Surgical precision

In today’s healthcare market decontamination procedures are becoming increasingly important. The process of decontaminating instruments used during surgery or invasive procedures must now follow a set protocol, which is traceable and validated, thus enabling each set of instruments to be traced back through the reprocessing chain. Should surgeons return an instrument set due to contaminants still being present, the cleaning record can be easily checked to ensure it went through the correct channels of decontamination.

To make this process as manageable as possible many hospitals now have central reprocessing departments, known as CSSDs. Many such departments have been undergoing an upgrade process to bring them up to ISO9000 standards.

At a key hospital in Wales, this upgrade project commenced in 2001 and involved a complete refit of the CSSD department with new equipment to make 90% of the cleaning process automated and traceable. This refit raised the sterilisation department to BS EN ISO Class 8 cleanroom standard.

A QA manager was brought in to oversee the project from the outset to ensure that the transition from old to new methods of instrument decontamination ran smoothly. The QA manager’s primary responsibility is to ensure that ISO standards are met on a daily basis and that any incidents thatresult in substandard instrument reprocessing are rectified as quickly as possible and the cause of the problem established and resolved.

One reason why validated reprocessing has grown in importance is the emergence of diseases that are transmitted within hospital environments. The vCJD scare caused initial concerns, but more recent, outbreaks of methicillin-resistant Staphylococcus aureus (MRSA) have led to implementation of a much stricter process.

As there are only a minimal number of vCJD cases reported each year, worries now focus on MRSA. The infection can be carried by anyone without their knowledge and without the display of any symptoms, and is easily spread in a hospital environment. Cleanliness is, therefore, crucial where instrument reprocessing is concerned and keeping human contact to a minimum is also important to reduce the risk of such cross infection occurring.

In the Welsh hospital, a report is produced by the infection control team each month, which is then passed on to the infection control committee and thereafter handed to the Welsh Assembly government to ensure the desired standards are being maintained.

The QA manager outlined the structure of the CSSD team at the Welsh hospital. “We have a dedicated team of 23 working within our department. I look after all QA aspects while the CSSD manger oversees the reprocessing procedures. We then have a clerical assistant to carry out other office-based tasks. There are three CSSD supervisors who deal with staff rotas and delegating jobs to those working within the dirty room, cleanroom and sterilisation room. We currently have 17 staff working to reprocess the instruments throughout the day, each being set specific tasks on a daily basis.”

Prior to the upgrade, the cleaning processes within the CSSD involved giving items a short manual clean before placing them in a tunnel washer. After washing they were removed from the tunnel washer in the cleanroom and were packaged up, ready for transfer into the autoclaves for the final sterilisation procedure. This was not an ideal set-up as, although the tunnel washer would provide the same cleaning time for each instrument set, the manual cleaning process meant some instruments could be cleaned less thoroughly than others.

No validation

“At this time there were no dedicated washer disinfector units or ultrasonic cleaners within the CSSD. This meant there was no validation occurring, which made it extremely difficult to trace the instrument set back to the staff member who carried out the cleaning procedure, if the set required a repeat clean. The only automated process within the cleanroom was that of instrument sterilisation. However, if items weren’t completely clean when entering this stage they would be leaving the department at an unacceptable level cleanliness, which ultimately created more work, as they required re-cleaning.

“The upgrade project has resulted in us having a state-of-the-art cleanroom where such incidents are few and far between.”

At present there are five washer disinfectors and a Hygea 5000 carrying out the instrument cleaning within the CSSD. Manual cleaning is still carried out but only where instrument manufacturers specify a manual cleaning process is necessary.

A high percentage of decontamination procedures within the cleanroom are achieved through the washer disinfectors but certain items cannot be cleaned effectively using this method. Rigid scopes and hollow lumens posed particular problems for the washer disinfector units as they have the ability to clean items only by subjecting them to a spray cleaning action.

The Hygea 5000 was designed for this purpose and carries out all the scope cleaning in this busy cleanroom. The ultrasonic cleaner is also used to clean a number of other items by placing them into the basket. These include orthopaedic items that are too intricate to be cleaned by hand and have areas into which a washer disinfector cannot penetrate.

