Class I Recalls Surge To Highest Point Ever; FDA Not Sure Why

The number of high-risk Class I medical device recalls skyrocketed to its highest point ever last year, leaving FDA officials to ponder what could have caused the dramatic upswing.

Class I recalls rose from 23 in 2009 to 51 in 2010, a 122-percent increase. Previously, 2004 and 2005 held the record for the largest number of Class I recalls, with 26 posted each of those two years. (See chart.)

“I can’t answer why the increase occurred,” said Armando Zamora, leader of FDA’s Recall Operations Team. “Recalls are dynamic. We don’t know what will cause one, and we don’t know the severity of one or the risk associated with one until we’re informed about it.”

Class I is FDA’s most serious recall category, reserved for situations where the agency believes patients face a reasonable probability of serious injury or death from use of the defective products.

BD and Cardiac Science tied for having the most Class I recalls of any company in 2010. BD’s three Class I’s were related to Q-Syte and Acacia infusion extension sets, Nexiva catheter systems, and various trays and kits, while Cardiac Science’s automated external defibrillators (AEDs) accounted for its three Class I recalls. (See chart.)

Other notable Class I recalls last year involved LifePak external defibrillator/monitors made by Physio-Control, dialysis systems and infusion pumps made by Baxter, and Hospira’s Symbiq one- and two-channel infusers.

FDA can typically point to a particular component or device that causes a jump in Class I recalls because it is used in so many finished products, such as “coring” Huber needles in 2009 or counterfeit glucose test strips in 2007 (“The Silver Sheet,” February 2010 and February 2008, respectively).

However, the types of devices involved in Class I recalls in 2010 were a hodgepodge of products, from the expected (infusion pumps; AEDs) to the more curious (antimicrobial susceptibility cards; saline syringes).

“We wonder about those recall numbers, as well. It’s difficult to say what prompted an increase like that,” Larry Spears, deputy director of regulatory affairs in CDRH’s Office of Compliance, told “The Silver Sheet.”

“It can certainly be a combination of different factors,” he said. “There are clearly more complex devices going on the market, so that could be part of it. And there are more companies. The registration numbers go up and so does the distribution of certain products. So it’s really hard to say.”

Overall recalls also rose in calendar year 2010. Manufacturers initiated a total of 717 device recalls last year, up 15 percent from 2009, when 626 recalls were logged. For its 2010 figures, “The Silver Sheet” counted device recalls issued during the calendar year. (See chart.)

According to FDA fiscal-year figures, there were 876 device recalls in 2010 and 776 in 2009.

In late 2009, FDA Commissioner Margaret Hamburg instructed agency staff to conduct inspections promptly after product recalls occur and to respond rapidly to any violations that jeopardize public health (“The Silver Sheet” December 2009).

Zamora suspects that Hamburg’s edict may be one reason why the number of recalls increased in 2010.

“Certainly one of the initiatives was for the agency to follow up enforcement-wise, with recalls being included in that bucket, so to speak,” Zamora told “The Silver Sheet.” “But I couldn’t tell you with certainty if there is a correlation with those initiatives and the reason for the increase and spike of these recalls.”

Nevertheless, Spears is confident that Hamburg’s enforcement approach to recalls has had an effect on industry and FDA.

“I think when you look at the commissioner’s enforcement initiative and the things that are associated with that, it does point to the fact that we’re going to be looking more closely at recalls, and therefore I think we’re going to be seeing more recalls than we did before,” he said.

Manufacturers “certainly heard what the commissioner said, and obviously when there is an increased focus on enforcement and [firms are] beginning to see enforcement actions – such as warning letters – pretty actively publicized, I think that gets the attention of industry that FDA is looking more closely. I think it definitely has in an impact.”

Denise Dion, senior regulatory consultant for EduQuest in Hyattstown, Md., and a former FDA investigator, suggests that the number of Class I’s and the overall number of recalls rose because companies are being more cautious when weighing the risk of a recall.

