FDA’s Tools for Patient Safety Assessment

by | Mar 17, 2021 | FDA, Quality, Regulatory, Safety, Tools

Patient Safety must be at the center point of all operations in the health care industry. Whether it is the manufacturer who is responsible for designing and developing the drug or the device, doctors and nurses administering the drug or the device, or the FDA who is responsible for regulating the use of such products on patients.

March 14th-20th, is celebrated as patient safety awareness week to celebrate everyone involved with providing quality care for patients while keeping them safe and free from harm. On the occasion of Patient Safety Awareness Week, let’s take a look at some of the tools available to the FDA to evaluate the patient safety of drugs and devices and how the FDA uses them to improve patient safety.1

The two mechanisms through which the FDA assesses the safety of drugs or devices on patients is

  • Pre-market review and approval
  • Post-market monitoring

FDA does not develop or routinely test products before granting any type of approval or clearance; however, FDA reviews the results of laboratory, animal, and human clinical tests done by the sponsor companies. Analysis of these test results provides FDA with the assurance that these products are safe for patient’s use.2

Sometimes, there are significant limitations of the pre-market testing performed despite the extensive evaluation of safety and there are residual risks that need to be closely monitored post-market. That is where FDA’s post-market safety monitoring tools are put to use. 2

FDA’s MedWatch program is a platform for reporting serious adverse events and product problems that have an impact on patient safety. FDA uses the data from this source to evaluate any trends, consult with medical practitioners and manufacturers when required, and conduct further epidemiological studies. This allows for evidence-based decision making to improve patient safety.2

In the coming years, there are more tools that the FDA plans on pushing out to protect patient safety such as the expansion of the UDI program, National Evaluation System for Health Technology program, and many more. I am personally looking forward to the expansion and implementation of these programs and to see how it is integrated into the industry.

EMMA International is here to assist you in all of your compliance needs and help you in your path to protect public health. Call us today at +1 248-987-4497 or email us at info@emmainternational.com


1Health.mil (2021) Patient Safety Awareness Week retrieved on 03/14/2021 fromhttps://www.health.mil/Military-Health-Topics/Access-Cost-Quality-and-Safety/Quality-And-Safety-of-Healthcare/Patient-Safety/Calendar-of-Events/Patient-Safety-Awareness-Week-PSAW

2FDA-FDA MedWatch and Patient Safety retrieved on 03/14/2021 from  https://www.fda.gov/media/89040/download

 

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

More Resources

Change Management And Control

Change Management And Control

One of the biggest and most important aspects of quality management is a system to monitor changes and how they impact the product. Change management is an approach for changing processes or products in a way which adheres to regulatory standards by ensuring stability and consistency throughout processes. It applies across all changes within a process and throughout an entire products life cycle.
Aseptic Technique and Gowning

Aseptic Technique and Gowning

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments...
Importance of Pharmaceutical GMP

Importance of Pharmaceutical GMP

Having high quality standards is vital to any organization but is even more essential in the pharmaceutical industry. Practices that are governed by these standards are commonly called Good Manufacturing Practices (GMP) and ensure consistent and controlled production of products. These practices govern all aspects and procedures within production and provide documented proof that procedures are consistently followed during the manufacturing processes every time products are made. They are designed to minimize risks throughout the manufacturing process that are not able to be eliminated in final product testing so that pharmaceuticals are safe for use...

Ready to learn more about working with us?

Pin It on Pinterest

Share This