A Biomedical Service provides quality biomedical services to health-care institutions throughout the United States. With a team of highly skilled and experienced technicians at our disposal, we can handle all kinds of medical equipment, regardless of complexity, so you can focus on your number one priority - your patients!
Some manufacturers get around this requirement by stating that their device or component is not serviceable, such as an ultrasound probe or MRI coil, even though some third parties have found ways to do so. The worst violators, however, are laser manufacturers, who refuse to provide service manuals despite knowing that there is a specific FDA regulation regarding it: 21 CFR 1040.10(h), reproduced below.
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Some manufacturers have also declined to provide service manuals by alleging their need to protect trade secrets, intellectual property, and confidential information. Case in point: Many manufacturers refuse to provide access to proprietary service software (i.e., release the soft-keys).
Training costs, service manuals that instruct the in-house service personnel to send critical equipment to a depot for repair, and service keys that are unobtainable have driven CE costs through the roof. Contracts only provide a known expenditure, not a reduction of expenditure. Hospitals are beginning to realize that shifting costs from capital expenditure to service expenditure is false economy.
I agree that any institution using these medical devices should be able to obtain the needed information to properly service and calibrate the equipment, however there has to be some type of of liability transfer if an institution chooses to perform their own service or farm that service out to a third party. Anytime that their is an incident and someone is harmed, the legal team tries to name everyone, particularity the manufacturer, in the lawsuit along with everone that ever drew a breath of air around said device. be457b7860
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