Ex­am­i­na­tion gloves fail lab test­ing

The Weekend Australian - Travel - - Health - Adam Cress­well Health ed­i­tor

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’’.

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