Over two and a half million used cars for sale online were subject to unresolved recalls in 2011.

This surprising statistic was announced by Carfax, a popular online resource for automobile information, in a recently released study discussed how ignoring auto recalls can threaten public safety. California, Florida and Texas led the nation with the most used cars for sale with open recalls, each having well over 100,000 last year.

What can the automobile industry and consumers do to stop these potentially unsafe vehicles from being sold online?

In order to keep these potentially hazardous vehicles off our roads, buyers, sellers and owners need to work together. And Carfax has a few suggestions on how to do so.

Auto makers and online sellers should routinely check the National Highway Traffic Safety Administration’s (NHTSA) Safercar.gov website for any incidents concerning vehicles for sale. Reviewing vehicle and maintenance reports is also recommended. Auto manufacturers are currently working with Carfax to further alert consumers about cars that have been recalled for safety issues.

But prospective car buyers should not assume that online retailers are taking that extra step to ensure the safety of their vehicles. Consumers would be smart to double check one of the several available online recall resources before purchasing any vehicles, from an online retailer or other source. It is better to spend a couple of minutes conducting a simple online check for open recalls than to take the chance of putting your family or others on the road in danger.

What do you think about Carfax’s study findings? Will the study’s findings effect your decision to buy used cars? Your comments are most welcome below.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

I will soon have the honor of co-chairing CBI’s Rx and OTC Product Recalls Boot Camp at the Conrad Indianapolis Hotel in Indianapolis.

Over the past seven years, CBI’s Product Recalls Series has continued to attract leading professionals from the biotech, pharmaceutical, and medical device industries as well as distributors, wholesalers, reverse logistics providers, law firms and consulting organizations from around the country.

This year’s Boot Camp, which is scheduled for June 11 and 12, 2012, will focus on preparation and communication strategies for the efficient and compliant execution of product recalls. The two-day event will consist of 13 sessions presented by 15 distinguished speakers from a number of industries.

Attendees will learn about a number of informative topics on the planning, execution and evaluation phases of a recall event, including:

• Preparation Strategies for Managing Global and International Recalls
• Cross-Function Training for Business Teams on Effective Execution of Product Recalls
• Best Practices for Continuous Communication Improvement

Additionally, attendees will also have the opportunity to take a recall logistics tour of Stericycle’s Indianapolis facility and hear from U.S. Food and Drug Administration (FDA) personnel on how to effectively work with local FDA offices during a recall.  The Recall Team Leader of the FDA’s Division of Compliance Management and Operations will also address the agency’s current state on product recalls affecting the life sciences industry.

Registration to the event is still open. Sign up here!

Will you be attending CBI’s Rx and OTC Product Recalls Camp? If so, what sessions are you the most excited about? We welcome your comments below.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

Imports of food and drug products regulated by the U.S. Food and Drug Administration (FDA) have risen 13 percent since 2011. At the same time, foodborne illness outbreaks linked to imported food also appear to have increased between 2009 and 2010.

With a large number of products traveling through intricate international supply chains, what can FDA and other organizations do to ensure product safety?

Currently, FDA is tasked with overseeing 20 million import lines arriving from 300,000 factories in 150 different countries. The agency’s traditional method of periodically inspecting such facilities to ensure product safety is simply impractical, especially given current budget constraints. The agency needs help from outside sources and other regulatory bodies.

Product safety cannot improve without international cooperation.

That is why the Institute of Medicine (IOM) has released a FDA-commissioned study outlining a strategy aimed at bridging gaps that currently affect food and medical product regulatory systems abroad. The report, “Ensuring Safe Foods and Medical Products through Stronger Regulatory Systems Abroad,” highlights 13 specific actions the federal government can take to strengthen such systems.

From pooling data and planning inspections, to creating partnerships that drive improvements in supply chain management, the IOM suggests FDA use enterprise risk management to guide its efforts in the developing world. This entails aggregating risk information across all products to analyze potential threats to consumer safety.

While there are certainly benefits to globalization, it also poses significant challenges to FDA and its ability to ensure the safety of all imported products. The agency has already responded to such issues by working to increase transparency and accountability throughout the supply chain and enhance collaborations with international regulatory counterparts. It will be interesting to see how the FDA responds to the IOM’s recent recommendations.

What do you think of the IOM’s recommendations? How do you believe the FDA will respond? Your comments are most welcome below.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

With 1,200 exhibitors and over 25,000 attendees, the American Meat Institute’s (AMI) 2012 International Meat Poultry and Seafood Industry Convention and Exposition in Dallas, Texas proved to be larger than ever before. This year, the AMI Expo partnered with the Food Marketing Institute’s (FMI) Food Retail Show, United Fresh Produce Association’s United Fresh 2012, and the National Association of State Departments of Agriculture (NASDA)’s U.S. Food Showcase to bring together a diverse group of stakeholders.

