1、 ISO 2013 Medical devices Hierarchical coding structure for adverse events Part 1: Event-type codes AMENDMENT 1 Dispositifs mdicaux Structure de codage pour la cause et le type dvnement dfavorable Partie 1: Codes de type dvnement AMENDEMENT 1 TECHNICAL SPECIFICATION ISO/TS 19218-1 First edition 2011
2、-05-15 Reference number ISO/TS 19218-1:2011/Amd.1:2013(E) AMENDMENT 1 2013-01-15 ISO/TS 19218-1:2011/Amd.1:2013(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standar
3、ds is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take
4、 part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is
5、to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. In other circumstances, particularly
6、when there is an urgent market requirement for such documents, a technical committee may decide to publish other types of document: an I SO P ub li c l y A v ailab l e Spec i fi c a tion ( I SO / P AS ) repre sen t s an agreemen t b et we e n t e c hni c a l ex p e r t s in an ISO working group and
7、is accepted for publication if it is approved by more than 50 % of the members of the parent committee casting a vote; an I SO Te c h n i c a l Spec ific a tion (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of t
8、he members of the committee casting a vote. An I SO / P AS or I S O/ T S is re vie w ed a f te r t hre e ye a r s in o rder to de c i de w he t her it w i ll be c onfir med fo r a f u r t her t hre e ye a r s , re vised to bec ome an In t e r na t i o nal S t an dar d , or w i t h d r aw n. If t he
9、I SO / P AS or I S O/ T S is c onfir med , it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent right
10、s. ISO shall not be held responsible for identifying any or all such patent rights. Amendment 1 to ISO/TS 19218-1:2011 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. ii ISO 2013 All rights reserved Medical devices Hierarchica
11、l coding structure for adverse events Part 1: Event-type codes AMENDMENT 1 Page 2, Clause 4 In T able 1, r e p l ac e t he f o u r t h, fif th an d si x t h c o lu m ns w it h t he fo ll o w in g : Level 2 code Level 2 term Level 2 definition Example(s) 1001 D i f fi c ult to Position Issue associat
12、ed with users e x p er i enc ing di f fi c ult y in deplo ying a device, device component or both to a specified loc a tion . When replacing a left ventricle lead, the physician had di f fi c ult y m ov i n g the lead ar ound a bend in a branc h of the coronary sinus and so had to remove the lead an
13、d use another one. 1002 Failure to Activate Issue associated with the inability of a device or device component to be activated. The remote monitor of a patient monitoring system was not receiving any power because the power cord was faulty. A defi br illator failed to deliv er a sho c k to a p a t
14、i e nt bec a use the electrical connection between the device cable and the electrode paddle failed. 1003 Failure to Separate Issue associated with the failure of the device or one of its components to detach or separate as intended. Failure of a unidirectional valve in an anaesthesia machine allowe
15、d CO 2rebreathing in the inspiratory limb of the breathing circuit. 1004 Premature Activation Issue associated with an early and une xpect ed activ a tion of the d ev i c e , device component, or both, from the system. W hen an in tra - oral X- r ay unit wa s fi r st tur ne d o n, it g e n e r ate d
16、 an e xposure on it s o w n. 1005 Delayed Activation Issue associated with a delayed and une xpect ed activ a tion of the d ev i c e , device component, or both from the system. A f te r a d e l ay of s eve r a l se c o n ds, the defi br illator deliv ered a shock. 1101 Hardware Issue Issue associat
17、ed with hardware that affects device performance. A fluorosc opic X- r ay s ystem st opped opera ting due to the failure of the hard drive. 1102 Network Issue Issue associated with deviations from documented network system specific a tions t h at af fe c t per for manc e of the whole system or devic
18、e or devices connected to the network. Radiation treatment planning (RTP) data was transmitted across a general use hospital information network. There was a delay in the transfer of the data due to the RTP applic a tion r unning i nt o c onflic t with ot h e r applic a tion demands on the network r
19、esources. 1201 Application Program Issue Issue associated with the requiremen t fo r sof t w are to f ul fi l it s function within an intended use or application. During the use of a patient database application, the computer locked up and the data could not be saved. 1202 Programming Issue Issue as
