1

U.S. CONSUMER PRODUCT SAFETY COMMISSION

PUBLIC HEARING ON

SAFETY STANDARD FOR MAGNET SETS

NOTICE OF PROPOSED RULEMAKING

T uesday, October 22, 2013

B ethesda, MarylandCOMMISSIONERS PRESENT:

INEZ MOORE TENENBAUM, Chairman

ROBERT ADLER, Commis sioner

NANCY NORD, Commissioner

MARIETTA ROBINSON, Commissioner

ANN MARIE BUERKLE, Commissioner3

A G E N D A

PAGE

Chairman's Introductions 4

ORAL PRESENTATIONS:

PANEL 1:

Ra chel Weintraub, Legislative Director and

Senior Counsel, Consumer Federation of America 9 Mark Gilger, M.D., FAAP, Pediatrician, Chief at

Children's Hospital of San Antonio, Professor and Vice Chair of the Baylor College of Medicine, repre senting the American Academy of Pediatrics 16 Ami Gadhia, Senior Policy Counsel, Consumers Union 23

PANEL 2: Bryan Rudolph, M.D., Assistant Professor of

Pediatrics, Division of Pediatric Gastroenterology and Nutrition, Albert E instein College of Medicine, Children's Hospital, Bronx, New York 57

Maria Oliva

- Hemker, M.D., Chief of Pediatric

Gastroenterology and Nutrition, Stermer Family Professor of Pediatric Inflammatory Bowel Disease, Johns Hopkins Childr en's Center, on behalf of North American Society for Pediatric Gastroenterology Hepatology and Nutrition 63

Ian Leibowitz, M.D., Assistant Professor of Pediatrics,

Department of Pediatrics, Virginia Commonwealth University, Director, Pediatric D igestive Diseases Center, Inova Fairfax Hospital for Children 734 Marsha Kay, M.D., Chair, Pediatric Gastroenterology,

Director, Pediatric Endoscopy, Cleveland Clinic Children's Hospital 805 P R O C E E D I N G S [10:00 a.m.] 1

CH AIRMAN'S INTRODUCTIONS 2

CHAIRMAN TENENBAUM: Good morning, everyone, and 3

welcome to the U.S. Consumer Product Safety Commission. We 4

are having a hearing this morning on magnets. 5

Before we get started, I'd like to bring to 6

everybody's attention that today i s Commissioner Nord's last 7

public meeting with the CPSC. She has been here many years 8

as a Commissioner, and then she was Acting Chairman for a 9

number of years. 10

Nancy, I just want to say it will be a large void. 11

When I first came here, I remember the fir st thing you did 12

was bring flowers over to my office, and taught me a lot of 13

things. I want to say that you will be missed, and thank you 14

for your years of service to the CPSC. 15

COMMISSIONER NORD: Madam Chairman, thank you. 16

COMMISSIONER ADLER: If I migh t say a few words. 17

COMMISSIONER NORD: What is different about this 18

morning than any other morning. 196 (Laughter.) 1

COMMISSIONER ADLER: I think, Nancy, you and I have 2

had what somebody once described to me as an A ongoing mini 3

version of cross fire, @ which I have greatly appreciated. I 4

think you have brought some forceful and eloquent and needed 5

views to the agency and agency discourse. I want you to know 6

how much I have appreciated all of the contributions you have 7

made to the agency over the years. 8

I consi der you a friend. One of the things I've 9

discovered about you as a friend that I'm not sure the public 10

knows so much is you have an unbelievably refined sense of 11

style, which I was admiring yesterday in your office. 12

Anybody that doesn't believe me should stop by her office to 13

see just how beautifully decorated it is. 14

The other thing is a delightful sense of humor, 15

which I have always enjoyed and I relish, and I look forward 16

to continuing to appreciate. I just want you to know how 17

much I will miss you and I wish you the best. 18

COMMISSIONER ROBINSON: Don't start on Nancy. 197 CHAIRMAN TENENBAUM: I just want to say that when I 1

was nominated by the President the first time in January 2

2012, Nancy was the first person who was a Commissioner with 3

whom I was able to have some interaction. 4

I was just very, very impressed with her 5

thoughtfulness, her wealth of knowledge about the agency, and 6

we were very much looking forward to working together for a 7

long time, unfortunately, the confirmation process took 8

longer tha n either of us anticipated. I am very sorry that 9

we didn't have longer together on the Commissioner, Nancy. 10

She is a person with such rich knowledge of the 11

agency and such a sense of history and thoughtfulness and 12

commitment to the agency's mission, and y ou will be missed. 13

COMMISSIONER BUERKLE: I just want to say from the 14

time I received a call about this appointment, Nancy was 15

available as a resource, help, and a friend. She has proved 16

to be just a wonderful mentor, cares deeply about what the 17

Consumer Product Safety Commission does, and really has, I 18

think, set an example for me and for all the Commissioners 198 for diligence, and her knowledge of the issues is really, I 1

think, what is most remarkable. 2

I know for one, for a lot of reasons, I will miss 3

Nancy and serving with her. I'm sorry we didn't have more 4

time together. Thank you. 5

COMMISSIONER NORD: Thank you so much. I'm really 6

very touched by your comments. I am so sorry our terms of 7

service didn't overlap to a greater extent than it did. I 8

think both of you bring new perspectives and freshness to the 9

agency that is very much needed and appreciated, even though 10

my time working with you both has been short, it has been an 11

absolutely delightful experience. 12

Bob, I think you summed it up well. I have 13

thoroughly enjoyed the intellectual jousting that we have had 14

the opportunity to do. In fact, this agency presents so many 15

rich intellectual issues. It has always been great fun to be 16

able to throw ideas up against the wall and have Bob at least 17

try to catch a few of them, not very many, but every once in 18

a while. 199 Madam Chairman, perhaps more than anyone else on 1

this Commission, I do know the challenges you face in trying 2

to run an organization that has a mission as big as it is, 3

having to deal with such diverse issues with resources that 4

are in the best of times very constrained. You have my 5

admiration in trying to keep all the balls up in the air. 6

This has been just an interesting eight and a half 7

years for me. I have seen the agency morph from one thing to 8

another. Nevertheless, I think we all appreciate and 9

understand the importance of the mission that we were 10

appointed to carry out. 11

All of us believe passionately in it, even though 12

sometimes we approach these issues from different points of 13

view , our interests and our desire to do the right thing for 14

the consumer is always there. 15

Thank you very much, colleagues. To the staff, I 16

will very much miss the wonderfully rich interaction I have 17

had with you also. Thank you. 18

CHAIRMAN TENENBAUM: Thank y ou. Good morning, 1910 everyone, and welcome to the public meeting relating to the 1

Notice of Proposed Rulemaking to create a standard to reduce 2

the risk of injury associated with magnet sets. 3

The Notice of this meeting was published in the 4

Federal Register on Tuesday, September 24. It has been duly 5

noticed. 6

I am pleased this morning that we do have seven 7

panelists who have requested the opportunity to make oral 8

presentations. The Commission also previously received 9

volumes of written comments on this rulemaki ng. Both the 10

oral and written comments will be part of the rulemaking 11

record. 12

I want to make sure we announce today that the 13

record will be held open for one week, in addition to the 14

full comment period which has now passed. 15

A copy of the agenda includes the rules of conduct 16

for this meeting. 17

I'd like to extend a special welcome to each of our 18

presenters who are here to testify this morning. Our 1911 panelists will be heard in the following order: 1

First, Rachel Weintraub, who is the Legislative 2

Director and Senior Counsel, representing the Consumer 3

Federation of America. Second, Dr. Mark Gilger, who is a 4

pediatrician and Chief at Children's Hospital of San Antonio, 5

and Professor and Vice Chair of the Baylor College of 6

Medicine, representing the American Aca demy of Pediatrics. 7

Ami Gadhia, Senior Policy Counsel, representing Consumers 8

Union. 9

Ms. Weintraub, will you start? 10

PRESENTATION OF MS. RACHEL WEINTRAUB 11

MS. WEINTRAUB: Chairman Tenenbaum, Commissioners 12

Adler, Nord, Robinson, and Buerkle, I appreciate the 13

opportunity to provide comments to you today on CPSC's Notice 14

of Proposed Rulemaking establishing a safety standard for 15

magnet sets. 16

I am Rachel Weintraub, Legislative Director and 17

Senior Counsel with Consumer Federation of America. Consumer 18

Federation or CFA is a non

- profit association of 1912 approximately 280 pro

- consumer groups that was founded in 1

1968 to advance the consumer interests through advocacy and 2

education. 3

CFA is basing our comments today upon our written 4

submission of comments of November 19, 2012 to the CPSC in 5

response to the open comment period regarding the NPR on the 6

safety standard for magnet sets. 7

CFA agrees with CPSC's preliminary determination 8

that there is an unreasonable risk of injury associated with 9

children ingesting high powered magnets that are part of 10

magnet sets. 11

The CPSC and pediatricians and pediatric 12

gastroenterologists from whom we will hear today have 13

documented the serious medical consequences that occur as a 14

result of a child ingesting such high powered magnets. These 15

magnets are appealing to both younger children and older 16

children as well. 17

Unique properties of these magnets cause serious 18

life threatening injuries when a child ingests two or more 1913 magnets. These injuries are vastly different from and more 1

serious tha n those that occur from the ingestion of other 2

small parts. 3

In the Notice of Proposed Rulemaking, the 4

Commission proposes safety standards for magnet sets. The 5

safety standard proposed would prohibit current magnet sets. 6

The proposed rule would require t hat magnets that fit into 7

the small part cylinder to have a flux density of less than 8

50 or they would be prohibited. We support that proposed 9

standard. 10

CPSC based this proposed rule in part upon ASTM 11

F963's provision addressing magnets in toys. We suppo rt that 12

reliance as the ASTM standard appears to have effectively 13

addressed the hazard posed by magnets in toys. 14

CPSC's proposed rule accurately describes the 15

serious injuries caused by the ingestion of magnets from 16

magnet sets, which can be grave and pote ntially life 17

threatening. 18

CPSC has estimated that 1,700 ingestion's of 1914 magnets from magnet sets were treated in emergency 1

rooms/hospitals across the country from 2009 to 2011, and a 2

survey by the North American Society for Pediatric 3

Gastroenterology, He patology and Nutrition that we will hear 4

about more from later panelists, released in October of 2012, 5

estimated that in the past ten years, there have been at 6

least 480 cases of high powered magnet ingestion's with 204 7

of those cases occurring in the past 12 months. 8

Thus, serious injuries, many of which required 9

surgical intervention, have been caused by these magnets. We 10

support the CPSC's assessment of the seriousness of these 11

injuries and agree that the data provides evidential support 12

for the promulga tion of a proposed rule that effectively 13

addresses this serious hazard. 14

We urge the CPSC to include individual magnets that 15

are sold to be used in conjunction with a magnet set as part 16

of the scope of the proposed rule. Individual magnets bought 17

separatel y would pose the same hazards as those bought as 18

part of magnet sets. Thus, the same standard should apply to 1915 these magnets. 1

We agree with the CPSC's recommendation in the 2

proposed standard that magnets sold as part of magnet sets 3

and magnets intended to be used as part of magnet sets that 4

are smaller than the choke test tube should have a flux 5

density of 50 or less, or else they should be prohibited. 6

First, we applaud the initial test of using the 7

choke test tube to ensure that magnets can be swallowed, the 8

focus of this standard. The incidence data supports that 9

ingestion is the main route of exposure for these severe 10

magnet injuries. The small size of these magnets not only 11

makes them so potentially harmful, but creates similarities 12

between these magn ets and candy and jewelry. 13

Regarding the flux density, the CPSC should study 14

whether magnets with a flux density of less than 50 could 15

also potentially cause harm. While the flux density of 50 16

put forth in this proposed standard was based upon the ASTM 17

to y standard and analysis of magnet containing toys on the 18

market, we also suggest that CPSC study other products 1916 containing magnets, including magnets used as refrigerator 1

magnets, push pins and jewelry, to evaluate whether a flux 2

density of 50 is in fact t he appropriate level. 3

We further urge the CPSC to study whether magnets 4

with a flux density of 50 when aggregated continue to have a 5

flux density of 50 or whether the aggregation of these 6

magnets increases the flux density and could pose more harm. 7

We agre e with the CPSC staff that warning labels 8

have never been effective in protecting children from the 9

hazards posed by ingesting magnets from magnet sets. 10

First, warnings are less effective injury 11

prevention methods than changing the product to reduce the 12

hazard. Second, this hazard is hidden. The potential harm 13

is not immediately obvious to purchasers or users of the 14

product, and warning labels are less effective when the harm 15

is not clearly known. 16

Warnings have been included on products and those 17

warni ngs have not curbed injuries and have not been 18

effective. Since the new label was required in March 2010 on 1917 a specific product, reported injuries continued to increase 1

