医療機器安全管理指針 - 日本臨床工学技士会
Contents
1.2.
3. 3
4. 4
5. 102 2
6. DVD
7. At SW SPP
8. 1 48 3P
9. 1 1
10. 62 2 AED 1 Automated External Defibrillator AED AED
11. 16 2 2 2 OO 1 12 0000 0000 OOOOOO
12. 11 50cmHz0 50 LED
13. 77 4 2 2 3 4 5 6 7 8 6 3 1 2
14. 39 2
15. 1 2 1 2
16. 2 3
17. 2 H 49 ml min TMP 3
18. V gt 20 DD niall IABP
19. uk 2 E
20. 13 L E 7
21. 3 1 2 2 2 OO 1 1 2 OOOOOO 1
22. 1 4 6 10 1 11 2 3
23. 76 Oml h
24. Or RS 109 qd
25. AC Bm se 0 START STOP START STOP 3 START STOP START STOP
26. 1 25 1 lt E H
27. Th 89 OO 1 12 TT 1
28. 2 11 1 2 3 4 5 E SN 0 7 12 8 9 11
29. 8l 1 1 MM
30. 2 2 4
31. H h OO O O OO O O OO O O OO O O OO O O OO O O OO O O OO O O Ub FE OO O O OO O O OO O O OO O O A
32. A E 0 2
33. 3 1 No 5 V V V V
34. 3 AED
35. SI ul
36. 1 OOOO 1 OO OO 1 2 3 4 5 6 7 8 9 10 11 12 00 00 00 01 E 1 2
37. No W 7 PPT LED ON
38. 29 1
39. 1 11 2 3 ss 1 2 104
40. 77 3 2 3 77 4 2 2 S
41. 3 1 11 2 3
42. AED Nat AED LL 1 AED g 23 Automated External FEF 15 11 J
43. 112 3 0705 5 F 24 7 5 ba 24 25 1 F 13 6 25 1 23 205 23 50 637 14
44. 0 6 6 1 2
45. 3 95
46. 2 1 5 1 1
47. f 1 1 No
48. f OO4 Ne EO A0003 Lom ome we EE smn mm 2 1 1 1 f U 1
49. 33 PEEP CPAP HE 4 No 3
50. 5 17 4 1 5 5 1
51. 3 uh 4
52. t 3 40 1 OO O OO 0 Na 13O 14O mEq L
53. 1 1 2
54. 1 1
55. 2 1
56. 1 16
57. 5 2 PCPS PCPS PCPS PCPS E RT ul nil 3
58. E 1 114 pli F AED
59. 1 Ee 1 ttp www info pmda go jp E anzensei hokoku estrigw mhlw go jp PMDA
60. 30 1 2 No Hy m E Cd
61. 4 3 1 2 3 5 66
62. 3 I f 4 1
63. 1000 uA 0 10 0 1 2 25mL hr 25 2 5mL L 10 60kPa kPa M 30 90kPa kPa H 60 140kPa 10mml
64. 74 tly 3 75 OA 1 1 1
65. 3 1 2 3 lt v lt v 5 91
66. f 113 25 5 24 183 1 1 2 3
67. http www med safe jp http www med safe jp mpsearch SearchReport action 4 Food and Drug Administration Medical Device Safety FDA E http www fda gov MedicalDevices Safety default htm Medicines and Healthcare Products Regulatory Agency MHRA Safety warnings alerts and ecalls 98 E http www mhra gov uk Safetyinf 5 1
68. AED 3 1 AED OO OO OO OO TT
69. 4 Qc 3 1 2 3 5 61
70. Del 11 2 E
71. IABP SE gt 3 1 3 3 E
72. 1 1 1 No
73. 1 1 1 1 2
74. 67 0701001 16 7 1 AED AED Defibrillators AED AED AED 1 H
