The Source | May 21, 2019

Advice from the Field

Central Sterile Processing Department technicians are far beyond just another hospital employee. The CSPD tech is a critical piece of the patient experience. Their work is critical & every new employee needs to know that even though a patient is not in front of them, a patient’s life is in their hands every time they touch an instrument.

Jessica, NY

Patient Care Director , Central Sterile Processing

Developing a Method: Burton J. Howard, chief of the Bureau of Chemistry's microchemical laboratory, is shown in the right foreground in this photo from the 1920s. Source: www.fda.gov

A Brief History of the FDA and Medical Devices

Author: Michelle Gallagher, CRCST, CIS, CER, CCSVP

The history of the Food and Drugs Administration (FDA) is rich with social, economic, and political changes. Mix in medical devices and I’m on the edge of my seat.  Today, I wanted to share a brief history of the FDA, medical device regulation, and one of the loopholes causing drama and confusion in our industry.

Protecting the Public

Our story begins in 1906 with the enactment of the Pure Food and Drugs Act. The Food and Drugs Administration (FDA), a name officially applied to this federal agency in the 1930s, passed the Pure Food and Drugs Act to ultimately protect consumers from “adulterated and misbranded food and drugs.” Though medical devices were not cited in the 1906 act, it was one of the first legal acts to protect consumers and regulate goods.  

The history of medical devices is quite intricate, beginning in the late 1700s with Dr. Elisha Perkins’ fraudulent patent tractors. Fast forward to 1938 when medical devices were brought under the FDA and then to the 1976 Medical Device Amendments. The 1976 Amendments, led by the Cooper Committee, “defined devices similarly to drugs, but noted that drugs cause a chemical reaction in the body, whereas devices do not. They called for all devices to be divided into classes, with varying amounts of control required in each one.”  This also cited the first time that devices were subject to pre-market review.

Though, at the rate which technology was developing versus safety regulations enacted, it would be almost 20 years before another act was put in place to better protect the public.

A Balancing Act

In 1990, the Safe Medical Devices Act (SMDA) was passed.  The act specifically required “nursing homes, hospitals, and other health care facilities that use medical devices to report to the FDA incidents suggesting that a medical device probably caused or contributed to a patient's death, serious illness, or serious injury.”  In turn, making the device manufacturers responsible to conduct post-market research on implanted devices. Breast implants at the time were causing increased public pressure for the Federal Government to create mandates that better protected the public (see the Mammography Quality Standards Act (MQSA) passed in 1992).

Balance has always been the key determinant for the FDA when enacting laws, protecting the public while fostering innovative, life-saving medical technology.  Which is why I find the following loophole fascinating.

The Loophole

The FDA provides a loophole that manufacturers can use to save time and resources when launching a new product: “Device manufacturers may forgo qualification studies if they can demonstrate that a device being considered represents no greater challenge to the cleaning process than another similar device that has been qualified.”

The manufacturer must still provide reprocessing instructions, but they don’t have to develop and test these instructions to make sure they are effective with the new device because it’s been declared similar enough to another device. Maybe the reprocessing instructions are suitable and successfully clean and sterilize the instruments, but it’s also possible that they don’t, and because no qualification studies have been done, we may not find out until a dire patient outcome points to a contaminated instrument.

Premarket Notifications 510(k) set by the FDA is gaining more coverage and even brought up in a recent Netflix documentary, The Bleeding Edge.

As always, there is work to be done in continuing to protect the public and lucky for us, we have the ability to keep the pulse and enact change.

 

Sources:

Medical Device & Radiological Health Regulations Come of Age

The History of FDA's Fight for Consumer Protection and Public Health

Compliance With the Manufacturer's Instructions for Use

Premarket Notification 510(k)

Mammography Quality Standards Act

Medical Device Reporting (MDR): How to Report Medical Device Problems

CDA FDA Health Advisory: 3 Recommendations [eBook]

We created this eBook to share our recommendations to ensure your facility is:

  • Complying with all steps as directed by the device manufacturers
  • The appropriate policies and procedures are in place and consistent with current standards and guidelines

Meet the Family: Derek Murray

After serving both his country and the public school system for over 25 years, Derek Murray joins the Censis family through music and fellowship.

From Public Schools To Sterile Processing

Hello!  My name is Derek Murray I have the honor of serving as Director of Professional Services for Censis.   

I am a Veteran of the U.S. Air Force and hold my Bachelor of Science degree in Psychology and a Master of Science degree in Leadership from Grand Canyon University.  

Before entering the world of Sterile Processing in 2015, I spent 25 years as an educator and trainer in the public school system.  After working as a Training Specialist, and Manager of Operations for a major medical software company, I joined the Censis family.   

My passion is to equip and empower people with the tools necessary to be their very best self, not only in the workplace but also in the arena of everyday life.  I currently reside in the greater St. Louis area with my extraordinary wife of 35 years, Lasetha.  We have 2 grown daughters and a grandson.  One fun fact about me, I enjoy singing and am a studio recorded artist.  

Just Announced: Three Value-Packed CtUC Sessions 

Small Wins with Big ROI 

In this session, led by Kelly Murray, Director of National Accounts, you’ll take away the tools to apply and test your own ROI tracker from individual instruments to scopes and robotics. 

Handling Loaners

Hear from your peers in these user-led sessions that are product focused on handling loaners in your Censis tracking systems.   

The Product Roadmap 

Presented by Todd Thomas, Chief Technology Officer, you’ll experience the all-new tools and products from hands-free scope processing to tray optimization and more. 

CtUC 2019: Here’s Why You Should Plan to Attend

For almost a decade, we’ve hosted CtUC as a way to support the Healthcare Professionals that depend on our portfolio of products. Hear the first-hand experience of Adele Fini's why you need to be at CtUC 2019 this year!