Most Americans assume that medical devices implanted in tens of millions of patients each year are federally tested for safety and effectiveness before reaching the market.

But a new Consumer Reports investigation says otherwise. The magazine’s probe into the government’s regulatory process found that in most cases implants and other high-risk devices brought to market aren’t tested by the U.S. Food and Drug Administration (FDA) prior to approval.

In order to develop a comprehensive understanding of current approval procedures and how they impact device safety, Consumer Reports interviewed doctors and patients, conducted an analysis of medical research and reviewed an FDA device-safety database. The investigation concluded that there is currently no systematic way for the government, researchers or even patients to identify or learn about problem devices.

So what can FDA do to better ensure medical devices are safe for patients?

Consumers Union, the advocacy arm of Consumer Reports, proposed several recommendations for FDA to consider. Among its suggestions are to create a “unique identifier system” and national registries that would allow the FDA to notify patients quickly about recalls and potential safety problems.

Consumers Union calls for more stringent approval procedures. But the group still does not go as far as last year’s Institute of Medicine (IOM) report. IOM called for a complete overhaul of FDA’s device regulatory system, which was met with severe backlash from the industry. As a result, Congress is currently debating a new law that would keep the present system intact, however it would create an agreement between FDA and industry to approve devices even faster.

FDA has responded to Consumers Union’s recommendations by reassuring the public that it’s taking a hard look at medical device safety. It’s now working on a new national surveillance program aimed at providing more information about devices once they are on the market and in use by patients.

Reports on the safety of medical devices, like the one released from Consumers Union, are nothing new. However, it has led FDA to take steps toward reviewing its current practices. Medical device makers should take careful note of how the FDA responds to such calls for action and be aware of how that may change the current approval process.

Are more stringent requirements for medical device manufacturers on the horizon? Should we expect FDA to take additional steps to ensure the safety of medical devices are safe? Your comments are welcomed 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.

More than four years after a new law required a barcode-like system to track medical devices, nothing has changed. So what’s the holdup?

President Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAA) in September, 2007. This ground-breaking act not only represented a significant change to the federal agency’s regulatory authority, but also proposed the creation of an international Unique Device Identification (UDI) System.

The UDI system aims to streamline the increasingly complex global supply chain and improve the medical device recall process. It requires all devices to bear a unique identifier, much like a barcode used on food products at supermarkets. After years of taking input from device regulators around the world and listening to specific questions and concerns from the industry, the FDA sent its UDI model to the Office of Management and Budget (OMB) in July 2011. It’s languished there ever since.

Not surprisingly, many industry representatives, health care providers and consumer groups believe the creation of a system aimed at improving detection of potentially unsafe devices is long overdue. Both the pharmaceutical and food industries currently have a uniform labeling system in place, making it that much easier to quickly track down problematic products. But without the UDI system, managing a medical device recall today remains a complicated and slow process.

The UDI program has the potential to save manufacturers time and money. The medical device and healthcare industries need to continue pushing FDA and OMB for its approval.

What’s your opinion of the proposed Unique Device Identification System? What do you think has caused the long-term delay in the OMB’s review of the proposal? We invite 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.

From congressional watchdog reports urging reform, to the medical device industry’s concern over delayed market entry, the FDA’s 510(k) review process is under fire again.

House Democrats have introduced a bill to close a provision in the fast-track approval process they say is putting consumers at risk. Under the existing premarket notification process, a medical device can win approval even if its design is similar to that of a product that has been previously recalled. The proposed Safety of Untested & New Devices Act of 2012 (SOUND Devices Act) would authorize the FDA to block this type of premarket clearance and require the FDA to determine whether previously-approved devices had recalls in their “device lineage,” the family tree from which the device originates.

In a statement announcing the proposed legislation, Rep. Edward Markey (D-Mass.) cites the case of transvaginal mesh implants, which were cleared by the 510(k) system without undergoing human testing. Those implants were later found to be defective and were recalled in 1999.

