USA FDA Medical Device Safety – The good and the better

This article brings a positive perspective on medical device recalls. There is good news and event better news. Medical devices are never perfect. Regulators and manufacturers know that. Processes are in place to ensure innovative devices continue to be developed and, when recalls occur, to make them even better. Should these processes be improved? Yes, continuously improved through both setting clear regulatory body expectations, updating manufacturers’ quality management system documentation, and demonstrating leadership that improves public health safety.?

When medical devices are finally introduced into the American consumer market, it is usually a triumphant moment for both developers and target markets for the device. There are numerous recent medical device developments and evolutions that can change the world.

When a firm learns that there is a problem with one of its medical devices, it proposes correction?or removal?depending on where the action takes place.

• Correction?- Addresses a problem with a medical device in the place where it is used or sold.
• Removal -?Addresses a problem with a medical device by removing it from where it is used or sold.

USA Food and Drug Administration (FDA) uses the term “recall” when a manufacturer takes a correction or removal action to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed.

USA FDA Recall Enterprise System (RES)

However, historically many FDA medical devices were not ready for the market but were cleared or approved, hurt patients, and initiated costly and embarrassing recalls. Recent information is shown below. The Recall Enterprise System (RES) is an electronic data system used by FDA recall personnel to submit, update, classify, and terminate recalls.

Recalls are an appropriate alternative method for removing or correcting marketed consumer products, their labeling, or promotional literature that violate the laws administered by the FDA. Recalls afford equal consumer protection but generally are more efficient and timely than formal administrative or civil actions, especially when the product has been widely distributed. Manufacturers or distributors may initiate a recall at any time to fulfill their responsibility to protect public health from products that present a risk of injury or gross deception or are otherwise defective. Firms may also initiate a recall following notification of a problem by the FDA or a state agency in response to a formal request or as ordered by the FDA.

These recall totals by industry type information were presented at The FDA Regulatory Education for Industry (REdI) Annual Conference in July 2021. The best way to discuss medical device safety in the USA is to examine how widespread and entrenched the problem is in the medical industry. The information presented here is public information. It shows just how important it is to the FDA and manufacturers to be transparent; leadership lessons learned over the years. Please refer to the FDA’s Medical Device Recall website to evaluate current, up-to-date information: https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls

Top Root Causes

The top root causes were presented at The FDA Regulatory Education for Industry (REdI) Annual Conference in July 2021. Similarities between medical device therapeutic areas are shown below.

How do so many defective, unfinished, and ineffective medical devices enter the market every year? Some statistics suggest that over 4,500 drug and medical devices are recalled annually in the USA, although that may be a very conservative estimate. It is not the purpose of this article to delve into the many and sundry issues that cause these recalls, but rather to point out, and once a recall happens, the positive activities that regulators and manufacturers are doing in a coordinated fashion. Generally, both share a desire to put safe and effective medical devices on the market.

The medical device industry, worth $456 billion in 2020, is projected to become worth $671 billion by 2027.?

Medical Device Recalls – Some good news; innovation continues

Robin Healthcare

The medical device industry is exceptionally lucrative and provides fantastic career options, and improves patients' lives worldwide. The medical device industry also gives hope. Breakthroughs and discoveries are evolving healthcare and helping patients live longer. The medical device industry is exceptionally lucrative and provides fantastic career options, and improves patients' lives worldwide. The medical device industry also gives hope. Breakthroughs and discoveries are evolving healthcare and helping patients live longer.

Even though medical device recalls occur, some manufacturers like Robin Healthcare are developing innovative medical devices. Scale Venture Partners was recently awarded over $50 million in their seed funding campaigns to develop an A.I. enabled patient monitor. It is called Robin Healthcare, and it is an egg-shaped monitor that can record patients via audio and video whenever medical staff is not around.?Read more at https://www.robinhealthcare.com/

Robin Healthcare will continuously monitor patients and help doctors make more informative examinations and precise diagnoses. There could be a Robin Healthcare monitor or similar A.I.-enabled monitoring device on every patient bedside in a hospital in the coming decades.