“Manufacturers are being more conservative, but not to cover their butts from FDA enforcement, but rather because I think they realize that there is a need for them to take a more conservative approach, given not just the FDA’s mood, but consumer mood,” she said.

“Consumers overall are really concerned about products and how manufacturers deal with recalls, and I think they want responsiveness from the manufacturers,” Dion said. “Customers saw what happened when Toyota didn’t do the right thing” when it failed to recall cars that had acceleration problems.

It’s also about the firm maintaining a good reputation, she said.

“What manufacturers care about is that their customers keep spending money,” Dion said. “So what they’re doing is trying to regain and hold onto whatever trust they can because in these economic times, if you lose the trust of your customers, then you’ve lost everything.”

It should come as no surprise that larger firms conducted the most recalls last year: Stryker, Philips, Beckman Coulter, Siemens, General Electric, and Biomet. (See complete list of 2010 recalls.)

Philips and Stryker led the pack with 30 recalls each in 2010. Philips has seen its number of recalls rise over the past few years (19 in 2009 and 23 in 2008), while Stryker’s recalls have fallen (39 in ’09 and 45 in ’08).

Rounding out the top six recalling firms for 2010: Beckman Coulter, which posted 24 recalls in 2010, four in 2009 and five in 2008; Siemens, with 22 in 2010, 30 in 2009 and 46 in 2008; General Electric, with 20 in 2010, 32 in 2009 and 35 in 2008; and Biomet with 16 in 2010, 13 in 2009 and 24 in 2008.

On Feb. 7, manufacturer Danaher announced a definitive agreement to buy Beckman Coulter. Danaher said one of its priorities for Beckman Coulter includes completing quality control fixes already underway at the firm.

Centrifuges To Blame For Two Class I Recalls

Two of the more notable Class I recalls in 2010 involved centrifuges, which are low-risk, Class I laboratory instruments.

“Usually when we look at IVD [in vitro diagnostic] recalls, we’re looking for the risk profile created by a false test result that can harm a patient,” said Alberto Gutierrez, director of FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD).

However, when it came to the two Class I recalls for centrifuges, “the issue was the safety of the laboratorians,” he said.

Mikro and Haematokrit centrifuges manufactured by Andreas Hettich and the Express 4 horizontal centrifuge made by StatSpin were the subject of the two recalls.

In those cases, the centrifuge rotor cracked and exploded outside of the centrifuge, spewing potentially dangerous projectiles.

“They are tabletop centrifuges that have probably been in the laboratories for several years – about 10 years or maybe longer than that. It is not unusual for centrifuge rotors to fail at some point,” Gutierrez told “The Silver Sheet.”

“If you go to a lab, they usually have big centrifuges that are encased in metal, or they’re made in such a way that if the rotor fails, the pieces are contained within and there is no problem,” he said. “But in both of these Class I cases, the top [of the centrifuge] failed, and the rotor then sprayed in the laboratories, causing potential harm to the people working in the lab. So these were a different type of recall for us.”

Gutierrez said the age of the centrifuge rotors likely played a part in the explosions. However, he is not ruling out design flaws.

In the meantime, OIVD has reached out to laboratories across the nation to let them know about the potential centrifuge dangers.

“We put a safety notice out and we let laboratorians know that this is an area that they need to be aware of and concerned with, and that they should keep an eye on the rotors, and that if they’re seeing issues, they should change the rotors and contact the manufacturers,” Gutierrez said.

As for the manufacturers of the centrifuges, “we have not done as much,” he said. “It’s a little difficult because a lot of these centrifuges are Class I devices, and it’s not always easy for us to know exactly where they are. Sometimes they’re made by small companies in small batches and were sold many years ago.”

Consultant Dion said she isn’t surprised by the Class I centrifuge recalls because many hospitals and other health care organizations are using extremely old devices.

“Some of my clients have a lot of recalls on products that are well past their expected shelf life,” she said. “Manufacturers have a tendency to keep servicing devices well past their expected shelf life, and I think they sometimes have a lack of understanding of the real reliability of their devices.”

