Required Manufacturer Testing

A step in the right direction

The recent requirement imposed by the FDA for scope manufacturers to test their products is a step in the right direction and hopefully, testing requirements won’t be limited to just scopes. The next step is to develop clear testing requirements, which will provide indisputable evidence that products can be cleaned, disinfected and sterilized properly, and that manufacturers can provide recommendations that coincide with infection prevention requirements and strategies.


There are several ways manufacturers may test their products:

  • In-house, often using some recognized testing protocol such as ISO and ANSI

  • Professional associations representing product manufacturers often provide testing

  • Third party independent laboratories

All options provide data and information about specific products. However, third party independent laboratory testing is unbiased. All products or materials in any given category are tested using the same protocol, providing an “apples to apples” comparison.  Often testing data is available online in the same format as other manufacturer results.

Testing Standards and Requirements

Testing standards and requirements need to be developed and put in place that take into consideration current infection control requirements and recommendations. Conflicts occur when manufacturer recommendations don’t coincide and those responsible for cleaning, disinfection, and sterilization step outside required and existing protocol. Potential risk and liability exist for everyone. If manufacturer recommendations are not followed warranties may be voided, leaving healthcare facilities vulnerable.

There is obviously a microbiology component of testing. Data may show that a specific product can be effectively cleaned or sterilized using a given process, but does this process effectively destroy or eliminate microbes and the potential for cross contamination? When establishing testing protocol this data must be collected as well.


Product testing often is done on individual components or parts rather than on complete assemblies. Characteristics and the ability to effectively clean, disinfect and sterilize changes once components are put together as a final assembly. It is important to have a clear understanding of how the assembly needs to be cleaned before the product enters the market.

Human Behavior

Product testing will provide data that shows if and how a product can be effectively disinfected/sterilized to destroy harmful microbes. What is not tested is human behavior. This is a great subject for a future blog, but felt it important to mention. Despite testing, we still must recognize that human behavior impacts the success or failure of the disinfection/sterilization process.

Don’t know what they don’t know

Silos play a key role in the current problem. Over the years, I have come to learn that manufacturers don’t know what they don’t know about infection prevention and control. Within the healthcare facility there are many different specialized silos that often conflict on the subject of infection prevention. If and when manufacturers or anyone for that matter, seek to learn something they receive many opinions.

The ultimate goal is to mitigate the spread of infection, save lives and provide a safe environment. Reaching this goal will also help reduce the financial loss healthcare facilities experience. I am pretty sure most people will agree this can’t be achieved by focusing on only one aspect of the problem.

Establishing testing standards and requirements will require communication, education and a clear understanding about the data that is necessary from all perspectives.


We certainly can’t stop by simply establishing standards and protocol. We need to establish who is going to enforce product testing and who will hold accountability and responsibility to verify all data has been collected.

There is so much more to do, but a big step in the right direction has been taken. Let’s make sure steps continue to be taken to reduce the spread of infection and risk to patients, healthcare workers and the general public.