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Scanning electron microscopy characterization of surgical instrument damage to breast implants.

In this article, mechanisms of breast-implant failure caused by surgical instruments commonly used to perform implantation, breast biopsies, needle localization procedures, cyst aspirations, and explantation are described. Failure was artificially induced in breast-implant shells using various types of surgical instruments, including scalpels, suture needles, hypodermic needles, hemostats, and Adson forceps. Field-emission scanning electron microscopy (SEM) was used to document the morphology of the failure sites produced by these instruments. Micrographs were used to categorize failure according to a specific type of surgical instrument. SEM micrographs were also obtained on explants that failed in situ, and the morphology of the corresponding failure sites was examined. The study was designed to document a range of failure mechanisms associated with gel-filled, saline-filled, double-lumen (saline-gel), and soybean oil-filled implants. The results of the study also demonstrate that SEM can often be used to determine the cause of breast-implant failure.

Breast Implants↗

Radiation sterilization of surgical instruments with a consideration of metal shielding on sterilization efficiency.

The feasibility of the use of radiation for sterilization of surgical instruments was evaluated. Two aspects were considered: radiation biology of relevant microorganisms, that is, bacterial spores and viruses, and shielding and radiation protection by the metal of the instruments. After proper cleaning and hot water machine washing, surgical instruments carry few, if any contaminants; however, subsequent handling increases the contamination load. Although large instruments may attenuate as much as 30% of the incident radiation, spores dried on the metal are sensitized to irradiation by some 40%. A dose of 25 kGy (2.5 Mrad) is adequate to inactivate a potential contamination load of approximately 10(7) bacterial spores or approximately 10(4) viruses. Therefore, 25 kGy will provide a high sterility assurance level, and can be recommended with a considerable degree of confidence for hospital-based sterilization of surgical instruments.

Animals↗

Surface decontamination of surgical instruments: an ongoing dilemma.

The issues of cross-infection and the survival of variant Creutzfeldt Jakob disease (vCJD) on surgical instruments have highlighted the importance of cleanliness of multiple-use surgical instruments. The aim of this study was to assess the levels of total protein contamination on a wide range of surgical instruments as an indication of the effectiveness of routine cleaning and disinfection in hospitals. Anonymized trays of wrapped and autoclaved instruments were supplied to two laboratories for analysis at the stage where they would normally be returned to operating theatres. Instruments were assessed for residual protein and total organic matter. Laboratory A showed that 17% (35/206) of instruments were above a threshold that equated to 200 microg. The worst examples, a McIvor gag, a Draffin rod (child) and a Yankaur sucker, had 1.028, 1.286 and 2.228 mg of extractable protein, respectively. The median (25th, 75th percentiles) amount of protein from instruments from different hospitals assessed in Laboratory B ranged from 8 (3, 30)mug (Hospital C) to 91 (35, 213) mug (Hospital D) (P=0.044). The residual matter washed from instruments varied from 0.62 (0.32, 0.81) mg (Hospital E) to 3.5 (3.5, 4.0) mg (Hospital A) (P=0.0001). In one case, 45 mg of residual organic matter was washed from an instrument (split stem). In conclusion, this study demonstrated that a proportion of instruments at the point of use show levels of protein that could pose a direct cross-infection risk via prion agents and other organic contamination that may reduce the effectiveness of cleaning/disinfection strategies targeted against either prions or traditional infectious agents.

Decontamination↗

Titanium nitride as a coating for surgical instruments used to collect human tissue for trace metal analysis.

When metallic surgical instruments are used to collect human tissue, metal contamination may occur, making accurate ultra-trace metal determinations very difficult. In order to reduce this risk as much as possible, surgical instruments made from a stainless-steel core covered by a film of titanium nitride, a very hard compound with high chemical stability and very good wear resistance, were prepared. The degree of risk from trace metal contamination during sample collection was investigated by neutron activation analysis and a radio-release in vitro serum test. As examples of their application, the titanium nitride coated instruments were used to determine Co, Cr and W in the skin of unexposed subjects and of uraemic patients under regular dialysis treatment.

Humans↗

Metallic surgical instruments for interventional MRI procedures: evaluation of MR safety.

