NESKLADNI MEDICINSKI PRIPOMOČKI NA TRGU EU: Ultrazvočni geli proizvajalca Eco-Med Pharmaceuticals Inc., ZDA

Javna agencija RS za zdravila in medicinske pripomočke (JAZMP) je bila s strani nemškega pristojnega organa za medicinske pripomočke (BfArM) obveščena o neustreznih medicinskih pripomočkih proizvajalca Eco-Med Pharmaceuticals Inc., ZDA. Zadevne medicinske pripomočke trži tudi vrsta distributerjev, uvoznikov in drugih proizvajalcev, bodisi pod svojim imenom bodisi tudi pod drugim trgovskim imenom pripomočka (Tabela 1).

Prizadeti medicinski pripomočki so t.i. ultrazvočni geli na vodni osnovi, ki se nanesejo na kožo na preiskovan del telesa za namene prevajanja ultrazvočnih valov.  

Obstaja tveganje, da so zadevni medicinski pripomočki kontaminirani z bakterijo Burkholderia cepacia complex (Bcc). Ameriški pristojni organ U.S. Food and Drug Administration (FDA) je z neodvisno preiskavo potrdil prisotnost omenjenih bakterij v gelih tega proizvajalca. Uporaba kontaminiranih ultrazvočnih gelov lahko rezultira v resnih okužbah. Po podatkih FDA in CDC (ZDA) je zaradi uporabe zadevnih pripomočkov zabeleženih že 66 tozadevnih okužb.

Eco-Med Pharmaceuticals je avgusta na področju Združenih držav Amerike izdal varnostno obvestilo za artikla EcoGel 200 in MediChoice Ultrasound Gel. Ameriška Uprava za hrano in zdravila (FDA) je za tem za področje Združenih držav Amerike izdala obvestilo o odpoklicu tudi za preostale tozadevne medicinske pripomočke tega proizvajalca.

Podjetje Eco-Med Pharmaceuticals Inc., ZDA naj bi po navedbah prenehal z vsemi poslovnimi aktivnostmi, kar je razlog, da ni mogoče pridobiti podrobnih podatkov o nadaljnji distribuciji kontaminiranih ultrazvočnih gelov. Zadevni pripomočki so lahko prisotni tudi na trgu EU.

JAZMP zato svetuje:

  • preverite, ali imate prizadete medicinske pripomočke, navedene v spodnji tabeli,
  • takoj prenehajte z njihovo uporabo ali distribucijo in poskrbite za ustrezno uničenje.

