infection prevention
infection prevention
By Carol Calabrese, RN, BS, CHESP, CIC
The Conflict with Manufacturers’ Instructions for Use
Several years ago, while attending the national APIC conference, I had numerous conversations with fellow attendees related to the frustrations they were dealing with trying to marry the manufacturers’ instructions for use( IFU) for the insurmountable number of medical devices in their facilities and the IFUs of the different chemicals used for cleaning and disinfecting. Some stated that they had charts showing the different medical devices and different disinfectants, indicating they had up to 15 different disinfectants being used.
This presents major issues, including time spent to review the chart to select the disinfectant, where to store this multitude of disinfectants, the money to purchase all the disinfectants only to have staff become frustrated and just pull one wipe – and not necessarily the one that the IFU says to use.
What precipitated the issue? It was that the Centers for Disease Control and Prevention( CDC) reported to the Food and Drug Administration( FDA) that there were several outbreaks of multidrug-resistant Carbapenem-resistant Enterobacteriaceae( CRE) at several large medical centers.
A very serious and reasonable concern, right? But the issue is complicated for several reasons.
The reports of CRE were related to semi-critical devices – duodenoscopes— which are very intricate devices which makes cleaning and high-level disinfection( HDL) difficult.
The FDA is responsible for ensuring that manufacturers of medical devices provide instructions for cleaning and disinfecting or sterilization within their labeling; while the Environmental Protection Agency( EPA) is responsible for approving the labeling that the manufacturers of the different chemicals develop for cleaning and disinfecting of the environment and medical devices, chemicals used as a high-level disinfectant or sterilant fall under the FDA for approval.
Click on this button to access the list of medical devices to which the FDA regulations apply
Of note, this FDA list did not contain many of the medical devices that are routinely used at the bedside, as it came after the 21st Century Cures Act( section 3059) was passed, which requires the FDA to identify and publish a list of reusable device types that are required to include such instructions for use and validation data regarding cleaning, disinfection and sterilization in 510( k) notifications.
Additionally, the Association for the Advancement of Medical Instrumentation( AAMI) publications ANSI / AAMI ST98:2022, and ANSI / AAMI ST91:2021 provide standards that pertain to medical devices that meet the critical criteria. [ See: https:// array. aami. org / content / news / joint-commission-provides-guidance-meeting-infection-control-standards ]
Regulatory Focus, a news and peer-reviewed content organization, reported on June 8, 2017 that the FDA released a list of reuseable devices requiring new validation data. Subsequent to the CDC report, in around 2017 The Joint Commission( TJC) added to the standards that IFUs must be adhered to because
there was a 72 percent rate of non-compliance with Standard IC. 02.02.01.
After the implementation of TJC Standard IC. 20.02.01, EP2 has continued to be the top standard out of compliance in 2017 and again was in the top 10 for 2020. In my IP mind, this is understandable, as there are numerous medical devices used throughout healthcare, hospitals, ambulatory surgery, long-term care, home health, hospice and others.
Medical devices to be sold in the United States they must go through rigorous approval process by the FDA to receive a 510K and / or pre-market approval. It has been reported that the FDA regulates more than 190,000 distinct devices. The FDA classification process is rigorous yet not perfect. Granted, many of these are surgical instruments which require sterilization. But I ask, is it not reasonable to consider that for non-critical medical devices the number of disinfectants could be streamlined from 15 to just two or three?
Many medical devices used have been on the market for a considerable length of time and IFUs for cleaning and disinfecting may not have been available. It takes a great deal of valuable time to contact the right person at a company to obtain insights as to what should be done to clean and disinfect a device if the IFUs are missing or incomplete.
According to the Spaulding classification, medical devices are divided into three categories:
● Critical: requires sterilization
● Semi-critical: requires high-level disinfection
● Non-critical: requires low to intermediate level disinfection
These classifications were created more than 65 years ago. While the FDA uses Spaulding, they use the additional categories below which are based on risk to the consumer.
Title 21, Chp I, Subchapter H of eCFR system Code of Federal Regulations has 16 parts addressing medical devices( See: https:// www. ecfr. gov / current / title-21 / chapter-I / subchapter-H). Per Part 860, devices are in one of the following categories:
Class I: medical devices are considered low risk; example – elastic bandage
Class II: medical devices considered moderate risk example- stethoscope
Class III: medical devices that are considered high risk – example – silicone gel-filled breast prosthesis
Per the FDA, device classification is based upon its intended use and although there are seven primary categories of disinfectant chemistries that can be used for low-level cleaning / disinfecting. Iodophors and alcohols are not routinely used to clean / disinfect, and the FDA does not instruct device manufacturers to test all of the disinfectants currently approved by the EPA to identify which disinfectant( s) would be best suited to that medical device.
The FDA’ s document,“ Reprocessing Medical Devices in Health Care Settings:
Click to View What are Reusable Medical Devices?
Click to View FDA Regulation of Medical Devices
14 • www. healthcarehygienemagazine. com • jul-aug 2025