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Dec. 16, 2024

5 Crucial Questions Patients Should Ask Concerning a Hospital's ...

(For further insights into topics in the CS/SPD industry, we invite you to follow the Beyond Clean Podcast. Our broadcasts feature industry leaders in surgical instrument reprocessing, discussing various critical issues concerning SPD professionals, facilities, administrators, manufacturers, and vendors.)

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Despite advancements in hospital quality metrics and ratings provided by platforms like Leapfrog, US News and World Report's Best Hospitals, and CMS's Five-Star Rating System, patients often lack insight into an essential aspect of surgical safety: the surgical instrument program of a hospital. Even the most skilled surgeons and the highest-rated nursing staff cannot compensate for inadequate surgical instruments that may pose risks to patients.

Here are 5 essential inquiries that patients should make about a hospital's surgical instrument program, but often do not:

1) Are the Sterile Processing technicians employed at this hospital nationally certified?

The technicians responsible for reprocessing surgical instruments, ranging from cranial drills to minimally-invasive cauterizing clamps, are often entry-level employees. Generally, a high school diploma is the only requirement for this position. Without a mandatory certification program for these technicians, there is no way to guarantee they possess the necessary foundational knowledge, such as basic microbiology and regulatory standards, essential for ensuring the safety of surgical instruments.

2) Is there a comprehensive preventative maintenance and repair program for their surgical instruments?

Many patients do not realize that surgical tools like scissors, clamps, and retractors have been used multiple times before. Just like any tool, surgical instruments have a finite lifespan and must be maintained, repaired, and replaced based on strict manufacturer guidelines. Neglecting this aspect can lead to various intra-operative instrument failures.

3) Does this hospital have adequate inspection tools and instrument models for proper reprocessing?

The increasing complexity of surgical instruments requires specialized inspection tools, such as desktop magnifiers for micro-eye instruments and protein detection systems to identify residual biological material before sterilization. First-generation instruments, like laparoscopic graspers and Kerrison rongeurs, cannot be disassembled easily for thorough cleaning during decontamination. Hospitals should therefore upgrade to advanced models that facilitate complete disassembly for reprocessing.

4) Is there an adequate inventory of instruments to meet the surgical volume of this hospital?

In the current competitive financial landscape of American healthcare, many hospitals attempt to optimize their operating room schedules at increased capacities without adequately investing in enough surgical instruments. This can lead to instances where necessary surgical instruments must be rapidly "turned over" from previous procedures. Such practices can result in insufficient inspections by Sterile Processing staff, delays in surgery schedules, and prolonged anesthesia times. Numerous services are available to assist hospital leadership in collecting significant data points to optimize their surgical inventory safely.

5) Do surgical implant vendor representatives comply with hospital policies?

Whether it’s a complex fracture repair or a planned spinal fusion, much of the surgical instrumentation comes from external vendors. Since these instruments are often not owned by the hospital, adhering to quality standards for their preparation is crucial before surgery. This includes requiring timely deliveries for processing (typically 48 hours prior to the procedure), complying with the manufacturer's usage instructions, and utilizing FDA-approved packaging methods. Late or poorly documented vendor instrument deliveries can be a significant factor in serious safety incidents in the operating room.

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While the quality of a hospital’s surgical instrument program serves as a vital indicator of the safety and efficiency of surgeries, patients currently have no means to research, compare, and advocate for improved standards related to CS/SPD departments. It’s imperative that this changes for better patient safety. Until then, patients ought to feel empowered to pose these questions to their healthcare providers and expect the correct answers.

What do you think?

W. Hank Balch  April 

This article solely represents the author's views and does not reflect the opinions of any employer or facility.

Discover over 75 additional Sterile Processing articles and insights here, alongside published works in Becker's Hospital Review, Infection Control Today, AAMI News, and contributions to Healthcare Purchasing News. My CS team in Louisville, KY, was honored as the "CS/SPD Department of the Year" by HPN, and I currently serve as the President of the South Texas Association of Sterile Processing Services, with a nomination for the President-Elect position of the International Association of Healthcare Central Service Materiel Management.

