Wednesday, October 24, 2012

Inseguretat+Ineficàcia en un pack

EU approval system leaves door open for dangerous devices

Si alguna feina ha de fer el regulador és garantir la seguretat i eficàcia de les prestacions sanitàries. Ja no li demano que d'entrada siguin cost-efectives, perquè si no resol bé aquestes dues coses prèvies no podem continuar. En anteriors ocasions he parlat del desgavell regulatori dels subministraments mèdics. El marcat CE és de fum. Doncs bé, esteu preparats? Llegiu el relat sencer del BMJ. Van fer això:
We developed an imaginary Chinese company, called Changi, which wanted to sell hip implants on the European market. We created a website and brochure of a large diameter metal-on-metal total hip implant based on a recalled hip implant from the US orthopaedic company DePuy.
The DePuy prosthesis was recalled in 2010 after pressure from surgeons and regulators. Metal debris from wear of the implant led to a reaction that destroyed the soft tissues surrounding the joint, leaving some patients with long term disability. Ions of cobalt and chromium—the metals from which the implant was made—were also released into the blood and cerebral spinal fluid in some patients. After establishing Changi, the reporters then visited several notified bodies in Slovakia, Hungary, the Czech Republic, Greece, Turkey, and South Korea. At each meeting, the journalists emphasised that the Chinese hip implant would be metal-on-metal. That it was a large diameter metal-on-metal total hip replacement was clarified in follow-up emails.
The reporters then submitted a “technical dossier” to EVPU in Slovakia. Again, there were no concerns about the basis of the application. The EVPU representative corrected the font of the dossier but did not raise concerns about the design.
Molt preocupant, això només fa que augmentar la urgència en resoldre acuradament una nova regulació dels subministraments mèdics. Pensar que els ciutadans es troben davant tal indefensió obliga a una moratòria immediata a l'entrada de nous productes fins que es posi en marxa una sistema garantista de seguretat i eficàcia de tots els subministraments mèdics. És urgent, no cal afegir res més.

PS. Aquí hi ha la segona part. I aquí l'editorial.

La música millora els ànims. Escolteu l'Adriana Partimpim en directe. Una troballa.

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