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