Aesculap Surgical Instruments

Transcription

1 Aesculap Surgical Instruments Think Aesculap. Reprocessing, Care and Maintenance of Aesculap Surgical Instruments. General Reprocessing Rules of Surgical Instruments

2 General rules for reprocessing of medical products Reprocessing of medical products Cleaning, disinfection and sterilization of medical products must be carried out in compliance with the manufacturers specifications according to DIN / EN / ISO 17664, using appropriate processes in such a way that the success of these processes is demonstrably ensured and the health and safety of patients, users and third parties is not endangered. (German Medical Device Operator Ordinance 4 para. 2) During the reprocessing of medical products, such structural and functional features that are essential for the safety and functionality of the product must be inspected and tested. Only instruments which are in perfect working order may be put to use. Instrument Cycle Storage Sterilization Setup Use Disposal wet/dry Procurement of new products/ repairs Disinfection Cleaning Packaging Discard/repair Visual inspection/ care/function test 3

3 General rules Visual check for cleaness and damages Visual inspection/result following each manual cleaning/disinfection and drying process Visual check for cleanliness Meaning the absence of blood, protein and other residues or debris. Checked visually macroscopic or with a magnifying glass. Recommended: Workbench/laboratory light with magnifying lens of 3-6 diopters. Areas to be checked with a special care are: grooves, serrations and joints; check all lumens, tubular shafts and sheaths for patency. Result: Instruments must be clean, i.e. free of visible residues Recommended treatment methods to remove tough residues: Residues Blood/protein residues Skin, bone residues Fats Adhesives Bone cement e.g. Palacos Treatment method/recommended agents approx. 5 minutes in 3%-hydrogen peroxide solution (H 2 O 2 ). Repeated manual reprocessing/ultrasound treatment. Use of a steam cleaning device. Repeated manual reprocessing/ultrasound treatment. Alcohol. Benzine, ether. Disposal of instruments and other products (small dishes and trays, drills etc.), because the removal of such residues is difficult and likely to damage the products. IMPORTANT GUIDELINE: Effective disinfection and sterilization can only be ensured if the instruments are visually clean. Sterilisation does not replace cleaning Visual check for damage: e.g. cracks, breakage, deformations, signs of wear and tear, fatigue and aging Delicate and fine instruments should always be checked under a magnifying glass. Visual inspection for surface changes, e.g. discoloration and corrosion, damaged chrome or nickel plating. IMPORTANT GUIDELINE: Sort out defective instruments, or have them repaired by the manufacturer. 5

4 General rules Function test Function test following each cleaning/disinfection and drying process. Check for cleanliness prior to sterilization Cool down Following mechanical reprocessing, let instruments cool down to room temperature to avoid the risk of metal abrasion witch could lead to friction corrosion damage. Maintenance and care Lubricate joints, threads and other gliding surfaces and assemble instruments prior to any function check. Instruments with joints and gliding surface must operate smoothly. Function test Function tests must be arranged so that instruments that have become unsuitable for their intended use, e.g. due to wear or damage, are discarded consistently. If in doubt, consult with the instrument manufacturer about appropriate test methods. Test materials for function tests Important note: Manufacturers instructions on the use of test materials must be followed under all circumstances! The test materials specified by Aesculap comply with DIN / EN / ISO requirements, as far as the latter can be applied to Aesculap products, or they are defined specifically for these products by Aesculap. If comparable competitors products are used, the person in charge of the test must take into account that s/he is dealing with manufacturer-specific test materials and that any test results, positive or negative, are not transferable. User (surgeon) feedback concerning the actual operational properties of the instruments should always be taken into account, since the properties of human tissue are different from those of artificial test materials. The responsibility for the test result always lies with the person instructed by the hospital to carry out the function test. 7

