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Medical Equipment: Counterfeit Manufacturing

Health written question – answered on 13th June 2011.

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Photo of David Davies David Davies Chair, Welsh Affairs Committee

To ask the Secretary of State for Health

(1) pursuant to the answer of 4 May 2011, Official Report, column 853W, on medical equipment: counterfeit manufacturing, if he will place in the Library a copy of the medical devices alert issued by the Medicines and Healthcare products Regulatory Agency requesting the withdrawal of the counterfeit devices in question; and by what means the alert was transmitted to all NHS trusts;

(2) pursuant to the answer of 4 May 2011, Official Report, column 853W, on medical equipment: counterfeit manufacturing, how many of the high volume consumable devices found to have reached the NHS supply chain in 2009 were distributed;

(3) pursuant to the answer of 4 May 2011, Official Report, column 853W, on medical equipment: counterfeit manufacturing, what the (a) type and (b) make is of each counterfeit medical device found to have reached the NHS supply chain in (i) 2009 and (ii) 2011;

(4) whether the Medicines and Healthcare products Regulatory Agency received information in (a) January and (b) March 2011 about the safety of a counterfeit pulse oximeter sensor found in use in a hospital;

(5) what progress has been made in the investigation into the counterfeit pulse oximeter sensors found in hospitals within the last year.

Photo of Simon Burns Simon Burns The Minister of State, Department of Health

A copy of the medical devices alert on counterfeit pulse oximeter sensors has been placed in the Library. This alert was originally disseminated to national health service trusts through the NHS central alerting system which brings together the chief medical officer’s public health link and the safety alert broadcast system. The central alerting system enables alerts and patient safety specific guidance issued by the Medicines and Healthcare products Regulatory Agency (MHRA) and the National Patient Safety Agency to be accessed at any time.

All of the counterfeit high volume consumable devices found in the NHS supply chain in 2009 were distributed.

The 110,000 counterfeit devices found in 2009 were single use needles for the delivery of insulin. In 2011, 300 counterfeit pulse oximeter sensors and six packs of counterfeit condoms were found in the NHS supply chain.

MHRA received information in January and March 2011 about the safety of a counterfeit pulse oximeter sensor found in use in a hospital. I refer the hon. Member to the written answer I gave him on 4 March 2011, Hansard, column 666W, for details of the subsequent investigation which is still continuing and the action taken.

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