Medical devices may cause deaths

Date: 25/04/02

By Laurence Frost

UNAUTHORISED re-use of disposable medical instruments could be responsible for thousands of deaths every year from infections caught in hospital, MEPs were told yesterday (24 April).

A European Parliament round table on the recycling of 'single-use' devices heard that the practice was widespread even in EU countries that have banned it, and may also breach Union law.

At the hearing, MEPs reviewed evidence of the dangers posed by 'reprocessing' disposable tools, presented by medical instrument makers.

'The Commission should listen very carefully to the case that's being made,' said MEP John Bowis, who chaired the session. 'This isn't just an industry looking to sell more products, it reflects real concerns about the safety of patients and medical staff.'

Hospital-acquired infections kill tens of thousands of EU patients every year - including up to 40,000 in Germany and 5,000 in the UK.

According to one study, two-thirds of reprocessed instruments still carried bacteria from previous use. Some even carry human tissue.

Another survey found that almost one in ten patients caught infections in hospital.

Instrument manufacturers' group Eucomed says although information is patchy on the relationship between reprocessed instruments and infection rates, there is in principle nothing to stop re-used devices carrying bacterial infections or viruses such as hepatitis B and C.

One of the Commission's own scientific committees found in 1998 that surgical instruments had transmitted Creutzfeldt-Jakob Disease (CJD), the fatal brain condition linked to mad cow disease.

'The dangers are obvious,' a Eucomed spokesman said. 'The only sure method of avoiding the risk of spreading CJD during medical procedures is to prevent the re-use of single-use devices.'

Backed by patients' groups, Eucomed is calling on the Commission to take action against countries that turn a blind eye to re-use of instruments, under the 1993 directive introducing harmonised regulations for medical devices.

A spokesman for Erkki Liikanen, the industry commissioner, acknowledged there were concerns.

'Where devices that have been designed for a single use are subject to re-use, this can create a potential health problem,' he said.

But he added that the Commission's powers to intervene 'remain limited' under the current EU rules, which do not apply to recycled instruments.

Unauthorised re-use of disposable medical instruments could be responsible for thousands of deaths every year from infections caught in hospital, MEPs were told on 24 April 2002.