Medical Device Single Audit Program is one of the key projects in International Medical Device Regulators Forum, which has much experience to be used for reference. This paper briefly describes the procedures and contents of the Witnessed Audit in Medical Device Single Audit Program. Some revelations about the work of Witnessed Audit have been discussed, for reference by the Regulatory Authorities and the Auditing Organizations.
Equipment and Supplies ; Medical Audit

The audit of the quality management system in the medical device single audit program covers the requirements of several national regulatory authorities, which has a very important reference value. This paper briefly described the procedures and contents of this audit. Some enlightenment on supervision and inspection are discussed in China, for reference by the regulatory authorities and auditing organizations.
China ; Equipment and Supplies ; Medical Audit ; Quality Control

Objective To compare the curative effect of fixation of adolescent tibial intercondylar emi-nence fracture among suture anchor,hollow screw and wire. Methods Forty-six adolescent cases of the tibial intercondylar eminence fracture treated with surgical treatment were selected from January 2010 to June 2016 and divided into three groups refer to intra-operative fixation suture anchor group(Group A),hollow screw group (Group B)and wire group(Group C).Duration of treatment,total operation time,hospital stay and surgery times were recorded. All patient condition was assessed with the Lysholm,Tegner,IKDC and VAS score. Results All patients received an average of 13(11~14)months follow-up visit. No blood-vessel,nerve and osteoepiphysis injured,infection and fracture displacement occurred.Before receiving treatment,difference in Lysholm,Tegner, IKDC and VAS score of group A,B and C showed no statistical difference.When it comes to hospitalization condi-tion,data were as follows.Group A/B/C:operation time(80.67 ± 16.68/114.00 ± 20.28/111.88 ± 20.07)min, hospital stay(8.40 ± 1.12/ 15.47 ± 1.25/ 15.19 ± 1.17)d,surgery times(1/2/2)times. Moreover,compared with those before operation and after operation in both of groups,the Lysholm,Tegner,IKDC and VAS score were improved(P < 0.05). Besides,the Lysholm,Tegner,IKDC and VAS score of group A,B and C did not have statistically significant difference yet after post treatment(P>0.05).Conclusions The curative effect of fixation of adolescent tibial intercondylar eminence fracture among suture anchor,hollow screw and wire was similar. By contrast,the fixation of fracture by use of suture anchor can decrease operation time and hospital stay to some extent. It had advantage of need not to have a second operation to remove the internal fixation and can be used in preference.