But while attractive in theory, proposals calling for recalls of medical devices based on previous recalls of other products would be difficult to implement and likely have little impact on device safety. In fact, the overwhelming majority of device recalls are attributable to manufacturing issues, not design flaws. Asking a sponsor to explore such issues simply adds an additional administrative burden and may not provide a full picture of recall details. Alternatively, simply disqualifying a device based on a prior recall of another product may substantially overstate the risk that the recall actually represented.

The FDA already employs a much better strategy. The agency now monitors device recalls across multiple products, identifies potential issues, and raise questions when sponsors seek clearance of new products with similar characteristics. Initiating the kind of change advocated by the proposed SOUND Devices Act would complicate matters without adding to consumer protection.

What are your thoughts on the proposed SOUND Devices Act? Do you believe the bill is too far-reaching? How would the legislation affect your business if passed? Let us know your thoughts below.

John J. Smith’s practice focuses on assisting medical device companies in addressing U.S. Food and Drug Administration (FDA) regulatory issues. You may contact him at (202) 637-3638 or john.smith@hoganlovells.com.

The Food and Drug Administration’s (FDA) 510(k) review process continues to face scrutiny due to its failure in regulatory oversight of medical device software, which has caused hundreds of deaths in the past several years according to a recent Los Angeles Times article.

Under the FDA’s 510(k) process, approximately 70 percent of medical devices that have been recalled since 2005 were originally approved for sale. This number illustrates a primary source of concern for both manufacturers and patients. Certain groups, including critics of the FDA and concerned patients, believe that the high percentage of recalls signals an indisputable need to reevaluate the current 510(k) process in order to prevent malfunctions that could lead to patient complications or death. Medical device software manufacturers, however, believe these reforms will impede their progress in the race to improve and evolve medical technology.

While claims by manufacturers on the potential impediment of innovation may bear some truth, those pushing for reform maintain the belief that device and software safety take priority over technological innovation. As debates continue on whether the review process needs to be reformed, manufacturers should be prepared for any potential lapses in the FDA’s oversight in order to effectively mitigate any future product recalls.

According to The Los Angeles Times, these medical software issues are now the third-leading cause for recalls of medical devices.  As this figure grows, so does the level of concern regarding patient safety and best practice models. The article notes that “the medical devices industry has been criticized for not adopting standard practices for developing and screening software before products go to market.” Without a system or standard practice to safeguard the industry, reform proponents argue, fatalities and risks of malfunction threaten to persist.

The Institute of Medicine recently critiqued the current 510(k) process and recommended that the agency “develop procedures to ensure safety and effectiveness of device software.” These procedures could prevent a wide range of software problems, both big and small. In spite of the increased attention and public pressure, the FDA asserts that “even within the accelerated process, it requires manufacturers to demonstrate that the products are safe and effective before marketing them and that they follow good manufacturing practices.”

Bakul Patel, FDA policy advisor explains that FDA officials recognize the validity of the issues that the Institute of Medicine Report raises. “We want to do the right thing…we understand that technology is growing,” said Patel, adding that the agency is currently awaiting feedback from its public meeting regarding the report on September 15.

While patients should remain aware of any pending issues regarding medical device software as well as the ongoing policy debates between proponents of reform and industry experts, responsibility chiefly rests with medical device software manufacturers. It is up to those companies to ensure that their products meet the highest safety standards. In the event that questions remain as to a particular products vulnerability to faulty defects, it is imperative that manufacturers are prepared with a comprehensive recall management plan.

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.

A new Institute of Medicine report scheduled for release Friday is already receiving pushback from the medical device industry, according to a recent New York Times article.

The report, commissioned by the Food and Drug Administration (FDA), will likely propose tougher regulations for the FDA’s 510(k) approval process, under which 70 percent of the medical devices that have been recalled since 2005 were originally approved for sale. Devices approved through the 510(k) process that were later recalled include hip implants and joint replacements.

