(1) In the introduction of "GB9706.27-2005 Special Safety Requirements for Infusion Pumps", "Only when the relevant consumable parts, especially the pipelines, are matched with the system, can the safe use of the equipment be ensured" The following should be noted:

(1) At present, most hospitals in China are using ordinary gravity infusion sets as consumables for infusion pumps;

(2) Gravity infusion sets approved for sale in China There are 100 types of infusion lines such as infusion sets, blood transfusion sets, light-proof infusion sets, precision infusion sets, belt-type infusion sets, and burette-type infusion sets. Each brand and specification of infusion lines have completely different pressure characteristics and flow characteristics.

(3) The open infusion pumps with consumables that are flooding the market encourage and allow clinical operators to use hundreds of consumables without control, and the flow characteristics and pressure characteristics as well as the uniqueness of the consumables are fully marked. neglect.

(4) The origin registration document of imported infusion pumps requires that only special infusion sets can be used. However, in order to adapt to the needs of the Chinese market, the manufacturer's engineering and technical personnel and sales staff also allow clinical personnel to use ordinary gravity infusion. device, but cannot provide supporting technology and unique identification.

(2) Paragraph 6.1 aa) of the special mark "If the patient tubing of the specified size or trademark is required to maintain the safe and normal use of the equipment, the relevant mark must be fixed or displayed in a conspicuous position of the equipment." It should be noted:

(1) If the manufacturer’s trademark of the infusion set, such as Weigao Jerry, is not marked with words, it is easy for clinical nurses to ignore and misunderstand it.

(2) Patient tubing of specified sizes, such as transparent infusion sets, light-proof infusion sets, blood transfusion sets, precision filter infusion sets, belt-type infusion sets, burette infusion sets and other consumable specifications must also be used The text is marked "in a prominent position on the device" to prevent clinical personnel from mistakenly selecting and using it.

(3) The unique identifier of consumable characteristics is the registration number. Therefore, the infusion pump should also provide clinical personnel with a means to check the consumable registration number.

(4) This kind of unique identification of consumables must be provided at the factory and cannot be temporarily affixed at the hospital site. Although it can provide some convenience to clinical personnel, it is also an uncontrolled link and hidden dangers. Huge risk.

(3) Paragraph 9) of Article 6.8.2 of the special standard "Description of the maximum infusion pressure and obstruction alarm pressure generated by the equipment" should be noted:

(1) Maximum infusion pressure If the occlusion alarm pressure is inaccurate, there will be a risk of rupture of the infusion set and insufficient drug delivery;

(2) Those open infusion pumps that encourage uncontrolled use of ordinary gravity infusion sets will amplify the above risks ;

(4) Item 6.8.3 ee) of the special standard "The manufacturer must specify the infusion pipeline applicable to all tests of this standard" should be noted:

(1 ) This standard contains more than 10 clauses for consumable characteristic testing, which shows the importance of consumable testing and control measures;

(2) Those open-consumable infusion pumps only provide bare pumps but not consumables When matched with the system, the risks caused by consumables are completely transferred to clinical operators and patients.

(5) Attention should be paid to 51.101 of the special standard "Within the recommended infusion line replacement interval, the equipment must maintain the accuracy stated by the manufacturer":

(1) The recommended infusion line replacement intervals for those consumable open infusion pumps are not in line with the characteristics of clinically used lines, and may even cause risks such as fatigue rupture within this interval, because these characteristic parameters cannot be tested clinically;

(2) The accuracy within the consumable replacement interval claimed by open-consumable infusion pumps cannot be guaranteed, because when clinical personnel simply match the consumables, they will not test the infusion accuracy according to the 3 to 5 hours claimed by the manufacturer.

(3) Only a consumables controlled strategy can be used to manage the full characteristics of clinically used consumables, and accurately predict and alarm the risk of attenuation of infusion accuracy and the risk of fatigue rupture of consumables.

(6) Paragraph a) of Article 51.1 of the Special Standard "To prevent overcurrent, a method must be provided to prevent overcurrent in a single fault state". Please note:

(1) Here The single faults referred to mainly include: if the nursing staff forgets to adjust the stop pulley on the infusion set to the appropriate position before releasing the line, the infusion pump must ensure that the infusion line passage is automatically blocked to prevent the medical solution from rapidly flowing under the action of gravity. , a large number of accidental perfusions.

(2) When the consumable open infusion pump allows clinical personnel to match consumables, it is impossible to take into account the complete compliance of this security mechanism with each type of pipeline.

(3) The infusion pump without a pump door does not have this mechanism itself. If clinical personnel are allowed to use ordinary gravity infusion sets, this risk will become a reality in a specific single failure. The probability of occurrence is not in the same order of magnitude as the previous risk.

In short, there are many specific risks regarding the "GB9706.27-2005 Special Safety Requirements for Infusion Pumps". Only a partial interpretation is given here, and further discussion can be made if necessary. If there are any irregularities, they can be resolved through legal means.