Examination gloves fail lab testing
MEDICAL examination gloves fail Australian standards in up to three-quarters of cases, either by having holes or by breaking, when stretched, more easily than they should.
Australia’s medical standards regulator is investigating after a survey of 24 brands of medical examination gloves — loose-fitting, ambidextrous gloves commonly donned by health workers where blood or other fluids are present, to protect themselves and their patients from cross-infection — has found 75 per cent fail required standards.
Of the 24 products, six failed on leaks, 14 broke too easily when stretched, and two were too thin. One brand of gloves was found to have holes in 34 out of the 40 individual gloves tested.
The testing was done by Enersol, an Australian medical device testing company that does a lot of work for international clients such as the UN.
The company this week described the findings as ‘‘ extremely disappointing’’, as they suggested that health workers and patients alike were not getting appropriate protection from infection.
Enersol managing director John Gerofi said the results also raised a question-mark over the effectiveness of the regulatory processes used by the Therapeutic Goods Administration.
A spokeswoman for the TGA said the results were not dissimilar to its own findings.
‘‘ Doctor Gerofi from Enersol advised the TGA on 18 September that several companies’ gloves failed to meet the ‘ elongation at break’ requirements and the water leakage requirements of the Australian and ISO standards,’’ she said. ‘‘ The TGA is investigating these allegations.’’
Gerofi told Weekend Health he ‘‘ became concerned about the rate of holes in gloves as a result of some tests we did for interlaboratory comparison purposes’’.
‘‘ As a result, we decided to conduct a more formal survey of the Australian market to see whether the available products were complying with accepted standards.
‘‘ The results show clearly that many of the examination glove brands on the Australian market do not meet the TGA requirements or the Australian or ISO standards.
‘‘ Health professionals using these products, and their clients, rightly expect that the products will meet accepted standards. Regrettably, many suppliers in the industry are not meeting these expectations and the Government’s regulatory processes are apparently not detecting the faulty products.’’
Gerofi said that many of the holes would not be noticeable on a casual inspection, and even occasional breakages would be ‘‘ shrugged off’’.
‘‘ It is only if there is a whole series of breakages that anyone will lodge a complaint,’’ he said. For the test, which assessed the brands against the relevant Australian standard AS/NZS 4011, gloves were filled with water and holes detected by any leaks.
For the tensile test, a sample of glove was cut out and measurements were taken for both how far it could be stretched before breaking, and the force required to break it.
While gloves with such holes were better for the purposes of infection control than no glove at all, the presence of even small holes meant infectious agents — bacteria or even superbugs such as MRSA, or viruses such as HIV — could pass through.
A spokeswoman for the TGA said the agency’s regulatory processes comprised a combination of pre-market assessment, postmarket monitoring and post-market vigilance programs.
‘‘ As part of its post-market monitoring program, the TGA routinely tests examination gloves for compliance with the relevant Australian and International (ISO) standards,’’ she said.
‘‘ Over the past 20 months, 34 different samples (drawn from different batches of gloves and a range of manufacturers) have been routinely tested.
‘‘ Of those samples tested, 12 samples passed, two samples have results pending and 20 samples failed.’’
Of these 20, nine were from one manufacturer in Asia but supplied by different suppliers in Australia.
Some of the sample failures were due to labelling and other minor issues, rather than being safety related. When glove samples fail, the manufacturer is required to correct the problem or recall the product depending on the type of problem.
The spokeswoman said gloves found to contain holes were ‘‘ always recalled’’.