Reusable Medical Device Disinfection and Cleaning Validation Requirements

Some valuable medical devices can be sterilized according to different requirements and can be reused, such as equipment used in ophthalmology, high flow oxygen devices, etc.

 

 

1. Reusable and Non Reusable Medical Devices

Reusable medical and health products refer to some sanitary products that meet the biological and quality standards after disinfection and sterilization, and can ensure safety and effectiveness. For example, for hemodialysis treatment, as long as the same catheter is fixed for the same person and strict disinfection, sterilization measures are taken, it can completely be reused. In addition, some disposable medical supplies that have been strictly disinfected and tested to meet the relevant national standards can also be reused, such as respiratory sacs, pipes and connectors for disposable anesthesia machines.

 

At present, there are 8 kinds of disposable medical supplies applied in medical institutions, among which infusion set and syringe types account for 15% - 20%, surgical dressing type accounts for 5% - 10%, and nursing materials account for 10% - 15%. These kinds of supplies are large in quantity and cheap in price, which will not bring too much burden to patients. And this kind of disposable medical supplies can not be reused after utilization. Diagnosis and treatment type accounts for 30% - 35%, such as cardiac pacemaker, coronary stent, heart valve and so on. Although they are expensive, but in order to save lives, they have to be used, and their embedding in vivo is not reusable.

 

 

2. Common Disinfection Methods of Reusable Medical Devices

Reusable medical devices come in a variety of shapes and sizes, from surgical speculum to colonial speculum, as well as laser speculum, etc. Generally speaking, these devices have expensive parts that need to be cleaned and disinfected. The specific operation depends on the specific equipment. The common disinfection methods of reusable medical devices include physical disinfection and chemical disinfection.

 

(1) Physical Disinfection

Physical disinfection is the application of physical factors to kill or remove pathogenic microorganisms, such as damp heat disinfection method. Hygrothermal disinfection is the utilization of higher temperature hot water (≥ 90 ℃) or steam as the disinfection medium, under the condition of maintaining the corresponding temperature and time, the bacterial protein can be denatured or solidified. Dampness and heat can denaturate the cell protein or inactivate the coagulase, resulting in metabolic disorder, which will lead to the death of microorganisms. In the hot water or steam environment, the higher the humidity is, the faster the protein deformation and solidification will be , and the better the killing effect on microorganisms will be. In addition, high-temperature steam and hot water are treated as disinfection media for damp heat disinfection, which has the advantages of safety, non-toxic residue and environmental protection.

 

(2) Chemical Disinfection

For equipment materials that are not resistant to heat and humidity, chemical disinfection method can be adopted. Chemical disinfection method is a method to kill pathogenic microorganisms with chemical drugs. According to the germicidal efficacy of disinfectants, they can be divided into high-efficiency disinfectants, medium-efficiency disinfectants and low-efficiency disinfectants. Because chemical disinfection has certain putrefaction to instruments, it is necessary to be chosen carefully when the instrument is disinfected.

 

 

3. Usage

(1) For heat-resistant and moisture-resistant medical instruments, appliances and articles, including scissors in medical, medical instruments forceps, etc., physical disinfection methods should be preferred, such as pressure steam sterilization, instead of chemical disinfectant immersion sterilization. Heat-resistant oil type and dry powder type should be sterilized by dry heat.

 

(2) Low temperature sterilization methods should be applied for heat and moisture resistant articles, such as ethylene oxide sterilization, hydrogen peroxide low-temperature plasma sterilization or low-temperature formaldehyde steam sterilization, etc.

 

(3) In general, the environment and the surface of objects should be cleaned first and then disinfected. When it is polluted by the patient's blood, body fluid and other pollution, first remove the pollutants, then clean and disinfect. The surface of the articles should be considered for surface disinfection. Suitable disinfectant or ultraviolet sterilizer should be selected for smooth surface. Immersion or spray disinfection should be adopted for the surface of porous materials.

 

The reusable medical instruments, appliances and articles should be cleaned before disinfection or sterilization. They include long surgical scissors, medical clamps forceps, safety scissors medical, etc.