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