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Tag: Maintenance


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FDA releases guidance on ‘remanufacturing’ of devices 

May 13, 2024HME News Staff

WASHINGTON – The U.S. Food and Drug Administration has issued final guidance to provide the medical device industry clarity on the definition of “remanufacturing” for reusable devices needing maintenance or repair. The final guidance was issued following the agency’s extensive review of post-market information and consideration of public comments, which highlighted the need for clarity, considering the different regulatory implications between “servicing” and “remanufacturing”...

Maintenance, remanufacturing, Repair


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Smart Talk

Equipment maintenance: Reduce service, 'touches'

June 10, 2020Jim Worrell

Q. What are the best ways to reduce the cost of maintaining equipment? A. Providers of respiratory equipment recognize the significant revenue opportunities that come with this line of business. They also recognize, sometimes with surprise, the equally significant expenses involved with keeping their fleet of respiratory equipment in clean, patient-ready condition. Here are five lessons we have learned in years of working with providers of respiratory equipment. Maintain PM schedules. Much...

Equipment, Jim Worrell, Maintenance, Quality Biomedical


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Smart Talk

Equipment Maintenance: Calculate hidden costs

May 13, 2020Jim Worrell

Q. What are the hidden costs of DIY respiratory equipment service? A. When you think about servicing your ventilators in-house, O2 concentrators and other respiratory equipment, it seems pretty simple and cost-effective. Just hire a few technicians, order the parts, put them to work and voila! You saved the expense of sending your equipment to an outside service provider. When you begin to examine the not-so-obvious expenses related to performing these services, you may decide after all to...

Equipment, Jim Worrell, Maintenance, Quality Biomedical, respiratory equipment


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