Current reference devices for hollow instrument loads as defined in standards are not a valid steam penetration test

In hospitals steam sterilization is an important aspect of infection prevention. Testing of steam penetration is a necessity. In some cases a hollow helix shaped Process Challenge (PCD) device is suggested as steam penetration test for hollow instruments. Since the introduction of these hollow A, hollow load, helix, or helix shaped PCD in standards, discussions about the use of these PCD s are ongoing. Conclusive experimental data on these hollow PCD s was not found in the literature. For the present study a strictly defined helix shaped PCD «reference» device was manufactured. Its performance was tested in a small (11 l) and a large (342 l) test steam sterilizer and compared with the minimum requirements for steam penetration defined in the ISO standards. It was found that this device does not fulfill these minimum requirements. Also these results indicate that hollow A or helix PCD s as presently defined in standards should not be used as steam penetration test in steam sterilization processes. Consequently, PCD s tested against this reference PCD or standard will also not meet the requirements for steam penetration. These PCD s should therefore not be used as steam penetration test for hollow instruments.