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