Laparoscopic Equipment Detail 4

Equipment Detail 1, Equipment Detail 2, Equipment Detail 3, Equipment Detail 4, Equipment Detail 5

READ ABOUT LAPAROSCOPIC EQUIPMENT AND INSTRUMENTS

Laproflattor

The Electronic CO2 Laproflattor is a versatile insufflation unit designed for laparoscopic examinations and procedures. This device facilitates controlled pressure insufflation of the peritoneal cavity, creating the requisite workspace for laparoscopic surgery by distending the anterior-lateral abdominal wall while displacing the hollow organs and soft tissues. Carbon dioxide is the preferred gas for insufflation due to its non-combustible nature, high solubility reducing the risk of gas embolism, and cost-effectiveness. The automatic insufflators allow surgeons to preset the required insufflation pressure and will automatically provide gas to meet the desired intra-abdominal pressure, activating if there are escapes or leaks from the ports. Pressure and flow values can be precisely adjusted using jog keys and digital displays, with insufflation pressure continuously adjustable from 0 to 30 mm Hg, and total gas flow volumes set from 0-9.9 liters/mm.

Patient safety is further assured through optical and acoustic alarms, alongside multiple independent safety circuits. Understanding the functional indicators of the insufflator, including preset pressure, actual pressure, flow rate, and total gas usage, is crucial for safety considerations.

Suction Irrigation Machine or Pelvis-Cleaner

Figure 2-29: Laparoscopic Suction Irrigation Machine

This machine is specifically utilized for flushing and cleaning the abdominal cavity during endoscopic surgical procedures. It is designed for use with the AR suction/instillation tube, featuring an electrically-driven pressure/suction pump protected against infiltration of bodily fluids. Frequently employed during laparoscopy, it aims to maintain a clear field of vision, utilizing normal saline or ringer lactate for irrigation. In cases of excessive intra-abdominal bleeding, heparinized saline may be employed to dissolve blood clots and ensure effective suction.

Disposable or Reusable Instruments

When selecting laparoscopic instruments, several factors must be weighed, including cost, availability, and reliability. Although reusable instruments entail a higher initial investment, they prove cost-effective in the long term. Disposables, while cheaper upfront, can elevate overall patient costs. Many facilities paradoxically reuse disposable instruments. In developing countries, disposables are hardly utilized due to lower labor costs compared to that of disposable instruments. Conversely, in Europe and the USA, surgeons often prefer disposables to mitigate higher labor expenses. The primary advantages of disposables lie in their higher performance and minimized risk of disease transmission due to certified high-end factory sterilization. Concerns regarding the environment and biodegradability arise once these instruments are disposed of. Ideally, disposables should not be reused, as the processes of handling, sorting, storing, and sterilizing can compromise their integrity. It is worth noting that disposable instruments are often inadequately sterilized if merely dipped in glutaraldehyde due to their non-dismountable nature, while insulation can be easily damaged, leading to potential electrosurgical injuries.

Veress Needle

Originally developed by a thoracic physician for the aspiration of pleural effusions, the Veress needle was designed with a spring mechanism and blunt tip to prevent lung injury. This apparatus comprises an outer cannula that has a beveled needle point for penetrating tissues, and an inner stylet that springs forward upon experiencing the sudden pressure drop when crossing the abdominal wall and entering the peritoneal cavity. The lateral hole in the stylet allows for CO2 delivery into the abdomen.

The Veress needle is primarily used for creating initial pneumoperitoneum, facilitating safe trocar insertion and expanding the distance between the abdominal wall and viscera. This technique is the most commonly practiced method of access. It is essential to check the Veress needle's potency and spring action before each use. Available in lengths of 80mm, 100mm, and 120mm, the choice depends on the patient's physique; 120mm for obese patients and 80mm for those with a scaphoid abdomen. The proper technique for Veress needle insertion and relevant safety measures are detailed in the subsequent access technique section.

Trocar and Cannula

While "trocar" typically refers to the entire system, the true trocar is the stylet introduced through the cannula. Trocars come with various tip designs, including cutting tips shaped as three-edged pyramids or flat two-edge blades.

Conical-tipped trocars are recognized for being less traumatic to tissues. Their design permits penetration through the parietal wall without cutting, leading to a reported reduction in hernia and hemorrhage risks.