TABELA 1

Trgovsko imeDistributer, uvoznik ali proizvajalec, ki distribuira pripomočke pod svojim imenom in/ali pod drugim trgovskim imenom pripomočka
Action de Gala FuSion Conductive GelAesthetics Systems (United States)
Athena Liaison Ultrasound GelMac Medical Supply Co Inc. (United States)
Conductor Transmission GelChattanooga Medical Supply (United States)
Conductor AustraliaDJO Australia (Australia)
DJO ConductorDJO Global (United States)
EcoGel 100Amtec Sales, Inc. (dba Print Media) (United States)
 Eco-Med Pharmaceutical (Canada)
 Cardinal Health (Canada)
 Fujifilm Sonosite, Inc. (United States)
 Maranda Lauzon Inc (Canada)
 Medline Canada (Canada)
 NDC Inc. (United States)
 STAT Healthcare Corporation (Canada)
 The Stevens Company Limited (Canada)
EcoGel 200Accelerated Care Plus (United States)
 Active Crystal Inc (Canada)
 Agencia Matamoros (Honduras)
 Amesys S.A. (Honduras)
 Amtec Sales, Inc. (dba Print Media) (United States)
 Anamed Corp. (United States)
 Best Medical Supply (United States)
 BP Medical (Dominican Republic)
 Cardinal Health (Canada)
 Cardinal Health, Inc. (United States)
 Choice Medical Systems, Inc. (United States)
 Christie Innomed Inc. (Canada)
 Clinomed, Inc. (United States)
 CMCC Supply Centre and Bookstore (Canada)
 Dada Dada & CIA (El Salvador)
 Dectro International (Canada)
 Dental & Medical Distributor (United States)
 DHG Specialties (United States)
 Dimesan USA (United States)
 Dolphin Med-Equipment & Supply (United States)
 Droredime (Honduras)
 Dunbar Medical (Canada)
 Dynamic Medical Supplies, Inc. (United States)
 Eastern Medical Supply Ltd (Canada)
 Eco-Med Pharmaceutical (Canada)
 Equimedic S.A. de C.V. (El Salvador)
 Eshus Merin, Inc (United States)
 Euro Essential Ltd. (Canada)
 Fernanada’s Beauty Products  (Canada)
 Gadelius Medical (Japan)
 Global Medical Solution (NZ) LTD (New Zealand)
 Good-link Electronics Ltd. (Hong Kong)
 Grobartig Solution, LLC. (United States)
 Health & Global Enterprises (United States)
 Healthy You (United States)
 Henry Schein Arcona (Canada)
 Innovaciones Medicas (Guatemala)
 Intrasound Products, LLC (United States)
 Inversiones C.A. (Honduras)
 Luizapata Corp. (United States)
 Lumenis Ltd (Israel)
 Maranda Lauzon Inc (Canada)
 Medical Depot, S.A. (Panama)
 Medical Services, LLC. (United States)
 Medical Specialists Co., Inc. (United States)
 Medis Part Ltd. (Thailand)
 Medline Canada (Canada)
 Medplus Supply S.A. (Panama)
 MJM Distributing (Canada)
 Multiservicios Electromedicos, S.A. (Costa Rica)
 NDC Inc. (United States)
 North Coast Medical (United States)
 Nova Skin, Inc. (United States)
 Ortho Canada (Canada)
 Owens & Minor Distribution, Inc. (United States)
 Paramedicos del El Salvador (El Salvador)
 PTmart, Inc. (United States)
 Quantum Products, Inc. (United States)
 RAF, S.A. DE C.V. (El Salvador)
 Reserma, SA (Panama)
 So medico SDN BHD (Malaysia)
 Spavaro Inc. (Canada)
 STAT Healthcare Corporation (Canada)
 The Stevens Company Limited (Canada)
 Trimedic Supply Network Ltd. (Canada)
 Vitality Depot (Canada)
 Westside Surgical Corporation (United States)
EcoGel 300Eco-Med Pharmaceutical (Canada) 
 MJM Distributing (Canada) 
 Vitality Depot (Canada) 
EcoLotionAmtec Sales, Inc. (dba Print Media) (United States) 
 Clinomed, Inc. (United States)
 Eco-Med Pharmaceutical (Canada) 
 Eshus Merin, Inc (United States)
 Grobartig Solution, LLC. (United States)
 Healthy You (United States)
 Medical Services, LLC. (United States)
 Medical Specialists Co., Inc. (United States)
 NDC Inc. (United States)
 North Coast Medical (United States) 
 PTmart, Inc. (United States)
 Quantum Products, Inc. (United States)
 The Stevens Company Limited (Canada) 
 Vitality Depot (Canada)
IntelectDJO Global (United States)
Liquasonic Athena Medical Products Inc. (United States)
 Cardinal Health Inc. (United States)
 Concordance Healthcare Solutions (United States)
 Henry Shein Inc. (United States)
 Mckesson Medical Surgical Inc. (United States)
 Medline Industries, Inc. (United States)
MAC Brand EcoGel Mac Medical Supply Co Inc. (United States)
MedelcoMedelco Inc. (Canada)
MediChoice Ultrasound GelExternal Link DisclaimerMac Medical Supply Co Inc. (United States) 
 North Coast Medical (United States)
 Owens & Minor (United States)
Medline Ultrasound GelMedline Industries Inc. (United States)
MyossageDJO Global (United States) 
 North Coast Medical (United States)
Norco Ultrasound GelNorth Coast Medical (United States)
North Coast Ultrasound Gel 
Omnisound Ultrasound Gel Accelerated Care Plus (United States)
Pro Advantage Ultrasound GelNDC Inc. (United States)
Red Medical Ultrasound GelRed Medical Supplies Ltd. (Canada)
Scrip Crème All Purpose LotionScrip Hessco (United States)
Scrip Ultrasound GelScrip Hessco (United States)
Smart (EcoGel 200 Ultrasound Gel)Smart Technology and Product Co., Ltd (Thailand)
Ultra-MyossageDJO Global (United States)

V Sloveniji do tega trenutka nimamo zabeleženega zapleta, povezanega z zadevnimi pripomočki.

Ob sumih na zaplet z medicinskim pripomočkom se posvetujte z zdravnikom, s farmacevtom ali drugim zdravstvenim delavcem. O zapletu z medicinskim pripomočkom lahko poročate tudi neposredno JAZMP, na način kot je objavljeno na spletni strani JAZMP.

Morebitna vprašanja v zvezi s tem obvestilom nam lahko posredujete na elektronski naslov: .

Številka dokumenta: 301-243/2021

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