MadgeTech Blog

What is IQ/OQ/PQ?

Posted on September 17, 2019September 17, 2019 by Kelly

Whether you are running tests in a laboratory, gathering data in the field or operating medical devices on behalf of patients, you must be able to trust that your equipment is consistently performing as intended and that the data is accurate.

Equipment validation, often referred to as IQ/OQ/PQ, provides a way of assessing quality through how the equipment functions and whether it meets requirements. IQ/OQ/PQ services may be required by association, state or federal guidelines depending upon the industry and the supervising regulatory agencies.

Installation Qualification (IQ)

When new equipment and software is received, IQ must be conducted to validate the equipment is producing accurate results and transmitting the data to the workstation where the software is installed. This initial step confirms that the equipment and software has been installed as outlined by the manufacturer and is working properly.

Operational Qualification (OQ)

OQ can only be performed after a successful IQ. During this phase, the equipment is tested to ensure consistently operating as designed and that it’s meeting user requirements. Each component of the system must be individually tested and documented to validate it’s operating as it should

Keep in mind, requalification must be carried out after any maintenance work or modifications to the equipment, and during routine quality assurance audits.

Performance Qualification (PQ)

This final step involves verifying and documenting that the equipment is consistently producing acceptable results under the normal operating conditions. PQ is testing how the equipment works as a system instead of individually. But before PQ begins, a detailed assessment plan must be created based on the process description.

MadgeTech offers on-site IQ/OQ/PQ services to help customers validate their data logger systems. With the help of our expert technicians, this service is a cost-effective way to ensure proper implementation while saving time and minimizing disruptions to staff and operations.

For more information give us a call at (603) 456-2011 or email us at [email protected]

Promedica Turns to MadgeTech for Autoclave Validation

Posted on September 12, 2019September 12, 2019 by Kelly

A leading designer and manufacturer of custom medical devices, Promedica turned to MadgeTech when they needed to validate their autoclave. Read more about their application below.

To read this case study in full, click here.

3 Factors to Consider when Sterilizing Dental Instruments

Posted on September 10, 2019September 10, 2019 by Kelly

Just like any other branch in the health care industry, dentistry is held to strict guidelines set forth by the Centers for Disease Control and Prevention (CDC) and the American Dental Association (ADA). Ensuring the highest level of patient and personnel safety relies on the implementation of an infection control program.

At the center of an infection control program, outlined by the CDC, is the proper sterilization and disinfection of patient-care items and devices. This step is critical to ensure all instruments are free of hazardous bodily fluids and materials. A staple at any dental facility, an autoclave, is utilized to validate sterilization cycles are carried out according to government regulations.

As one might expect, this is a process that must be executed with enormous care, as even a slight procedural lapse can compromise patient health. This includes the regular monitoring of the autoclave to ensure it is operating as expected. According to the CDC and ADA, dental professionals should carefully check three types of indicators when validating the effectiveness of the sterilization process.

Chemical

The use of indicator tapes and other types of chemical indicators can help the technician determine whether the autoclave has reached proper sterilization temperatures. An indicator tape works by changing color if sterilization conditions reach a certain threshold. If the indicator does not respond, it should be assumed that any item being sterilized during that cycle is not sterile. The use of this indicator alone is not a guarantee that sterilization was effective.

Mechanical

It’s important to monitor temperature, pressure, and cycle duration while validating or using an autoclave. To accomplish this, technicians typically use high-quality data loggers. In fact, there are data loggers that are specifically designed for use with autoclaves and provide reporting tools for easy data analysis and confirmation.

Biological

Finally, biological monitoring is important to root out problems with the autoclave and ensure successful sterilization cycles. According to the CDC, an autoclave used in a dental setting should be examined for biological indicators at least once a week. The technician may elect to use spore monitoring strips or resort to a “mail-in” service to check for the presence of harmful microbes.

It’s worth pointing out that, in addition to the above, a dental practice may be subject to state and local regulations that might impose further regulatory obligations. Dental professionals have a responsibility to stay current with any applicable guidelines.