From receptions, to meals, to exhibitor-hosted events, the whole industry came together to enjoy all that the AMI Expo had to offer. The two-day event consisted of more than 20 sessions designed to provide attendees real solutions and insight on several topics related to food safety, operation management and consumer trends.

I co-presented a session entitled “Insights from a Recall” with +30 year communications veteran Gene Grabowski, Executive Vice President of Levick Strategic Communications and manager of the firm’s Crisis and Litigation Practice Group.

During our seminar, we provided strategies and solutions for food manufacturers to consider when preparing and executing a recall event. With continued focus on food safety occurring in Washington, effectively managing a recall can make all the difference.

A successful recall response includes both a logistics and communication component.  And establishing a pre-crisis plan can ensure that your company is well prepared for whatever may come. Conducting mock recalls and knowing what information you will need to provide regulators, retailers, and business suppliers will also help recall events run as smoothly and quickly as possible.

Did you attend this year’s AMI International Expo? What sessions did you enjoy the most? How have you prepared your business to respond to a product recall? We welcome your comments below.

Mike Rozembajgier is Vice President of Recalls for Stericycle ExpertRECALL™. Mike is responsible for all aspects of recall service offerings, including development of strategic recall business initiatives, product enhancements, pricing and contracts, and marketing. Rozembajgier has more than 10 years of experience in the healthcare industry. Prior to joining ExpertRECALL he held various management positions at Guidant Corp. (now Boston Scientific) and at Deloitte in the Strategic Consulting practice.

Medical device recalls saw a dramatic 160 percent increase in the first quarter of 2012, according to the first quarterly ExpertRECALL™ Index of 2012.

From alcohol prep pads, to needles, and latex gloves, medical device recalls affected nearly 82 million units, a 508 percent increase over the previous quarter –  a five-quarter high. Joining this rise in recall activity were consumer products. Pharmaceutical recalls and food product recalls declined.

What is the cause behind the recent surge in medical device recalls?

While the quarter-over-quarter increase in medical device recalls may seem surprising at first glance, it should be expected given that recalls documented in fourth quarter 2011 U.S. Food and Drug Administration (FDA) Enforcement Reports were at an unprecedented low.

What is more alarming is the number of companies who are becoming repeat offenders and the large increase of units these recalls are affecting. With more and more Americans relying on these devices to maintain and improve their health and life, companies would be smart to reiterate their number-one priority – consumer and patient safety. Especially given that the media has been paying close attention to medical device safety and scrutinizing the government’s approval process. FDA has even responded to such criticisms by publicly reassuring its dedication to device safety.

The ExpertRECALL Index examines recall trends and issues that affect consumers and manufacturers alike. Additional takeaways from first-quarter findings in the ExpertRECALL Index include:

• 150 million units were recalled by pharmaceutical companies in the first quarter of 2012, recording a five-quarter high.
• First quarter Enforcement Reports saw a 90 percent decrease in the number of units affected by food recalls.
• 35 million units were affected by consumer product recalls across all 15 product categories.
• Recalls of children’s and infant products affected 1.1 million units during the first quarter.

You can read the full ExpertRECALL Index here. What first-quarter findings surprise you the most?  How do you believe FDA will react to the ongoing scrutiny it faces from consumer advocates and the media about its approval process? Your thoughts are most welcome.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

Indianapolis, IN (May 14, 2012) – Medical device recalls increased more than 160 percent in the first quarter of 2012, affecting more than five times as many units than the previous quarter, according to the quarterly ExpertRECALL^TM Index, released today.

Products impacted by the increase include alcohol prep pads, catheters, needles and latex gloves. Consumer product recalls also increased in the first quarter of 2012. Conversely, the ExpertRECALL Index found that pharmaceutical and food recalls decreased compared with previous quarters.

Medical device recalls documented in first quarter U.S. Food and Drug Administration (FDA) Enforcement Reports affected nearly 82 million units, representing a 508 percent increase over the previous quarter and recording a five-quarter high. Additionally, about one-third of companies that faced recalls in the first quarter were involved in more than one recall event – a trend that has continued over the last five recent quarters.

“While the quarter-over-quarter increase in medical device recalls is significant, this change was not all that unexpected given that recalls documented in fourth quarter 2011 Enforcement Reports were at an unprecedented low,” explained Mike Rozembajgier, vice president of recalls at Stericycle ExpertRECALL. “However, what is troublesome is the dramatic increase in units affected by the recalls and continued number of repeat offenders. It’s scary to think about given the increasing number of devices that American patients rely on to maintain and improve their health. Consumer and patient safety should be the number-one priority for every manufacturer, distributor, retailer, doctor’s office and healthcare facility.”

