Reusable medical device steralization

Reusable vs. Disposable Medical Devices: Which Is Best?

Single-use medical devices provide key benefits to both patients and healthcare providers, which is why they are becoming increasingly common in hospitals and ambulatory surgery centers.

Medical device manufacturers and suppliers need to be intimately familiar with the benefits of both disposable and reusable medical devices so they can provide their customers with the best tools for their practice.

Benefits of Disposable Medical Devices

The benefits of disposable medical devices and tools can include:

Improved Sanitation/Patient Safety

The most cited benefit of using a disposable medical device versus one meant for reuse is that sterility is inherently easier with single-use devices kept in sterile packaging until the time of use.

Sterility is a major concern for any medical practice—but especially so for those that routinely perform any kind of invasive procedure.

With reusable devices, there are risks associated with their cleaning, disinfection, and sterilization in between uses.

1. There could be a mishap during the cleaning process which leaves trace amounts of tissue, proteins, or other contaminants on the device.

2. There could be dust or other airborne contaminants introduced to a reusable device in between uses if not kept in perfectly sealed packaging.

3. The disinfecting agents used to disinfect the device could cause allergic reactions to either the healthcare staff or the patient.

Single-use medical devices reduce these risks significantly—which can help clinics avoid complications during medical procedures that lead to patient injury, malpractice lawsuits, and negative press.

Improved Performance

Single-use devices have a decreased risk of the device not performing optimally in the case where a device’s performance is a function of the number of uses it has seen during its life. This is especially important for devices where edge sharpness is important, where scale buildup can increase electrical resistance or impedance, or where the surface finish and clarity can affect imaging quality.

Medical devices can only be guaranteed to work reliably for a certain number of uses, which means that the healthcare staff must keep track of how many times a reusable device has been used, which can be very difficult and can result in devices being used well beyond their validated lifetime. A physician will often experience suboptimal performance during use and need to request a replacement device, which can cause a delay in the medical procedure.

Single-use devices are manufactured to meet all specifications and undergo sufficient testing to show objective evidence that they will continue meeting those specifications up until the time that they are used in a procedure.

Time and Labor Savings

The process of cleaning, disinfecting and sterilizing reusable medical devices can take a significant amount of time and labor—even with automated cleaning equipment. After cleaning, each reusable device must be checked for sanitation and stored in a sterile container—processes that take up valuable time for hospital/clinic staff.

Immediately before reuse, multiple-use devices must be double-checked to ensure sanitation, which can significantly add to preoperative prep time in medical practice. Meanwhile, single-use devices can be ready to go out of the box and simply disposed of (often via recycling programs) once the operation in question is finished.

Environmental Benefits

It’s easy to assume that, when it comes to environmental impact, disposable medical devices would lag behind reusable devices. After all, with reusable devices, hospitals aren’t sending devices into the waste stream.

However, the truth differs from that common perception.

While reusable medical devices aren’t sent to landfill or other waste streams after each use, they do result in the generation of another kind of waste: chemical waste. As noted by the World Health Organization (WHO), “health care wastes with chemical disinfectants can result in the release of chemical substances into the environment.”

In the USA, hospitals produce over 5.9 million tons of waste (of all kinds) every year (Source: All Points Medical Waste). Chemical waste from solvents and disinfectants used in the hospital is a major source of pollution generated by healthcare practices.

Disposable medical devices can help to reduce the chemical waste hospitals produce by removing the need for onsite sanitation of used tools. Instead, these devices can be sent to recycling centers to have their raw materials reclaimed and reprocessed into new products—helping to reduce the carbon footprint of the healthcare industry.

Using medical devices designed with easy-to-reclaim materials, such as thermoplastics and metals, can help maximize the environmental advantage by reducing the non-reclaimable waste produced.

