What Should You Consider When Purchasing a Medical Device?


Purchasing the right medical devices for your facility is an imperative task. But, there are a number of factors to consider when purchasing these devices that can help ensure you get the best value—and can offer the best care for your patients.

A strong first step in making your decision is understanding the background and general details of the device. Some initial considerations include:

  • Is this device easy to use?
  • Will we need training for this device? If so, is comprehensive training available?
  • Are the instructions clear, or does this device leave room for error?
  • Is this a single-use device, or can it be used multiple times?
  • Are there case studies or research to support this device?
  • Have there been previous patient safety or care concerns with this device?

Once you’ve done this preliminary research, it’s critical to more thoroughly review safety, regulation and certification information—as well as understand the customer service you can expect. Read on to discover more about these important criteria.


Aligning with Value-Based Purchasing

In an attempt to reduce inappropriate care and reward the best-performing providers, the Centers for Medicare and Medicaid Services (CMS) developed value-based purchasing. Now, when it relates to Medicare, healthcare providers and systems are evaluated on criteria to determine how they compare to other providers and systems—and if their care has improved from the previous period. The criteria include:

  • Mortality and complications
  • Healthcare-associated infections
  • Patient safety
  • Patient experience
  • Process
  • Efficiency and cost reduction

Based on the above, healthcare providers and systems are assessed, and through value-based purchasing, physicians, hospitals and other healthcare providers are incentivized to meet a certain level of performance that offers more value overall. The focus is now on the quality and improvement of care, not just the quantity of services provided. It’s more important now than ever to purchase devices that offer financial efficiencies and effective outcomes.

Fortunately, Bionix® focuses its efforts on technology that helps physicians and healthcare professionals meet the ever-changing demands of the healthcare industry. With devices like its entire Lighted Technology product line, Bionix can offer products that will benefit facilities in providing excellent care.


Improving Patient Safety

Optimal safety and performance of a medical device are key for quality patient care. As such, you should understand all aspects of a device, including the applicable safety standards, to keep patient-centered care top-of-mind when you’re purchasing. Remember: the medical devices that you choose should not compromise the clinical condition or safety of your patients, so you need to ensure that any device you purchase offers health and safety protection. And while all devices carry a certain degree of risk, performing a risk assessment can estimate the potential associated risk.

To prioritize patient safety, Bionix manufactures a number of single-use products that can reduce the risk of cross-contamination—and reduce the time and money needed to sterilize before each use. Plus, Bionix has also been awarded the ISO 13485 certification, meaning our medical technologies are held to a higher standard—across the world. This all assists with a better patient experience and stronger opportunity for you to justify the devices you purchase.


Certifications and Device Regulations

In an effort to improve patient safety, the Food and Drug Administration (FDA) regulates over 190,000 different medical devices worldwide, working to ensure that the devices healthcare facilities are using present more benefit than risk.

Medical devices are classified into Class I, II and III, with regulatory control increasing based on the classification. The basic regulatory requirements include:

  • Establishment registration
  • Medical Device Listing
  • Premarket Notification 501(k) or Premarket Approval (PMA)
  • Investigational Device Exemption (IDE) for clinical studies
  • Quality system (QS) regulation
  • Labeling requirements
  • Medical Device Reporting (MDR)

All applicable devices are regulated by the FDA at every stage of the life cycle, and the FDA uses this information to permit marketing of only the devices that have a favorable benefit-risk profile. As such, it’s imperative for device manufacturers to understand and comply with all regulations—and it’s important that as your facility’s decision maker, you know that the company you’re purchasing from is in line with safety and regulation standards.

At Bionix, we know you are committed to ensuring your facility is aligned with all regulations. And through our Bionix Safety Technologies product line, we can provide you with the tools to do so.


Strong Customer Support

While patient safety and care are top priorities, it’s also important to determine if you’ll be getting the best customer support from the manufacturer you order from. If a device arrives disassembled or damaged—or if you have questions on device usage—you want to get prompt support. Plus, some devices require ongoing servicing, so it’s imperative that you work with a manufacturer that will properly assist you.

At Bionix, we’re committed to exceptional customer service, helping serve the medical community as best as we can. We want to ensure that our products help enhance patient care, and we’re here to help every step of the way.


Bionix® Makes It Better

Bionix Development Corporation has spent over 30 years working to improve the medical device industry. In fact, our achievements over the years showcase our non-stop commitment to providing medical devices that improve your overall level of patient care.

We work to develop products with the sole purpose of improving healthcare, like our Lighted Ear Curette™ that combines illumination and magnification to help healthcare providers safely remove cerumen from the ear canal—in less time.

Ready to discover how the range of Bionix medical devices can benefit your facility and your patients? Reach out to a sales representative today!