Endoscope Manufacturers and Health Care Facilities to Increase Following UCLA’s “Superbug” Outbreak

The National Law Review June 24, 2015

This headline is one of many about the superbug resulting from the use of contaminated endoscopes.  There have been deaths around the country and this has resulted in a quick release by the FDA of rules for the reprocessing  reusable medical devices. 

These new rules increase the requirements for the cleaning, disinfection or sterilization of medical devices.  See the following link for more details: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/.

For any company supplying reusable devices there are several challenges. The first, is designing and building  a device that can be cleaned/disinfected/sterilized for reuse;  second is the development of user instructions that clearly define what steps need to be taken.  The third is ensuring through training that users follow the instructions.  Just like the ubiquitous “ employees must wash hands” signs in restrooms around America, instructions can be provided but we are dependent on the individuals to follow them. In a busy hospital the responsibility for cleaning up after a procedure may be assigned to a staff member, but depending on other needs or emergencies it may fall to someone else to clean and prepare the device.

For a manufacturer the question then becomes how to prevent the reuse of a device that has not been cleaned properly.  Can a completed checklist work?  Signed off storage notes?   Will these be followed In the event of an emergency?

This is a risk management issue that ends up being addressed by design and user instructions.  For any company, and hospital, the only way to ensure patient safety is to develop a work flow that  all users understand and adhere too.  A design that makes cleaning easier by limiting openings, areas that gather debris or that can be disassembled can help with cleaning.

In aviation the use of checklists is considered one of the essential tools for pilots. Of course even with these we have plane crashes and accidents.  But it is still a possible solution for the medical/health care industry.  A book I recommend is Atul Gawande’s The Checklist Manifesto – How to Get things Right. A medical doctor he explores how a checklist can limit problems and mitigate risks.

This is one case without a simple solution, we know people will make mistakes and we need to have a design that supports ease of cleaning and  includes  instructions/ processes that clearly delineate the steps to protect patients.  But in the end we are dependent on the human factor and how carefully people handle the information provided to them.

Bio:

Paul Kostek is Principal of Air Direct Solutions LLC a Seattle based systems engineering and project management firm.  Paul works with companies in the aerospace and medical device industries.