Title: RECOMMENDATION ON THE RISKS OF ACCIDENTAL INHALATION OR INGESTION OF SMALL OBJECTS BY
1RECOMMENDATION ON THE RISKS OF ACCIDENTAL
INHALATION OR INGESTION OF SMALL OBJECTS BY
- Dr Georges GARCIA-BARDIDIA
- Assisted by Odile FINKELSTEIN, Jacques BEDOUIN et
Patrick MESNARD, technical advisors
2DEFINITIONS
- INGESTION
- Introduction through the mouth of alimentary
solid or liquid substances that afterwads get
through the sophagus - INHALATION
- Accidental (except in the case of the absorption
through the airways in a curing purpose, of
gaseous or liquid substances) penetration in the
airways of solid or liquid substances (what they
call false passage )
3THE CONSEQUENCES OF INHALATION OR INGESTION OF
FOREIGN BODIES
- Foreign bodies that provoke food choking and
fall in the airways - Foreign bodies that follow the normal tract but
provoke problems because they are inedible
4THE NATURE OF THE FOREIGN BODIES
- Children under 3 80
- Peanuts 50
- Other vegetables (walnuts, hazel nuts, almonds)
between 20 and 25 - Metallic objects (needles) decreased and
replaced by plastic objects (15 ) tokens,
pearls - Other 10 à 15
- Adults
- Food represents most of the inhaled bodies (meat,
fruits, vegetables) - Dental protheses or fragments (dental or
maxillofacial surgery)
5LOCALISATION OF THE FOREIGN BODIES
- Sharp or prickly (piece of glass, needle, pin)
respiratory distress in all the stages of the
bronchial tree - Round FB go through more easily. More severe
obstruction - Soft FB (piece of plastic, balloon fragment)
cause of a valve phenomenon - Metallic FB better tolerated by the bronchial
mucosa than alimentary FB
6SYMPTOMATOLOGY
- Hypopharynx deglutitive disorders
- Larynx asphyxia soon fatal
- Trachea slowing down of breath (whooping-cough
like) - Bronchial tubes symptomatology varies
7EMERGENCY MANEUVERS (continuation)
- Moderate or even no respiratory distress calm
down the patient, place him in a comfortble
position but avoid mobilizing him. Avoid any
misplaced maneuver. Call the emergency units - Vital emergency
- Heimlich maneuver brutal intra-tracheobronchial
suppression. Makes the air in the airway move
powerfully enough to evacuate the FB to the oral
cavity.
8THE LEARNING OF FIRST AID GESTURES
- The unblocking of the airways is taught by
registered associations or bodies (RED CROSS). - France is lagging behind the other European
countries (10 are trained for 30 in Denmark) - This type of accidents takes place almost
exclusively in home environment or sphere - Law n 2004-811 of 13 August 2004 on
modernisation of civil safety should help make
schools aware of the necessity of teaching
children the first aid gestures (experiment in
Picardy) - Go further and make the consumers aware (posters
in restaurants like in the US, in cafeterias, in
institutional and school caterings, in old
peoples homes)
9ESOPHAGEAL FOREIGN BODIES
- Heavv or bulky objects (coins? chicken bones)
- Blocked in the third top part of the esophagus.
