Circular for care institutions on the (outsourcing of the) manufacture and reprocessing of medical devices and their accessories

In order to combat shortages of medical devices, care institutions have proceeded to manufacture medical devices and their accessories or to reprocess used medical devices. The FAMHP defines the modalities by means of a circular in order to offer more options to care institutions.

General information

Circular

Form for notification of in-house fabrication

Form for notification of reprocessing


 

Notifications received by the FAMHP:

Medical devices:

15/04/2020 in house Nasopharyngeal swab
Hospital CHU Liège
Avenue de l'hopital, 1
4000 - Liège
Contact point pierret.melin@uliege.be
Manufacturer Any-Shape
Rue de la Digue, 37
4400 - Flemalle
contact point info@any-shape.com
Methodology applied for the house 3D printing using SLS technology
Target population Healthcare professionnal
Quality management system ISO 9001 and EN9100 for design and production of parts using addtive technologies (3D printing). 
Risk management system Risk management is fully part of our EN9100 certification
Biocompatiblity testing PA12 mateiral used is biocompatible according to ISO 10993-1
guidance published by FAMHP /

 

21/04/2020 in house ventilator connector piece
Hospital Jessa hospital
Salvatorstraat, 20
3500 - Hasselt
Contact point

janne.theuwissen@jessazh.be

Manufacturer Materialise N.V.
Technologielaan, 15
3001 - Leuven
contact point

regulatory.affairs@materialise.be

Methodology applied for the house SLS if polyamide
Target population Patiet
Quality management system QMS certified according to ISO 13485:2016
Risk management system Yes
Biocompatiblity testing Yes
guidance published by FAMHP /

 

06/05/2020 In house Adapted Easybreath snorkeling mask
Hospital

O.L.V van Lourdes ziekenhuis
Vijfseweg, 150
8790 Waregem

Contact point  
Manufacturer BJ75
Jeanne D'Asnières, 14
92110 Clichy
France
contact point  
Methodology applied for the house Industrial production: masks ad adaptors
Target population Healthcare professional at hospital
Quality management system Lighter factories producing the adaptor are ISO 9001 certified for lighter production only.
Mask factories are certified ISO 14001 and/or ISO 9001
Risk management system not certified: not relevant for usual production scope
Biocompatiblity testing No such testing due to usual production scope
guidance published by FAMHP Not applicable
Please otherwise refer to ANMS temporary authorisation in France

 

07/05/2020 in house Connectors between Decathlon snorkeling masks and respiratory systemsb
Hospital Hôpital Erasme
Route de Lennik, 808
1070 - Anderlecht
Contact point contact@erasme.ulb.ac.be
Manufacturer Endo Tools Therapeutics S.A.
Rue Auguste Piccard, 48
6041 - Gosselies/td>
contact point info@endotools.be
Methodology applied for the house ABS Injection moulding
Target population Healthcare professionnal
Quality management system ISO 13485:2016 (scope in gastro-enterology)
Risk management system Yes
Biocompatiblity testing No testing performed on this part but same material and processes used as in fully tested devices
guidance published by FAMHP /

 

19/05/2020 in house Nasopharyngeal swab
Hospital Centre Hospitalier Universitaire et Psychiatrique de Mons-Borinage
Boulevard Kennedy, 2
7000 - Mons
Contact point  
Manufacturer Any-Shape
Rue de la Digue
4400 - Flemalle
contact point info@any-shape.com
Methodology applied for the house 3D printing using Selective Laser Sintering technology
Target population Healthcare professionnal
Quality management system ISO9001 and EN9100 (aerospace) for Design and production of parts using additive technologies (3D printing) AFNOR N° 2019/85276.1
Risk management system Risk Management is fully part of our EN9100 (aerospace) certification.
Biocompatiblity testing PA12 material used is biocompatible according to ISO 10993-1
guidance published by FAMHP Circulaire de l'AFMPS (09/04/2020) qui fixe le cadre permettant d'accroitre les possibilités pour les établissements de soins de travailler en collaboration avec des firmes externes sur des solutions alternatives.

 

19/05/2020 in house Nasopharyngeal swab
Hospital Hopital Erasme
Route de Lennik, 808
1070 - Bruxelles
Contact point  
Manufacturer Any-Shape
Rue de la Digue
4400 - Flemalle
contact point info@any-shape.com
Methodology applied for the house 3D printing using Selective Laser Sintering technology
Target population Healthcare professionnal
Quality management system ISO9001 and EN9100 (aerospace) for Design and production of parts using additive technologies (3D printing) AFNOR N° 2019/85276.1
Risk management system Risk Management is fully part of our EN9100 (aerospace) certification.
Biocompatiblity testing PA12 material used is biocompatible according to ISO 10993-1
guidance published by FAMHP Circulaire de l'AFMPS (09/04/2020) qui fixe le cadre permettant d'accroitre les possibilités pour les établissements de soins de travailler en collaboration avec des firmes externes sur des solutions alternatives.

 

19/05/2020 in house Nasopharyngeal swab
Hospital Université de Namur
Rue de Bruxelles, 61
5000 - Namur
Contact point  
Manufacturer Any-Shape
Rue de la Digue
4400 - Flemalle
contact point info@any-shape.com
Methodology applied for the house 3D printing using Selective Laser Sintering technology
Target population Healthcare professionnal
Quality management system ISO9001 and EN9100 (aerospace) for Design and production of parts using additive technologies (3D printing) AFNOR N° 2019/85276.1
Risk management system Risk Management is fully part of our EN9100 (aerospace) certification.
Biocompatiblity testing PA12 material used is biocompatible according to ISO 10993-1
guidance published by FAMHP Circulaire de l'AFMPS (09/04/2020) qui fixe le cadre permettant d'accroitre les possibilités pour les établissements de soins de travailler en collaboration avec des firmes externes sur des solutions alternatives.

