RECOMMENDATION ON THE RISKS OF ACCIDENTAL INHALATION OR INGESTION OF SMALL OBJECTS BY

1. Odile FINKELSTEIN RECOMMENDATION 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

2. Odile FINKELSTEIN DEFINITIONS INGESTION Introduction through the mouth of alimentary solid or liquid substances that afterwads get through the œsophagus 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 »)

3. Odile FINKELSTEIN THE 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

4. Odile FINKELSTEIN THE 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)

5. Odile FINKELSTEIN LOCALISATION 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

6. Odile FINKELSTEIN SYMPTOMATOLOGY Hypopharynx : deglutitive disorders Larynx : asphyxia soon fatal Trachea : slowing down of breath (whooping-cough like) Bronchial tubes : symptomatology varies

7. Odile FINKELSTEIN EMERGENCY 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.

8. Odile FINKELSTEIN THE 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 people’s homes…)

9. Odile FINKELSTEIN ESOPHAGEAL 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

10. Odile FINKELSTEIN FATAL CASES Toys : 18 months girl. Inhalation of a rubber « super-ball » (SAMU 92) 9 year old girl. Inhalation of pawn of a RAVENSBURGER E=M6 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)

11. Odile FINKELSTEIN NON 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 « diabolin’s 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.

12. Odile FINKELSTEIN NON 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 »

13. Odile FINKELSTEIN ACCIDENTOLOGY 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

14. Odile FINKELSTEIN ACCIDENTOLOGY 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.

15. Odile FINKELSTEIN ACCIDENTOLOGY 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

16. Odile FINKELSTEIN CHOKING 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 %…)

17. Odile FINKELSTEIN CHOKING 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 %

18. Odile FINKELSTEIN RISK 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)

19. Odile FINKELSTEIN RISK ASSESSMENT (2) Objects or products in the child’s 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)

20. Odile FINKELSTEIN ACCIDENTOLOGY 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

21. Odile FINKELSTEIN ACCIDENTOLOGY 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

22. Odile FINKELSTEIN ACCIDENTOLOGY 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

23. Odile FINKELSTEIN HEARINGS Quality Manager « Grocery-Liquids-Hardware-Perfumes-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

24. Odile FINKELSTEIN PRODUCTS 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)

25. Odile FINKELSTEIN THE 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 children’s 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

26. Odile FINKELSTEIN THE 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.

27. Odile FINKELSTEIN THE 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 => 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

28. Odile FINKELSTEIN THE 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.

29. Odile FINKELSTEIN OTHER 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).

30. Odile FINKELSTEIN THE 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 child’s throat The broken soother is inhaled by the child

31. Odile FINKELSTEIN THE 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.

32. Odile FINKELSTEIN 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 « diabolin’s 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. EXAMPLES FOR WICH THERE IS NO SPECIFIC REGULATION NOR STANDARD (1)

33. Odile FINKELSTEIN 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. EXAMPLES FOR WHICH THERE IS NO SPECIFIC REGULATION NOR STANDARD (2)

34. Odile FINKELSTEIN THE« 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

35. Odile FINKELSTEIN THE « 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. Reporter’s 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

36. Odile FINKELSTEIN MEDICINES 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.

37. Odile FINKELSTEIN RECOMMENDATIONS

38. Odile FINKELSTEIN TO 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.

39. Odile FINKELSTEIN TO 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 children’s 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. Odile FINKELSTEIN    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. Odile FINKELSTEIN   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).