Unnoticed phase often discovered several months
later. - Specific risk the button cells (electronic
toys, audiovisual aids, watchmaking). The dangers
comes from the liberation of corrosive and toxic
electrolytic products (mercury, zinc, silver,
acid) damaging and sometimes perforating the
digestive wall (several deaths in the US and in
Japan) - Absorption unnoticed abdominal pains, radio of
the abdomen shows the presence of the button
cell - Absorption known take the child to the hospital
for a radio to know at what level of the
digestive tract the cell is located - Elimination as quickly as possible by
gastrointestinal or esophagial endoscopy
10FATAL CASES
- Toys
- 18 months girl. Inhalation of a rubber
super-ball (SAMU 92) - 9 year old girl. Inhalation of pawn of a
RAVENSBURGER EM6 game - Sweets
- 15 months. inhaled a multicolored drop neckladce
(SAMU de Grenoble and a hospital doctor) - 2 ½ year-old girl. Ingestion of a Push-push
ARTIC ice-cream. Choked because the malabar was
too deep in the airways. The product was
immediately withdrawn from the market by ARTIC - 6 year-old child. Food false passage because of
the ingestion of a SHAMALLOW sweet (SAMU
Montpellier)
11NON FATAL CASES
- Toys
- Adult with a peashooter
- 5 year-old girl with the ball at the end of the
string of a stuffed musical clown MOULIN ROTY. - 30 months girl. Artifical precious gems freed
from a tiara of a SMOBY toy called The beauty
and the beast (not for children under 3 small
parts -). SMOBY promissed to improve the
adhesion of the gems on the crown - Confectioneries
- Risks of swallowing half a shell of a
surprise KINDER egg (2 cases, 1 in 1997 and 1
in 2003, the applicant )notices the ventilation
holes on the CADBURY eggs) - Submission by DGCCRF (20 November 2003) of the
ingestion risks of a diabolins egg sweet.
AFFSA 3 december 2001 opinion on the very great
acidity of a sweet called fini boom super
acid with high-grade citric acid.
12NON FATAL CASES (continuation)
- Other types of FB
- Inhalation of the cap protecting the rubber on a
STABILO frost 0,5 criterium (UFC Que Choisir,
10 décember 1998) - Soothers BEBISOL
13ACCIDENTOLOGY IN FRANCE
- Incoherent figures
- Sources vary
- figures vary
- Estimation of the annual number of deaths of
children from 1 to 4 between 20 and 40
14ACCIDENTOLOGY IN FRANCE (continuation)
- Data of the pediatric emergency unit of NECKER
ENFANTS MALADES - 1 to 3 annual cases for the Paris SAMU
- Since 1 January 1996 9 cases
- 3 cases with currents ITALIA (14 months, 9 months
and 5 years). Death. - Chewing-gum (22 months). Death
- Sausage slice (19 month). No after effects
- English fruit drop (12 months). No after effects.
- Spaghetti ball (7 year-old). No after effects.
- Marshmallows (3 year-old). Neurological after
effects - Rubber ball of a game belonging to older brother
(18 months). Death.
15ACCIDENTOLOGY IN FRANCE (continuation)
- Informations by InVS (Health Watch Institute)
Weekly epidemiological Bulletin (BEH n 19-20) 11
May 2004 - Choking was the 2nd cause of everyday life
accidents (3543 deaths in 1999, 6/10 000 et 18
of the AcVC) - ¾ on people over 65
- For children less than 1, choking was the 1st
cause of death among the 85 deaths by everyday
life accident of children under 1
16CHOKING AMONG CHILDREN UNDER 15
- 1243 accidents on 14 0310 between 1996 and 1999
- By age
- 0-4 66,3
- 5-9 25,9
- 10-14 7,8
- By sex
- Male 50,3
- Female 49,6
- Products causing the accidents
- Food (52 ) fish (7,2 ), sweets (2,2 ),
fruits (1,5 ), bones (1 ), others (3,5 ) - Non food 48 of the involved products (ex
coins 14 marbles 7,9 )
17CHOKING AMONG CHILDREN UNDER 5
- 824 cases (between 1996 and 1999)
- By sex
- Male 49
- Female 51
- Products cause of the accident same
classification as for children under 15, bur - More important number of injuries resulting from
the handling of toys (18 ) - Money, coins 12
- Marbles 6
- Games 6
- Toys in general 6
- Fish 5
- Other food 4
- Loose stones 3
- Unknown 14
18RISK ASSESSMENT (1)
- Objects or products specifically designed for
children - sweets
- products games or toys marbles, other games
or toys, pencils soothers (Cf the CSC
Recommendation)
19RISK ASSESSMENT (2)
- Objects or products in the childs environment
but not specifically intended for him - Food products (F) fishes, fruits, bones, but
also peanuts, pistachios, nuts, walnuts Their
design cannot be modified (See Recommendation of
3 Juy 1991 that asked for a better information
of the parents) - Non food products (non F) reasonably
foreseeable use without a parental mediation.
