CN111069140A

CN111069140A - Verification method of medical instrument final cleaning process

Info

Publication number: CN111069140A
Application number: CN201911168725.0A
Authority: CN
Inventors: 王建国; 陈义军
Original assignee: Harbin Sagebot Intelligent Medical Equipment Co Ltd
Current assignee: Suzhou Kangduo Robot Co ltd
Priority date: 2019-11-25
Filing date: 2019-11-25
Publication date: 2020-04-28

Abstract

The invention discloses a verification method of a medical instrument final cleaning process, which comprises the following steps: firstly, ultrasonically cleaning parts of a medical instrument; step two, detecting residual liquid of the ultrasonically cleaned medical instrument parts by using a conductivity method, if the difference of the conductivities is less than or equal to 0.1 mu s/cm, performing step three, otherwise, returning to the step one; step three, cleaning and flushing parts of the medical apparatus and instruments by using cleaning fluid, extracting residual liquid and testing by using a pH measuring instrument, if the increase of the pH value does not exceed 0.2 unit of the pH measuring instrument, performing step four, otherwise, returning to the step one; drying, observing under a magnifying glass, if no stain spots and visible particles exist, passing the verification, and packaging and warehousing; otherwise, returning to the step one. The invention can accurately detect the verification of the effect of the medical instrument after the final cleaning, and ensure that invisible residues of the instrument before delivery are controlled within a reasonable range.

Description

Verification method of medical instrument final cleaning process

Technical Field

The invention relates to a verification method of a medical instrument final cleaning process.

Background

After the medical instrument is processed and assembled, the medical instrument needs to be cleaned, random sampling inspection is carried out after cleaning, whether visible particles such as stains and spots exist is observed by eyes under a four-time magnifying lens, and a flow chart of the cleaning and detecting of the existing instrument is shown in fig. 1. However, in the production and manufacturing process of medical devices, cutting fluid and release agent are used for assisting the material forming in metal cutting, metal die casting, injection molding and the like, the residues are invisible to the naked eye, and the residual quantity after cleaning is difficult to control. Therefore, the detection method depends on visual observation, whether the product is clean or not can only be determined by the difference of individual vision of people, the fluctuation of quality control is large, the residue of soluble substances invisible to naked eyes cannot be accurately controlled, only the cleaning time can be increased, and the cleaning solution is frequently changed for control, thereby increasing the waste of personnel, equipment and cleaning solution invisibly.

Medical devices are now manufactured and packaged for delivery to users, and are classified into non-sterile packaged devices and sterile packaged devices. Sterilizing the packaged device, and directly using the device after opening the bag, such as a syringe and a heart stent. Non-sterile packaged instruments, such as surgical forceps, surgical scissors, endoscopes and the like, are subjected to secondary sterilization after arriving at a hospital. In either form, if harmful residues are left, they can be extremely harmful to the health of the patient. The high-temperature disinfection and low-temperature disinfection modes equipped in hospitals only can play a role in disinfection and sterilization, and are ineffective in removing residual chemicals.

Disclosure of Invention

Aiming at the problems in the prior art, the invention provides a verification method of a medical instrument final cleaning process. The method solves the problem of detection of residual substances such as cutting fluid, release agent, cleaning fluid and the like used in the machining process before the medical instrument leaves a factory, can verify the rationality and effectiveness of the cleaning process, and can reasonably determine the replacement time of the cleaning solution.

The purpose of the invention is realized by the following technical scheme:

a verification method of a medical instrument final cleaning process comprises the following steps:

firstly, ultrasonically cleaning parts of a medical instrument;

step two, detecting residual liquid of the ultrasonically cleaned medical instrument parts by using a conductivity method, if the difference between the conductivity after ultrasonic cleaning and the conductivity of purified water is less than or equal to 0.1 mu s/cm, performing step three, and if not, returning to the step one;

step three, cleaning and flushing the parts of the medical apparatus and instruments by using cleaning fluid, testing the extracted residual liquid by using a pH measuring instrument, if the pH value of the extracted residual liquid is increased by no more than 0.2 unit of the pH measuring instrument, performing step four, otherwise, returning to step one;

and step four, drying, observing under a magnifying glass, if no spot or spot and visible particles exist, passing the verification, packaging and warehousing, and otherwise, returning to the step one.

In the invention, the cleaning solution is prepared from the following components: 1-3 wt.% of sodium sulfosalicylate, 5-8 wt.% of surfactant (fatty acid alkanolamide), 2-4 wt.% of complexing agent (sodium citrate), 3-5 wt.% of builder A (sodium tripolyphosphate), 2-4 wt.% of builder B (sodium silicate), 0.05-0.10 wt.% of preservative (methyl/propyl paraben), 1-3 wt.% of antistatic agent (alkanolamide phosphate potassium salt), and the balance of water.

