Medical "cot:beds " : Decision determining manufacturing, import, export, marketing free or for a price and use 28/07/2010

Mcharpen

Description

Le lit médical,  dispositif  extrêmement répandu et utilisé,  peut être à l’origine de problèmes de sécurité parfois très graves. Entre 2006 et 2008, plus de 400 signalements d’incidents ou de risques d’incidents ont été enregistrés à l’Agence dans le cadre de la matériovigilance. Des travaux ont été engagés par l’Agence dans le but de sécuriser les dispositifs médicaux que sont le lit et ses barrières :Les documents présentés sur ce site concernent à la fois les professionnels de santé et autres utilisateurs de lits médicaux, les personnes responsables de la maintenance et de l’achat des lits, les industriels.Dans le cadre de la matériovigilance, l’Agence a été informée de plusieurs accidents graves survenus dans des établissements de santé avec des lits pédiatriques appelés communément « lits-parcs ».Dans tous les cas, l’espace entre les barreaux a permis à l’enfant de passer ses jambes et son corps et de rester coincé au niveau de la tête.Pour éviter la survenue de nouveaux accidents, la décision du 30/07/2008  limite l’espace entre les barreaux des lits-parcs à usage médical.Sécurité des lits médicaux - Sécurité des lits médicaux
28/07/2010

Informations

• Publié par: ansm-securite-des-lits-medicaux
• Publié le: 28 juillet 2010
• Nombre de lectures: 6
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, pas de modification
• Langue: Français

Extrait

 

 

        Decision of July 30th 2008

REPUBLIC OF FRANCE

Determining the special manufacturing, import, export, marketing (free or for a price) and use of medical beds, commonly referred to as medical "cot-beds"

The Director of the French Agency for Health Product Sanitary Safety,

With regards toof the Public Health Code (PHC) and in particular articles L.531 1- 1, L.5211-part five 1, L.5312-1; 

With regards to order no. 91-1292 of December 20th 1991 pertaining to the prevention of risks resulting from childcare articles 2 and 4, defined by the notice published in the Official Gazette of the French Republic, no. 0083, dated April 8th 2008 - text no. 116 pertaining to the application of this order; 

With regards tostandards NF EN 716-1 and NF EN 716–2 pertaining to fixed and folding body beds for domestic use with children of between 900 and 1400 mm in height, stating that the effective diameter of the holes, along with the distance between two structural elements, must be less than or equal to 65 mm; 

With regards tothe notice of the National Commission for medical devices, dated June 11th 2008; 

With regards tothe responses to the consultation of manufacturers and professional organisations of July 9th 2008; 

Consideringthat five accidents, occurring in 2002, 200 and 2006 were notified to the AFSSAPS in the context of materiovigilance, concerning children becoming trapped between the bars, or between the headboard and the first bar of the medical cot-bed rails, in spaces of between 80 and 110mm, where their entire body, with the exception of their head, had been able to pas. 

Considering that, though the above-mentioned accidents occurred with spaces of between 80 and 110mm, the risk of trapping is inherent to cot-beds whose bar spacing allows children's limbs and body to pass, but not the head, which is the case when spacing exceeds 65mm; that the dimension of 65mm has furthermore been retained in the context of the above-mentioned standards pertaining to fixed and folding body beds for domestic use with children; 

Considering the risk of death or of serious clinical consequences that may arise from such trapping, the child being suspended with no support, in a position of strangulation with breathing difficulties; 

Consideringthat cot-beds for medical use with bars spaced by more than 65mm are still, to this day, manufactured, imported, exported, marketed and used; 

Consideringthat the required safety level for the medical use of cot-beds must not be lower than that required for domestic use; that in this respect, the NF EN 716-1 and NF EN 716-2 standards, pertaining to fixed and folding body beds for domestic use with children, should be used as reference in order to ensure a similar safety level for medical cot-beds; 

Considering that this safety requirement must be applied to all medical cot-beds manufactured, imported, exported and marketed from the date of publication of the present decision; that considering the fraction of beds currently in use that fail to meet this requirement and the material impossibility of i d m ue m   e di d li i g at e e n ly c   e r  t e o p   l p a l c a i n n   g t   h t e h ir e     re co pl n a c c e e rn m e e d n   t  b a e s d  r s a  i p n i   d t ly h   e a   s h   e p a o l s t s h i c b a l r e  e a   n e d s , t   a a b t  l t is h h e  m la e t n e t s s t , ,     t b h y  e M se latt st m reus 900  t make ay 1 2 .

Decides, 

Article 1 Medical cot-beds must present a space, between bars or between the headboard and the - bed rail, smaller than or equal to 65mm as per the test defined by the NF EN 716-2 standard. 

Article 2or for a price) of cot-beds for medical- The manufacture, import, export and marketing (free use, must conform to the requirements of article 1   the date of publication of the present decision.from  

Article 3- The use of medical cot-beds must conform to the provisions of article 1   from May 1 st 2009. 

Article 4 - The director of inspection of medical devices and the director of establishments are each responsible for enforcing the present decision, which shall be published in theOfficial Gazette the of French Republic. 

Drawn up in Saint-Denis, on