Figure 2-32: Disposable Trocar and Cannula

Cannulas are typically crafted from plastic or metal. Plastic devices, whether transparent or opaque, are designed to minimize light reflection from the telescope. Reusable and disposable trocars are made from a combination of metal and plastic, with disposable ones featuring a two-edge blade tip. These are particularly effective at penetrating the abdominal wall by incising the tissue as they enter. Most disposable plastic trocars are equipped with spring-loaded mechanisms that retract the sharp tip immediately after passing the abdominal wall to reduce visceral injury incidence. Trocars and cannulas are available in various sizes and diameters depending on their application. The most common cannula diameters are 5 mm and 10 mm, though the range spans from 3 mm to 30 mm.

All cannulas have a valve mechanism at their top, which provides internal air seals, enabling instruments to move in and out without losing pneumoperitoneum. These valves can be oblique, transverse, or piston-configured.

Many mechanisms can enable manual or automatic retraction during instrument entry. Trumpet-type valves provide excellent sealing but can be impractical compared to other systems, requiring both hands for instrument insertion. Flexible valves limit carbon dioxide leakage, regardless of the instrument diameter.

Surgeons should remember that sharp trocars, while appearing dangerous, are actually superior to blunt ones as they require less force for abdominal cavity insertion, diminishing the chances of excessive force being applied during entry.

Trocars and cannulas must be held appropriately, ensuring the trocar's head rests on the thenar eminence, with the middle finger over the gas inlet while the index finger touches the sharp end of the trocar.

Laparoscopic Hand Instruments

Laparoscopic hand instruments range in diameter from 1.8 mm to 12 mm, with most designed for 5 to 10 mm cannulas. These hand instruments come in varying lengths (18 to 45 cm), ergonomically optimized, with 36 cm considered standard for adults and 28 cm for pediatric applications. Shorter instruments (18 to 25 cm) are typically used for cervical and pediatric surgeries. Certain procedures in adults may also utilize shorter instruments where space constrictions exist, while 45 cm instruments cater to obese or very tall patients. For optimal ergonomics, half of the instruments should remain internal while the other half is external, stabilizing the port and facilitating easier surgical operations.

Many laparoscopic procedures necessitate a combination of sharp and blunt dissection techniques, often employing the same instrument in various capacities. Both reusable and disposable laparoscopic instruments are readily available, with reusable ones generally being partially dismountable for effective cleaning. Some manufacturers offer modular systems, allowing customization of instruments according to the surgeon's preferences regarding handles or working tips.

Essential functionalities of laparoscopic instruments like graspers and scissors include basic opening and closing mechanisms. Recently, several manufacturers have enabled a 360-degree rotation for increased maneuverability. Some instrument designs also allow for angulations at the tips, complementing the standard four degrees of freedom. This feature is particularly advantageous for avoiding obstacles and lateral grasping when the instruments are outside the visual field. However, the complexity of such designs can complicate sterilization procedures.

A variety of retractors have been developed with multiple articulations along their shafts, assuming rigid shapes when fixed with tightened cables, sometimes challenging to introduce through cannulas.

Most hand instruments comprise three detachable components:

  • Handle
  • Insulated Outer Tube
  • Insert that forms the tip of the instrument

Different Handles of Hand Instrument

Some instrument handles allow for jaw locking, beneficial for securing tissues firmly over extended periods, alleviating hand fatigue for surgeons. Typically, the locking mechanism integrates into the handle, facilitating straightforward locking or releasing of the jaws. These systems usually include a ratchet for adaptable jaw closure to various positions and pressures. Most laparoscopic instrument handles feature attachments for unipolar electrosurgical leads, and several have rotating mechanisms for instrument tips. Some multifunctional laparoscopic handles enable suction and irrigation operations, accommodating electrosurgical cutting and coagulation switches.

The Cuschieri Ball Handle, invented by Professor Sir Alfred Cuschieri, fits comfortably in a surgeon’s hand. This ergonomic design minimizes fatigue and facilitates rotation of the instrument by allowing palm rotation rather than wrist movement. Compressing the front of the handle increases jaw-closing force, while squeezing the rear opens the jaws.

The Cuschieri Pencil Handle offers similar ergonomic benefits, especially with needle holders, letting surgeons alter the angle between the handle and instrument according to their wrist position.

