A critical reprocessed single-use device is a type of medical device that has been previously used and then reprocessed for reuse. According to federal law, this device is specifically designed to come into contact with normally sterile tissues or body spaces during its operation. The reprocessing ensures that the device is cleaned and sterilized to meet safety standards before being used again.
This term is primarily used in the medical and regulatory fields, particularly concerning the safety and efficacy of medical devices. It falls under the jurisdiction of the Food and Drug Administration (FDA) and is relevant in areas such as healthcare compliance and medical device regulation. Legal professionals may encounter this term when dealing with cases involving medical malpractice, product liability, or healthcare regulations.
Users can manage certain aspects of compliance or documentation related to critical reprocessed single-use devices using legal templates available through US Legal Forms, which are designed by experienced attorneys.
Here are a couple of examples of abatement:
Example 1: A surgical scalpel that is used in an operation, cleaned, sterilized, and then reused in another surgery qualifies as a critical reprocessed single-use device.
Example 2: A catheter that is designed for single use but is reprocessed and used again in a different patient, provided it meets safety standards, is also considered a critical reprocessed single-use device.
The primary statute governing critical reprocessed single-use devices is found in the Federal Food, Drug, and Cosmetic Act, specifically under 21 USCS § 321 (mm) (1). This statute defines the term and outlines the necessary safety requirements for reprocessing such devices.
| Term | Definition | Difference |
|---|---|---|
| Single-use device | A device intended for one-time use only. | Critical reprocessed single-use devices are reused after proper reprocessing. |
| Reprocessed device | A device that has been cleaned and sterilized for reuse. | Critical reprocessed devices specifically contact sterile tissues. |
If you are involved in the use or management of critical reprocessed single-use devices, ensure compliance with FDA regulations. You may want to consult legal resources or templates available through US Legal Forms to assist with documentation and compliance. If you face complex legal issues, seeking professional legal advice is recommended.
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| Attribute | Details |
|---|---|
| Regulating Body | Food and Drug Administration (FDA) |
| Primary Law | 21 USCS § 321 (mm) (1) |
| Reprocessing Standards | Must meet FDA safety and effectiveness guidelines |
It is a medical device that has been used once, cleaned, and sterilized for reuse, specifically designed to contact sterile tissues.