MHRA Medical Device Alert : Neonatal and paediatric support devices: Gel-E Donut and Squishon 2 manufactured by Philips Healthcare (Children’s Medical Ventures)

Neonatal and paediatric support devices

Gel-E Donut, part numbers: 
92025-A, 92025-B, 92025-C

Squishon 2, part number: 
91033-2
All batches

Manufactured by Philips Healthcare (Children’s Medical Ventures)

 These are gel-filled products used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head and/or body.

For detailed information on recall alert CLICK HERE

Brain cancer vaccine wins first UK 'innovative medicine' status...

A potential new cancer treatment has become the first therapeutic to be awarded the new ‘Promising Innovative Medicine’ (PIM) designation, which could lead to fast-track access to patients.

The Early Access to Medicines Scheme (EAMS) is a new scheme launched by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in April this year. It is intended to allow patients with ‘life threatening or seriously debilitating’ conditions access to potentially useful new medicines ahead of formal approval for their use, which can take several years. The scheme is intended to benefit both seriously ill patients who lack other viable treatment options, and companies developing new medicines who could find the designation helpful in attracting investment.

The news does not mean that patients will be able to receive the therapy yet, however. PIM designation is the first of two steps in the process indicating potential eligibility for the EAMS agreed by an MHRA scientific meeting and based on preliminary clinical trial data. The MHRA assesses whether or not the product:

• is for a serious condition with high unmet clinical need
• is likely to offer a major advantage over current treatments
• has potential benefits that outweigh the potential harms

The second stage is an Easy Access to Medicines Scientific Opinion from the MHRA, which describes the available data, the risks and benefits of the new medicine and allows a decision to be made on whether it is eligible for early access by selected patients ahead of licensing.

The new medicine, DCVax-L, has been developed by Northwest Biotherapeutics Inc. who will continue with clinical development and hope to accrue appropriate data to allow progression to an MHRA Scientific Opinion on eligibility for the EAMS. DCVax-L is for the treatment of new and recurrent malignant gliomas and is not a classical drug but a cellular or biological therapy – in this instance what is termed a cancer vaccineintended to prime the body’s own immune defences to target and destroy tumour cells.

NorthWest’s Chief Executive Linda Powers said that the scheme offered“a very practical balance between clinical benefits and risks, through careful scientific evaluations”.

Life Sciences Minister George Freeman commented: “We want to make Britain the best place in the world to design and deliver 21st Century healthcare technologies which is central to our life science strategy. This Promising Innovative Medicine designation is the first crucial step in accelerating access to new medicines, giving real hope to patients and their families”. He also said he hoped to see more companies of all sizes and medical charities nominating products for the EAMS.

MHRA Medical Device Recall Alert: Ellipse™ VR/DR implantable cardioverter defibrillators manufactured by St Jude Medical...

CAS deadlines
Action underway: 23 September 2014, action complete: 17 November 2014
 
EllipseTM VR/DR implantable cardioverter defibrillators (ICDs).

Model numbers CD1277, CD1377, CD2277, CD2377 (all -36, -36Q, -36C and -36QC suffixes). All serial numbers distributed before the field action.

Manufactured by St Jude Medical.

PROBLEM:  
Potential for delayed or insufficient energy defibrillation therapy due to a capacitor fault.

St Jude Medical issued a FSN dated 19 August 2014, describing a potential failure mode which can delay or reduce the therapy that can be delivered by the ICD. The problem has been traced to an ICD capacitor defect, accompanied in some returned devices with evidence of arcing between the capacitor anode and cathode. Analysis so far indicates that it is not possible to predict which ICDs will suffer this failure or when it may occur, so despite a low failure rate of 0.42%, all patients and clinicians will need to be vigilant.

All affected ICDs will exhibit extended charge times, evident not only during device testing / maintenance but also when preparing to deliver therapy. To date all potential failures reported to St Jude Medical have been identified through timeout warnings triggered by automated capacitor maintenance or during in-clinic testing, rather than being associated with serious adverse events.

The manufacturer has confirmed that all affected ICDs should now have been retrieved from hospital supplies and they are currently replacing them with newly designed product not expected to be susceptible to this failure mode. Replacement product can be identified according to the serial numbers detailed at the end of the FSN, and by the green label fixed to the ICD packaging.

For Detailed Information on Recall CLICK HERE
 

MHRA CLDA Company-Led Drug Alert - Dopacard 50mg/5ml Concentrate for Solution in 5ml vials - Cephalon UK Limited - CLDA (14)A/16

Company-led recalls

15 September 2014

CLDA number: CLDA (14)A/16
MDR number: 22-09/14
Company name: Cephalon UK Limited
Product description: Dopacard 50mg/5ml Concentrate for Solution in 5ml vials, PL 16260/0023 (Dopexamine hydrochloride) 
Batch number/expiry: 225738E01, 31/10/2015
Brief description of problem:
Teva UK limited, on behalf of Cephalon UK Limited, is recalling the above batch because two vials within the batch were found to have a grey discolouration and did not, therefore, comply with the required specification.
Company contact for stock enquiries:
Teva UK Customer Service team
0800 590 502
Company contact for medical information enquiries:
Teva UK Limited
0207 5407 117
Email: medinfo@tevauk.com