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Laparoscopic Instrument Sterilization and Care

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Medical device sterilisation is a critical process for ensuring patient safety and preventing the spread of infections in healthcare settings. It involves the physical or chemical removal of all microorganisms, including budding spores, from medical devices, dressings, and other objects to achieve a level of sterility known as the Sterility Assurance Level (SAL). The consensus for sterility is typically expressed as a SAL of 10-6. Effective sterilisation of medical devices is vital for preventing hospital-acquired infections and reducing their rates.

Medical devices that come into contact with human tissue, organs, broken skin, and broken mucous membranes are considered high-risk items and must be sterilised before use. Examples of such items include puncture needles, biopsy forceps, laparoscopes, and implantable medical devices.

The sources detail several common sterilisation methods, along with their principles, applications, advantages, and disadvantages:

  • Autoclaving (Steam Sterilisation):

    • Principle: Kills microorganisms by irreversibly coagulating and denaturing their enzymes and proteins through moist heat.
    • Applications: Mainly used for water, pharmaceuticals, regulated medical waste, and non-porous items that have direct contact with steam. It is also ideal for all reusable metal instruments. For perforated loads and instruments, typical sterilisation temperatures and times are 132-135°C for 3-4 minutes. Commonly used temperatures are 121°C and 132°C.
    • Advantages: It is non-toxic, environmentally friendly, and the process is easy to control and monitor. It is fast and effective, minimally affected by organic or inorganic contaminants, has a short cycle time, and effectively penetrates instrument packs and lumenal medical devices. It is also cost-effective.
    • Disadvantages: Damaging to heat-sensitive instruments. Repeated exposure can harm delicate surgical instruments, potentially causing rusting due to wet packs and a risk of scalding. Laparoscopic cameras, laparoscopes, and light cables, for example, are damaged by heat. To successfully autoclave long, narrow tubes found in laparoscopic equipment, an autoclave needs to perform vacuum air removal before steam injection. Many autoclaves, especially in rural settings, may lack the deep, pulsed vacuum cycles required for effective sterilisation of such porous loads.

  • Hydrogen Peroxide Plasma Sterilisation:

    • Principle: Exploits the high oxidising activity of hydrogen peroxide plasma to kill microorganisms by destroying cellular proteins, enzymes, and nucleic acids. It uses hydrogen peroxide vapour and low-temperature gas plasma, forming reactive species that interact with cell components.
    • Applications: Can be used to sterilise medical devices that are not heat or moisture resistant. It is compatible with most (>95%) laparoscopic instruments that cannot tolerate high temperatures and humidity.
    • Advantages: Safe and environmentally friendly with no toxic residues. The sterilisation cycle is relatively short (28-75 minutes), and no analysis (aeration) is required. It is suitable for heat- and moisture-sensitive items, easy to operate, install, and monitor, and compatible with most medical devices. Instruments are dry for immediate use or sterile storage, minimising recontamination risk.
    • Disadvantages: Not suitable for paper fibres, cotton, linen, and liquid items. The sterilised chamber is typically small (50-270 L), and it may not be suitable for lumens or medical devices with long and thin lumens, which require synthetic packaging. Hydrogen peroxide may be toxic at doses above 1 ppm.

  • Ethylene Oxide (EO) Sterilisation:

    • Principle: Induces cell death by alkylating proteins, DNA, and RNA, irreversibly preventing normal cell metabolism and replication. EO is a highly reactive and diffusive alkylating agent.
    • Applications: Used for high or medium risk items that are not resistant to moisture or heat. It is suitable for all disposable instruments, insulated hand instruments, and tubings used for gas, suction, and irrigation. It has emerged as the sterilisation method of choice for delicate, complex, and sophisticated medical devices because it is often the only acceptable method for sensitive materials.
    • Advantages: Can sterilise heat- and moisture-sensitive medical devices without harmful effects on their materials. It can effectively penetrate packaging materials and tubular medical devices. Modern systems use single-dose cartridges and negative pressure operation to reduce gas leakage risk. It is compatible with most medical devices. It is described as the most cost-effective, low-temperature sterilisation process with a recognised history of reliability.
    • Disadvantages: Costly and potentially hazardous to patients and medical personnel due to toxic, carcinogenic, and flammable nature. Requires a long aeration time to remove gas residues (typically 12-20 hours). Sterilisers are often small (110-250 L), and tanks must be stored in explosion-proof cabinets. EO is a mutagen and has carcinogenic potential, but modern equipment has greatly improved safety for workers. Residuals like ethylene chlorohydrin and ethylene glycol are toxic and require control according to ISO standards. EO sterilisation depends on four parameters: time, temperature (typically 49-60°C), gas concentration (even less than 300 mg/L today), and humidity (40-60%, must be >30%).

  • Ionising Radiation Sterilisation:

    • Principle: Uses gamma radiation emitted by radioisotope cobalt 60 to induce free radicals in cells, disrupting normal metabolism and inactivating microorganisms.
    • Applications: Low-temperature sterilisation for many medical products, such as tissue grafts, pharmaceuticals, and medical devices.
    • Advantages: No special temperature environment requirements; can be done at room temperature. Sterilisation is uniform, complete, fast, and continuous, making it suitable for mass sterilisation.
    • Disadvantages: High cost. The nature of some products may change after radiation, so safety issues must be considered. Gamma irradiation can cause polymer degradation and changes in physical or mechanical properties.

  • Dry Heat Sterilisation:

    • Principle: Kills bacteria through the oxidation of cellular components at high temperatures.
    • Applications: Used for materials not resistant to moist heat or that cannot be penetrated by moist heat, such as powders, petroleum products, and sharp instruments. Common times and temperatures include 170°C for 60 minutes, 160°C for 120 minutes, and 150°C for 150 minutes.
    • Advantages: Non-toxic, environmentally friendly, and dry heat cabinets are easy to install. Relatively inexpensive to operate, penetrates materials, and is non-corrosive to metals and sharp objects.
    • Disadvantages: Slow penetration and killing of microorganisms, making it time-consuming. High temperatures are not suitable for most materials.

  • Other Sterilisation Technologies: Peracetic acid sterilisation, ozone sterilisation, UV irradiation sterilisation, microwave sterilisation, and filter decontamination methods are also mentioned, though less commonly used. Peracetic acid liquid is a biocidal oxidiser that maintains efficacy with high organic debris levels and has short cycle times (20-30 minutes at 50-56°C), with no aeration required and safe discharge. However, items processed this way must be used immediately as containers are wet and unprotected. Glutaraldehyde (e.g., Cidex) and ortho-phthalaldehyde (OPA) (e.g., Cidex OPA) are widely used for high-level disinfection, particularly for lensed instruments as they are non-corrosive. While effective for disinfection, immersion sterilants like glutaraldehyde or peracetic acid are not considered adequate for sterilisation because maintaining instrument sterility until use is almost impossible. Formaldehyde gas (formalin) chambers are also used for disinfection and storage in some rural settings, but this method is unreliable due to difficulty in maintaining required conditions and is potentially carcinogenic.