Vulnerable age Children under 3. Limits of a
prevention policy (no chain of causation between
the nature of the product and the accident but
rather a concomitance) - The authorities have imposed safety tests for
rattles - the product is blamed for the accident - No tests for pawns or marbles the person is to
be blamed for the accident, unless the design of
the product is obviously accident-proning
( push-push malabar). Bad chewing (malabar) or
lack of supervision (marble)
20ACCIDENTOLOGY ABROAD (1)
- Report 28 February 2003 financed by the European
Commission Development of a method in order to
define safety rules for specific classes of
products. They must be met by technical standards
issued by European bodies under a mandate of the
European Commission (Pr Paul DEHEUVELS) very
different situations in the world - USA the blockage of the airways is the main
cause of mortality among children under 1, the
4th among children between 1 and 9. Other
products are incriminated. Dropping. - EUROPE (ANEC) over a period of 5 years, on
15339 accidents recorded, 1418 involving coins,
518 nails and screws, 5 food products associated
with domestic products
21ACCIDENTOLOGY ABROAD (2)
- English situation exemplary HADD exhaustive
figures and analysis given by the DTI (Department
of Traide and Industry). Study from 1986 to 1997. - 290 fatal accidents among which
- 130 children under 1
- 63 1 year-old children
- 30 2 year-old children
- 16 3 year-old children
- 85 children under 3, 90 children under 4.
- Average of 20 accidents a year (52 food
products, less than 6 toys) - 14 food
- 4 non alimentary products not toys
- 1 vomit
- 1 unidentified toy
22ACCIDENTOLOGY ABROAD (3)
- Study by CEREPRI (University of Athens) food
containing not comestible products in Europe - In Europe Cost 1 M 1996 écus. 7 deaths
clearly identified - 1977 5 ½ girl in Greece. The Hat of a doll in a
crisps bag - 1985 3 year old boy in Northern Irleand.
Plastic wheels and axle of a truck contained in a
chocolate egg - 1989 3 year-old girl in Birmingham (GB).
Detachable foot of a pink panther contained in a
chocolate egg - 1991 4 year-old girl in Brighton. Plastic toy
(2 ,5 cm long and 3 cm diameter in a Bart Simpson
egg) - 1996 68 year-old woman in Belgium. Cardboard
disc in a flippo Croky crisps bag - 1997 5 months old girl in France. Plastic
particule contained in a Thumb pop sweet - 1994 3 year-old child in Portugal. Surprise
doll contained in NESTUM honey cereal bags
23HEARINGS
- Quality Manager Grocery-Liquids-Hardware-Perfume
s-Hygiene AUCHAN - Les Entreprises du médicament (LEEM)
- The Union Alliance 7 (professionals of food
industry) - Association SAFETY CHANNEL
- Technical Manager of Responsable FJP
- Director scientific affairs, regulatory
CADBURY - RAVENSBURGER
- National Délégation to emergency and First aid
(RED CROSS) - FERRERO
- review PRESCRIRE
- Toy specialists at the LNE
24PRODUCTS FOR WHICH REGULATION OR STANDARD IMPOSE
DESIGN REQUIREMENTS IN ORDER TO PREVENT RISKS OF
INGESTION OR INHALATION OF SMALL FOREIGN BODIES
(FB)
- The regulation on toy safety
- The prevention of ingestion and inhalation of
small parts with the truncated cylinder test - Prevention of chokings by the gauge E
- The prevention of suffocations due to the
obstruction of the nose and of the mouth by
hemispheric toys - Other areas of application
- The regulation on pacifiers
- The standard on caps for writing and marking
instruments (ISO and BSI)
25THE REGULATION ON TOY SAFETY
- Decree n 89-662 of 12 september 1989 modified
transposing the 88/378/CEE Directive on toy
safety. The toys must meet the essential safety
requirements defined in Annex II - General principles users and third persons
protected against risks for health and injury
(toy used as it is designed for and forseeable
use considering childrens behaviour) - Specific risks detachable parts of the toys
obviously designed for children under 36
months must be of dimensions large enough for
them not to be swallowed or inhaled. No risks of
strangulation or suffocation - CE Marking compulsary conformity to standards
or CE type attestation - Notice OJ 28 February 2003 mentions standard EN
71
26THE PREVENTION OF INGESTION AND INHALATION OF
SMALL PARTS WITH THE TRUNCATED CYLINDER
- Created in the US in 1971, imported in Europe in
1982 and described in EN 71, par. 8.2. - Truncated diagonally (57,1 mm/25,4 mm), 31,7 mm
diameter. - Principle Any toy and detachable element that
completely fits in the cylinder without
compression and in all the directions possible is
said to be inappropriate for a child under 36
months. Mention Not for children under 36
months (this is the case for the RAVENSBURGER E
M6 game). - Anthropométric basis unknown (CF FJP or AFNOR).