steadily and significantly. 2

Warning labels do not prevent exposure to this 3

product but rather seek to convey information that would 4

alter a consumer's potentially risky interaction with the 5

product. 6

A more effective way to eliminate or reduce 7

ingestion hazards is to prevent exposure to this foreseeably 8

hazardous product. 9

Since the data s hows that children six and younger 10

make up the bulk of incidents, a warning label aimed at 11

children who can't read will not be effective. 12

Finally, for those children who could read, they 13

use these products outside of the container, so often the 14

warning la bel would not be visible to them either. 15

We further urge the CPSC not to rely upon 16

childproof containers but rather upon an effective standard 17

to curb the hazards caused by ingestion of these magnets from 18

magnet sets. 1918

Given the nature of the use of these m agnet sets, 1

it is likely that magnet sets would not remain in their 2

containers, they would be left out of their containers on a 3

table, dresser or desk, in a geometric shape that the 4

consumer created with the magnets. Given the intended use of 5

the product, the benefit of such a childproof container would 6

be extremely limited. 7

Similarly, CFA would not support bittering agents 8

as a solution to this product. The most effective way to 9

eliminate or reduce ingestion hazards is to prevent exposure 10

to the foreseea bly hazardous product. 11

Preventing ingestion by making magnets that are 12

smaller than the choke test tube cylinder, less powerful, 13

less dangerous, is the best way to do this. Bittering agents 14

are not the answer. They have not been shown to change 15

childr en's behavior in different applications. The agent 16

fades over time and may not be detected in the same way by 17

younger children who have less developed and different taste 18

buds. Also, children put everything in their mouths, and the 1919

bad taste will not sto p their natural mouthing behavior that 1

leads to these incidents. 2

The CPSC's cost analysis considers the extensive 3

costs of the injuries to children caused by these magnets and 4

magnet sets. The cost must also consider the ongoing health 5

impacts of injuries to children. 6

In conclusion, CFA strongly supports the adoption 7

of the Commission's standard as included in the Notice of 8

Proposed Rulemaking for magnet sets. This standard will 9

effectively limit exposure to the hazard caused by magnet 10

sets currently on t he market. Reducing the magnetic force of 11

magnets that can be swallowed is the most robust and 12

successful way to reduce the threat of injury and death to 13

children caused by these magnet sets. 14

Thank you. 15

CHAIRMAN TENENBAUM: Thank you. Dr. Gilger? 16

PRESENT ATION OF DR. MARK GILGER 17

DR. GILGER: Good morning. Chairwoman Tenenbaum, 18

Commissioners Nord, Adler, Buerkle and Robinson, I'm a 1920 pediatrician, and my job is to keep kids safe. I'm also a 1

pediatric gastroenterologist by training, so I have personal 2

exper ience with the safety of this very innocuous toy. 3

I appreciate the opportunity to offer comments to 4

the CPSC on behalf of more than 60,000 members of the 5

American Academy of Pediatrics, primary care pediatricians, 6

pediatric medical specialists, like mysel f, and pediatric 7

surgeons. 8

I intend to summarize the content of the testimony 9

submitted to the Commission. The AAP commends CPSC for 10

taking action to protect children from the serious and 11

growing hazard of neodymium or rare earth magnet ingestion. 12

The Aca demy supports the Commission's proposed rule 13

on magnet sets and applauds its effort as a significant step 14

toward reducing the incidence of child morbidities and 15

mortalities caused by magnet ingestion. 16

These magnets' unique properties can cause serious 17

and life threatening injuries when a child ingests two or 18

more magnets or a magnet and a ferromagnetic object. 1921 As a pediatrician, our job is primarily about 1

prevention, keeping kids safe. Vaccines, counseling for 2

parents, and especially unintended injuries su ch as with the 3

neodymium magnets. Our job is to prevent disease and injury. 4

Pediatricians have been aware of the rising dangers 5

associated with magnet ingestion for many years. We have 6

seen firsthand significant and life long health impact this 7

can have

. 8

Indeed, why am I here? About a year and a half 9

ago, one of my Fellows

-- I train pediatricians for a living 10

-- my Fellows presented a case of a young 18 month old infant 11

who had been playing with neodymium magnets left on the floor 12

after they had fall en off the desk of the dad who had used it 13

as a stress relieving desk toy. The magnets were all over 14

the floor and the baby got into them and ate several of them. 15

Kids eat anything. 16

Children are at risk for several reasons. Mouthing 17

behavior

- it is a v ery common and necessary part of early 18

childhood development. In fact, between two months and 36 1922 months of age, children spend anywhere from 20 minutes up to 1

2.5 hours per day with mouthing activity. This is a normal 2

part of early childhood development. As kids get older, they 3

stop that behavior. 4

Given this developmentally appropriate behavior, it 5

is very understandable why very young children would readily 6

put things like magnets in their mouths. 7

Second, there is an under estimation of the risks. 8

Todd lers can swallow neodymium magnets because of their 9

appearance. They can be easily mistaken for candy. 10

For example, I brought a prop. In here, I have a 11

cupcake. I hope you can see it. I hope you see the candy on 12

top. I don't know if you remember the old commercial, A Looks 13

like butter but it's not. @ These are not candy. These are 14

neodymium magnets. They look like candy to me and they look 15

like candy to you. They hold together very nicely. I can 16

pick them off this cupcake very easily. That is how strong 17

they are. 18

Once these little magnets get inside the intestine 1923 of an infant, bad things can happen. These magnets look a 1

lot like candy that children see on cakes and cookies. It is 2

not just little kids either. 3

Older kids, pre

- teens and adolescents , accidentally 4

ingest them or they are using these products to mimic 5

piercings . I've seen a lot of children with piercings now on 6

the tongue, on the lip, on the cheek, on the nose. How do we 7

look like an adult? We demonstrate piercings . These serve 8

tha t purpose rather well. 9

You can only guess how easily it might be for a 10

child to swallow one of these. Then what happens? The 11

teenager that swallows these is not about to tell mom and dad 12

that I just swallowed a bunch of magnets because I was 13

showing my friends how it looks to have a piercing. 14

From a developmental perspective, both children and 15

adolescents do not possess a full understanding of the risk 16

posed by these products. 17

Also important to know is children cannot always 18

identify or verbalize their injuries delaying diagnosis and 1924 treatment. Initial symptoms of ingestion of these high 1

powered magnets are very non

- specific. It could include 2

fever, nausea, vomiting, and abdominal pain. 3

Proper diagnosis and treatment can be delayed 4

because of the la ck of the specificity of such symptoms. 5

This is particularly the case when very young 6

children who are unable to verbalize have ingested a magnet, 7

and when older kids, as earlier I demonstrated, they are 8

embarrassed to say what they just did, and they do n't 9

immediately realize the connection between their symptoms and 10

the ingestion. 11

Delayed diagnosis and treatment can result in 12

additional and in some cases irreparable or life threatening 13

tissue injury. 14

Foreign body ingestion's are common. About 100,000 15

foreign body ingestion's occur annually in the U.S., and 80 16

percent of these occur in kids. By far and away, most pass 17

without symptoms and do not require surgical intervention. 18

However, high powered magnets are an entirely 1925 different ball of wax. Magn et ingestion has grown as a child 1

health issue since the mid

- 2000s when manufacturers 2

introduced to the marketplace children's toys containing 3

these powerful magnets. 4

These injuries are very different and far more 5

serious than ingestion of other small fore ign bodies. 6

Neodymium magnets are the strongest type of permanent magnet 7

manufactured. 8

When a child ingests multiple magnets or a magnet 9

along with another ferromagnetic object, they are capable of 10

attracting each other across the bowel wall. That can lead 11

to perforation, ulceration, and ultimately result in sepsis, 12

a life threatening infection. 13

About ten percent of affected children will require 14

long term or repeated interventions. The most common 15

intervention for high powered magnet ingestion is sur gical 16

repair of a perforation or fistula. In cases requiring bowel 17

resection, the health implications are long term and serious. 18

In 2012, pediatric gastroenterologists, my 1926 colleagues, found that children under age six represented 51 1

percent of all magnet ingestion cases, and 80 percent of 2

reported cases required endoscopic or surgical intervention. 3

These are serious morbidities and significant 4

health interventions that can have life long effects on 5

children. Sadly, most of these injuries are preventable. 6

The AAP commends CPSC for taking action to protect 7

children from the serious and growing hazard of neodymium 8

magnet ingestion, limiting the magnet strength for products 9

meeting the small part size is a common sense solution to 10

reduce the occurrence of thes e tragic and preventable 11

outcomes. 12

For these reasons, the AAP applauds CPSC for the 13

Notice of Proposed Rulemaking, and urges the Commissioners to 14

move this rule forward into implementation. 15

The safest and most effective regulatory action 16

that CPSC could ta ke to eliminate or reduce the hazard of 17

ingestion is to prevent exposure to this foreseeably 18

hazardous product. 1927 As I conclude, I would like to share the following 1

recommendations. Public education. We simply are not aware 2

of the dangers of these simple innocuous magnets. We must 3

remain vigilant. Parents and care givers need to understand 4

the dangers posed by this innocuous toy, and they need to be 5

aware that these products can be purchased today and are in 6

existence. 7

We need to continue to educate our physicians and 8

especially our emergency room physicians, our family 9

practitioners, our pediatricians, and our surgeons. We 10

support the Federal rule. 11

I want to thank you for the opportunity to provide 12

input to the CPSC on this critical child health issue, and I 13

would be happy to entertain any questions. Thank you. 14

CHAIRMAN TENENBAUM: Thank you. Ms. Gadhia? 15

PRESENTATION OF MS. AMI GADHIA 16

MS. GADHIA: Good morning. Chairman Tenenbaum, 17

Commissioners Nord, Adler, Robinson and Buerkle, my name is 18

Ami Gadhia, and I'm Senior Policy Counsel with Consumers 1928 Union, the public policy and advocacy arm of Consumer 1

Reports. 2

We very much appreciate the opportunity to provide 3

comments to the CPSC on this proposed rulemaking. 4

CU strongly supports CPSC's proposed rule to 5

address the unreasonable risk of injury associated with 6

children ingesting high powered magnets that are part of 7

magnet sets. 8

This proposed rule would effectively ban very 9

small, highly powerful rare earth magnets, and will help to 10

reduce significantly t he horrible incidents of internal 11

injury and life altering medical consequences due to 12

ingestion of these magnets by children and teenagers. 13

As the Commission notes in its Notice of Proposed 14

Rulemaking, in 2008, high powered rare earth magnet sets 15

became a vailable to U.S. consumers. 16

These magnet sets, which often consist of tens or 17

hundreds of tiny, colorful, powerful magnets, are very 18

attractive to children, including infants, as you just heard, 1929 and teenagers, and stick together with such force that if 1

t hey are ingested, they can bore holes in the stomach or 2

intestines, sometimes causing blood poisoning, tissue death, 3

perforations and other injuries that require emergency 4

surgery. 5

The unique and potent hazard posed by these 6

products is especially insidio us, because after ingestion, as 7

Dr. Gilger said, children often present with symptoms like 8

vomiting that resemble common illnesses such as the flu, 9

delaying medical attention. 10

While the largest portion of the estimated 1,700 11

incidents treated in emergency departments between 2009 and 12

2011 involved children 4 through 12 years of age, teenagers 13

are at risk as well, as Dr. Gilger well described. 14

A study published this August in the Annals of 15

Emergency Medicine concluded that A Magnet related injuries 16

are an inc reasing public health problem for young children as 17

well as for older children who may use magnets for play or to 18

imitate piercings . Education and improved magnet safety 1930 standards may decrease the risks small magnets pose to 1

children. @ 2

Magnet related inju ries can be serious and long 3

term. For example, after swallowing eight magnets in April 4

2012, then 22 month old Braylon Jordan of Kiln, Mississippi, 5

need to have almost all of his small intestine removed, 6

leaving him dependent on intravenous nutrition. 7

I n the March issue of the Canadian Medical 8

Association Journal, doctors described their treatment of a 9

three year old boy with laparoscopic surgery after he 10

ingested several small spherical magnets that came together 11

and tore a hole in his small intestine. 12

As the Commission moves forward on this rulemaking, 13

we urge you to consider the long term medical and other costs 14

to the victims of magnet based injuries and to their 15

families. 16

While we commend CPSC for the measures it has 17

already taken, we believe the nex t appropriate step to 18

address this hazard is the proposed prohibition on products 1931 in their current form and a safety standard for magnets. 1

It is clear that CPSC's action is necessary as the 2

potential uses of these rare earth magnets continue to grow, 3

posin g new potential hazards. Recently, we heard about a 4

crowd funding appeal for a pen and stylus product that is 5

composed of small, cylindrical neodymium magnets. 6

What happens if the small, cylindrical pieces are 7

swallowed by a child? Is the same devastat ing injury 8

possible as with the magnet sets? 9

The agency's action on magnet sets is necessary to 10

stay abreast of potential hazards with rare earth magnets. 11

Also, as the Commission moves forward with the 12

rulemaking and looks into examining magnet flux stren gth and 13

the possibility of developing tests to measure it, the agency 14

should ensure that such a standard adequately identifies and 15

eliminates hazardous magnets, including whether magnets of a 16

flux density less than 50 could also potentially cause harm. 17

The Commission should study other products 18

containing magnets including jewelry to evaluate if and 1932 whether a flux density of 50 is the appropriate level. 1

The CPSC's proposed rule rightly builds upon work 2

already done by industry, consumer groups, and the Comm ission 3

to address high powered magnets in toys. 4

In the mid

- 2000s, construction toys for children 5

featuring small powerful magnets were introduced. CPSC 6

received reports of injuries after the magnets inside these 7

toys came loose and children swallowed th em in multiples. 8

CPSC also received reports of incidents in which children had 9

swallowed intact magnet components that were small parts. 10

These incidents revealed the hazard posed by high 11

powered magnets. The Commission appropriately recalled those 12

magnet ic construction toys. 13

To better address this hazard and prevent injuries 14

before they occur, consumer advocates worked with the 15

Commission and with industry members of the ASTM F963 16

Subcommittee to create in 2011 a strong consensus based 17

standard which eve ntually became a mandatory Federal 18

standard, and upon which the CPSC now bases the proposal 1933 under consideration today. 1

