Investigations
Medical Device Testing Programme
Each year, a range of medical devices is tested in a programme developed in consultation with Environmental Science and Research Ltd (ESR) and the Australian Therapeutic Goods Administration (TGA). This testing is to ensure that medical devices that have a specific claim, for example sterility, meet that claim, or meet the applicable standard. In general, TGA and Medsafe endeavour to test similar groups of products at the same time by using the same testing procedure.
The following groups of medical devices were tested in New Zealand between July 1997 and June 1998:
- Forty-one different cotton products claimed to be sterile were tested for sterility. Five cotton products were found not to be sterile and these were recalled.
- Fourteen different brands of surgical gloves were tested against AS/NZS 4179:1997. All complied with the test for holes although two failed the requirements for the tensile test.
- Ten different brands of absorbable sutures were tested against the Therapeutic Goods Order 49 and all complied.
- Five different brands of hydrogel wound dressing claimed to be sterile were tested and found to be sterile. One brand which claimed not to be sterile contained less than 10 CFU per gram.
- Stability of condoms - 4 brands were tested and complied with NZS 7104:1993.
The testing programme from July 1998 to June 1999 proposes to test the following group of products:
- Twenty five brands of contact lens cleaning solutions will be tested for sterility.
- Fifteen brands of surgical scrubs and instrument disinfectants will be tested for micro-biological contamination.
- Twelve brands of acupuncture needles available on the New Zealand market will be tested for sterility.
- Forty-five different brands of cotton type products used by dentists will be tested for sterility or micro-biological contamination.
- Twenty batches of different brands of examination gloves will be tested for compliance with the AS/NZS 4011:1997 Single Use examination gloves specification.
- Stability of condoms - 4 brands are being tested annually until the end of the designated shelf-life. Two new brands will be added to this project.