It is not the trachea of a new born baby (7 mm)
or of an adult (25 mm). Maximum size for a child
under 47 mm for a boy, 41 mm for a girl
distance between 2 incisors (Cf CHILDATA
published in 1995 by the DTI).The standard
developpers took this bases to create a new
gauge E . - The truncated cylinder addresses the risks of
false passage but not those of suffocation
due to the obstruction of the airways.
27THE PREVENTION OF SUFFOCATIONS BY THE GAUGE E
- Amendment A8 to EN 71 standard July 2003 to meet
the risks of suffocation provoqued by a
spheric, ovoid or ellipsoidal intended to be
thrown, hitted, rolled, kicked or designed to
bounce - Origin of this amendment accidents in 1998 due
to the use of a LEGO ladybird , hemispheric.
Its concave part clinged - Called small balls because it concerns the
balls that can get into the airways behind the
mouth and in the upper part of the throat and
block them. If they get in this cylinder, the toy
is not fit for children under 36 months. - Spheric shape of the toys gt ventilation is not
considered as an appropriate means to avoid the
dangers presented by small balls. On what
scientific basis ? - Products with similar shapes for which holes have
been considered as necessary
28THE PREVENTION OF SUFFOCATION BY OBSTRUCTION OF
THE NOSE AND OF THE MOUTH CAUSED BY HEMISPHERIC
TOYS
- Amendment A 10 to EN 71 standard.
- Origin accidents in the US revealed by CPSC.
Children between 4 to 24 months suffocated
because they put on their nose or their mouth
kitchen utensils toys (bowls, cups) of a
diameter between 69 mm and 97 mm. - Ventilation holes considered necessary to allow
the child to breathe. 2 openings at least 13 mm
away from one another are provided.
29OTHER AREAS OF APPLICATION
- Liability of the gauges. The authorities wished
to apply them to other fields - Inadequate warning mentions
- Some products are considered by a professionnal
as obviously meant for children under 36 months
whereas they are not if you consider the
critirion of the reasonably foreseeable use of a
product - Products imitating foodstuffs
- Decree n 92-985 of 9 september 1992 the
products that are not food but that can be
mistaken for food must not present risks of
choking and must be big enough not to be
ingested by children under 36 months (that is
to say not fit in the 37,1 mm truncated cylinder) - Other examples children clothes, ventouses
pare-soleil, confectioneries associated with an
energy source, swimming pool fences - Cf decrees 26 February 2004 and 24 February 2005
suspending the marketing of a luminous sweet
shaped as a soother (a child ingested the button
cell that lighted its edible part).
30THE REGULATIONS ON PACIFIERS (1)
- Decree n 92-631 du 8 July 1992 on materials and
objects designed to be in contact with food,
products and drinks for man or animals. - Major risk suffocation.
- The shield remains blocked in the childs throat
- The broken soother is inhaled by the child
31THE REGULATION ON PACIFIERS (2)
- Standard NF EN 1400 child care articles
soothers for infants and young children May
2003 - The test gauge
- Precut sheet with dimensions (43 mm) near those
of gauge E - The shield must be introduced by the wrong size
and the right size. CSC Recommendation 2 April
2003 asks for a modification of this standard
providing a sideways introduction - The ventilation holes
- Reduce the risk of inhalation of the soother
through the pharynx - Dimension (20 mm2 and distance 15 mm) big enough
not to be obstructed by saliva and secretions.