Cost Efficiency

Another benefit of disposable medical devices that may surprise some is that they can be less expensive to source and maintain than reusable medical devices. This may sound counter-intuitive, but the reality is that there are several hidden costs to reusable devices that can make them more expensive than one might initially assume:

1. The acquisition, storage, and maintenance of cleaning/sanitation products and equipment

2. Healthcare staff labor spent on device sanitation

3. Increased risk of cross-contamination infections creating the need for additional procedures and possible malpractice suits

4. Additional accessories, replacement parts, and maintenance/service to keep devices in working order

Single-use devices avoid these recurring hidden costs by eliminating the need to clean used devices. So, in the long run, single-use devices can provide a cost advantage to hospitals.

Limited Reuse Technology

Reprocessing and reuse of single-use medical devices has become a prevalent practice throughout the healthcare industry. Single-use devices are discarded in bins that get sent to reprocessing centers. There they are taken apart, cleaned, disinfected, reassembled, repackaged, re-sterilized, and then sold back to the healthcare facility (at a reduced price) to be used again.

Though the reasons for reprocessing and reusing single-use devices range from “lowering costs” to “reducing medical waste” one thing is clear: The risk this practice presents to patients cannot be ignored by medical device companies. Perhaps having more control over the risks associated with reprocessing their devices might be one of the reasons why some major medical device manufacturers have decided to acquire these reprocessing companies. Two examples include the acquisition of Ascent Healthcare solutions by Stryker Corporation in 2009 and the acquisition of Sterilmed by Ethicon Endo-Surgery (Johnson and Johnson) in 2011. If the original device manufacturer also owns a reprocessing center, it can then design its devices to where only its reprocessing center can reprocess the device (if desired).

So, how can device manufacturers go about preventing their devices from being reprocessed? There are many options to choose from when it comes to use-limiting technology, including mechanical use-limiting, single wire/electric limiting, electrically erasable programmable read-only memory limiting (EEPROM), and radio frequency identification limiting (“RFID”). Learn more about these advancements by downloading our free eBook on the topic.

Benefits of Reusable Medical Devices

So, what are the benefits of reusable devices over single-use ones?

The primary benefit of a reusable device is that, in some cases, the hospital is less reliant on receiving a constant, uninterrupted supply of the devices they need to ensure that they have enough devices for their routine operations. The constant demand for single-use devices can put a healthcare provider at risk of having to delay or cancel procedures if there are any product supply issues. If a particular solvent or disinfectant distributor is unable to deliver cleaning supplies promptly, the hospital or clinic can easily source those products from a different supplier.

Sourcing, or product supply, issues can exist in two ways: between the healthcare provider and the device manufacturer or between the device manufacturer and their contractors or vendors. If a healthcare provider experiences difficulty in procuring sufficient devices to cover their demand, they could source similar devices from other device manufacturers unless contractual obligations prevent it. All alternate devices on the market for the same intended use have received regulatory clearance and have produced substantial evidence that their device is safe and effective. If a device manufacturer, however, experiences supply issues from a contractor or a vendor, it could be very difficult, costly, and take a long time to qualify assemblies, processes, or components from an alternate vendor due to specialized tooling and cGMP-compliant manufacturing processes required to manufacture the medical device.

This risk of disposable medical device manufacturing supply can easily be limited by device manufacturers partnering with a company that has manufacturing capabilities spread across multiple geographic locations.

There can also be a cost benefit to some reusable medical devices whose performance doesn’t degrade after each use, where, despite the risks and costs associated with reprocessing and reusing them that were described earlier, some of these reusable devices could end up costing less per procedure than single-use devices.

Reusable vs Disposable Medical Devices: Which Is Best?

For the benefit of patient safety alone, disposable medical devices should be preferred over reusable devices in every application where cleaning the device isn’t extremely consistent or where infection risk is high.

Any device for an invasive procedure would be better served as a disposable device rather than a reusable device.

Meanwhile, reusable devices may be more practical for topical applications or non-invasive procedures. Even here, specific parts of these devices may be disposable for improved safety. For example, vitals monitoring systems are reusable devices, but the sensor pads they use to contact a patient’s skin are disposable.

Need Help Optimizing Your Disposable Medical Device Supply Chain?

Reach out to ATL Technology for more information about how you can optimize your medical device supply chain to remove volatility and control costs!


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