Fully automated process

The hospital uses the Hygea to reprocess all its hollow lumen instruments because it produces far better cleaning than is possible by using a washer disinfector. The connectable ports within the Hygea mean the internal channels of the instruments are cleaned and flushed very thoroughly during the short 15min cycle. The fully automated process provides a traceable report for every instrument set, which is then stored on the hospital’s tracking system.

The QA manager explained: “All the instruments that pass through the Hygea still have to go through the washer disinfectors prior to the sterilisation, but since we have begun using the ultrasonic cleaner we haven’t had a single scope returned to us for re-cleaning. This was a problem that we suffered before as many of the scopes are simply too small to get a brush down when manually cleaning them. The unit has made a huge difference to our pre-cleaning process and it would not be unrealistic to say that it has reduced our manual cleaning by as much as 90%. Its ability to clean on a microscopic level means we can use it for other items that can be difficult to clean.”

Although ultrasonics have made a significant difference to the reprocessing of these items, they are still required to go though the washer disinfectors. Surgical instruments are required to be cleaned at no higher than 35°C to avoid any proteins becoming baked onto the item, while the temperature required to carry out a thermal disinfection process is much higher at around 80°C. For this reason hospital clearooms are being encouraged to incorporate both ultrasonic cleaning and washer disinfectors.

The complete decontamination process for a set of scopes normally takes in the region of 75 mins before it enters the cleanroom. But running items through the Hygea has not meant reduced cycle times in the washer disinfectors, said the QA manager. “We still run the full 15min cycle for scopes and then they have to go through a full 1hr cycle. This is primarily due to the long drying time of 20 mins which is needed to ensure all traces of liquid are removed from the items before they emerge into the cleanroom to be packed.”

So why use an ultrasonic cleaner at all? The benefits are better cleaning quality, leading to improved efficiencies in the long-term, according to the QA manager. “Ultrasonic cleaning is by far the better cleaning process because it has the ability to clean on a microscopic level. Being able to clean items on such a small scale means that ultrasonic cleaning is now a vital part of our process. Trying to compare a spray wash cycle is basically a ‘no contest’. They are simply too far apart.

“Although purchasing an ultrasonic cleaner brought with it the initial purchasing cost and also the running costs I believe it has saved us money – not in terms of labour costs or running costs, but in terms of potential litigation. Since using the Hygea we have not received a single scope back from any department within the hospital. When we used a manual cleaning process we used to have a number of scopes back with contamination still lodged in the internal channel. This could have been potentially disastrous and may have resulted in cross contamination between patients.

“So, although the cost-saving may not be a direct one, I believe that by eradicating the possibility of this happening it has saved us what could have potentially been huge sums of money.”

The implementation of CSSD departments throughout the UK is increasing as more hospitals are refitted. Many small surgeries in surrounding areas are being encouraged to send instruments to hospital cleanrooms to be reprocessed as the standards achieved in such an environment are so high.

When asked how instrument reprocessing and cleanroom technology will develop over the next decade, the QA manager’s answer was somewhat unexpected: “The main drivers for the processes used within medical cleanrooms are likely to stay the same. The standards we now have are strict enough to keep the risk of infections spreading or cross contamination to an acceptable level – if there is such a thing aside from zero cases.

“The key drivers will be the medical device manufacturers and instrument manu-facturers. Single use items are being promoted but many of these aren’t yet substantial enough to carry out certain procedures. In my opinion the only other areas where things will develop are the chemicals used within the ultrasonic cleaners and washer disinfectors.

Cutting edge

“There will obviously be developments in terms of the software and technology within the units, and touch screens look set to be the industry standard inside the next few years along with the process of traceability. We already have a cutting edge system here, whereby our units are connected a system called the Health Edge Tracker. All the items that come into the cleanroom are barcoded. Upon entry they are scanned into the system and the information is then stored onto the server, meaning there is an instant record of exactly what cleaning process each set has gone through. This includes the operator who carried out the processes making things easily accountable.”

With systems like this becoming ever more important within the hospital cleanroom environment, decontamination levels look set to improve.