What to expect from “equipment”
“Surgical instruments are tools or devices that perform such functions as cutting, dissecting, grasping, holding, retracting, or suturing the surgical site. Most surgical instruments are made from stainless steel.”1
The WHO guidelines mention various aspects of this measure, such as the decontamination facility, the methods of decontamination, the use of sterile instruments in the operating room and the handling of endoscopes,1 not all of which can be mentioned here.
Guidelines
Guidelines
| Guideline | Recommendation | Category (if mentioned) |
| CDC2 | “When visible soiling or contamination with blood or other body fluids of surfaces or equipment occurs during an operation, use an EPA-approved hospital disinfectant to clean the affected areas before the next operation.” | Category IB (Federal regulation: OSHA) |
| “No recommendation on disinfecting environmental surfaces of equipment used in operating rooms between operations in the absence of visible soiling.” | Unresolved issue | |
| “Assemble sterile equipment and solutions immediately prior to use.” | Category II | |
| WHO1 | “Do not soak instruments in disinfectant prior to cleaning.” | - |
| Changing of surgical instruments: “The panel decided not to formulate a recommendation on this topic due to the lack of evidence.” | - | |
| NICE3 | - | - |
| KRINKO4 | If the surgical gown, sterile field or surgical gloves become contaminated during the operation, change the gown or gloves or re-cover the surgical field and replace instruments that have become unsterile. | Category IB |
| Only properly reprocessed medical devices should be used. | Category IV | |
At the end of the operation, place instruments and other materials to be reprocessed in the operating room in suitable containers with manual preparation if necessary. These are taken to the central sterile supply department or to the transfer room for unclean goods. | Category IV | |
| Particular attention should be paid to the safe disposal of sharp objects. | Category IV | |
| When the intermediate surface disinfection has been completed after the previous operation, preparation for the next operation must begin. The sterile instruments and materials required in the operating room must be prepared on sterile-covered tables by a person wearing sterile clothing and then covered with sterile drapes until the actual operation begins. This activity must be carried out before other activities take place in the operating room (e.g. positioning, induction of anesthesia). | Category II | |
| A separate room must be used exclusively for the preparation of sterile instruments in advance (see "Instrument preparation" below). | Category II | |
| Instrument preparation: If instrument tables are not prepared in the OR, but in a separate room (preparation room for instrument tables), ensure the same hygienic conditions (e.g. ventilation conditions) there as in the OR. | - |
HARTMANN:
“The equipment that comes into direct contact with the inside of the patient's body must be subject to special hygiene requirements.”
Extract of recommendations
Only use properly reprocessed medical devices.4
Sterile devices and solutions should only be prepared immediately before use.2
Instruments that have become unsterile during an operation should be replaced4 or rather cleaned before the next operation.2
At the end of an operation, instruments to be reprocessed should be placed in suitable containers (particular care should be taken with sharp objects) and brought to the transfer room for unclean goods or to the sterile supply department in a sealed state.4
Prepare sterile instruments and materials required in the operating room on sterile-covered tables by a person wearing sterile clothing and then covered with sterile drapes until the actual operation begins.4
If performed in a separate room use instrument tables to prepare sterile instruments in advance and ensure the same hygienic conditions in this room as in the OR.4
Instruments should not be soaked in disinfectant before cleaning.1
Reasons for not soaking instruments in disinfectant1
- Instruments may be damaged or corroded
- Blood and body fluids can inactivate the disinfectant, which in turn can promote microbial contamination and lead to the formation of a biofilm
- When contaminated items are soaked in chemical disinfectants, transportation to the decontamination area can be dangerous for healthcare workers
- leading to improper handling and accidental damage
- Soaking can contribute to the development of antimicrobial resistance to disinfectants
Classification of equipment decontamination1
Classification
Table adapted from WHO Global guidelines for the prevention of surgical site infection 20181