USA Food and Drug Administration

The FDA mandates that medical device manufacturers comply with quality management systems to guarantee consistency in their products and comply with any specifications or requirements. In the 1960s and 1970s, the US Congress responded to the public’s desire for more oversight over medical devices by eventually passing the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. To increase product safety, the FDA began regulating medical device manufacturing in 1978. Then, in 1982, the organizational units at the FDA that regulated medical devices and radiation-emitting products merged to form the Center for Devices and Radiological Health (CDRH).??

The FDA has repeatedly delayed aligning its Quality System Regulation (known to many as QSR and found at 21 CFR 820) with ISO 13485 but has indicated it plans to issue proposed regulations in 2021. Since the US and international standards vary, it can make record-keeping and the cost of compliance expensive. Still, the adoption of the international standard could help reduce costs and make it easier for US companies to comply internationally. ?

The FDA recently made a formal announcement that they will be replacing parts of the existing Quality System Regulation (QSR 21 CFR 820) with the international standard ISO 13485:2016. This transition is still in the making and is in the ruling stage.?

In the past decade, there were over 80,000 deaths, 2 million injuries, and billions in lawsuit payouts related to medical device recalls. So, let's discuss the medical device safety crisis and why it could be happening.

Consult with Global Strategic Solutions today to get your medical device developed efficiently and approved.?

Related: The Most Common Manufacturing ISO Standards for Medical Devices

?Medical Device Recalls – Some better news

However, with every medical device triumph, there are also numerous accompanying failures, recalls, and scandals. This is inevitable. When recalls occur, it is just as important to point out benchmark examples of how regulators and manufacturers work together in the interest of public health and safety.

Contact Global Strategic Solutions now to assist with root cause investigations.

Examples of Medical Device Companies that Responded Correctly

Because of the sheer volume of medical devices that large manufacturers have worldwide, the probability of eventually having a recall is 100%. It’s the cost of doing business with innovative devices. Three manufacturers responded quickly and did the right thing for patients and their families. The public does not always know that when a manufacturer finds a serious safety signal, they communicate quickly with regulators and engage in active communications with a desire to do what is best for public health. ?

What the public sees is the headline-making recall announcements and harshly judge manufacturers. Sometimes this is justified. However, being in the pharmaceutical and biotech industry for over 25 years, what I see are manufacturers implementing quality processes to address these concerns quickly. They essentially become positive case studies and best practices within the medical device sector for others to learn from to prevent future health catastrophes and crises.

Vaginal Mesh Recall

In April 2019, the USA Food and Drug Administration made a shocking public statement that sent the medical device industry shockwaves. It made patients question the safety of medical devices they take for granted. ?

The FDA announced that vaginal mesh medical devices, also known as pelvic mesh, were no longer viable and could not be trusted to work as designed effectively or safely. Shortly after that, the FDA officially recalled vaginal mesh medical devices from the market.?

Vaginal mesh medical devices are micro-mesh products designed to keep pelvic organs in their proper place when pelvic muscles weaken due to ailment or age.?

The problem is that vaginal mesh medical devices of all kinds and sold to the public for decades before the 2019 announcement. The defective vaginal mesh caused untold life-altering injuries and 80 officially recorded deaths in 2018. Seven medical device companies have paid over $8 billion to settle over 100,000 lawsuits related to defective vaginal mesh medical devices.

What did regulators and manufacturers learn? First, post-market surveillance (PMS) activities are a must, including post-market clinical follow-up studies following medical device approvals. Although not endorsed by all worldwide, there is a significant emphasis on collecting real-world safety, performance, and clinical data once devices are placed on the market. Second, when recalls occur, a coordinated effort is required to activate a planned, quick approach to protect human health. Finally, review the evidence carefully and, when possible, modify the device to ensure it is safer and improves patients’ lives.