Challenges with Laparoscopic Instruments and Their Reprocessing: Laparoscopic instruments pose particular challenges for cleaning and sterilisation due to their complex design, featuring long, narrow shafts, multiple joints, crevices, and channels that are difficult to access. They also contain delicate and fragile parts that can be easily damaged during reprocessing. Blood and other organic matter can become trapped inside lumens and channels, making removal difficult. Some instruments may also be resistant to common cleaning and disinfecting agents.

Studies, particularly in rural India, reveal significant deficiencies in laparoscopic instrument reprocessing:

  • Lack of Updated Procedures and Training: Standard operating procedures often have not been updated since the introduction of laparoscopy, meaning the same reprocessing methods for regular surgical instruments are still applied. Staff often haven’t received additional training and are unaware of the hazardous effects of reprocessing detergents and disinfectants.
  • Insufficient Cleaning Practices: Instruments are often manually cleaned without specific brushes for long lumens, relying on toothbrushes or needles. Lumens are held under running water for rinsing. Dedicated detergents are often not used, instead, soap or clothes-washing powder may be used. Instruments may be soaked in bleach, which corrodes surgical instruments.
  • Inadequate Disinfection: High-level disinfection (HLD) methods like glutaraldehyde are used, but the minimal concentration level is often not tested. The effectiveness of glutaraldehyde is reduced by wet instruments or large amounts of bioburden, and it can bind proteins onto instruments if not sufficiently cleaned, leading to bioburden build-up. Formaldehyde gas is used but is unreliable due to difficulty in maintaining exact conditions.
  • Autoclave Limitations: Many autoclaves in rural settings lack the necessary vacuum phases for effective sterilisation of laparoscopic instruments, which are considered porous loads. This means air can remain trapped, preventing steam penetration and guaranteed sterilisation.
  • Financial Constraints: Hospitals may lack dedicated tools, equipment (e.g., automated washer-disinfectors, ultrasonic cleaners, PPE), and appropriate cleaning solutions due to financial limitations. This leads to the reuse of disposable instruments and pressure to quickly reprocess instruments due to a shortage of sets.

Reprocessing Cycle Steps and Important Considerations: The optimal processing of laparoscopic instruments involves several steps to reduce infection risk:

  1. Dismantling: Instruments should be designed for easy dismantling to prevent blood/debris from harbouring within shafts.
  2. Decontamination: Reduces bioburden. Begins in the operating theatre by wiping off visible soil with a damp sterile sponge and placing soiled instruments in a disinfectant solution (e.g., 0.5% chlorine) for a short soak.
  3. Pre-cleaning: An enzymatic pre-cleaning treatment is recommended to break up blood and protein soil. Instruments should be kept moist after use to prevent soil from drying.
  4. Cleaning and Rinsing: This is the most crucial step, removing approximately 99.8% of bioburden. Manual cleaning with soft brushes and warm water with an approved detergent is essential, paying attention to joints, crevices, and channels. For lumens, water jet guns can be used for thorough rinsing. Ultrasonic cleaning is highly effective (16 times better than hand-cleaning) for hard-to-reach places, using high-frequency sound waves to create microscopic implosions that scrub surfaces. Instruments should be cleaned of all visible debris before ultrasonic cleaning, and not overloaded. Proper rinsing with distilled water is crucial to remove residual detergent and prevent waterborne deposits.
  5. Drying: Instruments must be thoroughly dried after cleaning and rinsing, ideally using an air gun or oven.
  6. Inspection and Function Testing: After cleaning, instruments should be visually inspected for any remaining soil or damage.
  7. Packaging: Instruments must be dry before packaging for sterilisation, using appropriate medical-grade sterilisation pouches or wraps.
  8. Sterilisation: The final step, performed according to the manufacturer’s instructions.
  9. Storage: Properly stored items remain sterile until use, requiring moderate temperatures, low humidity, and minimal handling.

Key Takeaways:

  • Sterilisation of medical devices is paramount for patient safety, especially for high-risk laparoscopic instruments due to their complex design.
  • While various sterilisation methods exist, the choice depends on the device’s material compatibility (e.g., heat-sensitive vs. heat-resistant).
  • Proper and meticulous cleaning is a prerequisite for effective sterilisation, as it removes the majority of microorganisms and organic matter (bioburden) that would otherwise interfere with the sterilisation process.
  • There are significant challenges in reprocessing laparoscopic instruments in resource-constrained environments, leading to potential risks for patients and staff due to inadequate equipment, outdated procedures, and insufficient training.
  • Updated policies, comprehensive training programs for healthcare workers, and the design of more robust and easy-to-reprocess surgical instruments are crucial for improving patient safety in low- to middle-income countries.

Definition of Sterilisation

Sterilisation is a critical process in healthcare, particularly for medical devices, aimed at preventing infections and disease transmission.

Definition of Sterilisation
  • Sterilisation is defined as the physical or chemical removal of all microorganisms, including budding spores, from medical devices, dressings, and other objects to a specific level of sterility. Its purpose is to prevent infections and the spread of disease during the use of medical devices. It represents the absolute elimination or destruction of all forms of microbial life.
  • Sterility is quantified as the probability of survival of a single microorganism after sterilisation, often referred to as the Sterility Assurance Level (SAL), and is typically expressed as 10-n. A generally accepted consensus for the level of sterility is a SAL of 10-6.

Importance of Medical Device Sterilisation

The importance of sterilising medical devices is multifaceted, primarily revolving around patient safety and preventing healthcare-associated infections:

  • Preventing Infections: Sterilisation of medical devices is highly effective in preventing and reducing the rate of hospital-acquired infections. Failure to adequately sterilise medical devices can lead to significant institutional costs, patient nosocomial infections, and concerns regarding mortality and morbidity.
  • High-Risk Items: Medical devices that come into direct contact with human tissue, organs, broken skin, or broken mucous membranes are classified as high-risk items. These include puncture needles, biopsy forceps, laparoscopes, and implantable medical devices. Such items carry a high risk of infection and must be sterilised before use.
  • Maintaining Surgical Safety: Meticulous cleaning, maintenance, and sterilisation are necessary to avoid compromising the safety of the patient, the surgeon, and other operating room personnel. The increasing complexity of surgical procedures and the emergence of resistant strains of bacteria, mycobacteria, fungi, and viruses underscore the imperative for effective cleaning and disinfection of instruments.
  • Addressing Bioburden: Thorough cleaning is the first crucial step in the reprocessing cycle, as it removes debris, mucus, blood, and tissue (bioburden) that would otherwise interfere with the effectiveness of disinfection or sterilisation. Approximately 99.8% of bioburden can be removed by meticulous cleaning. Failure to thoroughly clean a device may prevent adequate sterilisation, posing a significant risk of infection to patients.

