Medical device disinfection is a real-world public health risk. So manufacturers need to step up.
By Ken Mitchell, CCE, and Caitlin Young
It is the responsibility of a medical device manufacturer to ensure the suitability of their final product for its intended end use, and to select all materials and components accordingly. Today more than ever before, we are reminded that a safe and effective medical device must be one that can be cleaned, sanitized, and/or disinfected as appropriate. In healthcare, this process often entails the use of ‘pop-up wipes’ that contain a variety of instant-kill chemicals capable of rapidly disinfecting device surfaces between each patient use or exposure.
Every medical device comes with ‘instructions for use.’ These instructions typically specify the cleaning and/or disinfecting products, processes, and procedures that are compatible with—and are therefore approved for use with—the device. The instructions are seldom, if ever, updated to keep pace with the changing infection prevention landscape. Deviation from these specifications, we are told, will void our device warranties. As dire as this sounds, voiding our warranties is now the least of our worries in frontline healthcare.
Locked in a heated battle against not only coronavirus, but HIV, MRSA, C-Diff, and other hospital-acquired infections, we cannot afford not to embrace novel (or readily available) chemistries, powerful disinfectants, or new disinfecting technologies (such as ultraviolet germicidal irradiation, or UVGI). Nor can we afford to spend excessive time and resources meeting the exacting specifications of hundreds of different devices. And we should not have to. The neglectful product stewardship, unrealistically narrow disinfection guidelines, and rigid mandates and consequences imposed by medical device manufacturers leave healthcare systems and end users with a plethora of dilemmas to untangle.
Some manufacturers, for instance, require that only a small handful of particular brand-name disinfecting products be used, failing to generically approve any standard disinfectants. When questioned as to the reasoning behind this decision, technical support will vaguely cite problems with either “inactive ingredients” or “untested chemistries” of comparable products. Yet they cannot or will not specify which inactive ingredients make a similar alternative product with the same active ingredient(s) incompatible.
Applying this brand-name product approach to each of the various device types in a hospital setting could easily require that facility to stock dozens, if not hundreds, of different products. Logistically, this is impossible, and would have been so even before a pandemic wreaked havoc on the disinfectant and cleaning product supply chain.
Some manufacturers specify standard chemicals but not concentrations, while others specify standard chemicals at concentrations insufficient to adequately disinfect the surfaces of their equipment. Many require that multiple different disinfecting products be used to clean various components on the same machine (we found up to three different specifications for one device). Most fail to specify which chemicals and concentrations, active or inactive, are incompatible with devices—making materials compatibility assessment an opaque process, and user comparison between brand-name products impossible.
Some manufacturers lack basic infection prevention and control recommendations entirely, making no mention of disinfectants and continuing to recommend cleaners like auto wax, mild detergent, and water! Still others caution against the use of “aggressive chemicals” that may “degrade surfaces” (whether this degradation is slight and cosmetic or significant and functional is not disclosed), despite the fact that these “aggressive” chemistries have now been standardized by healthcare systems for many years.
The list of problems doesn’t end there. Many medical device manufacturers list only isopropyl alcohol or glass cleaner as acceptable for use on optical surfaces and display screens of all kinds. This is problematic, since isopropyl alcohol on its own is seldom registered as a disinfectant due to its rapid evaporation rate and resulting insufficient wet time.
Medical equipment is not being designed to withstand exposure to a majority of standard hospital disinfectants including 10% bleach, 3% hydrogen peroxide, and quaternary ammonium-based compounds (QACs or QUATs). Medical device manufacturers fail to sufficiently test (or to disclose information about) both active and inactive ingredients. They fail to provide a reasonable process for allowing users to test new disinfecting products on equipment themselves. Yet, they enforce harsh punitive measures if their original instructions are not followed to the letter. They fail to test the feasibility of reprocessing single-use devices for use in global emergencies. They fail to select modern, durable materials that can withstand the common chemicals and practices of healthcare.
It is unethical to inhibit high-level materials compatibility assessment in an industry landscape where 433 disinfectant products (and counting) are now EPA-registered and approved by the CDC for combating COVID-19—especially, and critically, when there exists a very real potential for supply shortages to limit product availability. If hydrogen peroxide is generically approved for use on a device, yet the device manufacturer specifies that a particular brand-name product which lists hydrogen peroxide as its active ingredient is not, then a clinical engineer or other medical professional attempting to develop realistic and implementable cleaning guidelines for their facility should be able to learn the reason for this apparent contradiction.
Which ingredient(s) specifically in a certain brand of hydrogen peroxide disinfectant wipe (1.4% concentration) prohibits their use on ultrasound transducers that are otherwise unharmed by 3% hydrogen peroxide itself? The disinfectant manufacturer will not disclose its inactive ingredients, and the ultrasound manufacturer’s technical support representative will not answer the question.
This raises a second, closely related issue. The many disinfectant manufacturers that refuse to list their “proprietary” inactive ingredients are complicit in this dysfunctional system. Greater transparency with regard to chemical ingredients is essential. Medical equipment manufacturers and disinfectant manufacturers need to cooperate. Both parties should be designing their products to meet the demands of their intended uses and environments, first and foremost. That is what good manufacturing design means. Compatibility between the two and transparency from bothare just as essential as any other quality, as well as any other measure of efficacy or ethical responsibility.
Thankfully, there are solutions: 21st century materials and compatibility testing must fill the void. Virtually all device manufacturers seem to lack a standard process for the continuous testing of new cleaning products on existing device surfaces and against new viruses. All manufacturers have a responsibility to continually update and expand their approved list of disinfectants for widely used medical devices.
A few proposed changes:
- Device manufacturers must test and disclose their findings regarding all of the most common families of disinfecting chemicals, including acceptable concentrations where possible/applicable:
- 1) 10% bleach
- 2) QACs/QUATs
- 3) 3% hydrogen peroxide
- 4) Isopropyl alcohol/QAC combinations
- Device manufacturers must engineer and employ more resilient surfaces.
- Device manufacturers must develop a timely and cost-effective compatibility testing method for new cleaning products, as well as for the testing of new/alternative infection prevention science (i.e. UVGI).
- Device manufacturers must continue to test new products on older devices if those devices are still in widespread use, and to make this information available to users.
- Where device manufacturers are aware of a harmful ingredient, whether active or inactive, they must specify this ingredient as incompatible and make this information readily available to users.
- Disinfectant manufacturers must list all of their ingredients, active or inactive.
- Clinical Engineering/HTM/biomedical engineering professionals must continue to track equipment failures and repairs resulting from damages likely caused by disinfectant use.
Disinfectant producers and device manufacturers have a dual responsibility to step up and become part of the solution by cooperating more readily with end users. Tell us exactly what works and what doesn’t from a generic chemical compatibility standpoint, rather than dropping a few novel product names in the user manual and threatening us with voided warranties if we use anything else. Active ingredients, concentrations, and contraindications (of both active and inactive ingredients) are needed from device manufacturers and disinfectant producers alike.
Tell us if an “incompatible” standard chemical causes actual functional failure versus slight discoloration over time. Be our allies rather than our enemies when we are required to make judgment calls under pressure—such as in times of global crisis that lead to crucial supply shortages. As different facets of the same healthcare industry, we should all be in this fight together.
Ken Mitchell, CCE, is director of clinical engineering at Brewer, Maine-based Northern Light Health and Caitlin Young is a clinical engineering systems analyst at Northern Light Heath. Questions and comments can be directed to 24×7 Magazine chief editor at [email protected].