But holes too big can make the expulsion reflex
less efficient - The ingestion of the soother Cf Recommendation
du 2 April 2003 for the standard to provide that
the cutting tip should not only pierce the center
but the sides of the silicone soother - Standard ISO 11540 May 1993 on caps for writing
and marking instruments continuous air passage
on at least 6,8 mm2 on all the length of the cap.
Minimum air flow 8.1/min. Test methods.
32EXAMPLES FOR WICH THERE IS NO SPECIFIC REGULATION
NOR STANDARD (1)
- Confectioneries French market 620 M euros,
250 millions items - Traditional confectioneries importance of the
size, the shape, but also of the consistancy
(strong acidity, for exemple, cf AFSSA notice).
Suspension of marketing measures taken by the
administration on an individual basis following
experts advice (CSC, AFSSA) . - Example of deree n 2004-572 of 17 June 2004 on
jellied confectioneries (containing konjak). - The fatal ingestion of the push-push malabar
ice-cream The DGCCRF asked for it to be
withdrawn from the market but did not forbid it.
Could be put again on the market - diabolins egg marketting limited in time
(Until 27 May 2003). Shape and size (45 mm/30
mmm) would justify the use of gauge E because
it fits in this gauge. Risk of blockage in the
respiratory track of a child under 36 months.
33EXAMPLES FOR WHICH THERE IS NO SPECIFIC
REGULATION NOR STANDARD (2)
- Confectioneries sold with inedible objects risk
of ingestion or inhalation of the inedible
objects - The most usual ones combine sweets and toys, easy
to distinguish because the inedible object is not
directly in contact with the foodstuff. - New products bolder design, the
confectionery is jointed with the inedible part.
Ex. the luminous confectioneries. (lollipop).
Danger that the child might swallow all or part
of the inedible part. Suspended by a 26 February
2004 decree for 1 year. 25 March 2004 CSC
Recommendation asked for the cylinder test. - Guide of the ALLIANCE 7 Union of the
professionals of food industry the basic
reference is the NF EN 71 stadard. Provides the
truncated cylinder test. Refers to Amendement 8
( small balls ) for spheric, round or
ellipsoidal objects, but does not specify what
tests must be carried out. Now, it is a new
gauge. The guide will be updated.
34THE SURPRISE EGGS CASE (1)
- Market in 2003 34 M items, 62,5 M (10,2 of
the confectioneries market). - For chocolate products surprise eggs represent
1400 t, soit 33 M (2,5 of the market of
chocolate products, evaluated 55 000 t) - Kinder egg on the market for the first time in
1976. FERRERO (an italian company) holds a near
monopoly of the market. - AUCHAN sells 3,5 M surpise eggs a year, that is
to say 10 of the surpsie eggs market. - Cases known by the European commission of
accidents involving Kinder surprise eggs - 1989 3 year-old little girl in GB (foot of a
pink panther). CSC 6 March 1991 Recommendation
asked to put up to 5 the minimum age for a child
to handle the product. FERRERO agreed, then
stopped because of the reluctance of the DGCCRF - 3 other cases non fatal
- 1997 2 year-old. Swallowed a piece of plastic
fragment of a kinder surprise type. - 1998 1 year-old. Kinder toy in the nostril
- 1999 3 year-old. Swallowed a plastic flag in a
kinder egg
35THE SURPRISE EGG CASE (2)
- Another inedible element the two-parts shell.