Importance for Laparoscopic Instruments

Laparoscopic instruments, used in minimally invasive surgery (MIS), pose particular challenges for reprocessing and highlight the critical importance of effective sterilisation:

  • Complex Design and Delicate Parts: Laparoscopic instruments are described as sophisticated, precisely calibrated, and difficult to clean due to their complex design. They often feature multiple joints, crevices, and channels, along with delicate and fragile tubular components that can be easily damaged during the cleaning and disinfection process.
  • Bioburden Accumulation: Their intricate internal parts and crevices make them vulnerable to lodging bioburden (micro-organisms and debris). Organic matter like blood can become trapped in the instrument channels, making removal difficult. The build-up of residues can eventually lead to corrosive damage and pathogenic colonisation.
  • Specific Reprocessing Needs: The delicate nature of these instruments often means they cannot withstand the high temperatures and moisture of steam sterilisation (autoclaving). Therefore, alternative sterilisation methods suitable for heat- and moisture-sensitive items are required.
  • Impact of Insufficient Reprocessing: While laparoscopy offers significant benefits like faster recovery times, fewer post-surgical wound infections, and shorter hospital stays, these advantages are negated if instruments are not reprocessed according to manufacturer’s instructions. Insufficient sterilisation has directly led to several infection outbreaks after laparoscopic procedures. Studies in rural India have revealed deficiencies in equipment and staff training, leading to reprocessing methods that pose serious risks to patient and staff safety. For instance, high-level disinfection (HLD), if used as a substitute for sterilisation, does not reliably kill all bacterial endospores that cause severe diseases like tetanus or gas gangrene.

common sterilisation methods

Sterilisation is a critical process in healthcare aimed at preventing infections and disease transmission, particularly for medical devices. It is defined as the physical or chemical removal of all microorganisms, including budding spores, from medical devices, dressings, and other objects to a specific level of sterility. Sterility is quantified by the Sterility Assurance Level (SAL), typically expressed as 10-n, with a consensus for a SAL of 10-6. Effective sterilisation of medical devices is vital in preventing and reducing hospital-acquired infections. Devices that contact human tissue, organs, broken skin, or mucous membranes are considered high-risk items, such as puncture needles, biopsy forceps, laparoscopes, and implantable devices, and must be sterilised before use.

Before any sterilisation, thorough cleaning is an essential first step to remove bioburden (debris, mucus, blood, tissue) that can interfere with the sterilisation process. Approximately 99.8% of bioburden can be removed by meticulous cleaning. If a device is not cleaned properly, even potent sterilants or disinfectants can become less effective.

The sources discuss several common sterilisation methods, each with distinct principles, applications, advantages, and disadvantages:

  • 1. Autoclaving (Steam Sterilisation)

    • Principle: Kills microorganisms by irreversibly coagulating and denaturing their enzymes and proteins through moist heat. When steam is placed under pressure and temperature is raised, moist heat changes cell proteins, rendering them harmless.
    • Application: Primarily used for water, pharmaceuticals, regulated medical waste, and non-porous items directly contacting steam. It is also suitable for perforated loads and instruments. Autoclaving at 121°C for 15 minutes is considered ideal for all reusable metal instruments. For laparoscopic instruments, flash or vacuum steam sterilisation can be used, typically at 135°C at 30 psi pressure for 60 minutes, requiring post-vacuum and dry cycles. Instruments should rest on the steriliser rack for 45 minutes to prevent water condensation on lenses.
    • Advantages: It is non-toxic, environmentally friendly, and the process can be easily controlled and monitored. It is fast and effective, with a short sterilisation cycle time, and is minimally affected by organic or inorganic contaminants. Steam can effectively penetrate instrument packs and lumenal medical devices. It is effective, cheap, and non-toxic.
    • Disadvantages: It can be damaging to heat-sensitive instruments. Repeated exposure may damage delicate surgical instruments and cause rusting due to wet packs, with a potential risk of scalding. Laparoscopic cameras, laparoscopes, light cables, and flexible endoscopes can be damaged by the heat and moisture of steam sterilisation. Autoclaves used for complex instruments like laparoscopic equipment need to perform vacuum air removal before steam injection to ensure penetration into long tubes and porous loads. Studies in rural India found that manual autoclaves in hospitals were often unsuitable for laparoscopic instruments due to a lack of deep, pulsed, vacuum cycles, failing to sterilise the load.

  • 2. Hydrogen Peroxide Plasma Sterilisation

    • Principle: Exploits the high oxidising activity of hydrogen peroxide plasma to kill microorganisms by destroying cellular proteins, enzymes, and nucleic acids. This involves vaporising hydrogen peroxide, applying an electrical field to create plasma, which then breaks down peroxide into highly energised species that interact with cell components, forming water and oxygen as non-toxic byproducts.
    • Application: Can be used to sterilise medical devices that are not heat or moisture resistant. The STERRAD system (Johnson & Johnson) is a well-known example that uses hydrogen peroxide vapour and low-temperature gas plasma. It is compatible with most (>95%) laparoscopic instruments that cannot tolerate high temperatures and humidity.
    • Advantages: It is safe and environmentally friendly, with no toxic residues. The sterilisation cycle is relatively short (28-75 minutes, or as little as 30 minutes with newer versions) and requires no aeration. This means instruments are dry and ready for immediate use or sterile storage, minimising recontamination risk. It is easy to operate, install, and monitor, and is compatible with most medical devices. It requires minimal space and no venting or water hookup.
    • Disadvantages: Not suitable for paper fibres, cotton, linen, and liquid items. The sterilised chamber size can be small (50-270 L), and it may not be suitable for lumens or medical devices with long and thin lumens, unless synthetic packaging is used. Hydrogen peroxide can be toxic at doses above 1 ppm.

  • 3. Ethylene Oxide (EO) Sterilisation

    • Principle: Induces cell death by alkylating proteins, DNA, and RNA, irreversibly preventing normal cell metabolism and replication.
    • Application: Can be used for high or medium-risk items that are not resistant to moisture or heat. It is particularly valuable for delicate, complex, and sophisticated medical devices made of sensitive materials that cannot withstand other methods. It is suitable for disposable instruments, insulated hand instruments, and tubings.
    • Parameters: EO sterilisation depends on four parameters: time, temperature, gas concentration, and relative humidity. Typically operates at low temperatures (49-60°C or 85°C for cold gas, 145°C for warm gas) and relative humidity of 40-60% (must be >30%).
    • Advantages: Can sterilise heat and moisture-sensitive medical devices without harmful effects on their materials. It effectively penetrates packaging materials and tubular medical devices. It allows for single-dose cartridge and negative-pressure operation, reducing gas leakage risk. It is easy to handle and monitor and compatible with most medical devices. EO has emerged as the method of choice due to its effective bactericidal, sporicidal, and virucidal activity. It is often described as the most cost-effective low-temperature sterilisation process with a recognised history of reliability.
    • Disadvantages: Costly. It is potentially hazardous to patients and medical personnel due to its toxicity, carcinogenicity, and flammability. It requires long aeration times to remove ethylene oxide gas residues (up to 12 hours or even 20 hours total cycle time). The sterilisers are typically small (110-250L). Formaldehyde and ethylene oxide are known to be carcinogenic, and glutaraldehyde has been reported to cause asthma and allergic reactions.