This investigation evaluated metallic surgical instruments for magnetic resonance (MR) safety in association with a 1.5-Tesla/64-MHz MR system. Seven different instruments (mallet, bone punch, curette, Weil-Blakesley ethmoid forceps, suction cannula, septum speculum, and Kocher-Langenbeck retractor; Aesculap, Inc. (South San Francisco, CA) were tested for magnetic field interactions, heating, and generation of artifacts by using previously described techniques. Heating was evaluated for the septum speculum and Kocher-Langenbeck retractor by using a special gel-filled phantom and a fluoroptic thermometer to record temperatures immediately before and during MRI performed at a whole-body averaged SAR of 1.3 W/kg. Artifacts were assessed with the instruments placed inside of a gel-filled phantom and performing MRI using T1-weighted spin-echo and gradient-echo pulse sequences. Magnetic field interactions were relatively minor (deflection angles, 0 to 7 degrees; torque, 0 to +1), the highest temperature changes were < or = +0.8 degrees C, and the artifacts should not create substantial problems considering the "intended use" for these instruments. The findings of the MR safety tests indicated that the seven different metallic surgical instruments (Aesculap, Inc.) would be safe and acceptable for use in interventional MRI procedures performed with MR systems with static magnetic fields of 1.5 T or less. J. Magn. Reson. Imaging 2001;13:152-157.

Artifacts↗

Elimination of transmissible spongiform encephalopathy infectivity and decontamination of surgical instruments by using radio-frequency gas-plasma treatment.

It has now been established that transmissible spongiform encephalopathy (TSE) infectivity, which is highly resistant to conventional methods of deactivation, can be transmitted iatrogenically by contaminated stainless steel. It is important that new methods are evaluated for effective removal of protein residues from surgical instruments. Here, radio-frequency (RF) gas-plasma treatment was investigated as a method of removing both the protein debris and TSE infectivity. Stainless-steel spheres contaminated with the 263K strain of scrapie and a variety of used surgical instruments, which had been cleaned by a hospital sterile-services department, were examined both before and after treatment by RF gas plasma, using scanning electron microscopy and energy-dispersive X-ray spectroscopic analysis. Transmission of scrapie from the contaminated spheres was examined in hamsters by the peripheral route of infection. RF gas-plasma treatment effectively removed residual organic residues on reprocessed surgical instruments and gross contamination both from orthopaedic blades and from the experimentally contaminated spheres. In vivo testing showed that RF gas-plasma treatment of scrapie-infected spheres eliminated transmission of infectivity. The infectivity of the TSE agent adsorbed on metal spheres could be removed effectively by gas-plasma cleaning with argon/oxygen mixtures. This treatment can effectively remove 'stubborn' residual contamination on surgical instruments.

Animals↗

Quality of surgical instruments.

INTRODUCTION: Many surgeons will have encountered the scissors that would not cut, and the artery clip that comes off in a deep difficult location, but it would be reasonable to assume that new instruments should be of assured quality. This study reports the surprising findings of a local quality control exercise for new instruments supplied to a single trust. MATERIALS AND METHODS: Between January 2004 and June 2004, all batches of new surgical instruments ordered by the Central Sterile Supplies Department of St Bartholomew's and the Royal London Hospitals were assessed by three clinical engineers, with reference to British Standards (BS) requirements. RESULTS: Of 4800 instruments examined, 15% had potential problems. These included 116 with machining burrs and debris in the teeth of the tissue-holding regions, 71 defects of ratcheted instruments, 34 scissors with deficient cutting action, and 35 tissue forceps protruding guide pins. In addition, 254 instruments did not have a visible manufacturer's mark. CONCLUSIONS: This study demonstrates the value of local quality control for surgical instruments. This is of importance in an increasingly hazard-conscious environment, where there are concerns over instrument sterilisation, surgical glove puncture and the potential for transmission of blood-borne and prion diseases.

Equipment Design↗

Incorrect vector after calibration of surgical instruments for image guidance. The problem and the solution: technical note.