Outer Sheath of Hand Instrument

High-quality insulation is crucial for the outer sheath of hand instruments to prevent accidental electroburns to internal organs. This insulation may consist of silicone or plastic. Care must be taken during cleaning to avoid scratching the insulation with any sharp objects, as even minute pinhole breaches can be hazardous during electro-surgery.

Insert of Hand Instrument

Companies like Laparoscopic Instrument supply the best instruments worldwide. We are your go-to source for all your needs, with our specialized team ready to assist you in finding the perfect product.

The inserts of hand instruments vary only at the tips, which may include graspers, scissors, or forceps. Graspers may feature single-action or double-action jaws, with single-action gravitationally providing greater closural force than double action, hence most needle holders are single-action. Wider openings in double-action jaws are present in graspers and dissectors, while single-action types are often applied where greater force is required.

Single Action Jaw Graspers

These graspers are favorable when precision over depth is needed, allowing the surgeon to work in a focused manner, particularly during adhesiolysis.

Double Action Jaw Graspers

Instruments for Sharp Dissection

  1. Scissors
  2. Electrosurgery Hook
  3. HF Electrosurgery Spatula (Berci)
  4. HF Electrosurgery Knife
  5. Knife

Scissors

Scissors, one of the oldest surgical instruments, were invented in the fourteenth century B.C. by Jean-Claude Margueron of Emar. While scissors are widely used in open surgeries, their application in minimally invasive procedures requires higher precision as the potential for unnecessary bleeding and injury to crucial structures is significant in inexperienced hands.

Mechanism of cutting involves three parts:

  1. Blade
  2. Fulcrum
  3. Handle

The cutting force of scissors operates on the lever principle, where the force applied to the blade can be calculated based on the handle length and grip force. Laparoscopic scissors exemplify class 1 levers but do not strictly follow the lever law due to the cylindrical action of the long shaft; however, the handle design amplifies the cutting force.

Scissors function through a combination of:

  1. Gripping
  2. Squeezing
  3. Tearing

During operation, the interaction of scissors with tissue encompasses five stages:

1. Engagement

The engagement process involves the blades aligning with the tissue. The tissue amount should not exceed the jaw's internal space to prevent slippage during cutting. Once engaged, force applied triggers the cutting process.

2. Elastic Deformation

This occurs immediately after tissue engagement; the tissue begins to deform elastically, meaning it can recover to its original state without residual injury if forces are released.

3. Plastic Deformation

As additional force is applied, the tissue undergoes irreversible plastic deformation; even halting the cutting process at this stage leaves an imprint on the tissue.

4. Fracture

Further force application results in the fracture of the tissue's intercellular structure, distinct from scalpel cuts, as it occurs at the cellular level.

5. Separation

Post-fracture, the tissue separates along the cut line, continuing the cutting process on the engaged material.

Histology of Tissue after Cutting

Histological evaluations post-scissors use show separation through cellular planes, with microscopic examinations revealing serrated cut margins along the tissue separation line.

Types of Laparoscopic Scissors

Straight Scissors

The blades of the straight scissors are straight, widely employed for controlled dissection techniques in laparoscopic procedures. They provide greater stability as they offer only one moving jaw, which should be positioned upward while the fixed jaw remains down during cutting.

Curved Scissors

The slightly curved blades are among the most common in laparoscopic surgeries, with fixed or retractable handles. A fixed curvature near the scissors requires introduction through flexible, valve-less ports. Surgeons commonly prefer this design as it omits instrument manipulation angles and provides better visibility through telescopes.

Serrated Scissors

Serrated edges enhance grip on slippery tissues, making them effective for cutting ligatures or delicate structures.

Hook Scissors

Having a flattened C-form, the sharp edges permit partial closure for trapping tissue without division, aiding validation before complete closure. This instrument excels in severing secured ducts or arteries during laparoscopic procedures.

Micro-tip Scissors

These finely designed scissors, straight or angled, are utilized for partial transection of ducts, making them handy for small duct exploration, such as the common bile duct. Their fine blades facilitate delicate dissection, particularly useful in intra-operative cholangiography.

The endoscopic application of scissors necessitates slight modifications from open techniques. The foundational instrument is simply a miniaturized, long-handled version of conventional scissors, available in either single or double action.

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