The opening strength high, deterrent for child
under 3. Packing, not a toy, for CADBURY and
FERRERO. Petition 04-012 a child under 3
swallowed half a shell, the mother could talke it
off. Risk that the small balls is meant to
stop. FERREO and CADBURY make no particular
warning on the risk of blockage of the
respiratory track for children under 3. - CADBURY shells not tested with small balls
but with the 31,7 cm truncated cylinder. 32 mm or
33 mm shells cannot completely fit in it. Risks
of suffocation are known HASBRO (for the Action
Man range) asked in 1999 for 6 ovoid ventilation
holes about 7 mm onr 4 mm . This was applied to
the BARBIE shells for girls, smaller holes
(CADBURY could make them wider if their
efficiency was proved). The effeiciency of the
holes is not tested. - FERRERO the Kinder surprise . Shells not
tested with small balls but truncated
cylinder for small parts. Different from CADBURY
ventilation holes on the shells non efficient,
even dangerous. No accident data - Hygiene introduction of foreign bodies during
the phase following the packaging of the toys,
before and during the production of the chocolate
egg - Experts definite opinion General Secretary of
the French ORL Society. - Reporters comments the shell or the half-shell
has a secondary value of game and justifies a
warning. Reservations on the fact that the holes
have been excluded from the small balls
standard
36MEDICINES
- AFSSAPS sphere of competence. Nevertheless,
- According to the association for the prevention
of suffocation SAFETY CHANNEL - Medicines with a local anestheci can reveal
themselves dangerous risk of false passage
because of the anesthesia of the oropharyngial
area (bout 30 medicines according to the
automatic data bank on medicines) - Children particularly vulnerable (2600 cases a
year). The Academy of pharmacy raised the arm in
2004 most medicines on the market not
appropriate for children under 6. - The warnings are insufficient and difficult to
read - Solution a 3,2 mm ventilation canal for the
medicines but also for food (sweets,
delicatessens, chesse) - According to the Medicines Firms (LEEM)
- Attends official commissions at a national level
(AFSSAPS) and at an international level (EPIA
European Pharmaceutical Industries and
Associations - and FIIM Fédération
internationale des industries du médicament) - No precise informations on false passages But
obvious risks for older people they do not
drink enough while they take their tablets
(advice that figures on the instructions.)
Advertisings putting the glass of water in front. - The ergonomy of the medicine to prevent false
passage not taken into account - Holes would make the tablets biggers, risk of
diminishing the stability of the tablets,
impossible for the divisible tablets.
37RECOMMENDATIONS
38TO THE PUBLIC AUTHORITIES (1)
- A About the inventory of the accidents
- A more liable system of collection of the
accidents data, in particular in the area of
respiratory obstructions.. - B About formation and information
- Initiatives should be taken to impose on the
professionals in permanent contact with the
public and children to teach them the first aid
movements (in particular the Heimlich maneuver).
This could be done in schools, in firms, in homes
for older people, day cares, restaurants Posters
in those places. - C. About the safety of toys
- Amendement to EN 71.1 standard taking into
account the risks presented by the shells
containing toys in suprise eggs (Cf soothers,
regulation on similar products and provinding
holes has proved efficient for suffocation
accidents). - D. On confectioneries associated with inedible
products - accidents with very acid or very bulky sweets
removed from the market as they are banned. They
reappear later with other forms but with the same
design. For prevention purpose, a decree with the
essential safety requirements for the shape, the
consistency, the marking of sweets and their
packaging intended for children under 4. Cf the
ALLIANCE 7 guide.
39TO THE PUBLIC AUTHORITIES (2)
- E. On the vegetable bodies (peanuts, piscachios,
nuts, walnuts, almonts or nother products like
starter sausages that should be kept out of young
childrens reach.. - The CSC reiterates her recommendations of 3 July
1991 the packaging of those products should
have visible and easy to read mentions (perhaps
with pictograms) indicating that they do not fit
for children under 4 (they swallow them without
chewing them). - F. On the risks of ingestion presented by
medicines - The High Health Authority and AFSSAPS should see
to it that the risks while absorbing medicines,
for children or older people, are taken into
account by the pharpaceutical companies. - G. On the introduction of the shield of the
pacifiers in the test gauge . - The authorities should intervene with the CEN for
a modification of the test method in NF EN 1400
(diagonal passage of the shield in the gauge, and
not only right side and wrong side).
40 TO MANUFACTURERS, DISTRIBUTORS OR IMPORTATORS
OF SURPRISE EGGS
- Instructions for food containing inedible
products should mention that they are not
recommended for children under 3 (ingestion
risks, but also suffocation risks because of the
blockage of the airways by the shells). - The shells should be tested (in particular for
the holes number, size).
41 TO THE CONSUMERS
- Never let children under 6 come to food products
known for their risks of suffocation (peanuts)
generally served as a starter. - Follow first aid training and refer to the
existing guides n the maneuvers - Information of the consumers by associations and
by the National Consuming Institute (television
programs).