Recently, the use of intra-operative image guidance has gained an increasing role in neurosurgery for both spinal and cerebral interventions. Some modern neuronavigation systems are able to register any surgical instrument and create a virtual pointer. A virtual elongation of the digitized instrument is frequently used for neuroendoscopic procedures and spinal instrumentation. The instrument is equipped with a universal instrument adapter clamp and digitized by touching the tip of the instrument into a calibration cone. An algorithm calculates the vector of the instrument using two points: the tip of the instrument, and the geometrical center of the instrument adapter geometry. If a virtual elongation of the calibrated instrument is performed, the neuronavigation software may calculate an incorrect virtual target point. We developed an instrument calibration matrix (ICM) that automatically calibrates the correct vector, tip, and diameter of the instrument used for image-guided surgery. The ICM is easy to handle and does not cause a time delay during surgery. Virtual elongation of the surgical instruments shows correct anatomic data, which are fundamental for planning ventricular tapping and spinal screw placement in particular. The instrument calibration matrix is essential if surgical instruments are digitized and used for neuronavigation. It helps to avoid mis-planning of surgical vectors and mis-placement of the used instruments.

Calibration↗

[Study of surgical instruments contamination by bacteria from air during the operation].

Routinely sterilized surgical instruments were divided into two groups and put on the same instrument table, one group was covered with dressing and the other was exposed to the air. The samples were collected at 30 min, 60 min, and 90 min respectively after operation began and bacterium culture was done. The results showed that the general air contamination rate of the exposed group was 1.18 times higher than that of the covered one. The exposure time had a positive correlation with bacterium contamination rate. This study gave the laboratory evidence for controlling the infection in the operation room.

Air Microbiology↗

Automated processing of endoscopic surgical instruments.

This paper deals with the requirements for automated processing of endoscopic surgical instruments. After a brief analysis of the current problems, solutions are discussed. Test-procedures have been developed to validate the automated processing, so that the cleaning results are guaranteed and reproducable. Also a device for testing and cleaning was designed together with Netzsch Newamatic and PCI, called TC-MIC, to automate processing and reduce manual work.

Automation↗

Laser reflections from surgical instruments.

The potential hazards to the eye and skin from accidental exposures caused by reflected laser beams from surgical instruments has long been of concern to operating room staff members. Reflectance values for argon neodymium:YAG and CO2 laser wave-lengths were measured from 29 reference surfaces used on surgical instruments. From these measurements, nominal hazard zones could be determined for typical reflection hazards.

Equipment Design↗

Rapid method for the sensitive detection of protein contamination on surgical instruments.

Hospital sterile service departments (SSDs) currently rely on simple visual confirmation of cleanliness as an assessment of the efficacy of cleaning surgical instruments. The inherent inability to monitor low levels of infectious or proteinaceous contamination on surgical instruments creates the possibility that highly dangerous and robust biological agents may remain infectious and undetected even after standard cleaning and sterilization procedures have been employed. This paper describes the development of a novel microscopy technique, episcopic differential interference contrast microscope, combined with the fluorescent reagent, SYPRO Ruby, to rapidly detect brain tissue protein to below 400 pg/mm(2) on an instrument surface. This technique has displayed a minimum level of detection observed by 50% of volunteers of 85 pg/mm(2) (95% confidence intervals 67-112 pg/mm(2)). Quantitative assessment of instruments supplied from various SSDs enabled the establishment of a 'contamination index' of both proteinaceous and non-proteinaceous deposits on the surface. This new methodology for the assessment of surface contamination is generally applicable and should facilitate future quantitative surveys of instrument contamination in hospitals and other healthcare environments.

Animals↗

Surgical instrument manufacturing in southern Germany.

Most of the finer surgical instruments are manufactured in a small town in southern Germany. The creation of these instruments follows a complex process that has evolved since the turn of the century. This article discusses the history of the town's instrument manufacturing and the process the craftsmen follow as observed by the author.

Germany↗

New sterilisation technologies--are they applicable for endoscopic surgical instruments?

It has been well established that instruments for minimally invasive surgery (MIS) must be treated like ordinary surgical instruments when they are intended for use within sterile areas of the human body. Due to the special design of most MIS instruments autoclaving (i.e. application of heat) may damage these delicate items. Therefore, low temperature sterilisation processes are essential. Gas sterilisation with ethylene oxide and formaldehyde may pose significant health hazards to workers exposed to these gases and to patients due to residues remaining on the surface of the instruments. Their general use in hospitals is more and more discouraged. However, with the advent of hydrogen peroxide gas plasma sterilisation there is a true alternative available for the sterilisation of MIS instruments. In contrast, the use of immersion sterilants such as liquid glutaraldehyde or peracetic acid cannot be considered as adequate because it is almost impossible to keep the processed instruments sterile until their intended use.

Endoscopes↗