Biomedical subjects

International Standards Organization

Publications and source records attributed to International Standards Organization.

4 recordsLinked to original sources

PubMed2006

[Conceiving and implementing an ISO 9001:2000 quality management system: quality improvement and efficiency increase over 3 years at the Dept. of Ophthalmology, Sultan Qaboos University in Oman].

BACKGROUND: Oman is a developing country of the Middle East with a University Hospital in a national health system. Problems related to documentation, structure, and procedure prevailing in a multicultural environment result in a lack of productivity. The aim of this study was to test the feasibility of introducing a quality management system according to ISO 9001:2000 into a university department of ophthalmology with special reference to quality and efficiency data over 3 years. MATERIALS AND METHODS: Standardized types of documentation (35 documents, 183 forms and formats, and 453 registers) under a formal roof (booklets for work instructions, quality management, procedures) were conceived in 2001 and implemented, and were evaluated by descriptive statistics over the years 2002-2005 with respect to quality and efficiency. In 2005, the departmental QMS was merged into the QMS of the whole hospital. RESULTS: Establishment of "responsibility clusters" with structured surveillance tasks, procedural improvements, and continuous audits resulted in a significant quality improvement already during the implementation until ISO 9001:2000 certification in 2002, and over the following 3 years. The data were assessed by non-conformities documented monthly (total inpatients: -50%, outpatients: -20%, operating theater: -100%, teaching: -10%; p <0.05) and increased efficiency assessed by the most important performance indicators (before QMS vs a median of 3 years with QMS): major surgery: +459%, inpatient stay: -49.7%, occupancy rate: +63.9%, technical diagnostics: +292.9%, postgraduate teaching total: +740%, research output total: +330% (p <0.05). CONCLUSIONS: It is feasible to introduce the quality management system according to ISO 9001:2000 into a developing country in the Middle East. It has an immediate effect on the increase of efficiency (measured by performance indicators) and quality in all systems providing the possibility for regional benchmarking.

Academic Medical Centers↗

PubMed2006

The ISO 11607 Revisions.

Webinars on the revisions to ISO 11607, Packaging for Terminally Sterilised Medical Devices, have prompted many questions from manufacturers and package engineers concerned with validating their packaging under the new requirements. A selection of those questions are reviewed here.

Equipment Failure Analysis↗

PubMed2005

Fluid composition impacts standardized testing protocols in ultrahigh molecular weight polyethylene knee wear testing.

Wear of total knee replacements is determined gravimetrically in simulator studies. A mix of bovine serum, distilled water, and additives is intended to replicate the lubrication conditions in vivo. Weight gain due to fluid absorption during testing is corrected using a load soak station. In this study, three sets of ultrahigh molecular weight polyethylene tibial plateau were tested against highly polished titanium condyles. Test 1 was performed in two different institutions on the same simulator according to the standard ISO 14243-1, using two testing lubricants. Test 2 and test 3 repeated both previous test sections. The wear and load soak rates changed significantly with the lubricant. The wear rate decreased from 16.9 to 7.9 mg weight loss per million cycles when switching from fluid A to fluid B. The weight gain of the load soak specimen submersed in fluid A was 6.1 mg after 5 x 10(6) cycles, compared with 31.6 mg for the implant in fluid B after the same time period. Both lubricants were mixed in accordance with ISO 14243 (Implants for surgery - wear of total knee-joint prostheses), suggesting that calf serum should be diluted to 25 +/- 2 per cent with deionized water and a protein mass concentration of not less than 17 g/l. The main differences were the type and amount of additives that chemically stabilize the lubricant throughout the test. The results suggest that wear rates can only be compared if exactly the same testing conditions are applied. An agreement on detailed lubricant specifications is desirable.

Body Fluids↗

PubMed2004

Neutron calibration facilities.

Reliable measurement of neutron radiation is a difficult task due to the large energy range of neutrons, their complex and energy-dependent interaction mechanisms with matter and, consequently, the imperfect response characteristics of most instruments. Therefore, Calibration procedures and calibration facilities play an important role. Different types of calibration fields have been developed and made available at several institutions. The primary reference quantity used for the calibration of neutron measuring devices--area monitors, personal dosemeters, spectrometers, etc.--is the neutron fluence. This quantity is determined by appropriate experimental methods whereas dosimetric quantities are derived by applying recommended fluence-to-dose conversion coefficients. This paper summarises the basic principles underlying neutron production, the metrology employed to characterise the radiation fields and the calibration procedures employed. Examples of calibration facilities will be given, which enable routine calibrations, investigations of energy dependence and application-specific calibrations.

Calibration↗