| If you are the unit manager or finance
| |
| | subject to regular FDA audits and must
|
| controller or unit nurse in charge of the
| |
| | comply with Medical Device Reporting
|
| endoscopy centre, and your endoscope has
| |
| | (MDR) requirements.In recent years, there
|
| been identified with damages,what are
| |
| | have been newer Third Party Repair
|
| your alternatives for repairing it? Where
| |
| | companies called Independent Service
|
| do you send it to for repairs?What is
| |
| | Organisations(ISO).Some ISO's do not work
|
| your most important consideration in
| |
| | independently by themselves but are
|
| undertaking repairs to your endoscopic
| |
| | aligned to the original OEMs' and so
|
| equipment?The endoscopist spends his time
| |
| | become authorized ISO service
|
| on the technical work involving the
| |
| | partners.Some of these OEMs', notably
|
| endoscopy and its various areas of work,
| |
| | Pentax and Fujinon provide their
|
| while the finance controller of a health
| |
| | authorized ISO service partners with
|
| center or hospital holds the purse
| |
| | access to proprietary parts, adhesives,
|
| strings in allocating funds to repair
| |
| | training, and repair manuals. In
|
| equipment. It is very important that both
| |
| | contrast, independent ISO's develop their
|
| the endoscopist and the financial
| |
| | spares and parts through reverse
|
| controller take correlated action to get
| |
| | engineering to make them compatible to
|
| the endoscope repaired and functioning in
| |
| | the original equipment.The complexity of
|
| excellent condition at all times in the
| |
| | the repair will determine the cost of
|
| interest of patient and clinician safety,
| |
| | repair of the endoscope. So the first
|
| and of establishing optimal efficiency,
| |
| | step in locating a repair service center
|
| and in the savings of costs.What then are
| |
| | is to know whether your repair work is a
|
| the centers of repair and maintenance
| |
| | minor repair or a major repair.Negotiated
|
| available for endoscopes?Endoscopes can
| |
| | financial arrangements with repair
|
| be repaired by sending them back to the
| |
| | service centers may be set around
|
| Original Equipment Manufacturers (OEM)
| |
| | fee-for-service, cost-per-procedure and
|
| who provide repairs on all their original
| |
| | capitated service contracts, with the
|
| equipment. For endoscopes, the market in
| |
| | ISOs competing on cost and convenience,
|
| America has been dominated by at least
| |
| | with some providing on-site endoscope
|
| three big OEMs, namely Olympus America
| |
| | replacement during repair.Irrespective of
|
| Inc., Pentax Precision Instrument Corp
| |
| | whether you decide to have the endoscope
|
| and Fujinon Inc. For many years, OEMs
| |
| | repaired by the OEM, or a OEM
|
| consider themselves to be the only
| |
| | authorized-ISO or a third party ISO,
|
| authorized entity to perform repair and
| |
| | patient safety is of prime consideration
|
| refurbishment of their endoscopes, using
| |
| | and must never be compromised. This is
|
| specific proprietary parts, adhesives,
| |
| | your main factor to consider in sending
|
| lubricants, specifications, and repair
| |
| | your endoscopic equipment for
|
| manuals.OEMs must comply with the FDA's
| |
| | repair.Peter Lim is the webmaster of the
|
| Quality System Regulations (QSR).The
| |
| | website "Online Guide To Endoscopes" .
|
| repair and refurbishment process is
| |
| |
|