 

19/05/2020 in house Nasopharyngeal swab
Hospital UCL Saint-Luc Départemet Pharmacie Bruxelles
Avenue Hippocrate, 10
1200 - Bruxelles
Contact point  
Manufacturer Any-Shape
Rue de la Digue
4400 - Flemalle
contact point info@any-shape.com
Methodology applied for the house 3D printing using Selective Laser Sintering technology
Target population Healthcare professionnal
Quality management system ISO9001 and EN9100 (aerospace) for Design and production of parts using additive technologies (3D printing) AFNOR N° 2019/85276.1
Risk management system Risk Management is fully part of our EN9100 (aerospace) certification.
Biocompatiblity testing PA12 material used is biocompatible according to ISO 10993-1
guidance published by FAMHP Circulaire de l'AFMPS (09/04/2020) qui fixe le cadre permettant d'accroitre les possibilités pour les établissements de soins de travailler en collaboration avec des firmes externes sur des solutions alternatives.

 

Other than medical devices:

 

10/04/2020 in house Masques de soins – chirurgicaux
Blouses
Hospital CHU de Charleroi
Chaussée de Bruxelles, 140
6042 - Lodelinsart
Contact point

 

Manufacturer  
contact point  
Methodology applied for the house  
Target population  
Quality management system  
Risk management system  
Biocompatiblity testing  
guidance published by FAMHP  

 

10/04/2020 in house Masques de soins – chirurgicaux
Blouses
Hospital C.H. UNIVERSITAIRE ANDRE VESALE
Rue de Gozée, 706
6110 - Montigny-le-tilleul
Contact point  
Manufacturer /
contact point /
Methodology applied for the house /
Target population /
Quality management system /
Risk management system /
Biocompatiblity testing /
guidance published by FAMHP /

 

16/04/2020 in house Visières de protection (désinfection manuelle après chaque usage) réalisées par des personnes physiques (pas par des sociétés)

 

Tabliers/blouses non stériles confectionnées par des couturières

Masques « Décathlon® » adaptés en respirateurs avec embouts spécifiques

Hospital CHU NAMUR
Avenue Docteur G. Thérasse, 1
5530 Yvoir
Contact point  
Manufacturer /
contact point /
Methodology applied for the house /
Target population /
Quality management system /
Risk management system /
Biocompatiblity testing /
guidance published by FAMHP /

 

20/04/2020 Reuse FFP2/3 maskers
Hospital AZ Turnhout
Rubenstraat, 166
2300 Turnhout
Contact point nicky.declerck@azturnhout.be
Manufacturer /
contact point /
Methodology applied for the reprocessing /
Target population /
Methodology used to demonstrate mirobiological validation /
Methodology used to demonstrate filter performance - for Mask only /
Respect of the advice good pratices for the sterilication of MD SHC N°9256 /

 

20/04/2020 Reuse 3M Aura Particulate Respirators 9300+ Series
Hospital UZ Leuven
Herestraat, 49
3000 - Leuven
Contact point mira.dreesen@uzleuven.be
Manufacturer KU Leuven, represented by KU Leuven R&D, acting on request of Rega institute
Herestraat, 49
3000 - Leuven
contact point jef.arnout@kuleuven.be
Methodology applied for the reprocessing /
Target population /
Methodology used to demonstrate mirobiological validation /
Methodology used to demonstrate filter performance - for Mask only /
Respect of the advice good pratices for the sterilication of MD SHC N°9256 /

 

28/04/2020 Reuse Masque antipoussière 3M Aura, FFP2, sans soupape
Hospital CHU de Liège
Avenue de l'hopital, 1
4000 Liège
Contact point  
Manufacturer  
contact point  
Methodology applied for the reprocessing Stérilisation au peroxyde d'hydrogène
Target population Healthcare professional at hospital
Methodology used to demonstrate mirobiological validation Nous avons contaminé des masques avec des Pseudomonas, des Staphilicoques dorés et des virus à couronnes non pathogènes chez le porc.
Bonne stérilisation pour les Pseudomonas aeruginosa: de (6.400.000 + 6.00.00 + 9.000.00)/3 = 7,1 10^6 à < 0,25, soit une réduction de minimum 36.000.000 fois (minimum 7,6 log10)
Bonne stérilisation pour les Staphylococcus aureus : de (27.000.000 + 24.000.000)/ 3 = 25.000.000 à < 0,25, soit une réduction de minimum 110.000.000 fois (minimum 8,0 log10)
La stérilisation au peroxyde d'hydrogène a empêché de faire repousser les virus en culture cellulaire.
Methodology used to demonstrate filter performance - for Mask only Valisation du fabricant de masques, du fabricant du stérilisateur et des tests ont été réalisés par le ministère de la santé Néerlandais afin de garantir une réuilisation 5 fois des masques FFP2.
Respect of the advice good pratices for the sterilication of MD SHC N°9256 Non car ces recommandations exigent un nettoyage et une désinfection préalablement à la stérilisation

 

 

Last updated on 21/05/2020