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New generation instruments reprocessing challenges

Discover the challenges, IFUs, skilled manpower, and role of surgical instrument reprocessing in modern healthcare settings.

Advancement in technology has created new and more sophisticated surgical instruments. These instruments are very complex in their anatomy and made not only from stainless steel but also combined with nylon, Teflon, silicon, fiber, tungsten carbide, glass, and fiber optics etc.  Thus, surgical instruments have evolved into more complex ones, creating more challenges in reprocessing. So, the work of the CSSD has now become a complex operation.

In olden days, commonly used surgical instruments were mostly made up of stainless steel. But today’s new generation instruments are made up of 316L grade stainless steel which is corrosion resistant and withstands the sterilization process. Added materials increase the strength, durability, stiffness or malleability where necessary. Also it needs to be light weight. New types of plastics and polymers used in these instruments enhance shape retention properties at the same time withstanding high heat and radiation, allowing for effective device sterilization.

The introduction of an entirely new breed of surgical instrumentation of different materials as stated above are combined and used in various instruments for better result. Following are the few examples.

  1. Tungsten carbide inserts are used in cutting and holding instruments like scissors and needle holders.
  2. Cutting blades of some instruments are made of high carbon steel, which are disposable/ single use and these can honed to a high level of sharpness, and do not become dull during the sterilization process.  You can fit many types of blades to same handle and dispose it after use. For e.g., B.P. handle’s blade (surgical blade), skin grafting knife handle’s blade etc.
  3. Holding parts of some instruments are made from nylon or Teflon to avoid scratches on implants while implanting for e.g., DHS impactor, Nylon head Impactor.
  4. Some of them are radiolucent for e.g., radiolucent drive, where only ring is made of stainless steel & other whole body is made from radiolucent material to guide surgeon while drilling in nailing surgery.
  5. Power and cautery equipment are assembled with electric, battery or electronic circuit.
  6. Some of them are having brake wire or clutch wire for tightening purpose for e.g., Leyla retractor, Octopus etc.
  7. MIS instruments  have insulation on their outer surface to make them a bad conductor of electricity which avoids burning of internal tissue or body part for e.g., laparoscopy instruments.
  8. Handles of some instruments are made up of fibre to make it lighter and better grip for e.g., mallets, osteotomes, chisel etc.
  9. Diamond blades are used in sharp cutting knives to fine cut micro blood vessels for e.g., ophthalmic and CVTS diamond knife.
  10. Fiber Optic use in light source cables and scopes in MIS surgeries.

As technology advances the complexity of the instrument advances as well.  The surgeon demands new generation instruments with advance features for better outcome from surgical procedures.

These new breeds of instruments are costly and we cannot afford to have multiple numbers in the set. In the earlier open surgical technique, if any instrument did not work, the surgeon managed with a substitute instrument but in today’s advance surgeries it is not possible. Surgeon needs specific instruments. These instruments are unique and play a major role in surgeries. If these key instruments do not function properly then there is a chance of a spoilt surgery or patient injuries.

Advanced surgical instruments are good for the surgeon but create challenges in reprocessing.  Surgical techniques continually evolve and surgical instrument have kept pace with the age of technology. There is a constant pressure to speed up the entire process of reprocessing and minimize the amount of turnaround time.  This requires highly trained and innovative CSSD professionals who are able to deal with this complex technology and processes on a day to day scale.
CSSD staff should be made aware about IFU (Instruction For Use), do’s and don’ts of each and every instrument while reprocessing.  If IFU of these instruments are not followed then it may hazardous for patient, instrument or surgeon. 

Reprocessing of medical devices sounds like a simple process, but unfortunately there are many things that can happen which end in a device that has not been adequately cleaned and therefore cannot be disinfected or sterilized. In some cases, it has been documented that the IFU for cleaning was not followed, causing a device to not be sterilized, and resulting in a healthcare associated infection (HAI). In other cases, there are issues with following the IFU. Problems with cleaning and sterilization of medical devices include: 

  • The IFU is difficult to understand and follow,
  • The IFU is incomplete,
  • The person performing the cleaning process was not adequately trained,
  • The person performing the cleaning process did not follow the process.

IFUs for virtually identical medical devices made by different companies can be very different which makes it difficult for reprocessing personnel to remember how to process a particular device. Human factors need to be considered by manufacturer while designing these reprocessible instruments.  

With today’s technological advancement in the equipment, users may imagine that instruments can be quickly reprocessed and are then sent back to them. However, this is far from the actual process because the reprocessing of advanced surgical instruments is a time consuming job. 
Also, unfortunately some devices have been designed in a way that it is not possible to dismantle them for e.g. some Kerrison punches, laparoscopic instruments and others, without considering how the device would be reprocessed, disinfected and / or sterilized after it is used.  

To check functionality of these instruments we need different devices and artificial material with equivalent properties to tissue, artery/vein, bone, skin, etc. We need an insulation testing device to check insulation of laparoscopy instruments. We also need magnifying lighted lens for inspection. To protect these delicate, sharp and costly instruments we need ideal trays with silicon holders and tip protectors. Some times the management purchases instruments of well-known brands but due to cost cutting does not purchase ideal trays, thus facing the problem of damage of costly instruments. 

Decontamination, cleaning, assembly, packing, sterilization, storage, handling, transport, aseptic opening and presentation of instruments are critical doors through which these complex instruments must pass before use. Most of the multispecialty hospitals  have  advanced sterilizers and other instrument reprocessing equipment. However, they do not recruit skilled manpower. One should understand that skilled manpower is equally important for reprocessing.
Surgical instrument repair and servicing play a vital role in maintaining the quality and functionality of these advanced devices. Surgical instrument repair specialists are highly-trained professionals who undergo continuous education to keep in touch with the latest technologies. 
The difficulty in cleaning is compounded in middle and low income countries where automated cleaning infrastructure at CSSD is often unavailable and thus manual cleaning only is performed. There are chances of biofilm formation in these complex design surgical instruments if not cleaned properly.

Another challenge is loaner instruments. Most of the time these loaner instruments are received just in time and need immediate processing. To reprocess these devices, we need high temperature steam sterilization as well as low temperature sterilization facility in your health care center. Remember no matter how talented the surgeon, surgery cannot be performed without properly cleaned, assembled, tested and functional sterile instruments.

Sadashiv Gaonkar
Sr. Manager - CSSD, Saifee Hospital, Mumbai | + posts
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