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UK Regulator Issues Medical Device Alerts Show Comments PDF Print E-mail
Monday, 31 May 2004
LONDON (Agence de Presse Medicale for Reuters Health) - The Medicines and Healthcare Products Regulatory Agency has advised that Johnson & Johnson's Cidex (ortho-phthalaldehyde) disinfectant for urological instruments should not be used if an alternative is available following reports that it can induce hypersensitivity.

LONDON (Agence de Presse Medicale for Reuters Health) - The Medicines and Healthcare Products Regulatory Agency has advised that Johnson & Johnson's Cidex (ortho-phthalaldehyde) disinfectant for urological instruments should not be used if an alternative is available following reports that it can induce hypersensitivity.

A recent post-marketing surveillance review by the company had identified that, since the product was introduced in 1999, out of approximately 1 million urological procedures, 24 patients had experienced "anaphylaxis-like" reactions after repeated cystoscopy.

Symptoms reported to the manufacturer included nausea, penile swelling, hypotension, vomiting, breathing difficulty, wheezing, rash, hives, eye irritation, dizziness and anaphylactic shock.

The agency also advised that reusable nebulisers should be thoroughly dried after cleaning to avoid the potential risk of transmission of Legionella bacteria.

It said an investigation into an outbreak of Legionnaire's disease at a hospital could not rule out the possibility that the source of infection was Legionella bacteria in droplets of the water left in a nebuliser.


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