SAFE MEDICAL DEVICE ACT POLICY

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SAFE MEDICAL DEVICE ACT POLICY

• CLEVELAND CLINIC
• FOUNDATION

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SMDA 1990

• APPLIES TO ALL
• HOSPITALS
• AMBULATORY SURGICAL FACILITIES
• NURSING HOMES
• HOME HEALTH AGENCIES
• REHABILITATION FACILITIES

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HEALTHCARE FACILITIES MUST

• SUBMIT A WRITTEN REPORT WHENEVER THEY RECEIVE OR
  OTHWISE BECOME AWARE OF INFORMATION ,THAT FROM
  ANY SOURCE, THAT RESONABLY SUGGESTS THAT A DEVICE
  HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO THE
  DEATH OR SERIOUS INJURY.

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WHAT IS A MEDICAL DEVICE

• ANY PRODUCT DEVICE, OR INSTRUMENT OR MACHINE THAT
  IS USED TO DIAGNOSE, TREAT OR PREVENT DISEASE.
• INCLUDING BUT NOT LIMITED TO, IMPLANTS, INFUSION
  PUMPS, CATHETERS,MONITORS, SCOPES AND GAUZE PADS.

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SERIOUS ILLNESS OR INJURY

• ANY EVENT THAT
• IS LIFE THREATENING
• RESULTS IN PERMANENT IMPAIRMENT OF A BODY
  FUNCTION OR DAMAGE TO THE BODY STRUCTURE
• NECESSITATES TIMLEY MEDICAL OR SURGICALINTERVENTIO
  N TO PRECLUDE DAMAGE OR IMPAIRMENT

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REPORTING

• ANY CCF EMPLOYEE SHOULD CALL THE MEDICAL DEVICE
  HOTLINE AT 445-3680
• A RECORDED MESSAGE WILL GIVE SIMPLE INSTRUCTIONS
  TO ENSURE PATIENT SAFETY AND ISOLATE THE DEVICE,
  THE CALLER WILL ALSO BE INSTRUCTED TO LEAVE THE
  DEVICE INTACT, WITH PACKAGING IF POSSIBLE

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• THE CALLER WILL BE INSTRUCTED TO DOCUMENT THE
  EVENT ON THE COMPUTER IN THE PIRS ON THE INTRANET.

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• A PAGER WILL BE ACTIVATED TO CENTRAL SERVICES IN
  THE H BUILDING
• CENTRAL SERVICES WILL CALL THE INDIVIDUAL WITHIN
  ONE HOUR, AND RETRIVE THE DEVICE OR GIVE EXPLICIT
  INSTRUCTIONS TO FACILITATE THE ISOLATION OF THE
  DEVICE

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• FOR OFF CAMPUS LOCATIONS CENTRAL SERVICE WILL
  FACILITATE THE ISOLATION / RETRIEVAL OF THE
  DEVICE
• WHENEVER POSSIBLE ALL DEVICES WILL BE LABELED AND
  SECURED IN CENTRAL SERVICE UNTIL CLINICAL
  ENGINERING OR OTHER DWPARTMENTS CAN INVESTIGATE

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NEVER,NEVER,NEVER

• ALLOW A MANUFACTURER, SALES REPRESENTATIVE OR
  OUTSIDE VENDOR TO TAMPER WITH OR REMOVE THE
  DEVICE FROM THE FACILITY.

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• THE MEDICAL DEVICE HOTLINE NUMBER WILL BE PRINTED
  ON TROUBLE TAGS THAT ARE ALREADY ATTACHED TO
  EQUIPMENT.
• THE SYSTEM PROVIDES FOR 24 HOUR/ 7 DAY A WEEK
  COVERAGE.