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The device Quality System (QS) regulation covers the manufacture, storage (820.150), distribution (820.160) and installation (820.170) of finished devices. For manufacturers and importers, distribution is one of the most important steps in their quality system. After a product is distributed, a manufacturer rarely has direct control over the product or how it is used. Thus, it is important that controls be in place to assure that only correctly labeled, packaged and approved finished devices are distributed and, if necessary, installed.[1]

Parameters

For a clinical engineer, acceptance, initial inspection, or device installation is the initial phase after the device as arrived on site to be installed within the healthcare facility. If a new medical device is going to be installed many factors must be looked at and surveyed prior to installation to include but not limited to:

Structural Requirements

Examples include but are not limited to:

  • Are doorways/hallways tall or wide enough to fit equipment?
  • Will ceiling support weight of equipment?
  • Will wall or floor support weight of equipment?
  • Does equipment room provide adequate lighting?

(HVAC) Requirements

Examples of space include but are not limited to:

  • Does equipment require dedicated Temperature/Humidity ranges?
  • Does equipment require dedicated Air re-circulation (Exchanges per hour)?
  • Does equipment require dedicated exhaust/ventilation duct?
  • Does this unit discharge chemical wastes? If so, review the discharges and equipment design in accordance with health and environmental standards to prevent unwanted discharge of waste.

Electrical Requirements

Examples of electrical include but are not limited to:

  • What type of voltage (AC or DC), amperage, phases (single or three), hertz (50hz or 60hz) is required
  • Does equipment require dedicated or conditioned line power?
  • Does equipment require installation of Uninterrupted power supply?
  • Does room provide adequate lighting?

Plumbing requirements

Examples of electrical include but are not limited to:

  • Does equipment require set range of Hot or Cold water temperatures?
  • Does equipment require its own Air/O2/N2/NO/Vacuum connections?
  • Does equipment require Drainage source?
  • Does room provide adequate lighting?

Networking requirements

Examples of electrical include but are not limited to:

  • Does equipment require telephones, modems and computer networks data lines?
  • Is a manufacturer Disclosure Statement for Medical Device Security (MDS2) available from the manufacturer?
  • Does OEM provide an AE title?
  • Does IT provide IP addresses, Ethernet connectivity, admin Remote Access Accounts, to these medical devices ?

Pre-Purchase requirements

Examples of electrical include but are not limited to:

  • Does equipment require telephones, modems and computer networks data lines?
  • Is Test equipment/tools included in the pre-purchase package?
  • Is biomedical equipment technician and operator training included in the pre-purchase package?
  • Is technical service and repair manuals included in the pre-purchase package?

After installation, final acceptance is performed prior to patient usage to ensure the equipment is safe, reliable, and fully operational.

References

  1. FDA. Medical Device:Storage, Distribution and Installation. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/ucm122681.htm

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