  • 4. Ionising Radiation Sterilisation (Gamma Radiation)

    • Principle: Gamma radiation emitted by radioisotope cobalt 60 induces the production of free radicals in cells, disrupting normal metabolism and leading to the inactivation of micro-organisms. This causes molecular degradation through homolytic bond cleavage.
    • Application: Used for low-temperature sterilisation of many medical products, such as tissue grafts, pharmaceuticals, and medical devices.
    • Advantages: No special requirements for the temperature environment and can be carried out at room temperature. The sterilisation is uniform, complete, fast, and continuous, making it suitable for mass sterilisation.
    • Disadvantages: High cost of sterilisation. The nature of some products may change after radiation, and there are safety issues to be aware of.

  • 5. Dry Heat Sterilisation

    • Principle: Bacteria are killed through the oxidation of cellular components at high temperatures.
    • Application: Used for materials not resistant to moist heat or that cannot be penetrated by moist heat, such as powders, petroleum products, and sharp instruments. Common times and temperatures include 170°C for 60 minutes, 160°C for 120 minutes, and 150°C for 150 minutes.
    • Advantages: It is non-toxic and environmentally friendly. The dry heat cabinet is easy to install and relatively inexpensive to operate. It penetrates materials and is non-corrosive to metals and sharp objects.
    • Disadvantages: Slow to penetrate and kill microorganisms, making it time-consuming. The high temperatures are not suitable for most materials.

Other Sterilisation and Disinfection Methods: Beyond these five common methods, other techniques are mentioned. These include:

  • Peracetic Acid Sterilisation: A biocidal oxidiser that maintains efficacy in the presence of organic debris. It heats to 50-56°C during a 20-30 minute cycle and requires anti-corrosive additives. Items must be rinsed with sterile water and used immediately as they are wet and unprotected from the environment.
  • Ozone Sterilisation, UV Irradiation Sterilisation, Microwave Sterilisation, and Filter Decontamination Methods are also listed as less commonly used sterilisation techniques.
  • High-Level Disinfection (HLD): While not sterilisation, HLD (e.g., using 2% glutaraldehyde or 0.55% ortho-phthalaldehyde (OPA)) is often used for instruments that cannot be sterilised. HLD eliminates bacteria, viruses, fungi, and parasites but does not reliably kill all bacterial endospores. For laparoscopic instruments, HLD is used when sterilisation is not feasible. Glutaraldehyde is a common HLD agent, but it is irritating to skin, eyes, and respiratory system, and its efficacy is reduced by organic load or wet instruments. OPA is a non-glutaraldehyde option for delicate instruments, offering good material compatibility and faster action.
  • Formaldehyde Gas: Used as a disinfection method in some rural hospitals, often in formalin chambers. However, it is described as unreliable for sterilisation due to difficulty in maintaining exact conditions. It is also potentially carcinogenic and very irritating. Some sources explicitly discourage its general use in hospitals due to health hazards.

Challenges for Laparoscopic Instruments and Reprocessing: Laparoscopic instruments are sophisticated, precisely calibrated, and complex in design, making them difficult to clean. They often have multiple joints, crevices, channels, and delicate tubular components, making them vulnerable to lodging bioburden. Organic matter like blood can become trapped, hindering cleaning and potentially leading to corrosive damage and pathogenic colonisation. Because many laparoscopic instruments are heat-sensitive, low-temperature sterilisation processes are essential.

The choice of sterilisation method is crucial. Manufacturers are responsible for providing specific sterilisation recommendations for their devices, and users must follow these instructions strictly. Failure to follow manufacturer instructions can negate the benefits of laparoscopic surgery, leading to higher instrument wear and patient infection rates.

while various sterilisation methods exist, the definition of sterilisation as the absolute elimination of all microbial life, including spores, remains paramount. The selection of the appropriate method, often a low-temperature one for delicate laparoscopic instruments, must consider the instrument’s material compatibility, the method’s effectiveness against all microbial life, and potential hazards to patients and staff. Thorough cleaning is a non-negotiable prerequisite for any sterilisation method to be effective. The complexity of medical devices, especially laparoscopic instruments, and the need for rigorous reprocessing protocols underscore the critical importance of proper sterilisation in ensuring patient safety and preventing healthcare-associated infections.

Laparoscopic Instrument Reprocessing

Specific Challenges and Steps in Laparoscopic Instrument Reprocessing

  1. Dismantling:

    • Challenge: Many laparoscopic instruments have designs that make them prone to harbouring blood and debris within shafts and under seals.
    • Step: Instruments should be designed to allow easy dismantling, and it is crucial to take them apart to thoroughly clean all sections.

  2. Point of Use and Containment/Transportation:

    • Step: Immediately after use, instruments should be kept moist to prevent soil from drying, and heavy soil should be removed from surfaces and difficult-to-clean features.
    • Challenge: Proteins in blood and tissue can dry and cake on surfaces, making thorough cleaning extremely difficult.
    • Step: All soiled or contaminated instruments should be placed in a container with a disinfectant solution (e.g., 0.5% chlorine) and transported to the cleaning area in closed or covered containers to prevent unnecessary contamination and prevent biohazard material build-up.

  3. Pre-cleaning:

    • Step: This initial treatment, preferably in a controlled environment, often involves enzymatic cleaners (such as protease, lipase, amylase) that break down blood and proteinaceous material, facilitating their removal. Instruments should be soaked in a diluted multi-enzyme cleaning solution for a recommended time (e.g., 10 minutes).
    • Challenge: The enzymes themselves are proteins and must be thoroughly rinsed off.

