Alerte De Sécurité sur (1) IMAGE SCANNING SYSTEMS BY MAGNETIC RESONANCE. (2) INTRAVENOUS POLES. (3) HOSPITAL GAS CYLINDERS. (4) MACAS. (5) WHEELCHAIRS

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par N/A.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    115
  • Date
    2001-07-01
  • Pays de l'événement
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    XX
  • Cause
    Physicians of the westchester medical center in valhalla, ny reported an incident where a six year old boy that was being submitted to a magnetic resonance was fately reached in the head with an o2 tank which was magnized and closed in the examination room. this was not an isolated incident; other accidents have already happened in which metal objects are put to the area near the magnetic resonance units.
  • Action
    ECRI RECOMMENDS THE FOLLOWING FOR THE PREVENTION OF INDUCED MAGNETIC FIELD RELATED RISKS IN A MAGNETIC RESONANCE UNIT ENVIRONMENT: (1) INDICATE A SECURITY OFFICER IN THE MAGNETIC RESONANCE UNIT (URM) WHO WILL BE RESPONSIBLE FOR MAKING THAT THE MEASURES SAFETY INSTRUCTIONS. (2) IDENTIFY AREAS IN THE URM AND ROOMS NEARBY (INCLUDING THOSE ON ADJACENT FLOORS) WHERE THE MAGNETIC FIELD STRENGTH EXCEEDS 5G, AND LIMIT THE ACCESS TO THESE AREAS. (3) ALWAYS AWAY THAT THE STATIC OF THE MAGNETIC FIELD BE PRESENT AND TREAT THE SYSTEM PROPERLY. (4) DOES NOT ALLOW URM, EQUIPMENT OR EQUIPMENT THAT CONTAIN MAGNETIC (MAINLY FERROMAGNETIC) COMPONENTS ABOVE THE 5G LINE UNLESS THEY HAVE BEEN TESTED BY THE EQUIPMENT MANUFACTURER AND HAVE BEEN CONSIDERED SAFE FOR URM ENVIRONMENTAL USE. TAKE ANY RESTRICTIONS MENTIONED BY THE MANUFACTURER IN CONNECTION WITH THE USE OF EQUIPMENT SAFE AND COMPATIBLE WITH URM. (5) TEST ALL EQUIPMENTS THAT ARE IN THE ENVIRONMENT OF THE MAGNETIC RESONANCE UNIT WITH A POWERFUL MAGNETO BEFORE THEY ENTER THE AREA TO DETERMINE THEIR POTENTIAL OF ATTRACTION BY THE URM. (6) IF EQUIPMENT CONTAINING FERROMAGNETIC COMPONENTS MUST BE USED IN A URM ENVIRONMENT, CONSIDER THE FOLLOWING GUIDELINES: (A) PHYSICALLY FIX EQUIPMENT USING NON-MAGNETIC MEDIA (EG, NON-MAGNETIC NUTS, ROPE, PLASTIC CURRENTS, WEIGHT, VELCRO FIXERS) AT A MAGNETO DISTANCE (AS SPECIFIED BY THE MANUFACTURER), AND ADEQUATELY LABELED TO PREVENT THAT THE SAME IS PLACED VERY NEAR THE URM SYSTEM. IT IS IMPORTANT THAT THE PROPOSED METHOD FOR FIXING THE EQUIPMENT BE PROPERLY TESTED BEFORE ITS USE. (B) MAKE SURE THAT ALL SMALL COMPONENTS OF FERROMAGNETIC EQUIPMENT, SUCH AS COVERS AND COVERS ARE FIRMLY CLOSED TO THE EQUIPMENT (BY NON-MAGNETIC MEANS); ALONG THE TIME THE FERROMAGNETIC COMPONENTS CAN RELEASE. (7) BRING PATIENTS THAT ARE NOT AMBULATING THE URM ENVIRONMENT, USING WHEEL CHAIRS OR NON-MAGNETIC SOAPS. MAKE SURE THAT NO O2 BOTTLE IS HIDDEN UNDER THE LENGHT. (8) MAKE SURE THAT THE INTRAVENOUS POLES ACCOMPANYING THE PATIENT TO URM BE COMPATIBLE WITH THE ENVIRONMENT.

Manufacturer

N/A
  • Source
    ANVSANVISA