5 General rules Maintenance and care Maintenance and care Maintenance or care means targeted application of instrument oil to the joints, hinges, locks threads or friction surfaces of instruments such as clamps, scissors or punches, after they have been carefully cleaned and disinfected. Always before the function test: Allow instruments to cool down to room temperature to avoid the risk of metal abrasion, to prevent damage through fretting corrosion. Manually apply lubricant (e.g. Sterilit JG 600, JG 598) to the joint surface only. Repeated opening and closing of the instrument will ensure that the lubricant is evenly spread through the joint. Aim: Avoiding to high friction between metal surfaces; Preventing fretting corrosion. Demands on lubricants for stainless steel instruments Basic agent: Paraffin oil /white oil. Must comply with the relevant pharmacopoeia. Must be steam-penetrable / sterilizable / tissue-compatible. Using silicon oils for stainless steel is not recommended because joints get covered in resinous silicon. This can result in a stiffness of the joint. Caution: Do not use paraffin oils / white oils on rubber or latex products. Leads of swelling of surfaces and effects the machanical properties. Silicon oil or oil spray is recommended. 9

6 Surgical Instruments Design characteristics Intended use Practical tips for visual inspection Care and maintenance Function tests 1. Scissors 2. Dissecting forceps 3. Atraumatic Clamps 4. Needleholders 5. Bone rongeurs and bone cutting forceps 6. Bone punches 11

7 Scissors Construction details and intended use of scissors with and without tungsten carbide insert Severing of tissues, vessels, bone, organs, dressings and other auxiliary medical materials. Intended use of dissecting scissors Cutting, e.g. for tissues and vessels. Also allows blunt dissection, e.g. by forcing apart muscle and fascia, using the blunt outer part of the scissors blade. Construction details Blade tips blunt/blunt Cutting edges with inserted tungsten carbide cutting edges Blades curved on flat Blade ridge Shank Gold-plated rings indicates: Tungsten carbide inserts Lexer scissors curved BC283R 13

8 Scissors Visual inspection for cleanliness and damage. Recommendations for further treatment of the product. Organic residues in the joint area and on the surface. Repeated cleaning of the instruments. Bent or broken tips. Broken-off fragments or nicks in the tungsten carbide inserts. Metal abrasion in the joints. Corrosion, e.g. pittings, stress crack or friction corrosion. 15

9 Dissecting forceps Construction details and intended use of dissecting forceps Instruments for grasping, holding onto and holding off tissue, vessels, bones, organs and medical material Non-toothed dissecting forceps, cross or longitudinal serrated are used for gentle grasping and holding tissue Tissue forceps/toothed dissecting forceps with teeth allow the tissue to be held securely but may cause damages on vessels. Non-traumatic forceps allow tissue-preserving and safe grasping and holding, due to special, atraumatic jaw surfaces, e.g. De Bakey serration; predominantly used in cardiovascular surgery. In some cases used for haemostasis: The blood vessels are grasped and then coagulated by applying an active high-frequency electrode to the forceps Construction details Straight, rounded jaws Surfaces grooved across Neck Handle Mirror Spring Forceps link Non-toothed dissecting forceps BD047R 21

10 Dissecting forceps Visual inspection for cleanliness and damage. Recommendations for further treatment of the product. Organic residues in jaw and gap regions as well as on the surface. Repeated cleaning of the instruments. Bent tips and guide pins. Worn, broken grasping surfaces. Bent springs. Corrosion: pitting, stress or crevice corrosion. 23

11 Dissecting forceps Function test of non-toothed and atraumatic dissecting forceps Result: Forceps with grooved jaws, atraumatic De Bakey serration or tungsten carbide inserts close in a springable movement starting at the tip. Grooves/serrations or pyramid tips engage when the forceps are closed. The grasping surfaces are in firm contact with each other. They must not be worn, damaged or bent. The jaw tips must not open or shift laterally when the forceps are closed. 25

12 Dissecting forceps Function test of toothed dissecting forceps Result: Mouse-toothed forceps engage when being closed. Mouse teeth must all be intact and must not jam. The teeth must be sharp, on both sides equally sized and symmetrical. Construction details Jaw 1 x 2 teeth Neck Handle Mirror Spring Forceps link Dissecting forceps with teeth BD557R 27

13 Dissecting forceps Function tests of dissecting forceps The guide pin keeps the jaw parts from shifting laterally, it must not be bent. A The guide pin must slide centrally into the guide hole. When closing or opening the forceps, the guide pin must not jam or rub. B The spring must not be bent because this could affect the distance between the jaw parts. It could also change the spring force/closing pressure of the forceps. C The distance between the jaws is defined by Aesculap standards, depending on the size of the forceps. According to Aesculap standards, the spring force is measured in units of 1 newton and related to the form and length of the respective forceps. The spring can be deformed if the forceps are pushed closed during the packing process. - Impaired functionality Aesculap Technical Service. A C 29

