Defective Thermometers Put Lives At Risk

Main Category: Medical Devices / Diagnostics
Also Included In: Public Health
Article Date: 22 Apr 2009 - 2:00 PDT

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Consumers are being warned against purchasing AidFast, 1st Aid and Powerplast digital thermometers after rigorous tests by the Medicines and Healthcare products Regulatory Agency (MHRA) revealed some serious reading discrepancies in many of these devices.

An ongoing MHRA investigation into these products has revealed numerous similar thermometers marketed under a variety of brands and packaging may also be substandard.

The devices are giving an inaccurate reading which could pose a threat to users. For example, an error of up to 0.5°C could be significant, particularly to babies and small children, as consumers may not seek the medical attention required.

These products have been found for sale at various discount stores, online and in some high street pharmacies. The MHRA is currently investigating how they have been supplied to the UK market.

The public are urged to stop using these faulty devices if they have purchased one as there are inadequate instructions for use, inadequate warnings and precautions, and inadequate advice on cleaning for re-use. Additionally, the packaging does not supply information on the manufacturer or the batch, or serial number.

MHRA Director of Device Technology and Safety, Clive Bray said those who purchase these products have no assurance they meet the appropriate standards of safety and performance.

"These thermometers are not accurate and may lead to a critically high temperature not being identified," he said. "This could potentially endanger someone's life if the urgent professional medical attention required is not sought after."

The MHRA continues to encourage people to report faulty medical devices by calling our Adverse Incident Hotline on 020 7084 3080 or via our website at http://www.mhra.gov.uk.

Notes

1. The MHRA has not received any adverse incident reports regarding inaccurate readings from the digital thermometers.

2. There is an ongoing investigation by the MHRA as to how these thermometers are being supplied onto the UK market. As yet the Agency does not know how many of the thermometers have been sold.

3. The Agency commissioned testing from an independent test house to see whether the thermometers met acceptable standards in relation to the reliability of the thermometer readout. The results showed there to be serious deficiencies. The conclusion was that the accuracy of the readings raised concerns.

4. Deficiencies identified with the thermometers are:

- Lack of manufacturer details
- Device batch number and serial number
- Storage and handing instructions
- Concerns over the accuracy achieved and range of measurement possible
- Lack of information on conditions of use, special operating instructions, sufficient warnings and precautions to be taken
- Information on calibration and maintenance procedures and appropriate process of reuse.

All these items are essential to ensure the informed, and therefore safe, use of thermometers.

5. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgments to ensure that the benefits to patients and the public justify the risks. We keep watch over medical devices and medicines, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone -the public and healthcare professionals as well as the industry - to tell us about any problems with a medical device or medicine, so that we can investigate and take any necessary action. http://www.mhra.gov.uk

Source
MHRA

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