manufacturers warranty will be attached to
Equipment Acceptance/Assessment Form (EM Form 1).
3. Complete Equipment Acceptance/Assessment From (EM Form 1). Risk assessment
formula is explained within the Bio-Medical/Dental Equipment Management Plan
Policy and Procedures document. Preventative Maintenance cycle information
should be found within the equipment’s operator’s manual. If not, check with the
equipment’s manufacturer for the information. A copy of this form should also be
sent to the appropriate Systems Coordinator, a copy is kept with the Facility Manger
and the original is sent to the master file kept in the Director of Operation’s office.
4. Obtain a tracking number. Tracking numbers should be obtained from the
appropriate Systems Coordinator. Each piece of equipment must be given a separate
tracking number. This number must be written on every form pertaining to this
equipment. It is very important that each piece of equipment be given a tracking
number. All preventative maintenance and equipment histories will reference this
number.
5. Complete and attach the Safety Inspection Label (EM Form 2). The first safety
inspection part of the acceptance/assessment process. Subsequent inspections will be
completed as directed by the Equipment Acceptance/Assessment Form (EM Form 1).
6. Equipment is now ready for use. Insure that the appropriate staff is oriented and
educated per the Bio-Medical/Dental Equipment Management Plan Policy.
13.1
4/94
r3/01
r 9/02
r 4/04
r 4/06
13.1
Page 13 of 13