“Companies should be doing everything possible to minimize the safety concerns that would result in recalls,” Rozembajgier said. “Similarly, any business or individual within a supply chain, whether a distributor or a doctor, should keep close tabs on the products they handle to ensure that potential safety concerns are identified early and reported to the manufacturer and the regulatory agency. This due diligence ensures that the impact of recalls, when they do happen, is minimized. Ultimately fewer units, and thus fewer consumers, will be affected.”

The ExpertRECALL Index also found that while pharmaceutical recalls hit a five-quarter low, the recalls documented in FDA Enforcement Reports affected more units than in the previous four quarters. Of the recalls documented, 20 percent affected over-the-counter drugs while 80 percent affected prescription medications.

Consumer product recalls initiated at the request of the Consumer Product Safety Commission (CPSC) increased 24 percent quarter-over-quarter with fire hazards as the leading cause of recalls. While the consumer product category overall logged more recalls compared with the previous quarter, recalls of children’s products reached a five-quarter low and accounted for just 13 percent of CPSC recalls.

Food recalls documented in first quarter FDA Enforcement Reports decreased 19 percent. Of first quarter recalls, 56 percent earned the FDA’s most severe “Class I” designation.

The 2012 first-quarter ExpertRECALL Index is the only report that aggregates and tracks cumulative recall data from the CPSC and the FDA. Stericycle ExpertRECALL compiles the ExpertRECALL Index from data issued by the U.S. Food and Drug Administration and the Consumer Product Safety Commission. The ExpertRECALL Index report is available online at http://www.expertrecall.com/recallindex.

About Stericycle ExpertRECALL™

Stericycle ExpertRECALL^TM is the industry leader in managing consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. Stericycle ExpertRECALL streamlines the entire product recall process and manages Notification & Response, Processing & Tracking, and Compliance & Reporting for a variety of companies. For more information, visit http://www.expertrecall.com.

Contact:

Angie Puthoff
Senior Marketing Communications Manager
(317) 275-7562
aputhoff@stericycle.com

In light of the increased competition pharmaceutical and medical device manufacturers are facing in the marketplace, more of these companies are looking to contract manufacturing organizations (CMOs) for help.

In fact, a recent industry survey found that a typical U.S. manufacturing company depends on over 35 different CMOs to help cut costs and keep up with consumer demand. This add-on can lead to complex supply chains and significant business risks.

How could this upward trend in CMO reliance affect recall liability?

I recently wrote an article for Pharmaceutical Processing discussing the increased burden pharmaceutical and medical device manufacturers are now placing on contract manufacturers when a recall is announced. I have spoken with several CMOs whose customers are requiring they take all the necessary steps needed to effectively mitigate recall risks for all parties involved.  One company at a recent AdvaMed event even stated that it puts full product recall responsibility on its CMOs, leaving it up to them to negotiate other terms.

The U.S. Food and Drug Administration (FDA) has proposed legislation that would place more liability on pharmaceutical companies for the actions of CMOs. While the legislation has not been passed to date, it could lead to more of a burden on CMOs during a recall event.

Regardless of whether a CMO is required by its customers to take the necessary steps to diminish recall risks, every company should take pre-incident planning seriously.  Two very important steps contract manufacturers should already be taking is to invest in recall insurance and develop effective recall plans. Maintaining a transparent working relationship can also help ensure that a recall event is managed efficiently and ultimately protect your bottom line and reputation.

Are you surprised that the majority of U.S. manufacturers depend on over 35 different CMOs? What steps are you requiring CMOs to take to mitigate risks related to recalls? We welcome your thoughts below.

Mike Rozembajgier is Vice President of Recalls for Stericycle ExpertRECALL™. Mike is responsible for all aspects of recall service offerings, including development of strategic recall business initiatives, product enhancements, pricing and contracts, and marketing. Rozembajgier has more than 10 years of experience in the healthcare industry. Prior to joining ExpertRECALL he held various management positions at Guidant Corp. (now Boston Scientific) and at Deloitte in the Strategic Consulting practice.

Throughout George W. Bush’s presidency, the U.S. Food and Drug Administration (FDA) was on a short leash. His strong relationship with the pharmaceutical industry and close supervision over the agency led many to argue that FDA decisions were not being made based on science, but politics.

Is history repeating itself?

