Can device manufacturers withhold documentation?

Joint Commission EC 01/01.01 EP 3 (2018)

May 8, 2018

"The hospital has a library of information regarding inspection, testing, and
maintenance of its equipment and systems.
Note: This library includes manuals, procedures provided by manufacturers,
technical bulletins, and other information."

NFPA 99-2012

10.5.3 Servicing and Maintenance of Equipment The manufacturer of the appliance shall furnish documents containing at least a technical description, instructions for use, and a means of contacting the manufacturer. The documents specified in shall include the following, where applicable:

  1. Illustrations that show the location of controls
  2. Explanation of the function of each control
  3. Illustrations of proper connection to the patient or other equipment, or both
  4. Step-by-step procedures for testing and proper use of the appliance
  5. Safety considerations in use and servicing of the appliance
  6. Precautions to be taken if the appliance is used on a patient simultaneously with other electric appliances
  7. Schematics, wiring diagrams, mechanical layouts, parts lists and other pertinent data for the appliance
  8. Instructions for cleaning, disinfection, or sterilization
  9. Utility supply requirements (electric, gas, ventilation, heating, cooling, and so forth)
  10. Explanation of figures, symbols and abbreviations on the appliance
  11. Technical performance specifications
  12. Instructions for unpacking, inspection, installation, adjustment and alignment
  13. Preventive and corrective maintenance, inspection and repair procedures.

10.5.6 Record keeping – Patient Care Appliances Instruction Manuals Instruction and maintenance manuals shall be accessible to the group responsible for the maintenance of the appliance Instruction and user maintenance manuals shall be accessible to the user Any safety labels and condensed operating instructions on an appliance shall be maintained in legible condition.* Documentation A record shall be maintained of the tests required by this chapter and associated repairs or modifications. At a minimum, the record shall contain all of the following:

  1. Date
  2. Unique identification of the equipment tested
  3. Indication of which items have met or have failed to meet the performance requirements Section 10.2 Records Retention. The records shall be maintained and kept for a period of time in accordance with a health care facility’s record retention policy.

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