Meanwhile, device manufacturers have been busy producing their own reports claiming that any increase in regulation will slow the industry’s rate of innovation and possibly harm patients. Last month, the pro-business Washington Legal Foundation filed a petition with the FDA arguing that the  agency was legally barred from incorporating any of the report’s recommendations because the panel that produced was biased. According to the petition, the panel lacked industry officials, representatives from the investment community, and patients who had benefitted from the devices. In an interview with the Times, Richard A. Samp, a lawyer for the legal foundation, said “We wanted to let the FDA know that there were significant concerns with the composition of the committee”

The 510(k) process has previously come under fire for being both inadequate and lacking industry support. This past June, the Government Accountability Office released a report criticizing the FDA for its failure to efficiently regulate the medical device industry. As detailed by ExpertINSIGHTS, the report was highly critical of the FDA’s lack of a comprehensive recall management strategy for faulty and unsafe medical devices. The report recommended that that FDA create a program to routinely and systematically assess medical device recall information in order to proactively identify strategies for mitigating the health risks associated with recalled products.

An industry wide survey conducted by Northwestern University earlier this year found a serious lack of confidence in the 510(k) review process. Among the survey’s findings, two-thirds of industry representatives said they planned on seeking European clearance for their products before entering U.S. markets. Only eight percent of those surveyed cited the 510(k) process as the most predictable regulatory system available.

This latest criticism of the 510(k) process is likely to carry greater weight with the FDA since it seeks out new ways to revamp and update its approval process and recall management strategies. Speaking with the Times, the FDA’s chief scientist, Dr. William Maisel,  said that although the FDA is not required to accept the report’s recommendations, “it would be difficult to find a more reputable scientific organization than the Institute of Medicine.”

As both the medical device industry and the FDA react to the Institute of Medicine report, medical device manufacturers, retailers and patients should keep an eye out for further updates to the approval process and how they might affect the FDA’s recall management strategies.

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.

A new Government Accountability Office report (GAO) on the Food and Drug Administration’s (FDA) oversight of the medical device industry’s recall management process finds that the agency is failing to efficiently regulate the medical device industry. While the FDA oversees recalls of about 700 devices each year, the GAO report notes that the consumer agency could do a lot more to effectively assess whether those recalls have been effective.

The report is critical of the FDA’s lack of a comprehensive recall management strategy. Investigators argue that the FDA could do more with the data it collects from completed and ongoing recalls. According to the report, “more routine analysis of these data could help the FDA identify trends in the numbers and types of devices being recalled, as well as the underlying causes of device recalls.”

The vast majority of the recalls examined were of products approved through the FDA’s fast-tracked 510(k) approval process. The 510(k) process has been criticized by patient safety groups who are concerned over the speed and reliability of the review process, as well as by the medical device industry which considers the process to be inconsistent and unpredictable. A Northwestern University study of the 510(k) process notes that two-thirds of industry representatives surveyed are now planning to enter European markets before they come to the U.S., primarily because of the unpredictability associated with the fast-tracked FDA review. Over the past six years, 70 percent of all medical devices recalled were subject to the 510(k) approval process.

Among the recommendations in the GAO report are creating a program to routinely and systematically assess medical device recall information. The GAO suggests that this information would help the agency proactively identify strategies for mitigating the health risks associated with recalled products. Sen. Chuck Grassley (D-IA) echoed those recommendations in a news release issued after the release of the GAO report. According to Sen. Grassley, “Right now, it looks like the FDA is missing an opportunity to proactively identify and address risks presented by unsafe devices.  Doing so would establish greater accountability for patients.”

The GAO report goes on to recommend that the FDA enhance its oversight process by clarifying procedures for conducting medical device recall audit checks, developing explicit criteria for assessing whether firms have effectively managed the recall process, and documenting the agency’s rationale for closing out recalls.

As the FDA and concerned legislators continue to review and address the recommendations in the GAO report, medical device manufacturers should be getting ready to provide convincing documentation that their recalls are effective. Just as the FDA will be looking to analyze and assess past recalls to determine best practices, your company can learn from your own past recalls, and those of your competitors, just what recall management techniques work best. Now is the time to prepare your recall management team and test your recall plans so that you are ready when you suddenly have to initiate a recall.

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.