ASTM F963

- 11 defines a hazardous magnet and a 2

hazardous magnetic component as one that has a flux index 3

greater than 50, and that is a sm all object. 4

F963 applies to toys intended for children under 14 5

years of age. The ASTM Working Group established a flux 6

index of 50 as a cutoff for what it considered to be a safe 7

magnet based on measurements of toys on the market. 8

CPSC is right to build upon the work of the ASTM 9

F963 Subcommittee and to take a consensus based standard to 10

address the hazard posed by rare earth magnet sets. 11

The NPR also discusses possible alternatives to the 12

proposed rule. CU does not think that alternatives such as 13

packa ging changes or warning labels are sufficient. We agree 14

with CPSC that child resistant packaging would not deter 15

teenagers from accessing the magnets, and would only be 16

effective if an adult resembled the child resistant packaging 17

after each use, which se ems unlikely. 18

Nor do we think warning labels to be sufficient. 1934

CU believes that the best solution to such a hazard is to 1

design out the hazard by applying a safety standard such as 2

that proposed in the NPR. 3

A warning cannot sufficiently apprise care give rs 4

of the serious medical consequences associated with ingestion 5

of these magnets. In addition, parents and care givers may 6

not appreciate the unique harm posed by the high strength of 7

these magnets as opposed to the hazards posed by ingestion of 8

other sm all parts, nor will many consumers, especially young 9

children who access the product, whether from parents or 10

older siblings, be able to appreciate the message 11

communicated in the warning label. 12

In conclusion, CU strongly supports adoption of 13

CPSC's propos ed rule to address the serious and unreasonable 14

risks posed by high powered magnet sets. CPSC's previous 15

actions, including improving warnings, publishing public 16

service announcements, and recalling the existing products 17

were necessary and appropriate, bu t it is clear that 18

additional steps are needed to protect public safety. 1935 Alternative proposals will not adequately address 1

the medical consequences of ingestion of these products, 2

which some have likened to gunshot like injuries, to 3

children and teenager s. 4

CPSC's proposed mandatory safety standard for these 5

magnet sets will help reduce incidences of injury to some of 6

the most vulnerable consumers. 7

CHAIRMAN TENENBAUM: Thank you. Now we will have 8

questions from our Commissioners. I have a question about 9

the flux rate. You all said you would support a flux density 10

of 50 or less. 11

Dr. Gilger, what happens if a child swallows a 12

magnet, say we did the flux rate at 50, if he swallowed 13

several magnets that had a flux rate of 50? 14

DR. GILGER: Excellent question. I think it needs 15

further study to know exactly what lowering the flux, the 16

strength of the magnets, would actually do. 17

I think what we know is these high powered magnets 18

really do not separate. I think as that flux decreases, 1936 there is probably a level at which they will separate easily. 1

An example would be the most common foreign body 2

ingested by a young child is a penny found on the floor. 3

They eat these every day. Very common. Passes right on 4

through, really of no consequence whatsoever. 5

A metall ic object that doesn't have enough strength 6

to maintain its magnetic flux most likely would pass through 7

without consequence. 8

CHAIRMAN TENENBAUM: We don't know if 50, if we 9

dropped it to 50 as a threshold, would allow the object to 10

pass through? 11

DR. GILGE R: I don't think we know that for a fact. 12

I think there is reasonable suspicion that would be correct, 13

but I think those types of things need further evaluation. 14

CHAIRMAN TENENBAUM: Ms. Weintraub, you mentioned 15

in your presentation that you urged the CP SC to promulgate a 16

mandatory standard for these magnet sets under Sections 7 and 17

9 of the Consumer Product Safety Act rather than a ban under 18

Section 8, that A Promulgating a rule under Sections 7 and 9 1937 provides an effective framework for manufacturers who may 1

want to enter this product market. @ 2

Do you want to elaborate on that a little bit? 3

MS. WEINTRAUB: Sure. Our analysis was based on 4

the fact that if there was a rule that clarified what the 5

parameters were for manufacturers who may want to enter the 6

m arket, that would be even more effective than a straight out 7

ban. The consequence would be the same in terms of the 8

magnet sets that we are seeing on the market would not be 9

permitted to be sold, and it would also provide a framework 10

in which future produ cts could be developed. 11

CHAIRMAN TENENBAUM: We have banned very few 12

products over the course of decades. Lawn darts was one. If 13

you were looking and comparing the neodymium magnets to lawn 14

darts

-- I'm to ask you all

-- do you think lawn darts are 15

more dangerous or the neodymium magnets? 16

MS. WEINTRAUB: I think one thing that is certainly 17

clear is the hazard of lawn darts is not hidden. I think it 18

is much more clear what the consequences would be to the 1938 user, to the purchaser of a product like that. 1

I t hink for these magnet sets, it is very much 2

hidden, and I think it is not at all as clear what the 3

consequences are. I also think it is much more likely 4

because these products are so small in the way in which they 5

are used that what happened to the patien t that Dr. Gilger 6

described, that these things could be on the floor with a 7

parent not knowing, is very likely. 8

The hidden nature of this hazard is extreme and 9

problematic. 10

CHAIRMAN TENENBAUM: Dr. Gilger? 11

DR. GILGER: Chairman Tenenbaum, I remember pla ying 12

with lawn darts myself. It is a toy. It almost looks like a 13

weapon. It is pretty obvious to convey there might be 14

dangers involved. When I played with them, I threw them as 15

high as I possibly could throw them to come down with as much 16

force as the y possibly could. 17

The difference with neodymium magnets is they are 18

innocuous. I think we showed you, I think they look like 1939 candy. When you get a young child and show them something 1

that looks like candy, that is what they think it is. 2

Even more than that, kids experiment, and they take 3

these neodymium magnets and they mimic piercings , it is a 4

whole different ball game. I think it is the innocuous 5

nature and the fact that you get creative children playing, 6

and they will come up with creative things to do with these. 7

CHAIRMAN TENENBAUM: Ms. Gadhia? 8

MS. GADHIA: My answer is going to echo the other 9

panelists. As the parent of an 18 month old, you all know 10

very well you are intrinsically wired to keep them away from 11

sharp objects, but I think very few consumers know exactly 12

the kinds of injuries that can occur when these magnets are 13

swallowed in multiples, so the agency's approach is 14

appropriate. 15

CHAIRMAN TENENBAUM: Thank you. Commissioner Nord? 16

COMMISSIONER NORD: Thank you so much. I'm a bit 17

concer ned about the scope of the definition of A magnet sets @ 18

that we find in the NPR. In any of your views, would the 1940 definition that we have in the proposed rule cover the pen 1

example that was given early on? Do you think this 2

definition covers that? 3

MS. GADH IA: I think the agency rightfully took a 4

look at the products that were on the market, these kinds of 5

magnets. The pen example that I brought up, I actually just 6

became aware of it fairly recently as I was preparing my oral 7

testimony, it is clear this is something that has a lot of 8

potential to take off in a bunch of different directions. 9

I think it is very appropriate that the agency is 10

approaching the products that it has a lot of information 11

about. 12

COMMISSIONER NORD: I guess in my view something 13

that is intended for a pen is not something that is a 14

manipulative or construction desk toy, it seems on its face, 15

it wouldn't be covered by the definition that we have. 16

Hence, I'm wondering whether the scope of the definition in 17

the rule is appropriate. 18

I'm also curious about whether this definition 1941 picks up magnets that are intended for scientific purposes or 1

for crafting. I recently read an article in a national 2

magazine that is intended for potters in the ceramics 3

industry where it was suggested that thes e magnets have a use 4

in a pottery studio, just to give you an example of something 5

that perhaps our staff wouldn't have anticipated but is a 6

very useful use for these magnets. 7

Do you see it as appropriate to exclude magnets 8

that a crafter might use or some body using it in a science 9

kit for scientific experiments or for doing art projects and 10

that kind of thing? 11

MS. GADHIA: I think the agency staff is working 12

very hard to build the body of knowledge in the database 13

information and the previous steps taken o n these particular 14

magnet sets to build to the definition that is in the current 15

NPR. 16

It is clear from the link I just found very 17

recently that these uses are something that are changing and 18

morphing every day. We would urge the Commission to continue 1942

to study those new and emerging uses the way they have 1

studied so well the hazards presented by these magnets. 2

COMMISSIONER NORD: Okay. I take it you don't 3

think the data supports an expansion of the definition beyond 4

what is there? 5

MR. GADHIA: I think wh at is in the NPR is very 6

appropriate and what is clear is the hazard is ever changing, 7

and we know the agency likes to stay on top of emerging 8

hazards. 9

COMMISSIONER NORD: The definition in the NPR is 10

really keyed on the intent of the manufacturer. With r espect 11

to individual magnets, if a manufacturer makes them and sells 12

them to all comers, then I presume that manufacturer probably 13

wouldn't fit in this definition because it is not marketed 14

primarily as a manipulative or construction desk set. 15

I guess CFA argues we should keep in the individual 16

magnets' provisions of the NPR, but it just seems to me it 17

may be a provision that is so easily avoided, I'm just 18

wondering whether it really serves its purpose. 1943 MS. WEINTRAUB: We would argue, as you stated our 1

posi tion accurately, that individual magnets that can be used 2

in magnet sets should be subject to the same rules, because 3

they can be used in the same way. 4

COMMISSIONER NORD: Isn't it the manufacturer's 5

intent that is the key here in the definition? 6

MS. WEIN TRAUB: I think that is important. 7

COMMISSIONER NORD: It says it on its face. 8

MS. WEINTRAUB: Yes, I think it does. I think CPSC 9

needs to look broader and look at how these things would be 10

used. 11

COMMISSIONER NORD: You think we should expand the 12

scope a little bit? 13

MS. WEINTRAUB: I do. 14

COMMISSIONER NORD: Okay. Thank you. I'm tempted 15

to get into a discussion of how this rule would interact with 16

our 1110 rule and what kind of certificate would be needed, 17

given this conversation about a ban and a rule, and it really 18

is a ban except its being cast in terms of a rule. 1944 I think I'm going to forego that. Dr. Gilger, in 1

your testimony, you indicated there are additional things the 2

agency should be doing, including public education. I'm just 3

wondering what an effective public education campaign would 4

look like. 5

In your view if the agency were to do a one shot 6

public service announcement, would that be sufficient, or 7

does it need to be an ongoing effort? 8

DR. GILGER: Excellent question, of course. I 9

would say with physicians, we have what is called continuing 10

medical education, meaning I know myself I have to have 11

something repeated at least seven times until I remember it. 12

I think the essence is yes, we have to always be 13

constantly reminded of the dangers. These types of neodymium 14

magnets remind me of a product that simply has unintended 15

consequences. 16

I don't think for a minute that the manufacturers 17

when they came out with this toy just a matter of a few years 18

ago had any idea of the consequences of the magnets. I think 1945 now they do. 1

COMMISSIONER NORD: How do you educate the medical 2

community and the public? Again, I assume a one shot PSA is 3

not probably going to do it in your view, putting words in 4

your mouth. Does it have to be continuing? 5

DR. GILGE R: I think it has to be continuing. 6

There are some very good materials out now by CPSC which are 7

very to the point and very effective. I don't think that it 8

is widely known. 9

COMMISSIONER NORD: Have you seen a growing 10

awareness in the medical community about this and then as a 11

corollary, within those doctors' patients' community, about 12

this danger? 13

DR. GILGER: There is definitely a growing 14

awareness. I can just reflect back to even a year and a half 15

ago where when I realized what was happening with th ese 16

magnets, just in Texas, I went down to our emergency room and 17

I asked the first emergency room physician I came to, tell me 18

about these things and what kind of problem you are having. 1946 They looked at me with blank eyes, had no idea. 1

This is only a year and a half ago. We have a lot of work to 2

do. 3

COMMISSIONER NORD: Do you think if you went and 4

asked the same question today, there would be still blank 5

eyes? 6

DR. GILGER: We are still going to find people that 7

don't know. 8

COMMISSIONER NORD: You're going to have to keep 9

pushing the information out there. When you push the 10

information out there, do they understand the hazard? Do 11

they get it? 12

DR. GILGER: Yes. I think it's very easy to point 13

out what happens once they are ingested, and I think we are 14

g oing to learn a little bit more about this later this 15

morning. I think you can get very constructive, clear, 16

concise education that gets the point across very well. 17

COMMISSIONER NORD: Okay. You think if we were to 18

construct some sort of effort, working constructively with 1947 the medical community, to try to reach mom's and parents, 1

that is something that needs to be done? 2

DR. GILGER: Absolutely. 3

COMMISSIONER NORD: Okay. Thank you so much. 4

CHAIRMAN TENENBAUM: Commissioner Adler? 5

COMMISSIONER ADLER: Than k you very much, Madam 6

Chairman. I would point out to my colleague that the 7

definition is not just using the word A intending, @ it is also 8

using the word A marketed, @ which is to anybody who knows the 9

law, you always get two elements, you often get two elem ents. 10

One is what was the intent and the other is what 11

was the effect. I'm not sure I would agree with her that 12

A intent @ subsumes the entire concern that the Commission had. 13

I just note that in passing. 14

I did also want to make a quick observation about 15

lawn darts. One of the things that I've always found 16

fascinating about lawn darts is when I came to the Commission 17

there had been decades of concern about lawn darts which had 18

led first to very strong warnings about not using them around 1948 children, then ha d led to actual changes in marketing, such 1

that lawn darts were not sold in toy stores. They were only 2

sold in sporting goods stores or in the sporting goods area 3

of department stores. 4

Nevertheless, experience over decades demonstrated 5

that kids still got seriously injured by lawn darts, which 6

eventually led to a ban of lawn darts. 7

I'm not claiming that is an exact precedent, but it 8

is something that gives me pause. 9

What I'd like to do is ask Ms. Gadhia and Ms. 10

Weintraub a question about something you both raised, which 11

is intriguing, and I must admit it wasn't something I had 12

thought about, but I'm going to read from Ms. Gadhia's 13

testimony. 14

It says A We further urge CPSC to study magnets with 15

a flux density of 50 when aggregated continue to have a flux 16

dens ity of 50. @ That is intriguing. 17

Is this something you have any expert input on or 18

is this something you are raising as a concern that the staff 1949 ought to be focusing on? 1

