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.

Recent warnings of mercury found in lotions and formaldehyde detected in hair products have led consumers, regulators and others to question the U.S. Food and Drug Administration’s (FDA) authority over the cosmetics industry.

For the first time in 30 years, legislators are pushing for more regulation of cosmetics, lotions and hair care products. But how far should the FDA’s authority of the cosmetics industry extend?

That question has set off a public debate between large makeup manufacturers and consumer safety advocates.  While the industry is against legislation aimed at further restricting cosmetic companies’ use of certain ingredients and subsequent labels, it does acknowledge that the current regulatory environment needs a “makeover.” The sector wants to make certain that any new government authority does not impose on innovation, compromise trade secrets or needlessly restrict the use of key chemicals used in popular products.

The Personal Care Products Council circulated a bill of its own this spring to curb such threats. It also introduced alternative legislation in response to a more industry-friendly bill presented to Congress last month. The industry-backed bill would require FDA to investigate safety concerns only when petitioned by outside parties. It would also require companies to report facilities, product ingredients and adverse events. But safety advocates argue that the council’s bill would leave FDA’s chronically underfunded cosmetics office in a more compromising position in terms of fulfilling its myriad responsibilities.

One of the three proposed rules will likely be added to the reauthorization of the Prescription Drug User Fee Act program that expires in September. Even with these bills being introduced in an effort to further regulate the industry, consumer groups remain concerned.  Are these efforts enough? Could they further jeopardize the implementation of more aggressive laws? These are the types of questions leaving some wary.

The industry-funded Cosmetic Ingredient Review needs to step up its game. A recent barrage of press surrounding various cosmetic products has left consumers with questions about what they’re really lathering on themselves. This has led FDA to respond to mounting pressure in the name of consumer safety. Cosmetics companies would be wise to address such concerns by implementing industry standards and taking other actions to ensure the safety of their products.

Do you think expanding FDA’s control over the industry will help ban harmful cosmetic products? How do you think the cosmetics industry should respond? 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.

The goal of any recall is to get the product out of the marketplace with zero chance of re-entry and ultimately ensure that safety is the first priority. But once recalled products are collected, where do they go?

Do they eventually end up in the landfill alongside the 250 million tons of trash we produce in the U.S. each year?

Eco-friendly trends have led many consumers, and subsequently businesses, to consider how they can minimize waste. Whether it’s purchasing products that don’t have a lot of packaging, using reusable lunch bags, or recycling, there are many ways in which we can all refrain from throwing away so much trash.

At Stericycle, we admire such efforts and work to curb waste production when managing product recalls.  When permitted by our clients, our company utilizes sustainable business practices that allow for recalled items to be broken down and taken apart. Rather than throwing all of the individual product components away, defective parts can be separated from those that can be reused or recycled.

For instance, Stericycle ExpertSUSTAINABILITY can remove batteries from laptops that were recalled due to a faulty keyboard so they can be reused by the manufacturer.  The ability to categorize materials based on whether they can be re-used or recycled is just one of the many core services offered by our sustainability services group.

While “going green” may seem to be just the latest trend to some, those businesses who do implement environmentally-friendly initiatives certainly experience some perks. It can help you preserve resources, increase your bottom line and lead to positive publicity.

As you celebrate the 42^nd anniversary of Earth Day, take a moment and evaluate your business’ “go green” initiatives.  What changes can you make in the workplace to help maintain the health of the environment? Your thoughts are 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.

The dangers of counterfeit medications have been highlighted recently in the media. Within the past few months, we have seen an uptick in stories describing the discovery of fake drugs available in the U.S. Estimated worldwide sales of counterfeit medicines topped $75 billion last year, up 90 percent since 2005, according to the World Health Organization. Meanwhile, U.S. Customs and Border Protection reported that seizures of imitation meds have tripled in the past two years.

What is leading to this startling rise in counterfeit medications entering the market?

I recently wrote an article for Pharmaceutical Processing discussing this issue and how it is a symptom of something much more concerning – the increasingly complex and vulnerable global pharmaceutical supply chain.

The U.S. has no national system for tracking medications, yet its complex drug supply chain involves a maze of wholesalers and secondary wholesale marketers. Recent drug shortages have exacerbated the counterfeit problem because health providers have had to scramble more to find medications and may turn to new and possibly less-reputable suppliers.

The pharmaceutical industry is responsible for complying with federal regulations and ensuring the safety and quality of medications.  Just one problem within the global product flow can result in adulterated or contaminated products ending up on store shelves. And the reputation a company has worked on building for years can be destroyed in a matter of days.

Pharmaceutical manufacturers are quickly realizing that the ability to detect the physical location of any drug is vital when responding to issues within the fragile supply chain.

For instance, track-and-trace technologies can have a profound impact on a company’s ability to effectively manage a recall event. Consumers are less likely to forgive a business when potentially dangerous products are found in stockrooms months after a recall is announced. The ability to quickly identify specific quantities of product and shipments affected by the issue can save companies a great deal of time and money. Track-and-trace systems also prove beneficial during the notification process of a recall event by making it easy for companies to locate the contact information of affected customers.

It is not mandatory for pharmaceuticals to implement track-and-trace strategies at this time. But that is likely to change. At the federal level, legislation has been introduced in the House of Representatives to create a mandatory bar-code system to trace prescription drugs.

But, if there is anything recent regulatory events have taught us, it is that companies should not sit on their hands and wait for the government to issue mandates. Drug manufacturers should start looking into employing track-and-trace technologies sooner rather than later.

How does your business implement track-and-trace systems? If you currently do not have such a program in place, what is it that’s stopping you? 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.