Here on ExpertINSIGHTS recently we have discussed concerns about the Food and Drug Administration’s 510(k) approval process, including reports that since 2005 fully 70 percent of recalled medical devices had been approved through this fast track process. Not surprisingly, the process has come under fire from safety advocates, academics, and lawmakers alike. In light of this growing criticism, medical device manufacturers should be ready to provide convincing documentation that their devices are safe. And there is no time like the present to prepare your recall management team and test your recall plan just in case yiou do need to initiate a recall.

According to an industry-wide survey conducted by Northwestern University, only eight percent of respondents believe that the 510(k) review process for medical devices sold in the U.S., is the most predictable regulatory system available. Two-thirds cited the European system as the most predictable. As a result, many are now seeking European clearance for their products before trying to enter the U.S. market.

This is hardly surprising given that some 98 percent of those surveyed consider the predictability of regulatory requirements to be a critical factor in deciding where to invest in new product development. In a recent InHealth press release detailing the Northwestern survey, lead project researcher John Linehan, PhD, notes that “as the FDA considers regulatory revisions, what’s at stake is the ability of companies to attract investors in order to continue developing innovative, life-saving products and sustaining American competitiveness in the global marketplace.”

The Northwestern survey clearly shows that unclear guidelines, inconsistent implementation, and regulatory unpredictability are resulting in a lack of trust and a weakened regulatory system in the U.S. According to the survey, there is a growing crisis of confidence in the FDA’s overall ability to properly regulate the medical device industry.

The 510(k) process, which requires a manufacturer to provide only minimal data on safety and effectiveness in order to receive approval to manufacture and sell a device, has been positioned by some as the leading cause of this lack of confidence in the FDA. The many problems cited by industry professionals suggest that changes in the 510(k) process are necessary if the U.S. is to remain a key driver of innovation and bearer of high quality safety standards in high tech industries, such as medical devices.

All this is just another indication that the regulatory environment for consumer products of all kinds – from pharmaceuticals and medical devices to food and consumer products – is changing. Regulators, manufacturers and retailers alike are under increasing scrutiny from nervous regulators and concerned lawmakers looking to protect their constituents. In such an unpredictable regulatory environment, you would be wise to keep a close eye on changing regulations and prepare for the worst-case scenario.

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 U.S. Food and Drug Administration (FDA) may be next on the product safety hot seat. The Government Accountability Office (GAO) recently issued a report that found that some “high-risk” medical devices, including heart defibrillators and hip implants, have been approved for sale without being subject to the agency’s usual stringent oversight procedures. The FDA is also facing criticism over how it oversees recall management of defective devices. When the FDA is criticized for failing to appropriately manage recalls, you can expect that scrutiny to be quickly passed on to you as the manufacturer.

A GAO official in April discussed the Office’s findings with the Senate Special Committee on Aging, pointing out that 67 high-risk medical devices have been approved through the agency’s expedited 510(k) process since 2009. The 510(k) process only requires manufacturers to show that a device is similar to one already on the market. No human testing is required. The GAO argues that, when it comes to high-risk devices, similarity is not sufficient to establish safety.

The report also noted that the agency fails to monitor the reasons why these devices are recalled or document the closing out of the recall. One Los Angeles Times article suggested that, had the FDA monitored and analyzed the approximately 700 medical devices that were recalled each year from 2005 to 2009, the agency might have a better sense of what devices are safe and what risks are common among those that are not.

These two findings alone are a preview of changes we can expect from the FDA. Manufacturers must be aware of what these investigation by the GAO and Congress could mean for medical device approval in the future, but also how changes might impact recall management practices when a device is found to be unsafe.

Transparency with regulators is critical to maintaining a positive relationship with those who oversee your company. Whether your product might be at risk of losing federal approval, or if it is currently being tested for approval, stricter FDA requirements could be on their way.

To the extent possible, your company should begin using clinical trials to prove the safety of your products, regardless of whether those trials are required by the agency. Likewise, if you have managed a medical device recall in the past, be prepared to share with regulators all the   appropriate recall documentation to assist the agency as it considers what changes may need to be made and what previous recalls mean for future recall regulations, because the most effective regulations are those that are created and agreed upon by both manufacturers and regulators.