MS. WEINTRAUB: It's an issue we were discussing as 2

we were preparing our comments ac tually a year ago in 3

November, and it is something we think there needs to be 4

further study on, when these magnets are aggregated, even if 5

they have a flux density of 50, what is their flux density 6

when they are altogether. Does the nature of the aggregat ion 7

actually increase the flux density or does it not. 8

COMMISSIONER ADLER: I think it is a great 9

question. I am planning to call the engineering staff right 10

after the hearing and asking if they have any information on 11

that. I appreciate you raising the issue. 12

Did you want to

-- 13

MS. GADHIA: No, I think Rachel covered what I was 14

going to say. 15

COMMISSIONER ADLER: Dr. Gilger, I'm intrigued by 16

the notion of the difficulty of making a diagnosis, because 17

this goes to whether or not we have under reporting. I can 18

certainly understand how you would have the potential for a 1950 delay in diagnosis. 1

When it gets very serious, do you think that even 2

then some of these hazards are missed, that maybe a child 3

dies because nobody ever thought to look to see what the 4

issue was, or is this the sort of thing that we may not catch 5

it right away but ultimately we are very likely to catch it, 6

or you may not have any idea one way or the other? I'm 7

intrigued by that. 8

DR. GILGER: Interesting question. The symptoms 9

are very non - s pecific early. As the injury progresses, they 10

become more obvious, as the abdominal pain becomes 11

remarkable, vomiting and other things. 12

I think when the child is known to have ingested 13

them and is being observed, the correct diagnosis will be 14

made. 15

I th ink the issue is parents may have even have 16

seen the child eat them and not think anything of it. That 17

is where the concern is and I think it will remain there. 18

COMMISSIONER ADLER: I guess the question is 1951 suppose the parents don't realize the child has i ngested it 1

and they have come in, taken them to an emergency room. Is 2

it at some point quite likely that a physician, when it gets 3

to extreme symptoms, would be able to catch this, or is it 4

still the case that maybe no one really catches the hazard? 5

DR. GILGER: I think it can be missed. The example 6

earlier by Ami about little Braylon, a family I know, that 7

child was very delayed in presentation. As a matter of fact, 8

when the child got to the initial emergency room, they were 9

sent home. It was only qui te honestly an adept nurse who had 10

watched the web and said wait a minute, I heard about these 11

things. 12

I think there is an intense education that still 13

needs to be out there, both public, mom and dad, and 14

physicians alike. 15

MS. WEINTRAUB: One point that I wanted to make 16

addressing something you said as well, something Commissioner 17

Nord said, about a year ago when my nine year old son was 18

eight, it was in August when there is a lot of attention 1952 about these products, we were reading about it in the paper 1

in t he morning as we often do, and my eight year old said all 2

of my friends have these things. He's prone to exaggeration, 3

I don't think it is all his friends, but many of his friends, 4

his eight year old friends, have these products in their 5

homes. 6

It just p oints to the need for extensive consumer 7

education. These parents don't want to place their children 8

at risk but they don't know. They see these products. They 9

think they are interesting. When we were talking about it, 10

my son said yeah, I'd like that p roduct, why don't I have it, 11

it's not fair. 12

I think it just goes to the point about education, 13

that it is something that because of how hidden the hazard 14

is, how parents don't perceive the severity of the potential 15

consequence, that education is very impor tant, in conjunction 16

with a strong rule that would design out this hazard. 17

COMMISSIONER ADLER: Thank you very much. Dr. 18

Gilger, I'm delighted to hear the vote of confidence for 1953

nurses. 1

CHAIRMAN TENENBAUM: Commissioner Robinson? 2

COMMISSIONER ROBINSON: I think I'd like to start 3

with Dr. Gilger, and thank you, all three, for your 4

thoughtful comments today. 5

Dr. Gilger, in your testimony you referred to the 6

under estimation of risk and spoke about the 400,000 7

ingestion's and the different ways in which child ren of all 8

ages take these products in. 9

Commissioner Adler was talking about the under 10

reporting, but I would like to focus on another area, and 11

that is the numbers that we actually have where there have 12

been problems. 13

In looking at the written testimon y of all the 14

people who will be talking today and the information we have, 15

the numbers of actual incidents seem to be based exclusively 16

on estimates from the NEISS data, and from the survey

-- I'm 17

sure there is a way to pronounce this but I would blow it

- - 18

NASPGHAN. 1954 You listed in your oral testimony other areas of 1

medical specialty that deal with this problem where we may 2

not actually have the numbers even where doctors know this is 3

what happened but there is any forum in which they have 4

talked about the numbers. 5

I would just like your comments, if you would, on 6

whether the numbers that we do are anywhere close to 7

accurate. 8

DR. GILGER: I would venture to guess the data in 9

the NEISS database is the tip of the iceberg. We can report 10

it. CPSC certainly ha s abilities to report it. Obviously, 11

it can make the NEISS database, but that is a serious under 12

estimation. 13

Also, NASPGHAN, North American Society for 14

Pediatric Gastroenterology, Hepatology and Nutrition. 15

COMMISSIONER ROBINSON: Thank you. I would like to 16

go back for a moment to the issue that Commissioner Nord 17

raised. I guess I would focus on Ms. Weintraub and Ms. 18

Gadhia just because you brought it up, but Dr. Gilger, if you 1955 would like to comment as well, you are certainly welcome to. 1

This definition that we have, Ms. Weintraub, I know 2

you talked about the individual magnets. Certainly, Ms. 3

Gadhia, you talked about the pen and the fact that it 4

wouldn't be addressed in our definition of A magnet sets @ in 5

this proposed standard, and we are supposed to st ay on 6

emerging hazards. 7

Have any of you given thought, setting aside the 8

size and flux index, just the definition of A magnet sets? @ 9

Obviously, this is a limited definition. We all know what it 10

is aimed at through this definition. We are seeing other 11

thi ngs. 12

Have you given thought to the wording of that 13

definition of A magnet sets @ that might help us out if we were 14

to adopt such a standard? 15

MS. WEINTRAUB: I think the definition is a very 16

good start. I think in the review of this rule, the 17

Commission sho uld look at whether there are emerging hazards 18

that should be further included. I think the definition is a 1956 very important standard by which to move forward, because I 1

think it really reflects what we are seeing in the 2

marketplace when it was drafted, but I think what is also 3

very telling is just how important the promulgation and the 4

speedy promulgation of the standard is because the market is 5

developing and the standard needs to be in place to protect 6

children from this hazard. 7

COMMISSIONER ROBINSON: Ev en though you mentioned 8

the individual magnets, at this point you wouldn't advocate 9

expanding the definition? 10

MS. WEINTRAUB: I think individual magnets should 11

be included, but I think this is a good start and I think the 12

Commission staff should consider w hether adding individual 13

magnets and looking at the marketplace, how it has evolved 14

over time, whether it should be expanded. I think it is a 15

good base from which to do a further review. 16

MS. GADHIA: I concur. We wouldn't want to delay 17

what the agency i s trying to do here, but I think if I'm 18

understanding correctly what Rachel and I were trying to get 1957 at in our respective testimony was that with regard to the 1

individual magnets, it not essentially become a work around 2

to making sets available to consumer s through a big bin full 3

of individual magnets. 4

Yes, there are other uses out there like jewelry, 5

like this pen, which I think is the subject of a kick 6

starter, so it may not even exist yet. Clearly, it's moving 7

in other directions and it's going to need the same kind of 8

study and consideration by agency staff. 9

MS. WEINTRAUB: The concern with individual magnets 10

could be it could end up being a loophole around this 11

important standard, and it's also important for compliance 12

staff and enforcement staff to en sure that there is 13

widespread compliance with the standard when it is 14

promulgated. 15

Our point was we don't want there to be a loophole 16

that is inadvertently created by not covering individual 17

magnets. 18

COMMISSIONER ROBINSON: Dr. Gilger? 1958

DR. GILGER: I would just add that I think it is 1

the appropriate starting place for this common sense 2

approach, but human ingenuity is remarkable, and we are going 3

to see another 100 plus uses of these in a variety of 4

different forms that I can't imagine right now. 5

I just le arned about the pen in the past month. 6

It's remarkable. Technically, it can cause exactly the same 7

problems once it breaks apart. 8

How we define it? I think we need to really look 9

closely at that, but I think this is the appropriate starting 10

place to a ddress the current issue. 11

COMMISSIONER ROBINSON: Thank you all. 12

CHAIRMAN TENENBAUM: Commissioner Buerkle? 13

COMMISSIONER BUERKLE: Thank you, Madam Chair. Let 14

me begin by thanking all the members of the first panel for 15

your compelling testimony, for being here today, and for your 16

concern and interest about safety, especially among children. 17

I wanted to just kind of pick up where some of my 18

colleagues have talked about education, because I think 1959 education is where this should start. Dr. Gilger, you talked 1

about prevention. I think the way we prevent this is through 2

education. 3

I'd like to ask each one of you, can you tell me 4

and the rest of the Commissioners, what have your 5

organizations been doing to educate the public about this 6

potential risk? Rachel, i f we could start with you. 7

MS. WEINTRAUB: Sure. Like I said, I think 8

consumer education is very important but I think it is not 9

the sole solution, that a strong standard is very important 10

to design out the hazard. 11

Actually, our work has involved somethi ng 12

unprecedented, not only can I now perhaps appropriately 13

pronounced A NASPGHAN @ but I first found out about NASPGHAN 14

and started to work with them about this issue, and Consumers 15

Union, NASPGHAN and AAP have been working together for well 16

over a year now. 17

Working together, we have had periodic meetings at 18

different times, really organizing each other, having 1960

educational sort of seminars that we have had for members and 1

colleagues to truly educate, educate our members about the 2

hazard. 3

I think this is act ually rather unprecedented in 4

terms of the meetings that we have had and participated in to 5

get the word out. We have also issued a number of press 6

releases and have coordinated, had different panels at 7

conferences, where it has been a concerted effort to get the 8

word out. 9

COMMISSIONER BUERKLE: Have any of those meetings 10

and collaborations, which sound extremely important, resulted 11

in a public service campaign, other than a press release? 12

I think we have seen with SIDS and balloons, very, 13

very effective educational programs, where we have reduced 14

injuries from balloons and ingestion of them by 50 percent. 15

We were always taught to put our kids on their 16

stomachs when we laid them down, and now, my kids will say to 17

me, no, mom, no, no, they have to be on t heir back. That is 18

the result and effectiveness of public education. 1961 My concern is how can we educate when someone goes 1

into the emergency room, Dr. Gilger, this would probably be 2

best directed to you, when a child is brought into the 3

emergency room, how do we get physicians to immediately think 4

this could be

-- they think in terms of appendix

-- how can 5

we educate them and what has the American Academy of 6

Pediatrics doing about educating physicians? 7

Is there a blanket education program? Is there 8

somethin g included in medical school curriculum? How is this 9

being disseminated among our physicians? 10

DR. GILGER: A project in progress. The AAP in 11

concert with NASPGHAN has produced a series of webcasts, 12

websites, physician education seminars. There have bee n a 13

series of education seminars in medical schools across the 14

country, specifically pediatric departments, grand rounds, 15

that sort of thing. 16

I was actually encouraged recently, our Chief of ER 17

at Children's Hospital in San Antonio is actually an 18

authority on this topic. 1962 I think we are getting to people. I think we have 1

a lot of work to do. 2

In terms of medical school curricula, that is a 3

really interesting question and I will investigate that 4

personally at Baylor. I don't think so. I don't think it's 5

in the curricula. 6

I do know that when we train our residents, our 7

next generation of physicians, this is in there, when we 8

discus foreign body ingestion by children, I have included it 9

because it is part of what I do, but it is across the banner. 10

I think also with American Academy of Family 11

Practitioners and with our surgical colleagues, pediatric 12

surgical scenario's, they are now exquisitely aware of the 13

consequences of these magnets, but there is no question there 14

is more work to do. 15

COMMISSIONER BUERKL E: Thank you. 16

MS. GADHIA: Consumer Reports has written about 17

this going back over a year. We conducted interviews of some 18

of the victims and their families and we did a video on 1963 Consumer Reports on line to show to our subscribers and 1

people who come to the website, and the content is not just 2

available to subscribers but all consumers, of exactly what 3

is involved. The visual is always very helpful. We have put 4

video as well as text on our website to walk through the 5

hazard and nature of the concern

. 6

We have written about it several times since the 7

issue first started to crop up last year. We continue to 8

write about it. One of our writers participated recently in 9

a webinar with NASPGHAN doc's to inform, as I understand it, 10

State Department of Publi c Health and Poison Control folks 11

about the hazard, to begin to bring them up to speed. 12

We continue to get the word out and we will 13

continue to push on those fronts. 14

COMMISSIONER BUERKLE: Thank you. Dr. Gilger, to 15

your point about reaching beyond the pe diatric community 16

especially when you are talking about adolescents and making 17

sure family practice physicians and internists are aware of 18

this as well, I would really suggest that it is incumbent 1964 upon all of us to collaboratively work with along with the 1

industry to raise public education. 2

This is such a public health threat, we should all 3

be working collaboratively with this messaging and this 4

ongoing education. I think it is going to be critical. 5

Rachel, I just have one question, if you wouldn't 6

mind cl arifying. You mentioned using Section 7 and Section 9 7

for rulemaking was more effective than using Section 8, if 8

you could just clarify that for me. 9

MS. WEINTRAUB: Sure. Our analysis was based on 10

the fact that first of all the end result would be the sa me, 11

that the product would essentially not be permitted to remain 12

on the market, so the consequence would be the same, but that 13

using Section 7 or 9 would be more instructive for future 14

market entrants, and that in moving forward, a rule that 15

would contain information such as the parameters of the choke 16

test tubes and the flux density would be more instructive, 17

and would potentially prevent other similar products from 18

coming onto the market, and the rule would be broader and 1965 more instructive in that regard. 1

