Whether in a hospital, doctor office, university or clinical engineering setting, medical devices and specialty equipment are vital to developing successful procedures and treatments. It’s not just important that healthcare equipment records be properly maintained, it is a legal requirement in certain settings.
It is important to work with an experienced label manufacturer
If your organization adheres to any international quality standards or accreditations (ISO, ANSI/ASQC or JCAHO), properly formatted device calibration and inspection labels are a requirement. To help protect consumers, the FDA requires that healthcare providers and equipment operators document when medical devices have been calibrated and/or inspected. This documentation is usually in the form of a label or tag on a piece of equipment. It needs to be visible to operators and those responsible for calibrating or inspecting the device.
What is Required to Document
- The name of the organization responsible for the equipment maintenance
- Equipment identification, such as a serial number, to ensure certification to the specific equipment
- The date of the calibration or inspection, as well as the date of the next scheduled event
- The person, or individual who performed the calibration/inspection (an area for an I.D. stamp)
Types of Equipment Labels
There are a number of important factors healthcare providers should consider when selecting their equipment labels. To maintain a clean and healthy environment, these labels are likely to be exposed to harsh cleaning solutions and chemicals. ID Labels can be manufactured with a protective laminate flap for durability and security. It is important to work with an experienced label manufacturer that uses high quality materials and adhesives, and designs that have been proven in hospital, biomedical and clinical settings.
Labels and tags can be produced in a wide variety of colors and formats to satisfy a broad range of applications.
- Equipment inspection labels
- Equipment calibration labels
- Preventative maintenance labels
- Void seal labels
- Barcode labels with sequential numbering
- Labels with clear laminated covers
- Safety labels
- Asset tags and I.D. labels
- Labels with logos, graphics and multiple colors.
Properly documenting your equipment via an internationally acceptable label and tag system is critical for adherence to all the relevant worldwide quality standards.
List of Notable Quality Standards
- ISO 9000
- ISO 14000
- ISO/IEC
- ANSI/ASQC Q9001
- 21 CFR211, 21CRF820
- QS 9000
- OSHA
- JCAHO
As a leader in Scientific Equipment Repair and Medical Equipment Calibrations, Scientific Instrument Center works with many corporations, universities, and hospitals providing the highest level of laboratory services. Whether we are providing biosafety cabinet calibration or medical equipment calibration, we keep your equipment performing to industry codes and regulations. Feel free to contact us using our contact form or give us a call at (614) 771-4700