For example, “even if a device has been in the market for only three years, that device probably only has a two-year shelf life, but they keep limping them along, and part of that is because the manufacturers will continue to service them because they don’t want to lose the money, and then on top of that, the hospitals and doctors don’t want to buy new devices because they don’t have any money. So it’s a vicious circle,” Dion said.

“There are a lot more devices out there that are really aging, and I think that is going to lead to more recalls – and some serious recalls – because once a device gets really old, it can break in ways that would otherwise not happen if it was a younger device,” she said.

“I really think manufacturers need to get a hold on this reliability issue, because I think it’s going to hurt them.”

When Class I Devices Cause High-Risk Recalls

Laboratory centrifuges are low-risk, Class I devices, but what would FDA do if a trend emerged that showed that they were causing more and more high-risk, Class I recalls?

“Clearly if we are seeing either changes in the way products are being used or changes in the product risk profiles, we [will look] to see whether we need to up-classify or whether we need to put special controls in place,” OIVD’s Gutierrez said.

Centrifuges were just one device type that was evaluated after passage of the Medical Device Amendments of 1976, when an FDA panel reviewed products to determine their risk profile and classification.

“When the risk profile was created [in 1976], I don’t think they probably thought about the physical risks that the centrifuges could pose,” Gutierrez said. Rather, “I think they were considering risk when it came to negative or positive IVD test results – what the possibility was that the device could cause problems in the laboratory in that sense.

“So that makes this current problem a little different,” he continued. “I’m not sure that the problems that we’re seeing now will lead us to an up-classification [to a higher-risk Class II], but maybe we have to think about what we can to do to make sure that the industry understands what the issues are and what it needs to do to make sure that the centrifuges don’t put people at risk.”

Obviously with FDA’s limited resources, manufacturers of Class I products are not going to be inspected as often as makers of high-risk Class III devices.

“A lower-risk device, while they will be inspected, they’re typically not going to be inspected as often, provided the company has demonstrated that they’re in compliance,” CDRH’s Spears said.

However, if the firm “has a lot of compliance problems, that’s different,” he said. “So if we’re not paying as much attention to them in terms of inspections, then when we do find a situation where there is a recall that actually becomes a [high-risk] Class I recall, then it’s certainly going to get our attention.”

“We certainly have the option of making changes in the classification of a device. We have done that at different times where we have up-classified and down-classified. As we get new information on any classification of a device, we can certainly make those adjustments and changes,” Spears said.

“It’s fairly rare that we would see a Class I device that would result in a Class I recall. But when it does occur, it certainly gets our attention,” he said. “If it’s causing a serious problem, then what needs to be done? So that would be one of the options on the table – to look at changing the classification for that device.”

Consultant Dion isn’t holding her breath, however.

“I doubt that FDA would ever up-classify a centrifuge,” she said. “The agency has a tendency to spend more time down-classifying than they do considering an up-classification. Plus, you wouldn’t get the medical community behind FDA to change the classification of a centrifuge. I doubt that there is any real fix for it, because you’re not going to get people to say that a centrifuge is a high-risk device.”

Nevertheless, there are many low-risk devices that can cause high-risk Class I recalls.

“A lot of Class I devices do have some of the highest risks associated with their use,” Dion said. “Consider a patient lift, which is a Class I device. People have died from being dropped from a patient lift. So some of the highest risks to people can be associated with low-risk devices.

“There are very low-risk devices that have a high risk associated with their use because of the patient population or just because of the way they’re used,” she added. “Some of these products were grandfathered in at certain risk classifications [in 1976]. People have been harmed by patient lifts since the beginning, and I’ve never seen FDA change that device’s classification, and I doubt it ever will.”

Role Of FDA Staffers In Class I Uptick?

There is some speculation that the rise in Class I recalls is related to FDA’s hiring of many new staffers over the past few years to replace retiring officials.

“FDA has hired a lot of new people, and a lot of these people are now in the position of determining things about recalls, and in a lot of districts, the new recall coordinator has only been on the job for less than a year,” consultant and former FDA staffer Dion told “The Silver Sheet.”