COMMISSIONER BUERKLE: Thank you. Thank you all 2

very much. I yield back, Madam Chair. 3

CHAIRMAN TENENBAUM: Thank you. We thank all of 4

our panelists this morning and we will go on and move into 5

the second panel. Thank you very much. 6

For our second pan el, we have Dr. Bryan Rudolph, 7

who is the Assistant Professor of Pediatrics, Division of 8

Pediatric Gastroenterology and Nutrition, Albert Einstein 9

College of Medicine, Children's Hospital in the Bronx, New 10

York. 11

Dr. Maria Oliva

- Hemker, Chief of Pediatric 12

G astroenterology and Nutrition and Stermer Family Professor 13

of Pediatric Inflammatory Bowel Disease at Johns Hopkins 14

Children's Center in Baltimore, Maryland, and on behalf of 15

the North American Society for Pediatric Gastroenterology, 16

Hepatology and Nutriti on. 17

We have Dr. Ian Leibowitz, Assistant Professor of 18

Pediatrics, Department of Pediatrics, Virginia Commonwealth 1966 University, and Director, Pediatric Digestive Diseases Center 1

at Inova Fairfax Hospital for Children in Fairfax, Virginia. 2

We have Dr. Marsha Kay, Chair, Pediatric 3

Gastroenterology, Director of Pediatric Endoscopy, Cleveland 4

Clinic Children's Hospital in Cleveland, Ohio. 5

I am so impressed with all of your accomplishments 6

and titles, that I hope I did them all justice. 7

Typically, we are allowing our panelists to have 8

ten minutes, and if you look over here to Todd Stevenson, he 9

will give you the sign when it is five minutes remaining and 10

two minutes remaining, and then we will ask questions from 11

all the Commissioners. 12

Dr. Rudolph? 13

PRESENTATION OF DR. BRYAN RUDOLPH 14

DR. RUDOLPH: Thank you very much. I appreciate 15

the opportunity to be here today. Good morning to you all. 16

My name is Dr. Bryan Rudolph. I am Assistant 17

Professor of Pediatrics at Children's Hospital in Montefiore, 18

and a practicing pedi atric gastroenterologist and member of 1967 NASPGHAN, North American Society for Pediatric 1

Gastroenterology, Hepatology and Nutrition. 2

The focus of my comments today is on the 3

demographics of magnet ingestion's. I'd like to start by 4

echoing the statements of t he previous panelists and the 5

panelists up here by offering my own strong support for the 6

Commission's proposed safety standard for high powered magnet 7

sets. 8

I firmly believe that these products are 9

fundamentally unsafe and pose an unnecessary risk to 10

chi ldren. 11

For the past several years, pediatric 12

gastroenterologists have been on the front lines of this 13

national epidemic. Increasingly, there is a growing body of 14

medical literature documenting what we have known 15

anecdotally, that is high powered magnets i ngestion's are 16

common, they are dangerous, and they occur across all 17

pediatric age groups, including frequently in older children 18

and in adolescents. 1968

Much of this literature followed a NASPGHAN member 1

survey conducted from July to October 2012. This surve y 2

included responses from 201 pediatric gastroenterologists 3

from 44 states. NASPGHAN researchers identified 481 cases of 4

documented magnet ingestion's in children over a ten year 5

period with 320 occurring over the previous three years. 6

The high frequency of magnet ingestion's in the 7

latter time period corresponds to the introduction of rare 8

earth magnet sets to the market. 9

It's likely that this NASPGHAN survey under 10

estimates magnet ingestion's because pediatric 11

gastroenterologists were the only group sur veyed. A variety 12

of other specialists treat these ingestion's, including 13

pediatric surgeons, general pediatricians, family 14

practitioners, and emergency room physicians. 15

NASPGHAN researchers were able to obtain detailed 16

clinical data on 123 of these cases. Similar to other 17

foreign bodies, children between the ages of 13 months and 18

six years appear to be at the highest risk for ingestion. 1969 This age range accounted for slightly greater than 1

50 percent of ingestion's, but what is perhaps most striking 2

is the n umber of ingestion's occurring to those least 3

amenable to adult supervision, that is older children and 4

adolescents. 5

Magnet ingestion's were identified in 15 children 6

between the ages of six and nine years; 24 children between 7

the ages of nine and 12; 15 c hildren between the ages of 12 8

and 15; four adolescents between the ages of 15 and 18. 9

Most of the older children who ingested high 10

powered magnets did so accidentally while mimicking facial 11

piercings ; 12 percent of the ingestion's occurred in 12

developmenta lly delayed children, and five percent had a 13

diagnosed psychiatric condition. 14

Within the past year alone, there have been at 15

least seven additional published reports on high powered 16

magnet ingestion's affecting children in the United States. 17

An article p ublished three months ago and drawn from the 18

National Electronic Injury Surveillance System data estimates 1970 that 16,386 children visited an emergency department in the 1

United States over the past ten years, that is from 2002 to 2

2011, for possible magnet ing estion's. Of those, 45.3 3

percent occurred in children over the age of five. 4

The other six studies were all case series of 5

varying sizes in pediatric centers throughout the country, 6

Boston, Atlanta, Honolulu, Southern California, Buffalo, and 7

Seattle, all detailed ingestion's by adolescents and older 8

children. 9

Ingestion's involving toddlers are somewhat easier 10

to understand, as Dr. Gilger pointed out previously. These 11

toys are small, usually brightly colored, and often comes 12

with hundreds of individual mag nets to a pack. It is easy 13

for a care giver to lose individual magnets and even easier 14

to see why a child might be attracted to them. 15

The consequences of accidental magnet ingestion's, 16

however, are serious and potentially fatal. Approximately 17

six months ago, an 19 month girl who swallowed six of these 18

magnets required a colonoscopy at my institution. 1971 The mother was well educated, loving, and by all 1

measures, a good parent. The toddler found and swallowed the 2

toy magnets after they were accidentally drop ped by an older 3

sibling. Our patient was lucky and we were able to remove 4

the magnets endoscopically, and she was discharged home the 5

following day. 6

One toddler in Mississippi, who you already heard 7

about, Braylon Jordan, was not as fortunate. His parent s 8

accidentally dropped several magnets on a carpeted floor 9

prior to putting the magnet set away. 10

After finding the magnets and ingesting them, 11

Braylon required multiple abdominal surgeries, and has lost 12

the majority of his small intestine. He currently requires 13

an essential I.V. catheter for nutritional support, and will 14

need an intestinal transplant most likely in the coming 15

years. 16

This is not an issue of poor parenting. These 17

magnets are accidents involving an irreparably unsafe 18

product. There is no amount of warning or parental diligence 1972 sufficient to completely prevent accidental injuries in 1

children. 2

We have seen a dramatic increase in high powered 3

magnet ingestion's despite multiple product warnings, 4

widespread press and exhausted advocacy effort s, and 5

remember, ingestion's occur in older children as well as 6

toddlers. 7

Ultimately, removing high powered magnets from the 8

market constitutes the only course of action to adequately 9

reduce ingestion's and their associated injuries. 10

Unfortunately, high powered neodymium magnets are 11

no longer just found in desk toys and a variety of new 12

novelties are quickly appearing on the market, as you heard 13

about earlier. 14

A quick Internet search, for example, shows small, 15

individual neodymium magnets in a variety of shapes, sizes 16

and colors. 17

I guess it is two weeks ago now that I also came 18

across the Polar Pen on Kickstarter, which is a ball point 1973 pen comprised entirely of small interchangeable neodymium 1

magnets. In fact, the magnet components are similar in size 2

to the very product the proposed safety standard intends to 3

address. 4

The Polar Pen is being manufactured and will soon 5

be shipped all over the world including to consumers in the 6

United States. 7

I urge the Commission to quickly finalize its 8

proposed safety standards for high powered magnet sets and 9

ensure that the proposed definition of A magnet sets @ captures 10

new high powered magnet novelties such as the Polar Pen. 11

A consequence of small rare earth magnet 12

ingestion's in children can be catastrophic and are 13

completely preventable. 14

The longer these products remain commercially 15

available, the longer our children are needlessly exposed to 16

danger. 17

Thank you. 18

CHAIRMAN TENENBAUM: Thank you. Dr. Oliva

- Hemker? 1974

PRESENTATION OF DR. MARIA OLIVA

- HEMKER 1

DR. OLIVA

- HEMKER : Good morning, Chairman Tenenbaum 2

and Commissioners Buerkle, Nord, Adler and Robinson. 3

My name is Dr. Maria Oliva

- Hemker. I am the Chief 4

of Pediatric Gastroenterology and Nutrition and Stermer 5

Family Professor of Inflammatory Bowel Disease at the 6

Childr en's Center at Johns Hopkins and the John Hopkins 7

University School of Medicine in Baltimore, Maryland. 8

Thank you for the opportunity to present testimony 9

regarding the Commission's proposed standard to reduce the 10

risk of injury associated with magnet ing estion's in 11

children. 12

Specifically, I am here to offer comments on behalf 13

of the North American Society for Pediatric Gastroenterology, 14

Hepatology and Nutrition, which we now know goes by the name 15

of NASPGHAN. My comments are to demonstrate the correlatio n 16

between the emergence of high powered magnet sets in the 17

commercial market and the rise in the incidents of high 18

powered magnet ingestion's. 1975 Information from the medical literature tells us, 1

as you have heard, that about 80 percent of foreign body 2

ingest ion's occur in children. As experts in foreign body 3

ingestion, pediatric gastroenterologists expect most 4

gastrointestinal foreign bodies to pass spontaneously without 5

symptoms. 6

Only about 10 to 20 percent require endoscopic 7

removal, and less than one pe rcent require surgical 8

intervention. Surprisingly, even sharp objects like needles 9

and pins usually pass without incident. 10

High powered magnets, however, as we have heard 11

today, are different from other ingested foreign bodies. 12

These types of magnets ar e being increasingly ingested and 13

can seriously injure the GI tract, as you have heard. 14

Unfortunately, because the ingestion of high powered magnets 15

may initially cause no symptoms, there can be a marked delay 16

in diagnosis and treatment. At times, the in gestion is not 17

discovered until the child presents with signs and symptoms 18

of intestinal obstruction or perforations. 1976 NASPGHAN became aware of an apparent rise in high 1

powered magnet ingestion's in the Spring of 2012, when it was 2

noticed that more and more pediatric gastroenterologists were 3

discussing these types of cases on gastroenterology message 4

forums. 5

NASPGHAN leaders determined that a survey study was 6

needed to document any changes in the frequency of cases and 7

complications associated with these ing estion's. 8

A study survey was performed between July 26, 2012 9

and October 10, 2012. It was divided into two parts. The 10

first part of the survey was to determine the changes in 11

frequency of physicians encountering magnet ingestion's over 12

the past ten years

. 13

The second part of the survey was directed at 14

providing clinical case information on patients who had 15

ingested these neodymium magnet balls. 16

This clinical case survey concentrated on the 17

period from 2008 to 2012, and the researchers chose 2008 as 18

the st art of the clinical case review because this was the 1977 first year in which high powered or these neodymium magnet 1

ball sets were marketed and sold in the United States. 2

The first part of the survey was completed by 355 3

physicians who represented a total of 4 81 magnet cases over 4

the ten year period. 5

Respondents were 201 physicians from 44 states. 6

All the regions of the country, including Alaska and Hawaii, 7

had at least one physician who had been involved in a magnet 8

ingestion. 9

My figure here is not as visuall y appealing to 10

children as Dr. Gilger's cupcake, but it provides important 11

data nonetheless. 12

The number of cases per year increased during each 13

time period of the study. What I am showing you here is 14

using 2012 as the beginning year of the study and movin g 15

backward to the number of magnet cases that had been seen and 16

presented by the individuals, so we will show the first 17

figure, please. 18

As you can see, within a year of the study, there 1978 were 200 cases that had been reported by these physicians. 1

In blue, you see the number of cases for time period and then 2

in red is the average number of cases per year. 3

When you go back six to ten years, certainly the 4

number of cases that were reported were less. 5

So 320 of the 481 cases occurred during the past 6

three years

. 7

Turning to Figure 2, all cases reported in the 8

second part of the survey, which provided more detailed 9

information about the patients, came specifically from 10

physicians practicing in the United States. Of these 123 11

clinical cases, 102 occurred in 2011 and 2012. As you can 12

see, there was a sharp increase in the number of cases from 13

2010 to 2011 and then extending into 2012. 14

The data obtained from this survey is very 15

important in providing us with patient related information 16

and outcomes. However, thes e are individual case reports and 17

to get a sense as to whether there was a trend, an increased 18

trend in ingestion's, we needed additional information. 1979 Using the National Electronic Injury Surveillance 1