High (critical) | Intermediate (semi-critical) | Low (non-critical) |
Definition: Medical devices involved with a break in the skin or mucous membrane or entering a sterile body cavity. | Definition: Medical devices in contact with mucous membranes or non-intact skin. | Definition: Items in contact with intact skin. |
Level of microbial action: Kills all microorganisms. | Level of microbial action: Kills all microorganisms, except high numbers of bacterial spores. | Level of microbial action: Kills vegetative bacteria, fungi and lipid viruses. |
Method of decontamination: Sterilization (usually heat if heat-stable or chemical if heat-sensitive). | Method of decontamination: High-level disinfection by heat or chemicals (under controlled conditions with minimum toxicity for humans). | Method of decontamination: Low level disinfection (cleaning). |
Example of common items/ equipment: Surgical instruments, implants, prostheses and devices, urinary catheters, cardiac catheters, needles and syringes, dressing, sutures, delivery sets, dental instruments, rigid bronchoscopes, cystoscopies, etc. | Example of common items/ equipment: Respiratory therapy and anaesthetic equipment, flexible endoscopes, vaginal specula, reusable bedpans and urinals/urine bottles, patient bowls, etc. | Example of common items/ equipment: Blood pressure cuffs, stethoscopes, electrocardiogram leads, etc. Environmental surfaces, including the OR table and other environmental surfaces. |
Cycle of decontamination of reusable surgical instruments1
Risk assessment for contaminated instruments1
The risk for the transmission of microorganisms from instruments and devices depends on various factors:
- the presence of microorganisms, their number and their virulence
- the type of procedure that is going to be performed (invasive or non-invasive)
- the body site where the instrument or equipment will be used
Single-use vs. reusable instruments
Reprocessed instruments generate multiple level of costs: beyond direct costs (purchasing costs), layers of indirect costs (Central sterile services department/reprocessing costs, maintenance costs, administration costs).5
Inadequate reprocessing on instruments can lead to infections and tissue irritation.6
The risk of potential outbreaks associated with the use of reprocessed instruments is an important public health concern.6
- Sterilization responsibility transferred to the supplier7
- Benefits on microbiological safety7
All content and recommendations listed are to be regarded as extracts from the original literature and do not claim to be exhaustive.
Click to see full list
References
- WHO (2018) Global guidelines for the prevention of surgical site infection. World Health Organization 2018.
- CDC (1999) Guideline for Prevention of Surgical Site Infection. Infect Control Hosp Epidemiol. 20(4): 247–278.
- NICE (2020) Surgical site infections: prevention and treatment. NICE guidelines. Published: 11 April 2019. Last updated:19 August 2020. www.nice.org.uk/guidance/ng125.
- KRINKO (2018) Prävention postoperativer Wundinfektionen. Empfehlungen der Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO) beim Robert Koch-Institut. Bundesgesundheitsbl 61: 448–473.
- European Commission. Public Health. https://health.ec.europa.eu/medical-devices-topics-interest/reprocessing-medical-devices_en. Achieved March 2024.
- FDA. https://www.fda.gov/medical-devices/products-and-medical-procedures/reprocessing-reusable-medical-devices. Achieved March 2024.
- Réutilisable ou usage unique ? Stérilisation des brosses et des sets de soins versus usage unique. O. Chaput - C. Trang - P. Salat - Service pharmacie CHIC TARBES-VIC. 2001.
In focus
Infection Prevention at eye level
New open-access publication on practical recommendations for cleaning and disinfection in the healthcare sector.
Practical recommendations for routine cleaning and disinfection procedures in healthcare institutions: a narrative review
Healthcare-associated infections (HAIs) pose a substantial challenge for modern medicine.
An environmental cleaning bundle and healthcare-associated infections in hospitals (REACH): a multicentre, randomised trial
Healthcare-associated infections (HAIs) are causing prolonged stays in hospitals and pose a substantial burden for healthcare services and population.
Learn more here...
Learn more here...
Related & interesting
Clinically relevant pathogens in healthcare facilities
About 3.8 million people across Europe contract a nosocomial infection during a hospital stay every year. Although the majority of these infections are due to endogenous causes such as the body’s own microbial flora…
Bacillol® Zero Tissues
Cleaning and disinfecting wipes based on organic acids, highly effective and gentle on materials.