  4. Cleaning and Rinsing:

    • Challenge: The complex design of laparoscopic instruments with small moving parts, crevices, and channels can lead to residue build-up, potentially causing corrosive damage and pathogenic colonisation. Some instruments may also be resistant to common cleaning agents.
    • Manual Cleaning:
      • Step: Instruments are manually cleaned using soft brushes, cloths, or thin bottle brushes for shafts, paying special attention to joints, crevices, and channels. Running warm water or a water jet is used to rinse lumens and remove residual organic matter and cleaning solutions.
      • Challenge: In rural Indian hospitals, specific brushes for long lumens were often unavailable, with staff using toothbrushes or needles instead. Dedicated instrument detergents were also often lacking, with soap or clothes-washing powder being used. Manual cleaning alone is not a disinfectant process and requires supplementation.
    • Automated Cleaning:
      • Step: Washer-disinfector machines can be used with low-foaming, non-ionising cleaning agents. Instruments should be loaded carefully, with hinges open and concave surfaces facing down, and appropriate attachments used to flush lumens. Soft, high-purity water is recommended for the final rinse.
      • Challenge: Automated cleaning may not be suitable for all lumens and cannulas, sometimes necessitating manual or ultrasonic cleaning first. In some rural hospitals, automated washer-disinfectors were available but not in use due to insufficient instrument volume or lack of staff training.
    • Ultrasonic Cleaning:
      • Step: This method uses high-frequency sound waves to create microscopic implosions of tiny vapour bubbles, effectively scrubbing surfaces. Instruments are placed in a neutral pH solution for 10-15 minutes.
      • Advantage: It is considered highly efficient, up to 16 times better than hand-cleaning, and effective for hard-to-reach places.
      • Important Considerations: Visible debris should be removed before placing instruments in the unit, dissimilar metals should preferably not be mixed, the unit should not be overloaded, and hinged instruments should be opened.

  5. Drying and Inspection:

    • Step: Instruments must be thoroughly dried after cleaning and rinsing, ideally using an air gun, clean cloth, or drying cabinet, before packaging for sterilisation.
    • Step: After cleaning, all surfaces, cannulations, ratchets, joints, holes, and lumens must be visually inspected for any remaining soil or fluids. Hydrogen peroxide can be used as an additional check for blood residue. If any soil is visible, the instrument must be re-decontaminated.
    • Challenge: In rural India, inspection was often not actively performed due to time constraints, leading to visually contaminated instrument surfaces.

  6. Disinfection (High-Level Disinfection – HLD):

    • Definition: HLD destroys all life forms except bacterial spores. It is used for items that contact broken skin or intact mucous membranes.
    • Agents: Common agents include 2% glutaraldehyde (Cidex) and 0.55% ortho-phthalaldehyde (OPA). Formaldehyde gas (formalin) was also noted to be in use in rural India.
    • Challenges/Limitations:
      • HLD does not reliably kill all bacterial endospores, which cause serious diseases.
      • Glutaraldehyde effectiveness is impacted by organic load, contact time, and lack of periodic concentration testing. It is irritating and potentially toxic.
      • Formaldehyde gas is unreliable, difficult to maintain correct conditions, potentially carcinogenic, and highly irritating. Its routine use for sterilising instruments is not recommended due to efficacy concerns.
      • Some immersion sterilants like liquid glutaraldehyde or peracetic acid are not considered adequate because maintaining sterility until use is difficult.

  7. Sterilisation (The ultimate goal for high-risk items):

    • Definition: The physical or chemical removal of all microorganisms, including budding spores, to a level of sterility (SAL of 10-6). High-risk items must be sterilised before use.
    • Autoclaving (Steam Sterilisation):
      • Principle: Kills microorganisms by irreversibly coagulating and denaturing their enzymes and proteins using moist heat under pressure.
      • Process: Typically at 121°C or 132-135°C for 3-4 minutes. European standards may specify 134°C for 5 minutes (Germany) or 18 minutes (France).
      • Advantages: Non-toxic, environmentally friendly, fast, effective, and capable of penetrating instrument packs and lumenal devices. Cost-effective and reliable.
      • Challenges for Laparoscopic Instruments:
        • Heat Sensitivity: Autoclaving is damaging to heat-sensitive instruments, and repeated exposure can damage delicate surgical instruments, causing rusting or posing scalding risks. Laparoscopic cameras, light cables, and flexible endoscopes are specifically noted as being damaged by heat.
        • Porous Loads and Air Removal: Laparoscopic equipment often contains long narrow tubes and is considered a porous load. Successful sterilisation requires an autoclave with active air removal via deep, pulsed vacuum cycles before steam injection, which many older or manual autoclaves (like those observed in rural India) lack. Without this, air can remain trapped, preventing steam penetration and guaranteeing sterilisation.
    • Hydrogen Peroxide Plasma Sterilisation (e.g., STERRAD):
      • Principle: Uses the high oxidising activity of hydrogen peroxide plasma to destroy cellular proteins, enzymes, and nucleic acids.
      • Advantages: Safe, environmentally friendly with no toxic residues, short cycle times (28-75 minutes, or even 30 minutes for newer versions), and no aeration required. It is suitable for heat- and moisture-sensitive items and compatible with most medical devices. It represents a “true alternative” for MIS instruments where autoclaving might cause damage.
      • Disadvantages: Not suitable for paper fibres, cotton, linen, or liquid items, and may not be effective for lumens or medical devices with long and thin lumens unless synthetic packaging is used. Hydrogen peroxide can be toxic above 1 ppm.
    • Ethylene Oxide (EtO) Sterilisation:
      • Principle: Induces cell death by alkylating proteins, DNA, and RNA, irreversibly preventing normal cell metabolism and replication.
      • Parameters: Operates at low temperatures (49-60°C) and requires specific humidity (40-60%) for effectiveness.
      • Advantages: Suitable for high- or medium-risk items not resistant to moisture or heat, and effectively penetrates packaging materials and tubular medical devices. It is non-corrosive to optics. It has contributed significantly to the advancement of delicate, complex, and sophisticated medical devices made of sensitive materials, for which it may be the only acceptable sterilisation method.
      • Disadvantages: Costly, toxic, carcinogenic, and flammable. Requires long aeration times (12-20 hours) to remove gas residues, which can be hazardous to patients and medical personnel. Its general use in hospitals is increasingly discouraged due to health hazards. Residue control is critical, with ISO 10993-7 specifying allowable limits.
    • Other Methods: Ionising radiation and dry heat sterilisation are less common for general medical devices, with specific applications and limitations. Other techniques include peracetic acid, ozone, UV irradiation, microwave, and filter decontamination.

  8. Packaging:

    • Step: Instruments must be dry before packaging. They should be placed in appropriate medical-grade sterilisation pouches or wrapped, often double-wrapped, following local protocols and international standards. Biological or Chemical Indicators (BIs or CIs) should be placed within wrapped trays to monitor sterilisation performance.

  9. Storage:

    • Step: Sterilised items must be properly stored in dry, clean conditions at ambient room temperature to prevent recontamination.
    • Considerations: The shelf-life of a wrapped item is influenced by packaging material, handling frequency, cleanliness, humidity, temperature of the storage space, and whether packs are stored on open or closed shelves. Sterility is event-related, meaning the probability of contamination increases over time and with increased handling.

Overarching Issues in Low to Middle-Income Countries (LMICs) – Rural India Context

The assessment of laparoscopic instrument reprocessing in rural India revealed significant deficiencies, highlighting the complex challenges faced in these settings.