System, NEISS, database, Dr. Mazen Abass and colleague s 2

conducted a study of foreign body ingestion's in children, 3

and obtained epidemiologic data on magnet ingestion's from 4

2002 to 2011. This report is the first published study to 5

provide national estimates of emergency department visits for 6

magnet foreign body ingestion's in children, and it was 7

recently published in the Journal of Pediatric 8

Gastroenterology and Nutrition. 9

Since the NEISS database did not include an 10

officially designated category of magnets, in the study, each 11

case narrative was manually re viewed for the term A magnet, @ 12

and to further determine whether there was documentation for 13

the magnets as being round or spherical or small in size, as 14

well as how many magnets were involved in the ingestion. 15

Additional data collected included date of 16

emer gency department visit, age, gender, type of products 17

ingested and the emergency department disposition. 18

All children less than 18 years of age during the 1980 study period were included. 1

During the ten year study period, there was an 2

estimated 16,386 magnet i ngestion related emergency 3

department visits among children. These estimates were 4

derived from the 678 reported emergency department visits for 5

magnet ingestion's that were reported by these cohorts of 6

emergency departments across the country. 7

As I mentio ned earlier, there were no magnet 8

categories in the database, so most of the ingestion's were 9

actually reported under the categories of A kitchen magnets @ 10

or A toys. @ These had to be manually reviewed to extract 11

those emergency department visits that descri bed small and/or 12

round magnets. 13

With more than 16,000 magnet ingestion's, there was 14

enough information to estimate that 7,159 emergency 15

department visits for ingestion of magnets were described as 16

the magnets ingested were small and/or round. 17

Interesting ly, the patients ingesting these small 18

and/or round magnets when compared to those ingesting another 1981 type of magnet were more likely to be older than five years 1

of age, and this goes against the general trend for foreign 2

body ingestion's in children where typically it is the 3

younger children, as you have heard, who typically are at 4

highest risk for these types of ingestion's. 5

Further analysis of the cases with reported small 6

and/or round magnet ingestion's revealed that children older 7

than five years of ag e were more likely to ingest multiple 8

magnets compared to a single magnet. Those ingesting 9

multiple small and/or round magnets had a statistically 10

higher chance of being admitted, observed or transferred to 11

another hospital compared to those who had inges ted only one 12

magnet. 13

As you will see in our Figure 3, which shows you 14

both estimated total number of emergency department visits as 15

well as the estimated number of visits per 100,000 children, 16

what you see are three lines. In blue, the 5 to 13 years of 17

ag e, that is in the middle. Red, on the top, 0 to 4 years of 18

age. Purple, 14 to 17 years of age. 1982 All of the age groups had statistically significant 1

trend increases of magnet ingestion's over the ten year study 2

period. 3

The group of 14 to 17 years had alm ost no 4

documented magnet ingestion related emergency department 5

visits as you can see here until 2009, after which a 6

statistically significant rise is noted from a rate of 0.1 7

per 100,000 to 1.15 per 100,000. 8

The age group of 5 to 13 years had the largest 9

increase in those suspected to have multiple small and/or 10

round magnet ingestion's, and this is shown in the next 11

figure. The rate there increased from .02 per 100,000 in 12

2007 to 1.22 per 100,000 in 2011. This represents a 61 fold 13

increase. 14

To summarize , the ten year review of the NEISS 15

database that was independently conducted by Dr. Abass and 16

colleagues provides important information on the trend of 17

magnet ingestion's in children in the United States. 18

It was shown that during this ten year period, 1983

ther e were more than 16,000 emergency department visits for 1

magnet related ingestion's, and such visits in aggregate 2

overall increased more than eight

- fold. 3

Importantly, it shows that magnet ingestion's began 4

to increase in 2009. This was following a drop in cases from 5

2007 to 2009. We speculate that the drop in cases from 2007 6

to 2009 is attributed to the Commission's recall of numerous 7

toy products that contained high powered magnets and 8

adherence to toy safety standards. 9

The increase in magnet ingestion's correlates with 10

2009 being the first year of significant sales of high 11

powered magnet sets. For example, based on data available 12

from one company alone, 1.5 million units of Bucky Balls were 13

sold between 2009 and 2011, and other companies have similar 14

hi gh sales during that time period. 15

Critics of the Commission's proposed high powered 16

magnet safety standard have suggested that the Commission's 17

estimate of ingestion's of magnets from magnet sets is 18

overstated. We disagree. 1984 In fact, it is highly possible that some number of 1

the estimated 16,380 magnet ingested related emergency 2

department visits not classified as high powered magnets 3

could be attributable to those high powered magnet sets, 4

however, it is just that many of the NEISS reports did not 5

include sufficient detail to place them in that category. 6

Therefore, our numbers most likely underestimate 7

the prevalence of these ingestion's. 8

On behalf of NASPGHAN, I urge the Commission to 9

finalize this year its proposed safety standard for high 10

powered magnet sets. The sales of these sets by multiple 11

manufacturers indicate there are billions of high powered 12

magnet balls now in our environment. 13

Consequently, the risk of ingestion of magnets by 14

children will remain high for a period of time, despite 15

efforts by NASPGHAN as well as the American Academy of 16

Pediatrics and other physician and consumer groups from whom 17

you have heard today to educate the public about these 18

dangers. 1985 Thank you very much for your time. 1

CHAIRMAN TENENBAUM: Thank you. Dr. Leibowitz? 2

PRES ENTATION OF DR. IAN LEIBOWITZ 3

DR. LEIBOWITZ: Chairman Tenenbaum, thank you for 4

inviting me to come and speak here today. My name is Dr. Ian 5

Leibowitz and I am Director of the Pediatric Digestive 6

Disease Center at Inova Fairfax Hospital for Children right 7

here in Fairfax, Virginia. 8

I have for 25 years been a practicing pediatric 9

gastroenterologist, a member of NASPGHAN, which I won't 10

repeat the entire name, and Chair of the Clinical Care and 11

Quality Committee for that same organization nationally. 12

The fo cus of my comments today is in the management 13

and interventions required for these types of high powered 14

magnet ingestion's, and I will make every effort not to 15

repeat things you have already heard. 16

In June of 2012, I and several of my pediatric 17

gastroent erology colleagues had the opportunity to meet with 18

the Commission staff to alert them to the growing incidence 1986 of high powered magnet ingestion's, which I believe they were 1

already aware of. 2

I would like to start my presentation by thanking 3

the Commission for its swift and appropriate response to the 4

growing problem of magnet ingestion's. I strongly support 5

the Commission's proposed safety standard for high powered 6

magnet sets, and would encourage the Commission to finalize 7

its magnet safety standard as p roposed. 8

One of my first encounters as a clinical 9

gastroenterologist with these magnet ingestion's was this x

10

ray, called to me by the emergency room in our local 11

hospital, where a child had been actually transferred from a 12

smaller hospital where they don' t have pediatric emergency 13

room physicians, and in response to some of the questions 14

asked before, I'd like to point out the difficulty in 15

alerting all physicians to this. 16

Many, many hospitals don't have pediatric 17

gastroenterologists, pediatric surgeons, and educating that 18

part of the population is critical, but probably will never 1987 be complete and elimination of these risk products is 1

probably the only way we will get everyone protected. 2

This was a three year old child who had presented 3

with a string of magnets in her mid

- abdomen on x

- ray, which 4

she presented with relatively vague complaints of abdominal 5

pain. She was transferred to our hospital when this x

- ray 6

was obtained and an endoscopic examination under anesthesia 7

was performed, but only one magnet remained in the stomach, 8

even though it looks like many of them were, and only one 9

magnet could be removed. 10

The next day again under anesthesia she was taken 11

by our surgeons to the operating room where initially a 12

laparotomy was obtained, which is simply to make an incision 13

and look inside. 14

What they found was multiple loops of bowel that 15

were adherent to each other and they had to open up both her 16

stomach, her small intestine and her large intestine, 17

including several areas of her small intestine, as thes e 18

magnets had attracted each other through the wall of the 1988 bowel and created multiple fistulas. 1

She spent nine days in the hospital recovering from 2

her surgery and is still followed by us, and is at risk for 3

all kinds of complications. 4

All patients with f oreign body ingestion's are 5

generally referred to emergency rooms for evaluation of the 6

type and location of the foreign body. As pointed out by 7

multiple people before me, most of these foreign bodies, 8

which are extremely frequent, pass by themselves, eve n ones 9

that would seem dangerous. 10

Unfortunately, with magnets, these ingestion's are 11

frequently not recognized immediately, and it may take time 12

for their symptoms as opposed to things like coins which 13

frequently if they are going to cause problems get l odged in 14

the esophagus and children are immediately gagging and 15

choking and sometimes even vomiting. 16

When they present with immediate symptoms, those 17

patients are almost always brought in for medical care, the 18

symptoms are relatively clear. 1989 In this patient , they were witnessed actually by an 1

older brother who watched her swallow these magnets, didn't 2

tell his parents, approximately two to three weeks before she 3

was actually brought in with her abdominal pain. 4

The vast majority of these magnet ingestion's 5

re quire some type of medical intervention. In the 2012 6

survey that you have already heard about, 80 percent 7

underwent either endoscopy, surgery, or both, a dramatically 8

different number than we would find from patients with other 9

types of ingestion's. 10

Twen ty

- five percent of the patients required both 11

procedures with the concomitant risk of multiple 12

anesthesia's, and as few as two magnets, even though I showed 13

you multiple on this patient, create this entire risk. In 14

fact, if you looked at the data, most of the association did 15

not have to do with more magnet ingestion's, as many as two 16

cause problems. 17

Endoscopy is generally minor, although if they have 18

been in for several hours, ulceration and inflammation has 1990 been noted in as many as a third of the cases. Those 1

patients that require surgery have a much greater risk of 2

morbidity, with almost half having perforations and fistulas 3

which are significant medical life time risks. 4

We have also documented cases that have led to 5

extensive loss of intestine and poten tial complications, as 6

you have heard. 7

All of these patients who have surgery are at risk 8

for strictures or narrowing of the intestines as well as 9

adhesions which are the most common cause of bowel 10

obstructions in patients. 11

These interventions are markedl y different from the 12

management of most foreign body ingestion's in children. As 13

pointed out, the large number of ingestion's requires simply 14

checking and observation and frequently no other 15

intervention. 16

Coins are by far the most common object ingested 17

but it also includes things like nails, pins, safety pins, 18

even pencils. Despite this, only ten percent or so will 1991 require endoscopic removal and less than one percent actually 1

require surgery. 2

Compare those rates to intervention for ingestion 3

of high p owered magnets, where 80 percent need intervention 4

and 20 percent may need surgery. 5

Since our initial case at my institution, we have 6

had to develop a plan for management of magnets because we 7

have had several others, and this is one of the ways 8

institutio ns can handle it, so that the emergency room 9

physicians know as a referral center, if the child gets 10

magnets, they are not to be sent home until x

- rays are 11

obtained and appropriate consultation is done. 12

As medical providers, we have had to single out 13

thes e products for special attention. Unfortunately, they 14

are attractive to little children and easy to ingest, which 15

increases the risk of complications as they can swallow more 16

than one. 17

New products seem to appear continuously using 18

different types of thes e high powered magnets, all of which 1992 put our children at risk. 1

