Medical Equipment Safety and Regulations

When it comes to medical equipment, there are several regulations and inspections that must be carried out to ensure the equipment is safe and effective for medical use.

These rules and regulations help prevent malfunctions or breakdowns during medical procedures and keep patients protected.

Read on to learn more about medical equipment safety and regulations.

What Is Medical Equipment & Why Is It Important?

What Is Medical Equipment?

Medical equipment consists of different types of devices, tools, machines, or software. Medical equipment is important because it is used to diagnose, treat, and prevent a variety of medical conditions.

Types of Medical Equipment

Each type of medical equipment belongs to a designated category:

• Diagnostic Equipment – Medical imaging machines, patient scales, stethoscopes, dopplers, pulse oximetry, etc.
• Durable Medical Equipment – Wheelchairs, hospital beds, walkers, nebulizers, oxygen-concentrated ventilators, etc.
• Treatment Equipment – Infusion pumps, LASIK surgical machines, medical lasers, surgical clothing, diagnostic scopes, gauze, etc.
• Life Support Equipment – Heart-lung machines, medical ventilators, dialysis machines, incubators, etc.
• Medical Laboratory Equipment – Blood gas analyzers, chemistry analyzers, blood collection supplies, electrolyte analyzers, differential counters, etc.

Benefits and Risks of Using Medical Equipment

The use of medical equipment comes with both benefits and risks. As for benefits, medical equipment is a convenient way to help pinpoint, prevent, and treat different medical diseases. They are also great for research purposes.

That said, medical equipment does have the potential to fail due to technical issues, medical negligence, contamination, flammability, and radiation exposure. That’s why it’s so important that healthcare providers and manufacturers ensure the safety and effectiveness of medical equipment for patients.

What Are the Main Regulations and Standards for Medical Equipment?

1. FDA Authority
   The FDA is the regulatory authority for medical equipment in the United States. Their job is to regulate the firms that import, manufacture, repackage, and relabel medical equipment.
2. FD&C Act
   The FD&C Act (Federal Food, Drug, and Cosmetic Act) is responsible for the regulation of medical devices. This amendment classifies medical equipment into three different categories.

• • Class I
    Class I consists of devices like dental floss or bandages that must follow certain guidelines but do not need premarket approval first.
  • Class II
    Class II consists of devices like cardiac catheters and hearing aids which are approved in a 510(k) process.
  • Class III
    Class III consists of high-risk devices like a pacemaker or deep-brain stimulators.

Processes for Medical Equipment Registration

You must go through a standard process when registering your medical equipment. First, you must pay an annual registration user fee. Then, you will need to electronically submit your registration information.

Your medical equipment will not be registered until you receive an email from the FDA confirming that the process is complete.

The Role of FDA-Recognized Consensus Standards

The FDA-recognized consensus standard confirms that a medical device meets all of the standard requirements for medical use.

• ISO 14971 (Horizontal standard that applies to most medical devices)
• IEC 62304 (Semi-horizontal standard and applies to medical devices that have software)
• IEC 60601-1 (Applies to electronic medical devices)
• ISO 10993 (Semi-horizontal standard that covers medical devices that come in direct contact with patients)

How to Comply With the Regulations and Standards for Medical Equipment

To comply with the regulations and standards for medical equipment, medical professionals should make sure to extensively study the FDA’s rules and regulations.

The classification of your device, where you plan to market it, the components of your device, its interaction with patients, and where the device will be used are all factors that will affect the regulations and standards of your medical equipment.

That said, all medical devices should be registered and listed with the FDA and receive a 510(k) or premarket approval if necessary.

Devices should also be labeled with the proper medical verbiage as directed by the FDA and any medical device that has caused injury or death should be immediately reported to the FDA for investigation.

It’s always important for medical professionals to recycle metals and other devices with recyclable materials and dispose of hazardous wastes properly.

For example, items like catheters and syringes are dangerous to dispose of regularly. Instead, they should be delivered to a professional shredding and destruction company to be destroyed.

Enroll in Our Medical Equipment Technician Program at Erie Institute of Technology

Do you wish to further your knowledge of medical equipment? Starting your career as a medical equipment technician at Erie Institute of Technology might be the right choice for you.

By enrolling in this program, you will have the opportunity to advance in both the medical and technical fields through six terms of installing, troubleshooting, and repairing medical equipment.

Give us a call at (814) 529-7971 or request information today.