Further, Michael Verdi, the new director of executive operations staff at FDA’s Office of Regulatory Affairs (ORA), “came from CDRH’s Office of Compliance, and he happens to be a little on the hawkish side when it comes to devices,” Dion said. “He tends to be more conservative than his predecessor.”

Verdi previously served as the device center’s senior recall coordinator. ORA is the lead office for all of the agency’s field activities.

“So companies are spending more time talking to their district office about recalls, and because those FDA staffers in the districts tend to be less experienced, they rely heavily on talking to CDRH and Michael Verdi,” she said.

The new FDA staffers “are being tougher across the board because they are less experienced. When you have less-experienced people, they tend to be more conservative. They may think a certain recall is really bad, but perhaps people who have done the job for a long time might say, ‘Oh, actually, in the scheme of things, this recall is not so bad,’” Dion said.

For example, if a company conducts a recall and decides to label it as Class II, the agency staffers may come back to the firm and explain that they think the recall should be categorized as Class I.

“Manufacturers are doing what they need to do and reporting their recalls, and then at FDA they will sometimes have a tendency to classify things as a Class I rather than a Class II, and some of that is just because the agency is being a lot more conservative, and that happens when you have a turnover in staff,” Dion said.

Products FDA Is Watching In 2011

Prognosticating about device types that will likely be recalled over the coming year can prove tricky, but for CDRH it’s like déjà vu all over again.

For the device center, certain devices are perennial concerns – notably, infusion pumps and automated external defibrillators (AEDs).

“We continue to have problems with infusion pumps,” CDRH’s Spears said. “We had a public meeting in October looking at infusion pumps and basically trying to get input from industry and others to talk about what the issues are ... so they can work on addressing those problems.

“AEDs also continue to be an issue,” he noted. “We had a similar meeting with regard to defibrillators in December. So those are two product areas that continue to be of concern.”

As for in vitro diagnostics, Gutierrez said OIVD in 2011 will be taking a closer look at troponin tests, glucose meters and blood anticoagulation devices, especially those used in the home.

“We do see a fair amount of MDRs [Medical Device Reports, or adverse event reports] in those areas, and we do keep an eye peeled to make sure that if we’re seeing MDRs, we learn what the cause of those MDRs is, and whether there is a need for recalls,” he said.

FDA Reaching Out With Recall Information

As for communicating recall information to the public, FDA is working through different social networking channels to ensure that recall messages are widely disseminated.

“We certainly are making efforts to make recall information more readily available to industry and the public,” FDA’s Zamora said. “We have looked into redesigning our recall page that you can find at http://www.fda.gov/ to make it more consumer-friendly.”

Further, the agency has worked with Flickr, an online photo management and sharing application, to post pictures of labels and recalled products.

FDA and CDRH also have pages on Facebook where recall information could be announced. “FDA has reached out and is using social networking sites, and some of those sites may have some association with the recalls that we handle and the products we regulate,” Zamora said.

In addition, FDA’s recent transparency initiative has had an impact on recall communications, Spears said.

“There is a lot of activity around that initiative to try to get more information to the public quicker. That’s what the whole thing is about, and that includes the recall arena,” he said. “It helps us identify information we can share with the public right away, and we may go to the company and say, ‘You need to do this right away’ more actively than before.”

Nevertheless, there is still debate within the agency about what information should and should not be released.

FDA considers, “What can we put out early on, and what can’t we?” Spears said. “We’ve had a lot of discussions about that – about how much information we can put out – and then we get into verification of information, too, so we walk a fine line.

“We want to make sure that we put information out quickly to help protect users and patients, and so forth, but we don’t want to put out information that is not complete or is alarming if it has not been verified,” he added.

Group Looks To Improve Communication

Still, for patients with implanted devices and their physicians, it’s not always easy to know when a device has been recalled.

To fill that gap, the nonprofit Biomedical Research and Education Foundation recently developed the Medical Device Registry, an online database where patients can enter information about their implants and be notified if they are recalled.

The site also offers a searchable list of current device recalls and safety alerts, allowing patients to see if any questions have been raised about a device before agreeing to have it implanted.