I in my career have taken out hundreds of different 2

foreign body objects but few seem to pose the morbidity risk 3

of these magnets. 4

I urge the Commission in summary to finalize its 5

proposed safe ty standards for high powered magnet sets, and 6

to ensure that the A magnet set @ definition captures other 7

types of high powered magnets such as jewelry and some of the 8

other products you have been hearing about. 9

The risk to our children of these ingestion's is 10

significant, and more importantly, as a pediatrician, the 11

risks are entirely preventable. Designing these magnet sets 12

out of the product lines is probably the only effective way 13

to reach all of our children. 14

As a pediatrician, nothing is worse than a child 15

suffering a preventable injury. As long as these sets are 16

available, these injuries will inevitably occur. 17

Thank you for your time. 18

CHAIRMAN TENENBAUM: Thank you, Dr. Leibowitz. Dr. 1993

Kay? 1

PRESENTATION OF DR. MARSHA KAY 2

DR. KAY: I'm Dr. Marsha Kay , Chair of the 3

Pediatric Gastroenterology and Nutrition and Director of 4

Pediatric Endoscopy at Cleveland Clinic Children's Hospital 5

in Cleveland, Ohio. I am also a member of NASPGHAN. 6

I would like to thank the Commissioners, Chairman 7

Tenenbaum, Commission ers Buerkle, Nord, Adler, and Robinson, 8

and the Consumer Product Safety Commission for holding 9

today's hearing and providing me the opportunity to talk 10

about the dangers that high powered or neodymium magnets pose 11

to children. 12

In the interest of time, I wi ll focus my remarks on 13

the types and severity of injuries that result from ingestion 14

of high powered magnets and why there is a high likelihood of 15

injury upon ingestion. 16

As a physician who is an expert in the removal of 17

ingested foreign bodies, I want to e mphasize that high 18

powered magnet ingestion is different than other ingested 1994 foreign bodies. 1

Because of their small size and smooth surface, 2

ingestion of magnets may cause no immediate symptoms, 3

consequently, there can be a marked delay in diagnosis and 4

treatment. 5

Unless the ingestion is witnessed by an adult, as 6

you have heard, which is typically not the case, early 7

diagnosis is often complicated by the inability of a toddler, 8

a young child, or a child or adolescent with developmental 9

disabilities to v erbalize that an ingestion has occurred. 10

Injury from magnet ingestion occurs almost 11

immediately but initial symptoms are not unique to magnet 12

ingestion, making diagnosis difficult. 13

First symptoms, such as abdominal pain from bowel 14

trapped between magnets, may take 8 to 24 hours or longer to 15

occur. Later symptoms, such as fever and vomiting, are non

16

specific and resemble more common ailments such as an acute 17

infection, such as acute gastroenteritis. 18

Magnet ingestion's are serious and life 1995 threatening. If more than two of these high powered magnets 1

are swallowed, their attractive force allows the magnets to 2

find each other in the body. This can occur between 3

different segments of the bowel. For example, connections 4

can occur between the stomach and the sm all intestine, 5

between the small intestine and the colon, or sometimes cross 6

loops of bowel, as shown in the Figure. 7

Although the tissue of the intestinal tract is 8

tough, it is no match for these magnets. Once magnetically 9

attached across the bowel, they do not break apart or 10

separate, which can cause severe injury. 11

Ulceration can occur within eight hours or less 12

following ingestion. If left untreated, this can lead to 13

bowel wall perforation, which represents a serious and 14

immediate risk to the patient. The leakage of intestinal 15

contents into the abdominal cavity rapidly results in 16

infection and peritonitis, which is inflammation of the 17

tissues that cover the intestines and internal organs. 18

To answer the question that was asked of the first 1996 panel, this ca n be devastating and present with a child in a 1

serious condition. 2

Fistulization, which can be between the stomach and 3

the small intestine, between small intestinal loops or 4

between the stomach and the colon, are development of 5

connections between two bo wel segments not normally connected 6

caused by high powered magnet ingestion has been reported 7

frequently. In fare cases, magnets may attract across 8

several loops of bowel, causing the bowel to twist, which is 9

also known as volvulized, the twisted loop of bowel obstructs 10

the blood flow of intestinal contents, and the blood flow 11

leading to a lack of oxygen to the bowel wall and results in 12

ischemia or bowel wall death. This is a surgical emergency 13

requiring immediate operation. 14

Delay in treatment can lead to the need for 15

resecting necrotic or dead bowel. If too much bowel is 16

removed, a condition known as short bowel syndrome may be the 17

result, requiring life long intravenous nutrition, also known 18

as total parenteral nutrition or TPN, and potentially even a 1997

s mall bowel transplant, with both its morbidity and 1

associated costs. 2

In my institution, due to delay between time of 3

ingestion and the family recognizing the need to seek medical 4

attention, most patients who have suffered a magnet ingestion 5

have required s urgery as a result of subsequent 6

complications, including bowel obstruction and fistulization 7

between loops of bowel. 8

There is a spectrum of diagnostic issues, symptoms, 9

treatment requirements and injuries following ingestion. If 10

ingestion is recognized, it may be acted upon in a timely 11

way, including through endoscopic removal, which I and my 12

colleagues do, and/or surgical intervention. 13

However, even with a known ingestion, there may be 14

delay in recognition of the seriousness of the ingestion by 15

either t he family or the health care provider, which you have 16

heard testimony about today. 17

Other cases may be unrecognized until significant 18

consequences occur, and in the best case, this may yield a 1998 stable patient for whom surgery is required which may include 1

bo wel resection, and in the worse case, this may include an 2

unstable patient secondary to intestinal perforation who may 3

be septic, require admission or transfer to a pediatric 4

intensive care unit, and one or more bowel resections. 5

If the patient survives th e episode, significant 6

consequences are possible, including the need for additional 7

surgery. If the bowel is necrotic and needs to be removed, 8

the patient may develop short gut syndrome. 9

Over the long term, the patient may require 10

multiple hospitalization s due to complications, and in 11

addition, following peritonitis, there may be long term 12

fertility issues, especially in females analogous to what 13

happens following perforated appendicitis. 14

These magnet issues, ingestion issues, 15

unfortunately continue to oc cur, and patients that are cared 16

for at our hospital and medical institutions throughout the 17

country, despite educational efforts by both NASPGHAN, the 18

American Academy of Pediatrics, patient and consumer 1999 organizations, and the media, there remains a lack of 1

awareness by the lay public, primary care providers, and 2

emergency room personnel as to the potential consequences of 3

these types of ingestion's and the correct management 4

algorithms to be followed for management of magnet 5

ingestion's. 6

Additionally, bec ause patients may be initially 7

asymptomatic, the need for urgent evaluation as well as 8

urgent therapy may not be appreciated, resulting in 9

potentially devastating consequences for the patient as 10

outlined above. 11

For these reasons, I strongly support and ask the 12

Commission to finalize its proposed magnet safety standards. 13

Thank you. 14

CHAIRMAN TENENBAUM: Thank you, Dr. Kay. Thank all 15

of you for the excellent presentations and for the amount of 16

effort that you put into your presentations to let us know 17

how seri ous you think this issue is. 18

Dr. Kay, I was thinking about this as you were 19100 speaking because the cases I have read demonstrate that there 1

is a lack of knowledge about diagnosing this early. I have 2

read cases where the parents either brought the child to the 3

hospital, demonstrating flu like symptoms. 4

You said it correctly, despite the educational 5

efforts of both NASPGHAN, the American Academy of Pediatrics, 6

patient and consumer organizations and the media, there 7

remains a lack of awareness by the lay publi c, primary care 8

providers and emergency personnel about these hazards. 9

I am from a state, South Carolina, that has many 10

rural areas. You will go into the emergency room and you 11

will see a family practitioner. 12

I think it is beyond what we are able to do in 13

terms of educating all the physicians in America and 14

emergency personnel, but how could such an effort be 15

designed? We could work with FDA, HHS and other agencies, 16

but that is a very large problem, to link the time children 17

go misdiagnosed. 18

If you will elaborate on that, how can we get the 19101 word out to just family practitioners in all the states? 1

DR. KAY: I think a two part effort is required. 2

The first part, which you can be tremendously impactful on, 3

is in terms of preventing these ingestion's by re ducing the 4

availability of these products, and that is a huge impact on 5

it. 6

We as physician organizations and consumer 7

organizations and the Consumer Product Safety Commission 8

really do have a role in public service announcements. 9

It is interesting, I was at a family dinner on 10

Sunday and I was speaking with my family members about it. 11

My mom said is this like the mattresses. When we walked in 12

and I saw on the screen information that the Consumer Product 13

Safety Commission has done in terms of mattress safe ty, this 14

is the same thing. 15

This is an important area that we need to act 16

legislatively on in terms of preventing these ingestion's, 17

and then we as physician organizations and consumer 18

organizations need to get the word out to both patients, ER 19102 physicians, family physicians, about really the risk of these 1

objects that are perceived to be innocuous and harmless, and 2

how serious these ingestion's are. 3

CHAIRMAN TENENBAUM: Every state had a Medical 4

Board of Examiners that licenses physicians. They would have 5

the address of every physician, and also there is a Board of 6

Nursing Examiners. When we think about how we could best get 7

the word out, it is very difficult when no matter how many 8

PSAs you do

-- we have done over 20 campaigns here at the 9

Commission

-- i t is very hard to saturate it in such a way as 10

to inform everyone. 11

DR. KAY: I think the one thing that is interesting 12

about these magnet ingestion's is if you get a plain x

- ray, 13

you can see how obvious these are. What we need is that 14

physicians in an eme rgency room think about getting an 15

abdominal x

- ray in cases where this is a possibility. 16

More than 90 percent of foreign bodies that are 17

ingested by children are radiopaque, which means they are 18

readily seen on x

- ray. 19103 As pediatric gastroenterologists, we take care of a 1

tremendous number of foreign body ingestion's and we are 2

asked to remove those. Sometimes even for other reasons, 3

coins or things like that, the child may present with 4

respiratory symptoms. There is no history they have 5

swallowed somethin g. 6

Even getting the message out if there is a concern, 7

if a patient is presenting with unknown abdominal pain, these 8

products in the house, just get a plain x

- ray. Those are 9

very obvious immediately, and then the right algorithms for 10

management can occ ur. 11

CHAIRMAN TENENBAUM: Thank you. Dr. Rudolph, you 12

called these magnet injuries A a national epidemic. @ The 13

panel know how the injury rate and severities compare with 14

other similar childhood injuries? Is there any kind of 15

comparative study? 16

DR. RUDOLPH : Not to my knowledge. I don't think 17

this has been compared at least directly to other such 18

ingestion's, unless anyone else on the panel can correct me 19104

on that. 1

DR. OLIVA

- HEMKER: We actually do not have that 2

information although there have been a lot of studies in 3

ingestion's of batteries and other foreign objects. Based on 4

our experience being physicians that deal with foreign 5

bodies, the fact that we are seeing 20 percent of these 6

children are actually needing to go to surgery is a 7

significantly high increase compared to the one percent or 8

less that typically are associated with other foreign body 9

ingestion's. 10

Although we do not have head to head comparisons or 11

studies to be able to apply certain numbers, based on the 12

data that we have, I think we wou ld all agree these again are 13

different types of foreign bodies than what we have become 14

used to. 15

CHAIRMAN TENENBAUM: Dr. Leibowitz, do you want to 16

add anything? 17

DR. LEIBOWITZ: I would just make a couple of 18

comments. Mr. Adler asked earlier today about t he 19105

underestimation. I think we are all vulnerable to not 1

knowing the accurate details. 2

Being a veteran of many NASPGHAN surveys in the 3

past, I can speak to the fact that most NASPGHAN surveys way 4

underestimate all of the issues that we do because 5

unfortun ately, like many physicians, we are busy. We don't 6

get the kind of responses that we would like. Even looking 7

at the data, we probably got responses from about somewhere 8

between a third and a quarter of our membership, which either 9

suggests the others ha ven't dealt with this, which I think is 10

unlikely considering the frequency we have all dealt with it, 11

or they simply didn't take the time to respond. 12

The frequency has clearly gone up. I don't think 13

any of us would debate that. I think there is an uncer tainty 14

to these kinds of numbers. 15

What has impressed the NASPGHAN membership is 16

obviously the severity of the types of injury that occur with 17

these, more than the numbers themselves. 18

CHAIRMAN TENENBAUM: Certainly severe outcomes for 19106 swallowing these magne ts. That is all I have. I know 1

Commissioner Nord has questions. 2

COMMISSIONER NORD: Thank you so much, Madam 3

Chairman. Thank you to the panel. I think you have 4

certainly made the point that the medical community is very, 5

very concerned about the hazard s this product presents. 6

I guess I would just request that regardless of 7

what this body decides to do with respect to the rulemaking, 8

I would hope all my colleagues would agree that we need to 9

come together with the medical community to educate both 10

practi tioners and patients about the potential hazard here. 11

I just have one small question for you, Dr. Oliva

12

Hemker. You said in your testimony that kids older than five 13

years are more likely to ingest multiple magnets. I am 14

wondering if you can tell us why. That seems very 15

counterintuitive. I was just surprised to hear you say that. 16

DR. OLIVA

- HEMKER: As I said, about five, and the 17

teenage years. It is surprising as well. What we are 18

assuming is what we are seeing is these children are using 19107 the magnets as jewelry and piercings . This has already been 1

said. 2

Within that age range, it just so happens when you 3

swallow multiple magnets, they are in your mouth or you are 4

playing with them, these are the children that seem to be 5

swallowing them all at once at g reater numbers. 6

COMMISSIONER NORD: At what age is a child able to 7

understand danger and hazard? I'm a mom. I've raised 8

children. I know there are lots of things they wanted to get 9

into but when told no or explained about the danger, they 10

were able to p rocess that and understand it. 11

At what age does that happen? 12

DR. OLIVA

- HEMKER: Some might say there is no age 13

limit to that. There are very interesting studies coming up 14

actually in young adults showing that the mind is still not 15

fully formed to the poin t of identifying danger. 16

Here is the real issue. If a child touches a hot 17

stove or something that is sharp and cuts themselves, they 18

have an immediate reaction and response, realizing that is 19108 danger. 1

What we are dealing with here is these are objects 2

tha t are smooth, shiny and round, and nothing about them says 3

danger, whether you are two, three, or four, or 14, 15, 16. 4

It is a bit complex to think about the process that happens 5

and what the danger is that happens in your GI tract. 6

What I would say is th e issue here is you have a 7

product where the danger is not attached to the visual or 8

anything about the product. Irregardless of when children 9

understand true danger, like fire or not crossing the street, 10

not putting their hands on the stove, that wouldn' t 11

necessarily hold with a product like this. 12

COMMISSIONER NORD: I guess we see trends where 13

kids do things they think are pretty cool but are really 14

quite dangerous. We have this state of injuries with aerosol 15

cans a while back. When I was a kid, it was glue sniffing. 16

That fits into the same category that you just 17

described. Again, regardless of what this agency decides to 18

do with this particular rulemaking, it seems to me we ought 19109 to be thinking a lot more aggressively and creatively about 1

