Navigating the Challenges of the New AAMI ST108

The upcoming AAMI ST108: “Water for the processing of medical devices” is a giant leap forward from the TIR34:2014 document it replaces (see my previous post for a look at the differences). First and foremost, it is a standard, and will be an American National Standard (ANSI), not a technical information report (TIR), so you will have to follow it. Two of the provisions of ST108 that are somewhat new are the Water Management Team and the Water Management Program.

The intent of this article is to help you set up your team with an appropriate and useful membership and to set up a program that moves water quality issues closer to being “never” events.

The Water Management Team

This team is dedicated to ensuring that water quality issues get the attention they require, and on an ongoing and prospective basis (i.e., plan ahead; don’t react to a disaster). The team’s focus is defined by the standard as, “(a) multidisciplinary team responsible for water quality and the water management program…responsible for compliance with the physical environment as well as infection prevention and control accreditation standards…(and) should include representatives but is not limited to….”

The team membership was developed in the course of creating ST108 with the following reasoning:

  1. Senior organizational leadership/executive sponsorship: This implies the C-suite. Why? Who holds the purse strings? Who can decide if extraordinary measures must be taken?
  2. Facilities engineering staff: Why? Who is going to implement any needed changes in the water system?
  3. Infection prevention and control staff: Why? Who is going to evaluate the need for action based upon patient outcomes?
  4. Medical device processing personnel with knowledge of water use within the device processing areas (e.g., sterile processing): Why? Who knows the SPD world and how and where water is used in it best?
  5. Clinical engineering staff: Why? To ensure that the risk management issues present in any new equipment acquisition and procurement are addressed.
  6. Surgical suite/procedure room personnel: Why? To ensure that the final products—clean, sterile, stain-free instruments—are clean, sterile, and stain-free, and if they aren’t, to raise this issue in a prompt manner.
  7. Water treatment specialist: To provide technical guidance to the team as to what is available, what can or can’t be done, and what the available and appropriate technology is to respond to the problem at hand.

Okay, now we know who has the responsibilities. But what are they supposed to do?

Team responsibilities

The team is responsible for the following on a continual basis:

  • General assessment of water quality
  • Implementation of needed water treatment processes
  • Assurance of proper water quality for the various stages in medical device processing
  • Water program management

When, where, and how are all to be defined in the Water Management Program.

The Water Management Program

The team should meet regularly to ensure that things are still under control. But meetings without anything to discuss are a well-known waste of time. So, when do they meet?

  • When there’s a problem
  • When there’s data that can inform the team as to the state of control of the water system

Response to problems is an obvious time to meet. Having a dedicated team that has worked together to respond to problems as they occur enables an efficient response.

For the ongoing management of the water system, testing needs to be done. ST108 sets out a schedule for periodic monitoring of the water systems and provides information as to what should be monitored, based upon the likelihood of a problem situation resulting from an out-of-spec result and how critical a problem that result will be.

So, the ongoing management requires the following decisions to be made:

  • Where do we measure?
  • For what do we measure?
  • How often do we measure?
  • What are the acceptable limits for the items we measure?
Testing example

Since it’s best if you buy the standard to ensure that you have the whole picture in hand, and AAMI doesn’t like copyright violations, I am not going to answer all of those questions for all water types here. But, as an example, let’s look at part of the equation for monitoring critical water—your best friend for getting “stuff” off of the instruments before sterilization.

Critical water’s most obvious and meaningful telltale as to its suitability is conductivity. And since critical water is, well, critical to good processing, this should be monitored on a continuous basis. Most critical water systems (RO, DI) include a conductivity monitor that reads the conductivity on this frequency. If yours doesn’t, it should.

If the conductivity exceeds 10 microsiemens/cm, there should be an indication that things are heading in the wrong direction. But the indication can’t be hidden in a room where no one goes. This has to be where it can be seen and seen now! As someone who consults as a water treatment specialist, I recommend a visible and audible alarm be placed in the SPD, clearly labeled so that no one asks what that *%$* alarm is if or when it goes off.

Minimize risk

This is one example. It is an important one. Other testing is less frequent, but once an out-of-spec situation rears its ugly head, you need to test more frequently after the problem is solved to regain confidence in the water system. After all, it’s not like someone’s life is at stake. Oh. Sorry. Someone’s life is at stake and properly prepared water for processing is a very important piece of ensuring that these risks are kept to a minimum, at least as far as the SPD’s contribution is concerned.

Please contact me for further information. Together, the Water Management Team, Water Management Program, and each and every one of us involved in the SPD can make a big difference in patients’ outcomes and start to beat healthcare-acquired infections (HAI) and morbidity down to an acceptable level (a lot closer to zero than today’s level).

For more about ST108, read my previous post about filters and your water supply.