Primary care physicians “don’t get information at all” about their patients’ implanted medical devices, unless a patient remembers to record precise data about the implant and pass it on to his or her doctor, explained Terry Fadem, president of BREF’s board of directors.

“So we have a kind of flawed system,” he said.

Both BREF and its device registry – found at https://medicaldeviceregistry.org/ – are supported by funding from philanthropic groups and private donors. According to the organization’s website, “BREF’s information and research is free of market bias and has no vested or financial interest in any technology reviewed.”

In addition, Fadem said BREF made a decision early on not to take money from device manufacturers out of concern that patients would believe that industry was “somehow influencing how the data is collected and reported.”

In addition to his role at BREF, Fadem is director of the Office of Corporate Alliances at the University of Pennsylvania School of Medicine. He said he found himself repeatedly fielding questions from primary care physicians whose patients had heard about recalls involving stents, artificial joints and other implants.

The doctors had no choice but to call several hospitals to track down specific recall information on behalf of their patients.

It’s because of that problem that BREF developed its medical device registry as a resource. Patients who register their implants on the site are asked to provide the device’s name, manufacturer, device type, product code and lot number, plus information about whether their implant experience was “good,” “bad” or “neutral.”

In return, the BREF registry automatically forwards to patients FDA information on recalls and other device safety alerts. The registry is open to information on all types of implants.

The site also allows patients to enter detailed complaints about their devices, although those entries will not be viewable to others.

To the extent that the BREF registry allows “patients to register themselves, and then get timely information on the products they may use or be implanted with, it sounds like a reasonable idea,” said Tom Gross, deputy director of CDRH’s Office of Surveillance and Biometrics (OSB).

Gross added that while FDA has several avenues to disseminate information about device recalls and problems, most of them rely heavily on manufacturers to alert device users.

This is particularly true for user complaints, which are received and investigated by manufacturers. Those complaints may eventually be submitted for public posting on FDA’s Manufacturer and User Device Experience (MAUDE) database.

“What is contained in MAUDE are the adverse event reports that reflect a subset of the complaints received by manufacturers,” Gross said.

Although the information found in MAUDE is publicly accessible, Gross said, patients have to be proactive and search the FDA site themselves, as opposed to automatically receiving a report.

In addition, patients have to know the specific model name or product number of the implant they received to make effective use of the MAUDE site.

“There’s a way of getting that [information], but by and large, people don’t have, or don’t remember ... or don’t collect that kind of information,” Gross said.

CDRH Getting Signals Despite Loss Of Matrix

Last year former CDRH Compliance Director Tim Ulatowski told “The Silver Sheet” that CDRH’s matrix team played a “key role in signal identification and signal escalation” with regard to recalls (“The Silver Sheet” February 2010).

The matrix brought together pre-market reviewers, adverse event analysts, scientific researchers and others to evaluate safety risks for different device types (“The Silver Sheet” September 2009).

However, the device center discontinued the matrix last June. Does that mean CDRH lost a key tool for identifying troubling recall trends?

Not necessarily, says FDA’s Spears.

“I don’t know that I would agree that it was necessarily a ‘key signal,’” he said. “The matrix was certainly one source of signal information, but there are many other sources as well. In fact, in many cases the matrix was pulling information from various other sources we already had, such as MDR data, and other data with regard to the performance of product.

“The matrix was getting information and it was evaluating and characterizing the information to help us make better decisions,” Spears continued. “It was doing a valuable thing, I believe, but there are many other sources of signal information. I mentioned MDR reports, and the analysis of those reports to judge the impact. We certainly get signals from inspections. We get signals from trade complaints and from other agencies – state, federal and local – and so forth.

“We get signals from a lot of different sources, so I think it’s just a matter of looking at things a little bit differently,” Spears said. “The matrix served its purpose for awhile. The decision by center management at this point is to say, ‘Let’s look at something different. Let’s look at a different way of capturing that information.’ So I don’t really see it as a loss, I just think it’s just a change in direction.”

By Shawn M. Schmitt