  • Lack of Updated Procedures and Training: Standard operating procedures had not been updated to incorporate the specialised needs of laparoscopic instruments since their introduction, and staff had not received additional training. Nurses often relied on school teachings or senior staff, lacking access to new information or manufacturer instructions.
  • Limited Resources and Equipment: Rural hospitals lacked dedicated tools for reprocessing, such as specific brushes for lumens, automated washer-disinfectors (even if available, often unused), ultrasonic cleaners, and personal protective equipment (PPE) for staff. Financial constraints severely limited the availability of necessary machinery, tools, and appropriate chemicals.
  • Suboptimal Reprocessing Practices:
    • Instruments were often soaked in tap water in uncovered basins, and manually cleaned with inappropriate agents like soap or clothes-washing powder.
    • Drying was inconsistent; instruments were sometimes left to air dry rather than being actively dried.
    • High-level disinfection with glutaraldehyde or formaldehyde gas was commonly used for laparoscopic instruments instead of sterilisation, often without proper monitoring (e.g., not testing glutaraldehyde concentration).
    • Glutaraldehyde was used despite its tendency to bind proteins onto instruments, and formaldehyde’s unreliability and toxicity were not fully understood by staff.
  • Autoclave Limitations: The manual autoclaves measured in rural Indian hospitals were unsuitable for sterilising laparoscopic instruments due to a lack of deep, pulsed vacuum cycles necessary for active air removal in porous loads.
  • Instrument Shortage and Reuse: Hospitals often owned only one laparoscopic instrument set due to cost, leading to reuse of disposable items and pressure to quickly reprocess instruments between surgeries, limiting proper cleaning and inspection time.
  • Impact on Safety: These deficiencies pose serious risks to patient and staff safety, including higher patient infection rates (e.g., due to insufficient sterilisation and overlooked insulation failures) and occupational health hazards from chemical exposure.
  • Recommendations: There is a clear need for updated policies, training programmes for healthcare workers that consider their wide range of responsibilities, and the development of surgical instruments and reprocessing equipment specifically designed for resource-constrained environments to improve safety and reliability.

Standards & Regulations

Sterilisation of medical devices is a critical process designed to remove all microorganisms, including budding spores, to a level of sterility known as the Sterility Assurance Level (SAL), typically expressed as 10⁻⁶. This is crucial for preventing hospital-acquired infections and reducing their rate. Medical devices that come into contact with human tissue, organs, broken skin, and mucous membranes are classified as high-risk items, such as puncture needles, biopsy forceps, laparoscopes, and implantable devices, and must be sterilised before use.

Laparoscopic instruments, due to their complex design with multiple joints, crevices, and channels, delicate parts, and potential for organic matter to become trapped, present particular challenges for thorough cleaning and sterilisation. Some instruments may also be resistant to commonly used cleaning agents or unsuitable for heat-resistant sterilisation methods like autoclaving, necessitating alternative methods.

Here’s an overview of the standards, regulations, and guidelines governing medical device sterilisation:

Key Regulatory and Standard-Setting Bodies & Their Contributions

  • International Organization for Standardization (ISO):
    • ISO 10993-7 addresses the biological evaluation of medical devices, specifically focusing on ethylene oxide (EO) sterilisation residuals, by specifying allowable limits of EO and its byproducts based on the toxicological risk to the patient.
    • ISO 11135 and European Norm (EN) 550 provide detailed guidance for the validation and routine control of EO sterilisation of medical devices.
    • ISO 15883 sets standards for cleaning tools and systems like washer-disinfectors.
    • ISO 11607 covers conditioning and sterilisation systems.
    • ISO 14161 offers guidance for the selection, use, and interpretation of results for biological indicators in healthcare product sterilisation.
    • ISO 14937 outlines general requirements for characterising a sterilising agent and for the development, validation, and routine control of a sterilisation process for medical devices.
    • ISO 17664 details the information that must be provided by medical device manufacturers for the processing of medical devices.
    • ISO 17665-1 specifies requirements for the development, validation, and routine control of moist heat sterilisation of healthcare products.
  • European Norms (EN):
    • EN 285 specifies that autoclaves used for sterilising long, narrow tubes (like those in laparoscopic instruments) must perform vacuum air removal before injecting steam to ensure proper sterilisation.
    • BS EN 455 Parts 1, 2, and 3 are standards for examination gloves, covering freedom from holes, physical properties, and biological evaluation.
  • World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC):
    • These organisations provide guidelines for the reprocessing of medical instruments.
    • The WHO recommends specific disinfection/steam sterilisation parameters for reusable instruments where there’s concern about Transmissible Spongiform Encephalopathies (TSE)/Creutzfeldt-Jakob Disease (CJD) contamination.
    • The CDC recommends that rigid laparoscopic instruments be sterilised, or at minimum, subjected to high-level disinfection if sterilisation is not feasible.
  • Food and Drug Administration (FDA – USA):
    • The FDA has established different sterilisation criteria for reusable instruments in the United States.
  • Association for the Advancement of Medical Instrumentation (AAMI):
    • AAMI TIR 20 concerns parametric release for EO sterilisation, a method that relies solely on the measurement and evaluation of physical process parameters that comply with previously validated parameters.
    • AAMI TIR 16 details process development and performance qualification for EO sterilisation, specifically addressing microbiological aspects.
    • ANSI/AAMI ST79 provides a comprehensive guide to steam sterilisation and sterility assurance in healthcare facilities.
    • AAMI TIR12 guides medical device manufacturers on designing, testing, and labelling reusable medical devices for reprocessing in healthcare facilities.

Adherence to Standards and Regulations

  • Manufacturer’s Instructions: It is paramount that cleaning and sterilisation procedures are performed strictly according to the manufacturer’s guidelines. The instrument manufacturer is the sole authority for providing sterilisation recommendations for their products due to their specific design and material knowledge.
  • Process Validation: Sterilisation processes must be validated and routinely monitored to ensure consistent and effective results. This validation includes both physical and microbiological performance qualifications. Users are responsible for validating the sterilisation process parameters (e.g., time, temperature) used with their specific equipment.
  • Parametric Release: This advanced approach to market release of sterilised medical devices relies solely on the recording and evaluation of process parameters, eliminating the need for routine microbiological testing after validation. It is considered scientifically and strategically superior due to its enhanced process control and flexibility.