how we can a ddress this issue. 2

I hope we can count on the medical community to 3

help us do that. 4

DR. OLIVA

- HEMKER: Thank you, Commissioner Nord. 5

Your point is very well taken. There is another group that 6

we haven't mentioned here in aggregate, and that is the 7

schoo l system, and all our educators. In the last three 8

months, it was a sixth grade girl who ingested a whole series 9

of magnets. She was playing with them at school and she 10

swallowed them, and she didn't want to tell anybody, but one 11

of her classmates realiz ed it and said well, I think there is 12

something about this that's not right, and then went to the 13

teacher. 14

The teacher was unsure but she had enough sense to 15

actually call the parent, call the nurse, and say the child 16

has to be taken to our emergency depar tment, where we handled 17

things appropriately and we actually were able to remove the 18

magnets. 19110 These are now in our school systems, as stated 1

before, and that is an entire other group of individuals, our 2

teachers, our educators, that also need to be given t his 3

information. 4

DR. LEIBOWITZ: If I might add one thing, there is 5

in medicine a well known time frame of diffusion of 6

information, and it is way longer than any of us would like 7

to admit. I think we all recognize that. 8

Diffusion of information here fro m 9

gastroenterologists to emergency room, pediatric emergency 10

room doctors to adult emergency room doctors at hospitals, in 11

South Carolina, it will inevitably be a process that will 12

take more time than any of us would want to admit. 13

I just think we all need to take that into 14

consideration as we talk about what we are going to do. 15

CHAIRMAN TENENBAUM: Commissioner Adler? 16

COMMISSIONER ADLER: Thank you very much, Madam 17

Chairman. I just wanted to pose a question to the panel at 18

large, but I'm going to start wi th Dr. Rudolph. 19111 I have over the last year or so received probably 1

on the order of 3,000 very, very angry e

- mails from folks who 2

oppose any regulatory action with respect to magnets by 3

making the argument that most of these incidents would not 4

occur if pa rents were more conscientious, in other words, bad 5

parents. 6

I was struck, Dr. Rudolph, by your comment and the 7

specific example of the case that seemed so dramatic was 8

someone you characterized as a good parent, and you said this 9

is not just an issue of po or parenting. 10

I am just curious, how many of you have had much 11

experience in meeting the parents of kids who have had these 12

problems, and have you drawn any conclusions one way or the 13

other about the degree of care or carelessness of the parents 14

involve d in these incidents? 15

DR. RUDOLPH: I think the panel has much more 16

experience than me and they have seen a lot of patients that 17

have had foreign body ingestion's. I think one thing that is 18

not going to change is kids are going to swallow things. I'm 19112

sur e you have dealt with this repeatedly and we deal with it 1

on a day by day basis as well. 2

This really can happen pretty much in any family. 3

These are accidents, they happen. I've met one or two 4

families. Again, as I said in my testimony, by all intents 5

a nd purposes, they have been great parents, very concerned. 6

This particular mother didn't leave the bedside the entire 7

time, was hysterical and in tears. I really felt for her. 8

This is something that I think truly can happen. 9

These products are there, it is going to happen. They are 10

unsafe. 11

COMMISSIONER ADLER: Thank you. I'd be curious to 12

hear if any of the other panelists have drawn any conclusions 13

or made any observations. 14

DR. OLIVA

- HEMKER: What I would just say is this is 15

not an issue of bad paren ting. This is an issue of 16

availability of devices that unfortunately cause way more 17

harm than initially thought. They thought they were 18

innocuous. Many of these children are having access to these 19113 magnets outside of the home, in the school system, in a 1

friend's house, in other places, where the parent is not even 2

around. 3

I think we would be pointing in the wrong direction 4

to say this is something that would be fixed by a good 5

parent. These are all very caring and good parents. I think 6

that line of argu ment is incorrect. I would think my other 7

colleagues probably feel the same way. 8

DR. LEIBOWITZ: Far and away the most common 9

foreign body swallowed is coins. I've taken coins out of 10

famous people's children and important people's children and 11

physician colleagues' children, and physician colleagues' 12

children who are embarrassed to admit it in medical staff 13

meetings. I can't speak to what they do at home, but they 14

all seem to be extraordinarily responsible people who care 15

intensely about their children to the point of being 16

helicopter type of parents, and that doesn't seem to prevent 17

it. 18

I think magnets are no different. In fact, they 19114 cause no discomfort going down, so they may be more 1

attractive in some ways to doing multiple ingestion's rather 2

than co ins which are uncomfortable to go down. 3

Like the others, I would say the issue of parenting 4

is probably not the core issue here. 5

DR. KAY: I would concur with the previous 6

comments. This really isn't a parenting issue. It is an 7

object issue and a risk issue. In kids, sometimes the 8

ingestion occurs because one sibling feeds the object to 9

another sibling. There are a variety of reasons for it. 10

Parenting is not the cause of this, and better 11

parenting would not prevent this in any way. 12

COMMISSIONER ADLER: Dr. Kay, you commented about 13

the importance of education, as did all of you, but you also 14

seemed to feel that education by itself would not solve the 15

problem. I'm curious, if I've stated your position 16

correctly, and if any of you have additional thought s about 17

that? 18

DR. KAY: As Mark alluded to in the earlier 19115 testimony, this is a product that had unanticipated 1

consequences, it was thought to be an innocuous product. 2

Some of the prior magnet sets were actually used for kids 3

with developmental disabiliti es because they were smooth, 4

they were thought not to be sharp. 5

We can educate but we are behind the game when we 6

are educating on this. Although that is a component of it, 7

we really need to try to prevent these ingestion's, and that 8

is why we are seeki ng your assistance in that, to try to 9

offer appropriate regulations to prevent the vast majority of 10

these ingestion's. 11

COMMISSIONER ADLER: Dr. Leibowitz, anything to 12

add? 13

DR. LEIBOWITZ: No. 14

COMMISSIONER ADLER: Okay. Thank you all very 15

much. 16

CHAIRMAN TE NENBAUM: Commissioner Robinson? 17

COMMISSIONER ROBINSON: Thank you, Madam Chair. I 18

would like to preliminarily say that CPSC has the task of 19116 identifying and addressing emerging hazards, but I really 1

view doctors, hospitals, and medical organizations as be ing 2

critical partners of ours in helping us do our jobs. 3

I would first of all like to thank all of you for 4

coming here and taking the time to answer our questions today 5

and to testify, but I would also very much like to applaud 6

NASPGHAN and Dr. Abass for the effort that went into getting 7

us good information that we could not have otherwise 8

obtained, and acting so promptly and proactively. 9

In another venue, I am just reminded of this, 30 10

years ago, anesthesiologists took it upon themselves as a 11

group to fig ure out why the morbidities and mortalities under 12

general anesthesia were so high, and found wonderful ways of 13

addressing that. 14

I know it is different, but the proactivity is 15

there, and I just want to thank you and your organization 16

very much for that, in helping us do our jobs better. 17

When I asked Dr. Gilger in panel one about the 18

numbers, and I know, Dr. Oliva

- Hemker and Dr. Leibowitz, you 19117 have talked about the tip of the iceberg, as Dr. Gilger said, 1

but I noticed, Dr. Rudolph, for example, you were shaki ng 2

your head pretty hard when I asked the question. 3

If you or Dr. Kay would like to comment on that, I 4

would very much like to hear your thoughts. 5

DR. RUDOLPH: Sure. I think if you look at just 6

the case series, and I mentioned several in my testimony, 7

there were six others from across the country, there is one 8

in Boston that had 112 kids, I think. Another center listed 9

two, another listed one, one had listed eight. There is a 10

wide range. 11

Many of them were not from pediatric 12

gastroenterologists. A lo t of them were from surgeons. A 13

lot of them were ingestion's elsewhere, outside the GI tract. 14

The data we have I don't think really does justice 15

to the magnitude of this issue. 16

DR. KAY: I'll just give you an anecdotal story. 17

Ten days ago we had our n ational meeting. At our meeting, I 18

was one of the faculty in an endoscopy course. I met a young 19118 Fellow who was training in New York, a young lady who was 14 1

months into her fellowship. She had already encountered 2

these neodymium magnets five times in th ose 14 months, and 3

she's not on call every day. 4

The incidence of this is escalating, it is despite 5

actions to withdraw some of these products from the market. 6

We really don't know the total numbers. What happens with 7

case reports is as something that ha s been published a number 8

of times, as editors of journals, we say it is already 9

published, it is already known, we are not going to 10

necessarily accept that. 11

The case reports don't keep up with really the true 12

frequency of these ingestion's but they are ha ppening 13

throughout the country. I'm sure they are happening 14

throughout the world. Like I said, this really just 15

represents the tip of the iceberg of what's going on. 16

COMMISSIONER ROBINSON: All of you today at some 17

level have addressed the fact that thes e kinds of injuries 18

that occur with the magnets require long term care. I 19119 wondered and I know all of you are qualified to answer this 1

question, so I don't really care who decides to respond, but 2

I would very much like a little bit of amplification

-- I 3

un derstand the long term care, for example, of fistulas would 4

be very different than a bowel resection. 5

I just wondered if one of you could just address 6

what we are talking about, if a young child, for example, has 7

a bowel resection, in terms of long term ca re. 8

DR. KAY: If a child loses a substantial part of 9

their bowel, and we will say 50 percent of their small 10

intestine, as was alluded to, they typically require 11

placement of a catheter, for which the family will need to 12

administer nutrition every single d ay and night, because they 13

can't absorb nutrients adequately through the GI tract. 14

Those catheters are associated with a high risk of 15

infection, even in the best parenting situations. The child 16

may be admitted repetitively to the hospital for septic 17

episo des associated with that catheter. Typically, the 18

catheters need to be replaced, so they need to undergo 19120 repetitive surgical procedures. 1

Despite advances in nutrition, a lot of times long 2

term intravenous nutrition, and we know this from babies who 3

have a condition of colitis, who ultimately develop liver 4

disease as a consequence and stage liver disease, so patients 5

may need a liver transplant, they may need a small bowel 6

transplant. Those procedures cost hundreds of thousands of 7

dollars on an individual basis, up to $1 million, and are not 8

always successful. Even if you get a liver transplant or a 9

small bowel transplant, you may not survive that for more 10

than five years. 11

The cost to an individual patient or the health 12

care system may be $1 million or mor e for a child who suffers 13

and needs a bowel resection from one of these ingestion's. 14

Just from a financial aspect, these are really 15

devastating to the family in terms of the child's life 16

expectancy, the quality of life, and finances for the family 17

and the health care system. 18

COMMISSIONER ROBINSON: Thank you. I would also 19121 like to know if any of you have any thoughts with respect to 1

this definition of A magnet sets, @ given what you are 2

encountering, and whether you think it is broad enough. 3

DR. LEIBOWITZ: I think we would all agree that 4

this is the beginning of a process and we would be obviously 5

in favor of moving forward with as far as we have gone. 6

It is always difficult to predict the future, but 7

having seen the evolution of the use of these kinds of 8

ma gnets over the last couple of years, in a million different 9

ways, I think we all expect them to continue to expand and 10

continue to be new ways found. 11

How many of them will be something we can address 12

or that require addressing, I think is uncertain, but I think 13

we are all very, very concerned that even with the absence of 14

these, that you all will be dealing with this issue again in 15

the future unless the rules are significant enough to predict 16

for the future, which I think is very hard. 17

COMMISSIONER ROBINSO N: Thank you all very much. I 18

would only like to say in concluding that if you think of any 19122 ways in which your organizations can give us information, we 1

are a data drive organization, and we are looking for the 2

best information we can find, and we really appreciate this 3

very much. Thank you. 4

CHAIRMAN TENENBAUM: Commissioner Buerkle? 5

COMMISSIONER BUERKLE: Thank you, Madam Chair. I 6

want to concur with my colleagues, thank you all very much 7

for being here, for being on the front lines, for bringing 8

this critical information to us. 9

You all present, as I mentioned to the first panel, 10

very compelling information to us. 11

I just want to continue on with this education 12

suggestion because as you were talking, you mentioned it and 13

preempted my question, what abo ut schools? We have anti

14

bullying campaigns. We have massive educational efforts to 15

educate our kids about dangers. 16

Is there anything that is being done right now? 17

Certainly, that would address the problem of rural areas or 18

at least help to, and should be considered a component of 19123

this collaboration of education efforts? 1

DR. OLIVA

- HEMKER: You are certainly right. We as 2

physicians, while we have started the processes of 3

collaborating with other multiple physician groups, as you 4

have heard, as well as o n our own and with other groups 5

trying to educate the public directly, and school teachers 6

are part of the public, but certainly additional campaigns 7

are going to be required to that effect. 8

Again, I guess I would stress that clearly we need 9

education beca use as I mentioned, even if these magnets 10

stopped existing now, there are so many in the environment, 11

billions in the environment, that still education is going to 12

be needed, but we stress the fact that ultimately education 13

is not going to solve the proble m, that more likely removal 14

of these products in some shape or form is getting to the 15

root cause of the problem and will be more beneficial to the 16

children in the long run. 17

COMMISSIONER BUERKLE: Thank you. I should have 18

said this first time around but I want to thank the Chair for 19124 extending the comment period for a week. I think that has 1

given the confusion about this morning's hearing. I think 2

that is the appropriate thing to do. I want to thank you for 3

doing that. 4

Again, thank you to all our experts here this 5

morning and the testimony you have given. It is all very 6

compelling and I thank you for being here. 7

CHAIRMAN TENENBAUM: Thank you all very much again. 8

We look forward to being partners with you. Perhaps we can 9

design and work together on edu cation campaigns. We 10

appreciate you spending the time you have with us this 11

morning. Thank you. 12

(Whereupon, at 12:15 p.m., the hearing was 13

concluded.) 14

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