75. k 3 2 1 1 1 1
76. 1 PMDA FDA 2 PMDA PMDA http www info pmda go jp mdevices mdevices htm PMDA http www info pmda go jp iryo html 3
77. 7 FE 8 9 10 E
78. 17 18 19 9 E E
79. No 2
80. 1 1 E No RT 1 HH Me
81. Ch E H 1 HH a Na0C1 b c d a b
82. PCPS No 0 E 2 1
83. 1 1 32 1 Hy Ni No 2 2 E No Hy
84. 1 2 3 107 A 2 35
85. 24 3 PCPS 1 percutaneous cardiopulmonary support PCPS 1 1
86. 2 3 3 Ss ds sa NM et 4 15 2 E 4 1
87. pH 2 30 1 3 2
88. 11 4 0 ar 5
89. 2 1 2 E E 3 1 FE 2 H OO 1 1 2
90. PEEP CPAP 31 4 No 3 5 EB B 9
91. 9 3 2 3 No 2
92. 10 3 6 1 5 0 10 9 00zA 1000 A
93. E 63 AED OO OO OO OO TTT Hp ml 111111111 3 2 RG A RT AED
94. 1 1 11 2 3 1
95. p minimal in 36 I T 1 0 0 4 lt v 5
96. h ormation index htm ES 4 1 1
97. 2 3 97
98. No 70 2 en No RT ul nil 3 NN No
99. 2 AED 108 1
100. ON OFF EC 3 1 1
101. 1 1 1 2 MM No ON
102. 3 PD Ne a 4 ET 3 1
103. 3 1 2 2 2 3 6 1 E 500A 1000A 0 10 90 H HH DC2 8 3 0V 3
104. 600A E 52 Dp yy pl ny i gt hy n gt py a D gt yy gt yy n gt o gt by SE I MPa MPa MPa MPa MPa CC mEq 1 cm 10min mmHg mmHg ol 0 6 2007 0 2007 01 O O x 2007 0 1 2007 01 2007 0 2007 01 2007 0 2007 01 2007 0 2007 01 OHX 2007 02 x x fF 2 2 4 2 9000 3000 12000 16000
105. 5 86 87 1 X
106. 6 19 2 IABP 1 Intra aortic Baloon Panping IABP i
107. 2 1i 2 2
108. BE a ne NN 1 i E HE BE EY 84 es 3 1 A
109. gt 50 3 1 2 2 2 E 4 5 1 7
110. 2 EE ES i 5 3 1 2 2 2 1 DE
111. 3
112. m7 gt 1 1 1 0 02 0 3 E 1 09 1
113. E 4 5 6 f 7 f 8 BB 9 AED ee AED 6
114. 2 OO OO OO lt OO OO OO E 3 0 Ce IL
115. 2 1 2 3 4 5 3 H PR E00 OV 3 1 2 4
116. 3 lt v 2 1
117. 0 2 3 5 PCPS 1 AC 2 3 6
118. 15 9 12 AED 4 EE 2 AED FE oo 3 AED lt O ul AED
119. P33 39 2006 9 11 1 65 67 2004 7 8 P68 72 2006 9 P73 77 2006 1 0 ME 3 2011 56 1 MOSS
120. 2 SEI 3 E AED i E 69 3 lt 3 i
121. 111 3 26 0 0328003 20 3 28 8 1 0801001 19 3 30 0330001 20 50
122. 15 2 i i E SU SR
123. No 4 BB Fn 7 3
124. 1 1 1 2 No LED 57 2
125. 115 20183 7
126. 3 NI 1H 77 3 2 3 3
127. 9 3 1 2 2 2 2 1 OO
128. AC 50J AC 100J AED 60 3
129. Ver 1 02 3 4 f 1 2 3 4 5 LD vv 1 E 19 4
130. 13 3 12 188 16 330018 2 23 50 I 4 33 162 6 1970
131. 90 25mL hr 3 ee Do eo to mt i i sn 3 1 2 3 Qc ul 3 S 4 80 5
