Docket Management
Docket: 01D-0514 - Medical Devices; Guidance on Labeling of Reprocessed Single Use Devices
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Mr. Joe Rohling Date/Time 2001-12-21 08:26:03
Organization Wausau Hospital
Category Health Professional

Comments for FDA General
1. General Comments The new requirements for the reprossing of disposable items for single patient use are crazy. There are many non-invasive products that have been reprocessed and used safely for years. I know in my department alone we could save over $10,000.00 per year in plastic products that are now going to landfills. This price does not include disposal costs and effects on the enviroment. Given we are a medium size hospital and there are over 6,200 hospital in the United States, the cost of these regulations could eaisly be estimated to be over $62,000,000.00 per year that health care needs to pay out. Seems kind of crazy when we keep hearing how we have to save money and decrease health care costs, that regulations continue to hinder that process. Think these rules really need to be looked at closely. I know patient safety is important and I agree there need to be some rules and regulations, but lets look closely at what we really want to acheive and save things that are working well.

EC -1