Three Considerations for Reusable Medical Device Design – MedTech Intelligence
Designers of reusable medical devices must take numerous considerations into account during their processes. The following are essential considerations.
1. Infection Prevention
Making reusable medical devices easy to clean is critical for keeping patients safe. For example, in April, the FDA investigated reports of complications associated with reprocessed urological endoscopes, which are used to view patients’ urinary tracts. The agency raised concerns about three patient deaths outside of the United States associated with those devices.
An FDA official said the device design was one of several factors under investigation as representatives searched for possible causes. Infection risk is also present with items used much more broadly in patient care. Stethoscopes are examples of reusable medical devices. However, research shows providers often don’t follow the associated cleaning recommendations, so they carry cross-contamination risks.
However, one study indicated that using copper on a stethoscope’s diaphragm, binaural tube, and ear tubes substantially reduced the device’s colony-forming units (CFU). For example, the copper binaural tube had a mean of 2 CFU/cm, while the non-copper versions showed a mean of 108 CFU/cm. The paper also confirmed UVC light was an effective method of cleaning stethoscopes between patients.
Since stethoscopes are not single-use medical devices, reducing any associated infection risk is important. One newer product shows how a specialized accessory device could help. It’s a small box-style product that slips into the pocket of a medical coat. Once a user attaches it to a stethoscope diaphragm, the gadget automatically begins an LED-generated UVC cleaning cycle lasting three or five minutes. Such options could reduce instances of providers forgetting to follow cleaning instructions between patients.
Designers of reusable medical devices must explore how to make their products as easy as possible for patients, providers and any other applicable parties to interact with during expected usage.
Simplifying Usage for Professionals
Making a product easy enough to operate could be critical for ensuring compliance in regulated industries. For example, proper calibration is a major factor ensuring the accuracy of some specialized equipment. However, a product’s design also plays a significant part in helping professionals use it properly on their patients.
The FDA provides several suggestions for practical ways to make reprocessed medical devices as user-friendly as possible. Some of the organization’s tips include:
- Making devices easy to disassemble if they have multiple components
- Ensuring that critical connections, such as those on endoscope tubes, have non-interchangeable connections
- Including clear markings to show which components are not suitable for reprocessing or identifying which pieces are connecting accessories, such as drainage tubes
Those strategies aid medical professionals in using reprocessed products safely and productively. The FDA also recommends providing clear instructions for reprocessing, plus offering advice for verifying that the chosen reprocessing method worked as anticipated. Such guidance removes the possibility that providers could make the wrong assumptions when using reprocessed medical items.
Some examples of reusable medical devices are created to meet emerging needs. One product for oral healthcare providers is a suction device that more effectively reduces aerosols versus existing offerings—which are usually disposable. Aerosol minimization is a crucial advantage, especially during a global pandemic. The product works outside a patient’s mouth, increasing the field of view for providers. Users can also sterilize it in autoclaves.
Increasing Patient Adoption
Reducing patient inconvenience is another worthwhile consideration that ties into user-friendliness. Penn State researchers developed a reusable glucose meter that detects blood sugar levels through a person’s sweat. The device is sensitive enough to give the required accuracy, even though the glucose concentration in human perspiration is about 100 times less than that in blood.
The entire device is about the size of a quarter. It attaches to the arm with a skin-safe adhesive. Another primary advantage is that this innovation removes the need for needle-based blood sugar checks. Eliminating the pain from those assessments could increase a patient’s willingness to use the device while following a doctor’s orders.
Such noninvasive methods of measuring patient statistics in real-time could also further the advancement of precision medicine. For example, one study involved having hypertensive patients take prescribed medication to lower their blood pressure while using an app to record their experiences. Since participants’ physicians received real-time data, they could adjust their medication outside of office visits. Other devices could come into the picture, too, such as smart blood pressure cuffs.
As people become increasingly concerned with the Earth’s future, they often look for sustainable designs in the products they use. For example, the applications of parenteral or invasive medical products require that they’re single-use medical devices. That may not be the case forever, though. Designers are investigating hybrid options. For example, a product may have disposable and easily removable components alongside parts that are sterilized and reused numerous times. Such solutions are also attractive due to the a growing number of medical devices that have embedded electronics. Failing to make at least some components reusable could be too cost-intense for manufacturers and users alike.
Sustainability is also a factor when determining what happens to the products at the end of their life span. For example, how easy is it to disassemble the items? Is there a risk of toxic chemicals leaking into the environment after a product’s disposal?
Conversely, what materials would make the device as durable as possible during patient care and ongoing use? How can designers reduce the risk of accidental breakage? Answering those questions will go a long way in ensuring all medical devices are as sustainable as possible, whether people use them once or many times.
Sustainability also makes devices more appealing to people making purchasing decisions. One study found that, during a single year, medical device reprocessing brought an estimated $470 million in savings to medical facilities, plus diverted about 15 million pounds of health care waste from landfills.
Reusable Medical Devices Support Healthcare Progress
It is not financially feasible for a healthcare center to solely rely on single-use medical devices. However, reusable devices come with some unique challenges. This overview should give design professionals some food for thought. It should encourage them to evaluate how to keep healthcare device design moving forward without sacrificing patient safety, ease of use or sustainability. Although they are not the only factors worth considering, they provide a starting point to help designers realize the crucial role they have in the medical industry’s future.
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