Short Answer 
The Mass General Brigham Medical Equipment Management Program requires medical devices to have multiple labels for safe use, following FDA regulations. There are three main types of FDA labeling‚ÄöAiapproved, promotional, and package-insert‚ÄöAiand effective labeling should include critical information about the device, such as manufacturer details, indications, warnings, and adverse reactions.
Step 1: Understand the Labeling Requirement
The Mass General Brigham Medical Equipment Management Program mandates that each medical device must feature multiple labels. This requirement ensures comprehensive information is available for safe use and management of medical devices.
Step 2: Recognize the Types of FDA Labeling
According to the FDA, there are three primary types of labeling that must be adhered to when it comes to medical devices:
- FDA-approved labeling
- FDA-promotional labeling
- Package-insert labeling
Step 3: Follow the Basic Outline for Device Labeling
Effective medical device labeling should include key information to guide users, such as:
- Manufacturer
- Device Name
- Description
- Indication
- Contraindications
- Warnings and Precautions
- Use in Specific Populations
- Prescription device statement
- Adverse reactions
- Date of issue