Safety Test Call For Eye And Heart Implants
Sydney Morning Herald
Monday October 16, 2006
MEDICAL devices used to treat conditions such as heart disease and blindness could be subject to stricter safety tests under a proposal prompted by studies suggesting they are harmful to some patients.
Research indicates that drug-coated stents routinely used to correct coronary disease may increase the risk of lethal blood clots. Doubts have also surfaced about some lens implants used in cataract surgery. The Australian Health Insurance Association will today demand that Government introduce compulsory clinical testing for all new devices in three areas of medical gadgetry - cardiac, lens and spinal treatments - before and after devices are put into use.The association wants compulsory clinical testing and national surveys of the kind introduced for joint replacements. The survey on joint replacement, released last week, showed a quarter of artificial hips and knees failed and that newer, more expensive models were more likely to fail.The association's chief executive, Dr Michael Armitage, said uncertainties about other prostheses identified by the association were "an area of great concern".The Health Department is considering a revamp to tighten up the regulatory assessment of joint prostheses and is scheduled to discuss the issue with industry, health fund and medical representatives this week. The health funds' call follows the findings of several European studies showing that coated stents were linked to a small but increased risk, of 0.6 per cent, in the rate of death and heart attacks.The stents, inserted to open diseased arteries, are coated with a drug to hinder re-growth of artery tissue. At about $3500 each, the drug-coated version is three times the cost of the uncoated stent and has been the subject of previous criticism as to whether it is worth the extra expense. About 20,000 patients a year in Australia have stents inserted and 90 per cent of private patients have the drug-coated version, according to the Health Insurance Association.It questioned the widespread implant use of "blue blocking" intraocular lenses used in cataract surgery, citing an American ophthalmologist, Dr Marin Mainster, who says the lenses, which filter light, could harm vision and interfere with sleep patterns.The association has expressed concerns about another therapy it describes as controversial for chronic lower back pain - intradiscal electrothermal annuloplasty. A study by an Adelaide orthopaedic surgeon found it made "absolutely no difference". A former Liberal health minister, Michael Wooldridge, has said the national joint replacement register survey, which records all such operations in Australia, provides compelling evidence for the extension of such a survey to other areas of medicine.The Health Minister, Tony Abbott, last week said his department was discussing tightening the regulatory assessment process with the Therapeutic Goods Administration. A Health Department spokeswoman said yesterday that every device was subject to assessment but this did not routinely include clinical testing.The president of the Australian Medical Association, Mukesh Haikerwal, has backed the call for a tougher checking system. He said any review should be by doctors and decisions had to be made on a medical not fiscal basis.GADGET ALERT* Artificial joints: Up to 25% fail. New model hip replacements cost up to $10,000 but have higher failure rate.* Drug-coated stents: Cost $3500 - three times more than uncoated devices - but linked with small but significantly increased risk of heart attack and death.* Blue-blocking intraocular lens: About $400. May harm vision and sleep patterns.* Intradiscal electrothermal annuloplasty: Therapy for lower back pain. Costs more than $1000. Australian study finds no evidence it works. Source: Australian Health Insurance Association
© 2006 Sydney Morning Herald