Challenges in Adherence (Example: Rural India)

A study assessing laparoscopic instrument reprocessing in rural India revealed significant deficiencies in adherence to international standards and guidelines:

  • Lack of Enforcement: Despite India being an ISO member, ISO standards and reprocessing procedures from WHO and CDC were not enforced in the rural hospitals studied.
  • Outdated Procedures and Training: Standard operating procedures had not been updated to account for the specialised reprocessing needs of laparoscopic instruments since their introduction, and staff had not received additional training. Nurses often lacked written procedures and relied on senior staff or surgeons for information, which itself was often insufficient.
  • Inadequate Equipment and Practices:
    • Hospitals lacked dedicated tools and equipment for reprocessing, such as specific brushes for long lumens, often resorting to toothbrushes or needles.
    • Instead of dedicated detergents, soap or clothes-washing powder was used for cleaning.
    • Bleach was used for disinfection when patients were known to be infected, a practice known to corrode surgical instruments.
    • Glutaraldehyde concentration was not routinely tested, and its efficacy was compromised by wet instruments or large amounts of bioburden.
    • Formaldehyde gas chambers were used for disinfection, an unreliable method due to difficulties in maintaining necessary environmental conditions. Both formaldehyde and EO are known to be carcinogenic, and glutaraldehyde can cause adverse reactions, highlighting the risks to staff.
    • Measured autoclaves failed to sterilise loads due to a lack of adequate air removal or underpowered steam generation, rendering them unsuitable for laparoscopic instruments which require deep, pulsed vacuum cycles (as per EN 285).
    • Personal Protective Equipment (PPE) was largely absent, with staff often only using standard surgical gloves, increasing risks of cross-contamination.
  • Consequences of Non-Compliance: Such insufficient sterilisation has led to infection outbreaks after laparoscopic procedures. The lack of proper inspection tools meant damages, like electrical insulation failure on instruments, could be overlooked, leading to complications.
  • Recommendations for Improvement: The study recommended an updated policy to incorporate minimally invasive instrument reprocessing into training programs for medical practitioners and staff. It also highlighted the need for “minimum viable safety standards” and the redesign of surgical equipment and reprocessing tools to be more robust, repairable, and less dependent on local knowledge and practices, especially in resource-constrained environments.

Ultimately, effective sterilisation, guided by comprehensive standards and regulations, is essential to ensure patient and staff safety and the longevity of delicate medical equipment.

Issues in Rural India (Case Study)

The sources provide a comprehensive, albeit concerning, overview of the issues related to medical device sterilisation in rural India, contrasting local practices with international standards and guidelines. The “Assessment of laparoscopic instrument reprocessing in rural India: a mixed methods study” serves as the primary case study, highlighting significant deficiencies and their consequences.

Key Issues in Rural India (Case Study) regarding Medical Device Sterilisation:

  • Lack of Enforcement of International Standards and Guidelines:

    • Despite India being an ISO member, ISO standards and reprocessing procedures from organisations like the WHO and CDC were not enforced in the rural hospitals studied. This is a fundamental failing, as these international bodies provide comprehensive guidance for reprocessing medical instruments.
    • The study found that the existing standard operating procedures (SOPs) had not been updated to account for the specialised reprocessing needs of laparoscopic instruments since their introduction.

  • Inadequate Training and Knowledge among Staff:

    • Staff, particularly nurses responsible for reprocessing, had not received additional training for minimally invasive equipment.
    • Nurses were unaware of the hazardous effects of reprocessing detergents and disinfectants, such as glutaraldehyde and formaldehyde.
    • Rural nurses receive a general nursing course which is inadequate for reprocessing complex laparoscopic instruments. They often lack written procedures and rely on outdated information from senior staff or surgeons.
    • There is a strong preconception in sterile reprocessing, and new knowledge, including scientific literature and manufacturer’s instructions, does not reach the nurses.

  • Deficient Equipment and Infrastructure:

    • Hospitals lacked dedicated tools and equipment for reprocessing, such as specific brushes for long lumens. Instead, makeshift items like toothbrushes or needles were used.
    • Dedicated detergents were not used; instead, soap or clothes-washing powder was applied.
    • Personal Protective Equipment (PPE) was largely absent, with staff often only using standard surgical gloves, increasing risks of cross-contamination and exposure to hazardous chemicals.
    • Only two out of four hospitals had a designated Sterile Supply Department (SSD), and even then, staff often did not follow the established workflow within these areas.
    • Financial limitations severely impact the ability to acquire necessary machinery, tools, and chemicals.

  • Unsuitable Reprocessing Practices:

    • Instead of sterilisation, laparoscopic instruments were often subjected to high-level disinfection. While high-level disinfection eliminates most microorganisms, it does not reliably kill all bacterial endospores, which are crucial for true sterilisation.
    • Practices included soaking instruments in bleach, which is known to corrode surgical instruments.
    • Glutaraldehyde concentration was not routinely tested, and its efficacy was compromised by wet instruments or high bioburden. Glutaraldehyde also impedes cleaning by binding proteins.
    • Formaldehyde gas chambers were used for disinfection, an unreliable method due to difficulties in maintaining necessary environmental conditions like humidity.
    • Measured autoclaves, even when present, failed to sterilise loads due to a lack of adequate air removal or underpowered steam generation. These autoclaves were not suitable for laparoscopic instruments which require deep, pulsed vacuum cycles as specified by standards like EN 285.
    • Instruments were not always thoroughly dried, and proper inspection was often overlooked due to time constraints.

Consequences of Non-Compliance:

  • Infection Outbreaks: Insufficient sterilisation has directly led to infection outbreaks after laparoscopic procedures.
  • Compromised Patient Safety: Overlooked damage, such as electrical insulation failure on instruments, could lead to complications like burns during surgery. The lack of replacements for broken instruments can force conversion to open procedures, increasing infection risk.
  • Increased Operating Costs and Instrument Wear: Instruments not reprocessed according to manufacturer’s instructions lead to higher wear and increased operating costs.
  • Staff Safety Risks: Staff were exposed to hazardous chemicals like formaldehyde and ethylene oxide (known carcinogens) and glutaraldehyde (which can cause asthma and allergic reactions) without proper PPE.

Recommendations for Improvement:

  • Policy Update and Training: An updated policy is crucial to incorporate minimally invasive instrument reprocessing into training programmes for medical practitioners and staff. Training should take into account the wide range of responsibilities healthcare workers carry in rural settings.
  • “Minimum Viable Safety Standards”: Given the financial and infrastructural limitations of many rural hospitals, the study suggests establishing “minimum viable safety standards” that are achievable within resource-constrained environments, rather than attempting to meet all international standards designed for large, high-turnover facilities.
  • Redesign of Equipment: Surgical instruments and reprocessing tools need to be redesigned to be more robust, repairable, and easier to inspect. This would maximise their lifespan and reduce dependence on specific local knowledge and practices. Reprocessing equipment should also be suitable for small batches and considerate of resource consumption.

In essence, the case study reveals a significant gap between international best practices and the realities of medical device sterilisation in rural Indian hospitals. This highlights the critical need for a holistic approach that addresses not only equipment and infrastructure but also policy, training, and the practical design of medical devices suitable for such resource-constrained settings.

Recommendations for Improvement

Recommendations for Improvement in Rural India regarding Medical Device Sterilisation:

  1. Updated Policy and Comprehensive Training Programmes:

    • A crucial recommendation is the urgent need for updated policy to properly incorporate the reprocessing of minimally invasive instruments into training programmes for medical practitioners and staff.
    • Training programmes should be specifically compiled to account for the wide range of responsibilities rural healthcare workers typically carry, as their general nursing courses are currently inadequate for reprocessing complex laparoscopic instruments.
    • Basic nursing training should explicitly incorporate the handling of complex instruments.
    • Staff must be made aware of the hazardous effects of reprocessing chemicals like glutaraldehyde and formaldehyde. New knowledge, including scientific literature and manufacturer’s instructions, needs to effectively reach the nurses, as they currently rely on outdated information or senior staff.