Cook Medical Catheters

In 2016, medical device company Cook Medical initiated a voluntary global recall of over 4.14 million medical catheter units. Over 408,000 of these defective catheters were recalled in the United States alone.?The Cook Medical catheter featuring Beacon? Tip technology was prone to accelerated degradation, fracture, and separation of components once inserted into patients. It was a severe defect that caused the catheter to become useless. ?

Additionally, micro-fragments of fractured catheter components can enter the bloodstream and cause catastrophic health problems.?

Cook Medical’s quality system worked excellently as their procedures required the manufacturer to scope the problem globally. They also to immediate steps to address the issue. ?

Among innovative companies, there is a saying, “The first is the worst.” When problems in medical device design occur, this typically results in redesigning the product to ensure an even safer device is placed on the market. There is always room for improvement with innovative, complicated medical devices, and companies like Cook Medical know that.

Vial2Bag Fluid Transfer Systems

One of the most extensive recalls of medical devices in history occurred in January 2019.?West Pharmaceutical Services recalled almost 39 million of their Vial2Bag fluid transfer units because of unpredictable malfunctioning issues.?

The Vial2Bag fluid transfer system is designed to automatically connect different medication vials to the primary IV therapy unit bag to be mixed before delivering a calculated injection into a patient. ?

Unfortunately, the Vial2Bag fluid transfer system was prone to inadequately transferring the correct amounts of IV medication from bag to bag before mixing. In many cases, malfunctioning Vial2Bag fluid transfer units possibly caused underdosing or overdosing of medication to patients.

Recalls are disruptive for any business, and the total costs cannot always be calculated. It is also a challenge with morale as intelligent, diligent, and caring employees set out with an “all hands on deck” philosophy to address the issue. The external communications from West Pharmaceutical Services represent a model for the medical device sector. Their leadership role in managing a recall is recognized as admirable.

Key Take-Home Messages

FDA CDRH Reviewers are responsible for the classification of the recall. Recalls come from – Complaints, Internal audits, inspection/audits. Mandatory recalls are rare. Class III devices are most likely a Class I recall due to the biggest harm. The number of Class II recalls is the biggest. For example, there usually are 900-1000 recalls per year. In 2020, 850 were Class II. ?

Are the large processes control issues due to outsourcing issues? Not necessarily. Does the FDA need to agree with the manufacturer? The FDA looks at it, speaks with the firm, and asks to provide evidence to agree. ?

Conduct an in-depth root cause. Take bias out and follow the data, and have the right people on the team. Develop criteria for what will be used to determine the effectiveness of the investigation.

Related: What is The Difference Between Quality Control and Quality Assurance?

Conclusion

These are only a few highlighted cases of the millions of defective medical devices that have been recalled over the past decade. According to some statistics, almost 15% of all medical devices approved by the FDA in 2019 ended up being recalled.

Medical device industry critics say that FDA regulatory loopholes need to be closed. Many medical device companies take advantage of loopholes to introduce products to the market that are defective or haven't been tested on humans. It is a dangerous strategy that can hurt patients, leave companies open to legal liability, and ruin reputations.

The USA FDA is taking steps to reorganize the quality system process within the law to align with global standards and expectations (ISO 13485).

Over 6,000 employees from one medical device company lost their jobs when the recall of their product put the company out of business. However, it is too easy to blame medical recalls on the FDA or inadequate regulations. A medical device company needs to own this responsibility and know when its product is ready for application and approval. This starts at the very senior levels of management and continues throughout the organization down to the level of the employee engaged in day-to-day operations.

?Contact Global Strategic Solutions now to get your medical device ready for FDA approval.

?David R Rutledge, Pharm.D., FCCP, FAHA,?President & CEO, Global Strategic Solutions, LLC, Silicon Valley in California.

www.GlobalStrategicSolutions.com +1 (630) 846-0350 cell [email protected]