Self-inspection of Orthopedic Surgery Appliances and Devices Enterprise-wide Use License - Ministry of Health, Labor and Welfare Pharmaceutical and Food Safety Bureau Notification No. 0311001 March 11, 2004 To: Each metropolitan and prefectural Head of Public Health Department (Bureau) From: Director Safety Division Pharmaceutical and Food Safety Bureau  MHLW Self-inspection of Orthopedic Surgery Appliances and Devices Reusable orthopedic surgery appliances are leased by manufactures to medical institutions per demand. Recently, cases are reported that such appliances break down during operation leaving fractions of device in the human body. A survey revealed a hammer-crack on such a device, and therefore, the cause is deemed to be a metal fatigue. It was impossible to clarify, however, when the metal fatigue had begun due to dissatisfactory quality control of leasing appliances. Break down of appliances during operation can lead to leaving fractions in the body, extension of surgery time. The authority hereby ask those who may concern to perform necessary inspection according to the following procedure and carry out adequate measures. Appendix: see p. 5 Note: The title of the PFSB Notification in Japanese. Appendix Self-inspection of Orthopedic Surgery Appliances and Devices Manufacturers, importing and sales agents, and licensed manufactures or local agents of overseas products of reusable orthopedic surgery appliances should self-inspect their appliances and if necessary, take the following measures. At the same time, they should notify the medical institutions on the adequate use of the appliance in a thorough manner. 1. Detailed Procedure Manual should be composed to verify the quality of restored appliances and those prior to leasing in order to effectively remove those with deformation, deterioration and other quality deficiencies. 2. The Procedure Manual should be made so to enable the processing each device fully and independently. When inspecting the returned appliance, procedures such as cleansing, sterilizing, and others should be conducted separately by each device in order to avoid mixing up with devices of different manufacturing year. 3. The years of durability or number of usages should be established for each part of the device based on scientific data to prevent malfunction of the appliance. 4. For the package inserts, it should be reconfirmed on whether instructions for cautions for medical institutions are included in precautions, which indicate such factors as contraindication or restriction of use. Promptly revise when postscripts are necessary. (The above signed) Note: Medicines (largely pharmaceutical and biologicals) and quasi-medicines (quasi-drugs), cosmetics and medical devices are the four categories of the regulated medicinal products in Japan. MHLW/PFSB Notification No. 0311011/March 11, 2004 Japanese Regulations Copyright (c) 2001-2004 by JKS LLC - 3 -