14 Vascular clamps Construction details and intended use of atraumatic vascular clamps Allow tissue-preserving, safe closure, grasping and holding of vessels and tissue without trauma or injury. Serrations: De Bakey 1 : 2 tooth rows De Bakey 2 : 3 tooth rows Cooley 2 : 2 tooth rows Construction details Angled jaws (Satinsky curve, De Bakey serration) Olive Box look Shank Ratchet Rings De Bakey/Satinsky clamp FB506R 31

15 Vascular clamps Visual inspection for cleanliness and damage. Recommendations for further treatment of the product. Organic residues in the atraumatic serration, in joints, on the instrument surface. Repeated cleaning of the instruments. Bent jaws, ratchets, shanks. Damaged serration. Corrosion: Pittings, stress crack, friction corrosion. 33

16 Vascular clamps Function test of atraumatic clamps Jaws close spring-like, beginning at the jaw tip, over the entire serration profile while the ratchet is pushed together to the last click. Jaws cover each other completely. Ratchet must be in alignment when closed completely. Serrations must engage with each other completely. Testing atraumatic properties Test material by Aesculap Standard: single-layer tissue paper. Result: Jaw serrations must leave complete teeth impressions when the instrument is closed, but must not perforate the tissue paper. If the jaws do not leave a complete impression, the clamp is not closing properly (positioning defect at the jaw). Please send Instruments with a defective atraumatic serration and instruments with a positioning defect at the jaws to the Aesculap Technical Service for repair. 35

17 Needle holders BM010R smooth BM011R 0.2 mm Construction details and intended use of needle holders with and without tungsten carbide inserts Instruments to hold and guide surgical needles. Intended to hold the needle so that it cannot slip or tilt, and to ensure a secure grip in guiding the needle. Needle holders without tungsten carbide inserts are usually cross-serrated, with or without longitudinal groove. The form size of the needle holder and the profile size of the tungsten carbide inserts, which are adjusted to the indication-related suture material, are determined by the intended application. Surface profile variants of tungsten carbide inserts smooth tip for needles on suture material 9/0-11/0 0.2 mm pitch of serration for needles on suture material 6/0-10/0 0.4 mm pitch of serration for needles on suture material 4/0-6/0 0.5 mm pitch of serration for needles on suture material up to 3/0 More details please find in the Aesculap General catalogue. BM035R 0.4 mm Construction details Jaw with tungsten carbide inserts Box lock BM066R 0.5 mm Shank Ratchet Mayo-Hegar needle holder BM067R Gold-plated rings indicates: Tungsten carbide inserts 37

18 Needle holders Visual inspection for cleanliness and damage. Recommendations for further treatment of the product. Organic residues in jaws, joints and ratchet and on the surface. Repeated cleaning of the instruments. Worn gripping surface profiles. Cracks in the tungsten carbide inserts and/or gripping surface and in the joint. Bent shanks. Defective ratchet. Corrosion: Pitting, stress crack or friction corrosion. 39

19 Needle holders Function test of needle holders with or without tungsten carbide inserts. Jaws should come together at the tips without having to apply closing pressure. With increasing pressure, jaws should close without leaving any gap throughout the gripping area. The grooves/serrations or pyramid tips of the tungsten carbide inserts engage with each other when the instrument is being closed. Ratchet must cover each other when the instrument is closed completely. Checking function (action, set, tension) The two halves of the ratchet are aligned as the jaw tips touch Any serrations must fully engage with each other when the instrument is closed completely. Checking function (action, set, tension) With the ratchet on the last tooth the jaw is closed along at least 2 ¼3 of its length Checking function (action, set, tension) Here the jaw tip is open when the ratchet is closed on the last tooth. A case for the 41

20 Bone rongeurs and bone cutting forceps Construction details and intended use of bone rongeurs and bone cutting forceps Nibbling of bone and cartilage in neuro and spine surgery Removal of bone chips and cartilage Cutting of small bones Rounding and smoothing of fractured bones Construction details Jaw Jaw surface Double action joint Dual spring Shanks Screws Bone rongeur FO514R Liston Bone cutting forceps FO620R 43

