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 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 priorto 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 – Defibulators10
  • Surgical and Intensive Care– Oxygen Autoclave Nitrous09
  • Physical Therapy and Treatment – none on site08`````

Diagnostic

  • Surgical and Intensive Care Monitoring - EKG07
  • Additional Physiological Monitoring and Diagnostic 06

Pulse Oximeter, X-Ray, and Mammography``

Analytical

  • Analytical Laboratory

Hgb A1C, Glucometers Thermometers05

Audiometer Titmus Microscopes,

Tympanogram Spirmoter, Hemocue

  • Laboratory Accessories 04
  • Computer and Related 03

Miscellaneous

  • Patient Related and Other –Scales, Blood Pressure Units,02
  • Non-Patient Related 01

Copiers, Refrigerators, Space Heaters,

Dental Chairs, Electric tables, Amalgamators,

Ultrasound Cleaner Lights

Physical Risk:

  • Patient Death05
  • Patient or Operator Injury04
  • Inappropriate Therapy or Misdiagnosis03
  • No Significant Risks01

Maintenance Requirement:

  • Extensive05
  • Above Average04
  • Average03
  • Below Average02
  • Minimal01

Equipment Incidents and Inherent Risks:

  • Very High Inherent Risks05
  • High Inherent Risks04
  • Average Inherent Risks03
  • Minimal Risks02
  • No Significant Risks01

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 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.

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 ofproblems 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

  • 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.

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.

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ATTACHMENTS
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)[]

Operator Manual Location:

PM Cycle:[] Weekly[] Bi-Weekly[] Monthly

[] Quarterly[] Semi Annual[] Annual

Purchase Date:

Outside Service Contract:

Inspection Conducted By:

Reports Noted: Date:

Director of Operations

Tracking Number ______

PM will be done by ______

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SAFETY INSPECTION
Serial No ______

Test Date ______By ______

Pass ______Fail ______

EM Form 2

TRACKING NUMBER ______

EM Form 2

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 ______

SUMMARY/HISTORY OF EQUIPMENT MALFUNCTION & MAINTENANCE

DATE / DESCRIPTION OF MALFUNCTION / SUMMARY OF RELATED REPAIR

COMMENTS:

______

Tracking Number ______

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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.

  1. 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.
  1. 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).
  1. Equipment is now ready for use. Insure that the appropriate staff is oriented and educated per the Bio-Medical/Dental Equipment Management Plan Policy.

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r 9/02

r 4/04

r 4/06

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