The election of President Barack Obama in 2008 led many of the FDA’s staff to believe it would restore the agency’s independence. But a series of disputes between FDA and White House officials have escalated within the past four years. Fights over the regulation of sunscreen, asthma inhalers and other issues affecting the marketplace have left some agency employees disillusioned.

Consumer advocates have joined FDA in expressing their frustrations over the Obama administration’s “overly cautious” attitude towards approving regulations affecting food and medical devices. They believe that Obama is merely attempting to avoid Republican attacks. On the other hand, consumer groups have also applauded the White House for increasing the FDA’s budget for Fiscal Year 2013, as the agency has been underfunded and understaffed although it regulates 80% of the nation’s food, drugs, vaccines and medical devices.

As the presidential election nears, President Obama is keeping a watchful eye on how his administration’s decisions are being publicly perceived, including criticisms related to his “overzealous” regulations. Many view the President’s recent actions towards FDA as a strategic reaction to Republicans’ attempts to paint Obama as a “job-killer” and a “nanny-state champion.”  Some experts even argue that continued politicization may hurt industry profits and consumer protection.

But both White House officials and FDA are quick to note that their disagreements are just part of a normal give-and-take process over policy. FDA Commissioner Dr. Margaret A. Hamburg states that the agency “will continue to work with our colleagues at the White House and across government to protect and promote the health of all Americans.” While debates can be healthy when it comes to important policy decisions, they should not deter from the goal of protecting public safety.

How do you think the election year has impacted President Obama’s response to proposed FDA regulation? Do you think that this politicization could impact the global perception of FDA? We welcome your comments below.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

One of my colleagues recently attended the 2012 biennial Conference for Food Protection held in Indianapolis, Indiana.

Since 1971, this event has brought together food safety experts, federal regulators, industry representatives, professional organizations academia and consumers from around the country to work together towards enhancing our nation’s food safety efforts. The conference serves as a platform to voice recommendations and develop practices that provide resolutions to some of the most pressing problems affecting the supply chain.

In recent years, the U.S. has made strides towards increasing food safety initiatives with the passage of the U.S. Food Safety Modernization Act (FSMA). But recent stories of foodborne illness outbreaks and an uptick in food recalls announced during the end of last year, means there is still more work to be done.

This year’s conference included a workshop that centered around the lessons industry representatives and regulators should take away from the recent Norovirus outbreak that sickened nearly 500 people aboard a cruise ship. It served as a great reminder that prevention and response methods are key to successfully managing foodborne illness events and product recalls.

Companies need to be prepared to effectively respond to recalls, illness outbreaks and other product safety risks. This means keeping up with the changing regulatory environment, updating recall procedures, and utilizing new technologies aimed at monitoring the supply chain.

If you attended the Conference for Food Protection, did you find it insightful? Are there any changes to your recall plans you will implement as a result? What were the main points you took away from the event? We welcome your comments below.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.

One year after recalling dirt bikes, Baja Motorsports has found its name back in the news again.

Under the request of the U.S. Consumer Product Safety Commission (CPSC), the company re-announced a March 2011 recall after learning of ten incidents that occurred following the initial notice. The faulty bike’s fuel tank can leak and pose the risk of a fire or burn injuries to consumers. The new announcement even asks those consumers who participated in the first recall to contact the company to see if a new repair is required.

Where do you think the breakdown in Baja Motorsports’ recall management happened?

While we do not know what steps Baja Motorsports took in executing their recall last year, or what measures were used to determine recall effectiveness, we do know that it didn’t work.

Recalls are time consuming, costly, and painful experiences for any organization. That’s why the planning, execution and evaluation phases of a recall are so important. They must be completed in a timely manner and in full cooperation with the regulatory agencies involved.

Baja Motorsports is a prime example of how failing to effectively manage a recall can have a catastrophic effect on a company. Businesses that have to re-issue recalls and start the process over again must endure the cost and pain of managing the event once more, including unwanted publicity. Not to mention the negative impact recalls can have on a company’s reputation.

At Stericycle ExpertRecall™ we focus on protecting people and reducing risk.  All manufacturers, distributors and retailers should do the same. Despite a company’s best efforts to design, produce and sell safe and reliable products, the possibility of defective items reaching consumers always exists. The very survival of your company may depend on how well and quickly you respond to that first notice that there’s a potential problem. And attempting to manage a recall without adequate planning can prove costly.

What steps does your company take in planning for managing a potential recall? How would you handle having to re-issue a recall announcement? Your thoughts are most welcome.

Stericycle ExpertRECALL™ is the industry leader in recall logistics and regulatory compliance for consumer product, pharmaceutical, medical device, juvenile product, and food and beverage recalls. ExpertRECALL’s professionals are experts in recall management who can help you streamline the entire product recall process.