132. 1 1 1 2 a b c Ey am an a b
133. 3 2 No 34 2 1
134. i 1 2 1 1
135. 1 1 19 4 1 11 2 3
136. 1 1 amp gt EE lt 1 1 IABP 1 2 2 ee 2 TABP jt No IABP 1 1 E
137. AED AED 1 1 AED AED AED
138. 6 18 EGG 3 23 205 15
139. AED 2 AED AED 1 FE 3 3 4 68 APD 201 17
140. 25 1 E CE F 19 3 30
141. ee r 2 3
142. 18 6 21 18 84 23 205 1 1 23 201 23 202
143. gt Ei TI ul 4 A 3 3 2 LC AED E ks AED LL 5 1 3 15 3 26
144. 5 1 5 1 2 3 I
145. KG 1 3 No HH PEEP CPAP
146. E 326 25 1 638 24 23 bs 3 NI 22 67 245 4 1 0330010
147. OO 1 1 2 7 8 9 10 11 OOOO 1 3 1 2 3 1 2 2 2 3 6 1 ES twt
148. 1 4 SS ee SEN gt 5 E E E 94 P TRNALCAN E
149. 3 1 2 3 6 37
150. v 13 14 96 20 15
151. A PMDA 3 19 4 5
152. 19 70 19 92 19 93 3 30 101
153. LE 4 E f 1 3 E 3 55 4 E 1 1 P61 64 2006 2 3 11 P13 4 5
154. ys E i 2 2 1 1 1 NN
155. 3 3 2 7 8 9 10
156. 4 92 4 1 1 1 1 63 2 1 H
157. AED AED OO OO OO OO No
158. Tr lt v Ff 4 OO 1 1 2 ee OOOOOO 9 OOOOOO 3 1 5 3 6 1 UP FE En 12 ET om em 51 0 10 3
159. 1 2 0330018 19 3 30 3 248 13 3 27 4 CDC Recommendations for Preventing Nosocomial Pneumonia 2003 5 CDC 2004 6 2012 7 2 2011 12 033001 i 3
160. OO OO OO OC OO OO 83 3 NIS No 2
161. 1 11 2 3 D Se 1 Y fr 2
162. 1 2 DER No E 1 3 2 hy ul 1
163. D 44 4 3
164. E 1 3 1 jl 78 i 3 4 5 sj
165. CRT 2 1 No RD
166. a 15 30 b E AZ a BE L NE v
167. B FAX HH 20 f 5 3 E 3 145 2 4
168. LEE a b C a RA d No
169. 3 1 1 i 3 6 1 ET al ET mas E 00xA E 600xA 1 1000wA 0 10
170. 3 a 47 2 1 1 7 9 9 1
171. 1 1 4 3 1 2 3 5
172. 1 1 PCPS 1 2 PCPS LED
173. 82 OOml h lt 2
174. OO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO ooooo ooooo OOOOO O0000 ooooo OoOooo ooooo ooooo Ooooo 1 ee 3 1 E T 35 3 6 1 nil 500zA 500 A 10004 A gt LED
175. oe 15 2 4 105 1 11 2 3 SS gt TK E
176. AED 1 AED E HF 1 E E 1 1
177. 0 a 5 ea z 8 3 3 6 1 E 100A 500zA E 5007A 1000wA 0 9 Ds 8
178. 1 11 1 2 1 3 1 11 1 3
179. a b 14 No
180. c d e 2 a CHaCOOH b
181. PCPS OO 1 12 3 1 PCPS 3 6 1 TT mmm 0 ET 00A 500A 500zA 1000zA 3 0 10
182. 3 3 6 1 1000 uA 0 10 43 EB DK F
183. 6 1 E Doar HT 3 Qr 7 T Ver1 02
184. 1 10 5 LED AC100V 50 3 RM ON i ele sll ili
185. 1 201 3 7 1 I 1 2 3 3 1 3 2 AED 6 13 14 29 30 38 39 56 57 69 70 75 76 81 82 87 88 92 4 4 1 II 93 100 101 113