20、sociated with the written program code or application software used to satisfy a stated need or objective for functioning of the device, including incorrect software programming, dose, parameter and power calculations. A nurse programmed an infusion pump with a dose that was outside the permissible
21、limits for that drug, which the software did not identify, resulting in the patient receiving an overdose of the drug. ISO/TS 19218-1:2011/Amd.1:2013(E) ISO 2013 All rights reserved 1 ISO/TS 19218-1:2011/Amd.1:2013(E) Level 2 code Level 2 term Level 2 definition Example(s) 1301 Connection issue Issu
22、e associated with linking of a device, device component, or the functional units set up to provide means for a transfer of liquid, gas, electricity or data. Syringe pump did not recognize its dedicated syringe. 1302 Disconnection Issue associated with a linked device, device component, or both, havi
23、ng a suf fi c ien t open spac e ( disc onnection ) to prevent gas, liquid or electrical c u r r e nt fl ow in g b et we e n c onnect ors. Two components of a breathing circuit became disconnected. 1303 Failure to Disconnect Issue associated with the linking of a device, device component, or both whe
24、reby termination of the transfer of liquid, gas, electricity, or information cannot be accomplished, or linking components do not come apart, or di sc o nne c t , when e xpect ed . During a reintervention to address dislodgement of a pacemaker lead, the physician was not able to loosen the set-screw
25、 connecting the lead to the pacemaker. This resulted in both the lead and pacemaker having to be replaced. 1304 Fitting Problem Issue associated with the connection of a device, device component, or both, whereby channels, switching systems, and other functional units set up to provide means for a t
26、ransfer of liquid, gas, electricity, or in for ma tion do n ot m atc h or fit. Syringe pump did not accommodate its dedicated syringe. An infusion pump designed for use with standard- sized tubing did not accommodate tubing from another manufacturer. 1305 Loose or Intermittent Connection Issue assoc
27、iated with the connection of a device or device component being loose or intermittent. A fluorosc opic X- r ay d ev i c e di d n ot produc e an e xposure due to a bad interconnection cable that caused an intermittent connection to the X-ray generator. 1306 Misconnection Issue associated with the imp
28、roper connection of a device, device component or a connection not in accordance with device specific a tions. Patients enteral feeding tube was connected to the peripheral intravenous administration set instead of to the gavage tube. 1401 Arcing Issue associated with electrical c u r r e nt fl ow i
29、n g through a gap between two conductive surfaces, t y pic ally re sult ing in a visible fl ash of light. Arcing between a power cord and a device occurred at their point of contact. 1402 Circuit Failure Issue associated with a failure of the internal network paths or electrical circuitry (i.e. elec
30、trical components, circuit boards, wiring). The circuit board in a perfusion pump failed, causing it to not cool the heart surgery solution to the correct temperature. 1403 Device Sensing Issue Issue associated with device features that are designed to respond to a physical stimulus (temperature, il
31、lumination, motion, cardiac rhythms) that do not transmit a resulting signal for interpretation or measurement. An analysers waste sensor failed to generate a waste full message a n d, as a re sult , the wa s te c o nt a i n e r ove r fl o w e d . 1404 Power Source Issue Issue associated with the in
32、ternal power of the device (e.g. battery, transformer, fuel cell or other power sources). The battery for a powered wheelchair did not have enough stored energy to power the chair for the period of time specified in the labelling. 1405 Spark Issue associated with the discharge of electricity between
33、 two bodies previously electrically charged (e.g. electrostatic discharge). Due to an electrostatic discharge between an electrically- charged nurse wearing shoes without rubber soles and a patient ventilator, the display screen of the device went blank. 1501 Environmental Particulates I s sue a s s
34、 o c i ate d with fine s o li ds or liquid particles such as dust, smoke, fume or mist suspended in the immediate atmosphere in which the device is being used. A device system pump component emitted an oil mist. 2 ISO 2013 All rights reserved ISO/TS 19218-1:2011/Amd.1:2013(E) Level 2 code Level 2 te
35、rm Level 2 definition Example(s) 1502 Fumes or Vapours Issue associated with the visibility, odour or t ox i c i t y of an ambien t va p o u r or gas which affects the operation of the device. Due to inadequate room ventilation, an abnormally high c onc en tra tion of c ar bon dio xide in the room c