21 Bone rongeurs and bone cutting forceps Visual inspection for cleanliness and damage. Recommendations for further treatment of the product. Organic residues in the jaw, joint and spring area and on the surfaces. Repeated cleaning of the instruments. Luer Notches in the jaw region; blunt cutting edges. Edges do not engage parallel (risk of tissue contusion). Loose screws at the joint and at the spring area. Defective joints (e.g. loose joints; cracks). Bent spring. Corrosion: Pitting or stress crack corrosion. Liston 45

22 Bone rongeurs and bone cutting forceps Function test of bone rongeurs and bone cutting forceps The jaws must be of equal size and symmetry. The screws at the joint and spring area must be tight and must not come loose when the instrument is used. The spring must not be damaged. The joint must not be taken apart - risk of screws coming loose during use Testing cutting performance (DIN Part 4): Test material DIN: index cardboard 250 g/m 2. Cutting test DIN: 1/3 of the cutting edges of the bone rongeur and bone cutting forceps must cut the test material. Three cuts have to be performed in the test. Test material Aesculap Standard: index cardboard g/m 2 Cutting test Aesculap Standard: 2/3 of the cutting edges of the bone rongeur and bone cutting forceps must cut the test material. Three cuts have to be performed in the test. Result: The test material must be cut through smoothly and without tearing. The cutting edges must not miss out at any stage of the cut. Construction details Jaw Jaw surface Box lock Dual spring Shanks Screws Luer FO463R 47

23 Kerrison bone punches Construction details and intended use of Kerrison bone punches Nibbling of cartilage and tissue in neuro, spine, maxillo-facial surgery. The footplate of the punch is designed for different cutting angles ( ) for cutting upward or downward. Construction details Sliding part Footplate Shank Handle body Screw Mountable part (movable part of handle) Dual spring Kerrison punch FG823R Upward cutting Guide flute Sliding part Footplate

24 Kerrison bone punches Visual inspection for cleanliness and damage. Recommendations for further treatment of the product. Organic residues in the footplate and the sliding part, in the guide flute, handle and spring. Repeated cleaning of the instruments. Bent footplate. Worn cutting edges on the footplate and the sliding part. Nicks on the cutting edges. Defective springs. Loose screws. Corrosion: Pittings and stress crack corrosion. 51

25 Kerrison bone punches Function test of Kerrison bone punches Test criteria: The footplate must not be bent upward or downward. The sliding part and footplate must not be deformed at the cutting edge. When assembling the punch, the sliding part must slide neatly in the guide flute. During the process of cutting, the sliding part must not be pressed out too far from the shank. The guide mechanism, which consists of the handle body and the sliding part, must not show too much slackness. The screws must be tight and must not slacken when the instrument is being used. The springs must not be damaged. Testing the cutting performance: Test material Aesculap Standard: Index cardboard ( g/m 2 ) Result: 2/3 of the cutting edge must cut the test material. The test material must be punched through smoothly and without tearing. The test material must be completely removed from the pusher of the bone punch 53

26 Chisels, osteotomes and gouges Intended use of chisels, osteotomes and gouges To cut through bone or remove portions of bone. Design Lambotte osteotome FL650R Shape of cutting edge Stille chisel FL503R Stille gouge FL573R 55

27 Chisels, osteotomes and gouges Visual inspection for cleanliness and damage. Recommendations for further treatment of the product. Organic residues on the surface. Repeated cleaning of the instruments. Notches on the cutting edge. Worn cutting edge. Pitting corrosion. Function test on chisels, osteotomes and gouges Testing cutting ability Test material DIN standard: synthetic, POM-C or Teflon hardness. Test material Aesculap standard: plexiglas rod (article no. DB086). Result The cutting edge of the chisel must be applied to the plexiglas rod with slight pressure at an angle of approx. 45. The cutting edge must attack the rod cleanly. The cutting edge must not slide over the plexiglas. Repeat the shaving test in several places on the plexiglas rod. Test the entire cutting surface of the chisel. 57