  2. Establishment of “Minimum Viable Safety Standards”:

    • Given the significant financial and infrastructural limitations of many rural hospitals in India, the study advocates for establishing “minimum viable safety standards“. This approach acknowledges that attempting to meet all international standards (which are often designed for large, high-turnover facilities) may not be financially viable for smaller rural hospitals. These standards would clarify the achievable level of process improvement within resource-constrained environments.

  3. Redesign of Surgical Instruments and Reprocessing Tools:

    • Both surgical instruments and reprocessing equipment need to be redesigned to be more robust, repairable, and easier to inspect. This would maximise their lifespan and reduce the reliance on specific local knowledge and practices, which can often be incorrect or outdated.
    • Reprocessing equipment should also be suitable for processing small batches of instruments and be considerate of resource consumption, such as water.
    • Instruments should ideally be designed to allow easy dismantling to prevent bioburden from harbouring within shafts and crevices, enhancing the efficacy of cleaning and sterilisation.

  4. Improved Cleaning and Decontamination Protocols with Appropriate Equipment:

    • Minimise the duration between instruments leaving the surgical field and the commencement of the cleaning process to prevent organic matter from drying and caking. Instruments should be placed in a basin of solution immediately after surgery.
    • Ensure proper initial decontamination by wiping visible bioburden and then soaking instruments in a disinfectant solution (e.g., 0.5% chlorine for 10 minutes).
    • Provide dedicated tools and equipment for reprocessing, such as specific brushes for long lumens, rather than makeshift items like toothbrushes or needles. Ultrasonic cleaners are highly recommended as they are efficient for hard-to-reach places. “Cleaning guns” with fine, pointed nozzles are also useful for cleaning instrument shafts.
    • Utilise dedicated detergents and enzymatic cleaning solutions that are approved for surgical instruments, as opposed to soap or clothes-washing powder, which are ineffective and can leave residues. These solutions should be capable of removing organic and inorganic soil, be low foaming, rinse completely, and be compatible with the materials being cleaned.
    • Emphasise thorough manual cleaning with soft-bristled brushes, paying attention to joints, crevices, and channels. Instruments should be fully disassembled where intended for cleaning. For non-dismantlable instruments, water under pressure should be irrigated through cleaning channels.
    • Instruments should be rinsed thoroughly with warm running water or soft, high purity water, preferably deionised water, to remove residual organic matter and cleaning solution, reducing mineral deposits and corrosion risk.
    • Actuate movable mechanisms (hinges, box locks) during cleaning and rinsing to ensure trapped debris is removed.
    • Instruments must be thoroughly dried after cleaning and rinsing, ideally using an air gun or oven, before packaging or disinfection/sterilisation.

  5. Appropriate Sterilisation/High-Level Disinfection Methods:

    • For laparoscopic instruments, which are high-risk items due to contact with human tissue, sterilisation or high-level disinfection (HLD) at best should be used. The Centers for Disease Control (CDC) recommends rigid laparoscopic instruments be sterile or, if not feasible, high-level disinfected.
    • Hospitals must ensure they possess autoclaves suitable for laparoscopic instruments, which require deep, pulsed vacuum cycles for effective air removal to ensure steam penetration into lumens, as specified by standards like EN 285. Measured autoclaves in rural India were found to fail in this regard.
    • Avoid outdated and unreliable methods such as formaldehyde gas chambers for sterilisation, as they struggle to maintain necessary environmental conditions and are carcinogenic.
    • While high-level disinfection methods like glutaraldehyde are used, their concentration must be routinely tested with indicator strips, and efficacy can be compromised by wet instruments or high bioburden. Glutaraldehyde also impedes cleaning by binding proteins.
    • Consider safer and more effective alternatives for heat-sensitive instruments when available and feasible. Hydrogen peroxide gas plasma (e.g., STERRAD system) is a suitable low-temperature sterilisation method that is quick and leaves no toxic residues. Ortho-phthalaldehyde (OPA) is another recommended non-glutaraldehyde solution for delicate instruments due to its speed, efficiency, and material compatibility.
    • Adhere strictly to manufacturer’s guidelines (IFU) for sterilisation methods, as they provide critical information specific to the device’s materials and design.

  6. Enhanced Safety Measures for Staff:

    • Personal Protective Equipment (PPE), such as waterproof gowns, thick elbow gloves, and face shields, must be readily available and consistently used by staff reprocessing instruments. Currently, staff often use only standard surgical gloves, exposing them to hazardous chemicals and cross-contamination.

  7. Robust Inspection and Maintenance:

    • Thorough visual inspection of all surfaces, cannulations, joints, and lumens for complete removal of soil or fluids after cleaning is paramount; if any soil is visible, the instrument should be reprocessed. The current lack of inspection leads to overlooked damage like electrical insulation failure, a common complication in laparoscopy.
    • Regular application of surgical grade lubricants to hinges, joints, and moving parts is necessary. However, silicon-based lubricants should be avoided as they can hinder sterilisation.
    • Instruments should be checked for damage and wear; blunt, worn, flaking, fractured, or damaged instruments must be removed for repair or replacement. Insulated instruments should be checked for breach in insulation before sterilisation.

  8. Addressing Financial Constraints and Resource Availability:

    • While direct financial solutions are outside the scope of procedural recommendations, the sources repeatedly highlight that financial limitations severely impact the ability to acquire necessary machinery, tools, and chemicals. Increased financial means would allow hospitals to afford proper equipment.
    • The problem of shortage of laparoscopic instrument sets means instruments are needed immediately for the next operation, putting pressure on cleaning time and often leading to incomplete reprocessing. This also leads to the reuse of disposable instruments.

  9. Standardisation and Documentation:

    • Implementation of written procedures and checklists for instrument cleaning and sterilisation is essential, as many rural hospitals currently lack them. This helps ensure consistency and accountability.
    • Maintaining records of sterile processing and periodic reviews are also critical aspects of quality assurance.
    • Proper packaging and labelling of instruments after sterilisation is crucial for maintaining sterility during storage. Storage should be in dry, clean conditions at ambient room temperature, away from heavy traffic.

In summary, improving medical device sterilisation in rural India requires a multi-faceted approach, integrating updated policies and comprehensive training with appropriate infrastructure, modern equipment, and rigorous adherence to detailed cleaning and sterilisation protocols. This must be balanced with the practical realities and financial constraints of rural settings, perhaps by initially aiming for contextually relevant “minimum viable safety standards” and promoting the design of more durable and easily reprocessed instruments.

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