We wanted to talk a little about the Steris System 1E. We'll be covering the basics on how it works and what things you should consider when choosing a company to handle your Steris System 1E PM (preventative maintenance).

The Steris System 1E is used for high-level disinfection of medical instruments. It's obviously manufactured by Steris and has been an extremely popular unit. The Steris Corporation has been specializing in infection prevention and sterilization solutions in the healthcare industry for years now and clearly have a good handle on producing high quality medical devices.

The Steris System 1E is designed to disinfect heat sensitive and moisture sensitive medical equipment. I.e. Medical equipment that cannot withstand traditional autoclave sterilization. Just so we've covered everything, autoclave sterilization is a widely used method of achieving complete sterilization in the medical industry that involves using high temperature and pressure to kill or inactivate microorganisms. 

The Steris System 1E instead employs a process called "low-temperature sterilization" or "high-level disinfection," which is critical for devices like endoscopes, bronchoscopes and other medical devices that cannot be heat sterilized.

The following is not a tutorial. But we wanted to go over the basic steps of using the System 1E so that you fully understand how the system is used so that you can better understand what might be necessary when it comes to the preventative maintenance requirements. Please reference the manufacturer's specific instructions for actual use. 

1. Preparation | The medical instruments you're wanting to sterilize should be manually cleaned and prepared for disinfection. All visible debris, fluids or contaminants should be removed prior to the disinfection process.
   
   
2. Loading | The cleaned medical instruments are placed in the System 1E chamber. Then the connectors and adapters are attached to ensure proper circulation of the disinfection solution.
   
   
3. Chemical Injection | The high-level disinfection solution is injected into the chamber and the chamber is sealed.
   
   
4. Exposure | The medical instruments are then exposed to the disinfection solutions for a specified amount of time. The chemical properties of the solution then go to work eliminating pathogens and microorganisms.
   
   
5. Neutralization and Aeration | On completion of the exposure, the solution is neutralized. The chamber can then be aerated removing residual fumes of the chemicals. This step is vital to the safety of your employee(s).
   
   
6. Completion | After aeration is complete, the medical instruments can be removed and put back into service.

Specific training and maintenance are both required to use the Steris System 1E. Please follow the manufacturer's complete guidelines to ensure proper disinfection of the medical instruments used in your practice.

Maintenance

Maintenance is crucial with any medical device. The System 1E is no different in this respect. Keeping your System 1E properly maintained is the only way to ensure its proper function, reliability and safety. The guidelines below are not meant to replace the manufacturer's own, but only give you a quick peek into some of the basic guidelines. For a full and up-to-date understanding please refer to the manufacturer's specific guidelines when using your device.

Regular Inspections | Please create a schedule for all routine inspections of the System 1E. At each inspection any signs of damage, wear or corrosion should be noted and corrected. Additionally, all seals, gaskets and other components should be inspected making sure they are in good working order.

Calibrations | Check the calibrations that are necessary for your unit. If calibrations are necessary, please do so according to the manufacturer's own guidelines to ensure proper operation.

Cleaning | The manufacturer outlines what external surfaces need to be cleaned, how they should be cleaned and how often. Please adhere to this schedule, how it should be done and use approved cleaning agents.

Fluid | The quality of the disinfection solution used should be regularly monitored. Maintaining the chemical concentrations and changing solution cartridges as needed.

Filters and Consumables |The manufacturer outlines a recommended schedule of replacement for the filters and consumables used on the System 1E. Please follow this schedule to maintain the quality of the disinfection process. 

Aeration System | The aeration system must be checked making sure that the residual disinfection chemicals are completely removed prior to the use of any disinfected instruments to ensure the safety of your patients.

Software | If your System 1E has software components, you'll want to make sure that you have the latest software updates to maintain compliance with relevant standards and guidelines.

Documentation | All maintenance records should be properly maintained for services to your device. Make sure to include all inspections, calibrations or repairs along with any other service items. 

Training | Proper training is critical. It's imperative that you provide proper training to your staff who will be using or maintaining your Steris 1E. Documenting the training you provided may also prove to be a best practice. 

Manufacturer Guidelines |Always follow the manufacturer's guidelines for use, maintenance schedules and all maintenance performed.

Preventative Maintenance Choices

When selecting any company to provide maintenance services for any medical device including the Steris System 1E, you should always look for a reputable and qualified maintenance service provider. The time spent going through reviews, seeking references and researching the reputation of preventative maintenance service providers will pay off. It may even improve the safety and functionality of the System 1E as reputable preventative maintenance providers may help you keep the device in full compliance with the manufacturer's guidelines.

The experience and expertise of maintenance companies come into play as well. Companies that specialize in medical equipment maintenance, especially with disinfection and sterilization equipment may be best suited to handle your maintenance. The more experience they have, the more likely the service technicians will fully understand the nuances of issues that might arise with your devices.

You also may want to ask about their certifications and training. A properly trained and certified maintenance and repair technician may come at a little higher price, but typically they will work much more efficiently bringing your System 1E back into service more quickly which may cover the higher costs, if any and keep your practices patient schedule on track. Compliance with regulatory bodies like the FDA or similar agencies is also typically a benefit of using properly trained and certified technicians.

6 More questions to ask a medical device maintenance service provider:

1.  What quality control processes do you have in place?
   
   
2. What is your availability with regards to Steris parts & filters replacement?
   
   
3. What is your response time?
   
   
4. Do you provide full documentation of the maintenance services provided for regulatory compliance?
   
   
5. Can you provide a complete estimate whereas there are no unexpected charges?
   
   
6. Can you verify your insurance coverage?

You may consider asking for an initial consultation or site visit so you can solidify your decision based on personal interface. This gives you the chance to ask all of these questions in person and not only get answers, but see the reactions and their comfort level with each.

If you take your time and do the research, your choice of a maintenance service provider may prove to be a long-lasting relationship that will maintain the safety and effectiveness for your patients and staff.