186. 0000 0000 OOOOOO 4 0000 0000 1 3 6 OOOOOO 1 3 1 1 1 a 1 a b c 3 a b 6 a b c 1 a Hy gt
187. En LA 5 No Dy 2
188. 2 2 1 3 1
189. LED 2 1 2 RT m 58
190. Na K We 1 1 ei es El 2 S i be ba
191. 1 2 E A4 8 4 1 1 11 2 A4 93 1 1 11 2 12 3
192. 4 59 E 54 l 5 1
193. No IABP 3 IABP No 2 1 1 2 1000 SN
194. 1 2 1 6 D 10 1 11 1 11 1 1 11 1 1 2
195. MR a ee x 6
196. C 3 1 3 Ce 4 OO No OOOOOOO 5 _ 8P
197. 6 1 26 2 1000 2 3 6 1 3 4 3 1 2 2 2
198. 2 3 5 18 1 AC ii AC a 3 2 3
199. 23 50 1 11 0330010 E ff 1 6 10 1 5 2 3
200. 23 203 4 1 19 9 1 19 19 27 19 5 3 3 26 19 39 19 108
201. 9 B 3 1 1 CRT A Be 250rpm 50
202. OOOO 2 OO OO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO OOOOO 2 2 2 pu I T S T JIS GEO oath ap hea i
203. 1 1 2 3 3 106 2 0330001 0330018 19 3 30 23 205 6 10
204. 3 6000 53 3 2 H
205. RESET EN AUTO PRIMINC 3 6 15 CHG PCPS Be ff OE 28 4
206. 1 11 1 4 Wr 103
207. 16 6C c 46 b C d e a b
208. 13 4 5 6 7 17 8 18 9 19 10 1 1 2 H 3
209. 4 00zA 85 500A E 600A 1000wA 0 10 3 OR ss we 3 1 2 3 4 i
210. http www info pmda go jp info houkoku htm 17 4 1 6 03170006 99 1 17 3 2 10 wn 0310003 4 22 100 E11 16 II 1 19 4 1 0330010 19 3 30
211. 2 2 No AC 15 3 No
212. 5 1 AC 2 3 6
213. 14 158 14 159 71 1 8 5 24 10 108 3 31
214. b 1 5 E E E AI lt v E 3 1 2 3 6 3
215. 2 1 8 6 1 3 3 1 2 2 2 I bat HU lt TABP OO 1 12
216. S 9 2 2 3 E 3 1 2 2 2 0 2 OO 1 12
217. 0330001 E 1 2 ee 1 E IV 35 4 A AED
218. 1 1 2 L_ alslelelg 6 OOOO 00 01 1 ooo TT 1 3 6 1 100A 500 A 500zA 1 1000zA SW H
219. E 5 APD 3 6 1 65 E AE D AED
220. 145 2 4 1 2 3
221. sj sj ij 11 0000 0000 OOOOO 0000 0000 3 OOOOOO 0000 0000 OOOOOO 1 2 3 1 2 2 2
222. 4 3 1 2 3 5 99 45
223. 1 ET 3 js OO No Gilc e P70IE70 c 1 oo oo 2 CD GO OO gt WR 3 Go Go 4 EP oo 5 sim 5 EE EOS lt 6 oo oo EE oo T x x OO 8 oo OO 9 oo oo 10 Go GO 11 OO oo 1 co OO LO 12 EHP ooO OO _ODOODD ooxoo oo oo DVD 13 CO CD 2 155 14 TO OO 1 koeosoc oo oce_ DVD 15 OO OO 3 16 OO CO DVD 17 OO oo0
224. 4 18 oo GO 1 DVD 19 OO OO lt 1 20 OO OO i R DVD ms EE ET OCOOOF OOOOS ONOOE OOOOE OO 5 1 2 3 3 1 1
225. 8 1 2012 7 N 1
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