Preparing for, reacting to FDA process, product halts

When the Food and Drug Administration alerts healthcare facilities to stop using a device or implementing a certain procedure, sterile processing departments know they must comply.

But that doesn’t alleviate any ensuing confusion about what to do next, particularly as surgical procedures aren’t interrupted or even paused until a back-up plan is working.

What steps should healthcare facilities take when the FDA halts the use of a particular piece of washing, disinfecting or sterilizing equipment? Experts from Advanced Sterilization Products and Integrated Medical Systems International Inc. offered their insights.

"Change can be viewed as a challenge or an opportunity," according to Carol K. Stevens, BSN, R.N., CGRN, clinical education consultant, ASP. "For many facilities, a recent change provided an opportunity to assess facility practices and raise the standard of care. As many facilities introduced new reprocessing technologies, they also took the opportunity to update staff members on protocols and steps that need to be taken so that they can continue to improve safety, prevent infection and save valuable time when high-level disinfecting endoscopes. Again, education is key to understanding FDA or industry guidance and how to apply that to your facility."

The FDA alleviates the pressure, according to Ryan Klebba, vice president, endoscopy, IMS.

"When the FDA halts the use of a piece of equipment, it typically provides a ‘phase-out’ period," he said. "Within this time frame, explore alternatives for reprocessing using these questions and guidelines:

1. Do you currently have another approved method of reprocessing available in your facility? Does that method provide the same standard of care as the halted equipment method? If it is inferior to the halted method — e.g., manually soaking a piece of equipment in a high-level disinfectant as the only alternative to using an automated reprocessing method — you should continue using the halted method until a new device is purchased. The phase-out period gives you time to develop a plan for funding, acquiring, and installing a new reprocessor and educating your staff on its use.

2. If you don’t currently have an accepted alternate method, explore the available options. Doing a thorough evaluation of all options and pricing will ensure you make the right decision for the long term. Contact equipment manufacturers and ask for demonstrations of their various equipment types. Make sure you understand the features, benefits, and disadvantages of each machine. When comparing options, be realistic in considering whether spending more will lead to real advantages. Evaluate your equipment inventory. Will all of your current inventory be compatible with your newly purchased device?  If not, what will be the cost of bringing that equipment up to the necessary specifications to be used with your new device? A key part of the evaluation: determine whether your current repair company is able to support the new device and related equipment.