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.

A new study of recalled medical devices highlights the need for thorough safety checks before products are put on the market. This month, a study conducted by the National Research Center for Women & Families and published in the Archives of Internal Medicine found that the majority of the medical devices recalled since 2005 were originally approved using the “accelerated” 510(K) process. Medical device manufacturers embraced the 510(K) for its efficiency, but they probably did not consider its potential impact on recall management.

According to the study, 80 out of 113, or 70 percent of recalled products were approved for distribution through 510(K), an abbreviated FDA approval process designed for low and moderate risk devices. Those outside the medical device industry may be surprised to learn that the FDA approval process normally does not include human testing or manufacturing plant inspections. Because most new devices are now cleared for sale through 510(K), we can expect that pattern to continue.

Diana Zuckerman, one of the study’s researchers, argues that the “findings reveal critical flaws in the current FDA device review system and its implementation that will require either congressional action or major changes in regulatory policy.” Everyone from activist groups and trade organizations to regulatory agencies have voiced their opinions and reactions to the study, and some experts believe that the findings are likely to spur regulatory and congressional action. According to the Washington Post, the FDA is already considering further modifications to the medical device approval process to raise safety standards. 

With the FDA more carefully regulating products, setting stricter standards, and ordering more recalls, manufacturers should be sure that their products have passed several rounds of safety checks before the go on sale – whether or not those checks are required by the regulators. Regardless of whether a longer approval process becomes the dominant FDA inspection method, medical device manufacturers must be careful to do their due diligence to make sure their products are safe.

Companies should also increase their communications efforts with customers and distributors. Zuckerman suggested that the study’s results could “shock” patients as they “learn how often new medical products using different materials, made by a different manufacturers, are not scientifically tested in humans to see how well they work.”

Communicating with these critical audiences is essential to managing a successful business. And by communicating with key audiences now, before a recall, you can build up a goodwill bank that will serve you well as the medical device industry faces increased scrutiny from lawmakers and regulators. If and when a recall is required, continued transparency and communication will help position your company for recall compliance and could even enhance your brand once the recall is over.

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 the FDA and Congress turning their attention to the recent joint replacement recalls, new technology is poised to beat them to the punch. A new mobile app called iTraycer, which debuted earlier this month, is designed to trace medical devices from manufacture to surgery and beyond. This is just the latest example of how new technology is helping streamline the process of tracking products and identifying potential problems.

iTraycer is the first mobile phone-based system for tracking medical devices, but a range of new databases have been created across industries to keep track of product distribution and product safety trends. Whether it be the FDA’s Reportable Food Registry, industry-implemented produce traceability initiatives, or the CPSC’s electronic recall database, advanced technology is playing an increasingly important role both in identifying product safety problems before they get out of hand and streamlining the recall notification process in the event of a recall.

But these examples hardly represent the full extent of technology’s role in recall planning and recall management. A mobile recall app developed by regulators earlier this year makes it easy for consumers to check for recalls on products even before purchasing, and eNotifications are becoming an increasingly important  supplemental tool for companies managing a recall to get the word out to customers.

With the public spotlight focusing more brightly than ever on product safety, companies would be wise to leverage these technological advances to protect consumers and themselves. Manufacturers are being held increasingly responsible for product safety problems, especially if they fail to identify developing safety issues and act quickly to remedy them. Regulators are monitoring recall effectiveness more closely than ever before. Electronic databases play a critical role in successful recall notification and execution.

Instead of viewing these advancing technologies as a threat to business, manufacturers should instead embrace these new technologies as a fact of life in today’s era of increased regulatory scrutiny. While advances in tracking technology can make it easier for regulators to spot problems and crack down on offenders, these advances also provide manufacturers with the same opportunity to beat regulators to the punch. Technology is a critical tool for not only preventing product safety problems in the first place, but also for quickly identifying and addressing those issues if they do become a problem.

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.