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Association of Indian Medical Device Industry (AIMED)
Abstracts Of Regulatory Report – July 2011
e) 13 Jul 2011 Implantable Pulse Generators (IPGs) –
Neurostimulators manufactured by St Jude Medical (MDA/2011/079) , Issued because
the manufacturer issued a Field Safety Notice (FSN) but has not had sufficient
confirmation from users that they have received and acted on this information.
The issue concerns faulty battery components resulting in some IPGs losing the
ability to communicate with the programmer or recharge.
f) 07 Jul 2011 28% air entrainment (white Venturi) jet
adapter for use with oxygen facemasks (MDA/2011/078) , Issued due to a risk of
inadequate oxygen supply.
g) 07 Jul 2011 Level 1® Normothermic IV fluid administration
sets for use with the Level 1® Fast Flow fluid warmer units manufactured by
Smiths Medical (MDA/2011/077), Issued as this IV fluid administration set has a
heat exchanger assembly that may be too long to fit into Fast Flow fluid
warmers, making the set unusable.
h) 07 Jul 2011 Level 1® Normothermic IV fluid administration
sets manufactured by Smiths Medical (MDA/2011/076) , Issued due to reports of
kinking of the tubing and leaking at the F-50 gas vent filter assembly.
i) 06 Jul 2011 Headrests attachment to operating tables
manufactured by Maquet Ltd. (MDA/2011/075). Issued because the manufacturer
issued a Field Safety Notice (FSN) for this device on 12 May 2011, but has not
had sufficient confirmation from users that they have received and acted on this
information. The issue concerns the safe use of connection fixture 1002.65A0 and
1002.65S0.
j) 05 Jul 2011 Cortoss™ Delivery Gun manufactured by
Orthovita Inc and distributed in the UK by Orthovita UK Ltd (MDA/2011/074);
Issued because the manufacturer issued a Field Safety Notice (FSN) for this
device on 15 April 2011, but has not had sufficient confirmation from users that
they have received and acted on this information. The issue was a deficiency
with the packaging configuration of the Cortoss™ Delivery Gun (Part number
2110-0008).
k) 29 Jun 2011 Implantable cardioverter defibrillator (ICD)
manufactured by Sorin CRM (MDA/2011/073) Issued because of a risk of bradycardia
/ syncope due to pacing inhibition. There is also potential for pacing
inhibition associated with ventricular oversensing if the follow-up monitoring
feature, PhD, is programmed ON and the device is connected to high polarisation
defibrillation leads.
STANDARDS UP-DATE
On 1 June 2011 the EC made publicly available its
"Communication on a strategic vision for European Standards" and the proposal
for a regulation on European Standardization, the latter having to be approved
by the European Parliament.
The idea is to make standardisation more inclusive and more
transparent by responding to SMEs' needs and reaching to areas where
standardization is not much used (e.g. services)
Note the reduced standards list this month, standard
committee activity always drops off during the summer months.
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