36、 au s e d an IVD autoanalyser being used to m easure blood c ar bon dio xide levels to generate erroneous test results. 1503 Inadequate Storage Issue associated with inadequate or inappropriate storage of the device. As a result of the user storing the test strips in a plastic bag instead of the ori
37、ginal container, the glucose monitor reported erroneous readings that resulted in unnecessary treatment. 1504 Loss of Power Issue associated with the failure of primary power provided by the fac ilit y , e .g . elec tr ic al , g as, fl ui d pressure. A patient was being transported by helicopter. Th
38、e intra- aortic balloon pump was plugged into a power inverter that failed, which resulted in loss of power to the balloon pump. 1601 Migration of Device or Device Component Issue associated with an undesired movement of a device, device component, or both, related to its movement away from or dislo
39、dging from a source. After a stenting procedure was completed, it was determined that the stent migrated and no longer completely covered the lesion. 1602 Osseo- disintegration Issue Issue association with interconnection between bone and an implanted device. Due to loosening of the connection betwe
40、en the hip implant and the femur, the patient required revision to address persistent pain. 1701 Component or Accessory Incompatibility Issue associated with the incompatibility of any device, device component, or both, while being operated in the same use environment thereby leading to a dysfunctio
41、n between the device and its components. When the bulb in a phototherapy lamp burned out, the neonatal intensive care unit nurse replaced it with a bulb t h at di d n ot mee t the manuf ac ture r s specific a tions. The lamp overheated and burned the babys skin. 1702 Device-Device Incompatibility Is
42、sue associated with the incompatibility of two or more devices while being operated in the same use environment thereby leading to a dysfunction of more than one device. Users of a newly distributed enhanced algorithm found the algorithm was incompatible with the electrocardiographs operating softwa
43、re, resulting in operational errors. 1703 Patient-Device Incompatibility Issue associated with the interaction between the patients physiology or anatomy and the device that affects patient or device (e.g. biocompatibility or immunological issues). During a procedure to replace a right ventricular l
44、ead, the placement was not successful due to the size of the patients vein. 1801 Defla tion I s sue Issue associated with the inability of a device, device component, or both, to release its contents. After the balloon of a percutaneous transluminal angi oplast y ( P TA ) ballo on d i l at at i o n
45、c at h ete r wa s i n fl ate d, it c oul d n ot be d e fl ate d without sur gi c al i nt e r v e nt i o n. 1802 Improper Flow or Infusion Issue associated with the unsubstantiated regulation and delivery of therapy, e.g. air, gas, dr ugs or fl ui ds i nt o a d ev i c e or a patient under positive pr
46、essure that is being generated by a pump. An infusion pump delivered a larger volume of drug than programmed to deliver. The total parenteral nutrition solution was improperly mix ed a n d, when the bag wa s c onnect ed for inf usi on , the pump was unable to deliver the solution because it clogged
47、the tubing. 1803 Infla tion I s sue Issue associated with the inability of a device, device component, or both, to e x pand or enlarge with the i nt e n d e d infla tion a g e nt (e . g . s aline or a i r) . During a blood pressure reading, the limb cuff continued to i n fl ate to a l eve l b ey o n
48、 d nor mal practic e . 1804 No Flow Issue arising from the device failing to deliv er the specified li qui d or g as. A ventilator alarmed due to a valve stuck in a closed c ondition blocking fl ow of ox y g e n to the pa tien t. 1805 E xc e s s i v e Fl ow or Overinfusion Issue associated with an o
49、verdose of delivery therapy, such as drugs or fl ui ds being deliv ered i nt o a d ev i c e or a patient under positive pressure. The infusion pump operator inadvertently entered an inappropriately high value for the volume of drug to be infused. ISO 2013 All rights reserved 3 ISO/TS 19218-1:2011/Amd.1:2013(E) Level 2 code Level 2 term Level 2 definition Example(s) 1806 Insuf fic ien t Flow or Underinfusion Issue associated with an underdose of therapy, e.g. epidural, intrathecal, intravenous, subcutaneous, such as dr ugs or fl ui ds being deliv
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