Compared with the prior art, the invention has the following advantages:

1. the invention uses the measurement method of the conductivity to control the verification of the cleaning effect of the medical apparatus and instruments, uses a conductivity meter to measure the capability of directly reading the conduction current of the solution, and reflects the content of impurities in the liquid by phase change, namely: the extent of noxious substance remaining on the device.

2. According to the invention, the residual degree of the soluble harmful substances on the surface of the cleaned medical instrument is controlled by using a pH value measurement method, and the degree of residual acid and alkali on the surface of the medical instrument is accurately controlled.

3. The invention can accurately detect the verification of the effect of the medical instrument after the final cleaning, and ensure that invisible residues are controlled within a reasonable range before the instrument leaves a factory.

Drawings

FIG. 1 is a flow chart of a prior art instrument cleaning test;

FIG. 2 is a flow chart illustrating the final cleaning process of the medical device according to the present invention.

Detailed Description

The technical solution of the present invention is further described below with reference to the accompanying drawings, but not limited thereto, and any modification or equivalent replacement of the technical solution of the present invention without departing from the spirit and scope of the technical solution of the present invention shall be covered by the protection scope of the present invention.

The invention provides a verification method of a final cleaning process of a medical instrument, which comprises the following steps as shown in figure 2:

step one, cleaning medical instrument parts by using an ultrasonic cleaning machine.

Step two, detecting residual liquid of the cleaned medical instrument parts by using a conductivity method, if the difference between the cleaned conductivity and the conductivity of the used purified water is less than or equal to 0.1 mu s/cm, performing step three, and if not, returning to the step one;

and step three, cleaning and flushing the parts of the medical apparatus and instruments by using cleaning fluid, testing the extracted residual liquid by using a pH measuring instrument, if the pH value of the extracted residual liquid is increased by no more than 0.2 unit of the pH measuring instrument, performing step four, otherwise, returning to the step one.

Detection of conductivity:

(1) each set of the extracted samples is soaked in 1000ml of purified water in a detection room for 40 minutes at normal temperature to prepare a test solution. A mutual control test was carried out after sampling 1000ml of purified water for a test solution and leaving the sampled 1000ml of purified water under the same environment for 40 minutes.

(2) The conductivity of the test solution and the control solution is measured by a conductivity meter, and the difference between the conductivities is recorded. Detection of conductivity acceptance criteria: the difference between the conductivity after the fine washing and the conductivity of the purified water is less than or equal to 0.1 mu s/cm. The results are shown in Table 1.

TABLE 1

The digital meter shows the ability of the solution to conduct current. The unit is expressed in microsiemens per centimeter (mu s/cm), and the content of impurities in the liquid is directly reflected, namely the cleanness of the medical instrument after cleaning is indirectly reflected.

Step three, washing and flushing the parts of the medical apparatus and instruments by using the prepared cleaning solution, extracting the residual solution, and testing by using a pH measuring instrument, wherein the acceptable residual level of the cleaning solution is as follows: the increase in pH is not allowed to exceed 0.2 units of the pH meter (accuracy 0.1 units). And if so, performing the fourth step, and if not, returning to the first step. The results of the pH meter measurements are shown in Table 2.

TABLE 2

In this step, the cleaning solution is prepared from the following components: 2wt.% sodium sulfosalicylate, 6wt.% surfactant (fatty acid alkanolamide), 3wt.% complexing agent (sodium citrate), 4wt.% builder a (sodium tripolyphosphate), 3wt.% builder B (sodium silicate), 0.10wt.% preservative (methyl/propyl paraben), 2wt.% antistatic agent (potassium alkanolamide phosphate), and the balance water.

And step four, drying by a drying furnace, observing whether stains and visible particles exist under a quadruple magnifier by eyes, if the stains and visible particles do not exist, passing the verification, packaging and warehousing, and if not, returning to the step one.

Claims

1. A verification method for a medical instrument final cleaning process is characterized by comprising the following steps:

firstly, ultrasonically cleaning parts of a medical instrument;

2. The method of claim 1, wherein the cleaning solution is made from the following ingredients: 1-3 wt.% of sodium sulfosalicylate, 5-8 wt.% of surfactant, 2-4 wt.% of complexing agent, 3-5 wt.% of builder A, 2-4 wt.% of builder B, 0.05-0.10 wt.% of preservative, 1-3 wt.% of antistatic agent and the balance of water.

3. The method of claim 2, wherein the surfactant is fatty acid alkanolamides.

4. The method of claim 2, wherein the complexing agent is sodium citrate.

5. The method of validating a process for cleaning a medical device during a finishing operation according to claim 2, wherein said builder A is sodium tripolyphosphate.

6. The method of validating a process for cleaning a medical device finish according to claim 2, wherein said builder B is sodium silicate.

7. The method of claim 2, wherein the preservative is methyl paraben or propyl paraben.

8. The method of claim 2, wherein the antistatic agent is potassium alkanolamide phosphate.