Think of your loved ones

The most expedient policy covering validation of the twin components of sterile processing procedures – cleaning and disinfection/sterilization – calls for good parenting skills.

Actions lead to consequences.

When an auto racer fails to follow the rules and commits an error on the track – accidentally or flagrantly – he or she earns a black flag. That driver then must leave the track, regardless of position, return to his or her pit, bring the car to a complete stop and then return to the track. The risk? The driver may lose hard-earned positioning and be taken out of contention for the win. But that’s the price you pay for violating a rule.

Within the last few weeks, we’ve spotted several news reports shining a spotlight on breakdowns in the sterile processing field.

For one article, a reporter and her editor questioned whether bioburden left on a surgical instrument after the cleaning process poses any problems once the instrument exits the sterilization process. Certified, experienced and forward-thinking sterile processing experts know the answer.

In another article, a hospital failed to notify patients that contaminated duodenoscopes were used on them, leading to post-operative infections. Furthermore, the hospital failed to follow proper cleaning guidelines. To wit: They used canned compressed air from an office supply store to dry scopes.

In yet another article, the FDA issued mixed messages about a prominent manufacturer of automated washers, originally ordering a recall based on questions about the equipment’s effectiveness and how it handles duodenoscopes, but then backpedaling from that recall to allow the equipment to be used on “instruments including most endoscopes – just not duodenoscopes.” Call this “in-dispute” technology.

For both cleaning and sterilization, effectiveness should be the prerequisite for efficiency – and certainly cleaning first and foremost. Nothing should be left behind in the cleaning process; only a completely clean instrument can be sterilized with the finished product being an instrument ready for duty with absolutely no residual moisture. Many sterile processing pros know this. Others apparently need reminding: Only a completely clean instrument should be sent through the sterilization process.

This philosophy has been the mantra for decades, even before the debut of more complex minimally invasive instruments in the 1980s.

One challenge with MIS instruments is that their guts cannot be visualized easily, typically requiring disassembly and/or running a tiny camera through them, if necessary. But that can add time to the reprocessing process, which affects patient throughput and revenue. To compensate, facilities either invest in more costly MIS instruments or cut corners and hope for the best.

It’s more important to be effective first than to be efficient. Once you can demonstrate effectiveness, then and only then should you concern yourself with efficiency. If you don’t accept that then you should not be allowed to practice medicine or be in the business of delivering healthcare. Quibbling hospital executives who tacitly value revenue over safety should be forced to partake personally in this game of surgical Russian roulette. Ask them to think of any of their loved ones on the surgical table. Or themselves. Watch how fast opinions, policies and procedures change when their long-term health security is called into question.

This is as it should be. The only way to make change is to personalize the consequences of doing nothing.

Everyone needs to share in the responsibility.

First, the FDA must require validation of cleaning and sterilization of all surgical instruments and the sterile processing equipment through which they’re run – preferably via certified independent, third-party laboratories.

Second, hospitals should be required to tell patients in advance of a surgical procedure whether they are using recalled or “in-dispute” products.

Third, to influence patients with their decision, the insurance companies – including Medicare and Medicaid – should issue a directive denying reimbursement (e.g., coverage) for any procedure where recalled or “in-dispute” products are used or any product is used without proper validation credentials. This gives the patient the opportunity to choose another healthcare provider or assume the risk if they don’t.

We need to act responsibly. And fast.