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 To Modify or Not to Modify? That Is the Question

When it comes to your surgical instrumentation, you may often find yourself in a debacle. A surgeon wants an instrument tweaked to be at a different angle, or you need to reorder a specialty instrument that is no longer available on the market. What are you to do?  

First, understand that yes, it can be done, but as most things in life you must ask yourself if it should it be done? Is it safe to modify that specific surgical instrument from the most important perspective, patient safety?

Second, you must understand that the FDA requires surgical instruments to be classified. “FDA regulates medical devices and categorizes them into one of three classes (I, II, or III) based on their level of risk and the regulatory controls necessary to provide a reasonable assurance of safety and effectiveness. Class I and II devices are generally considered to be lower risk devices. Class I devices are typically exempt from submission of a premarket notification, or 510(k). Class II devices typically require FDA clearance of a 510(k) to permit the device to be marketed and sold in the United States (US). Class III devices, which tend to be higher risk and first-of-a-kind devices, require FDA approval in the form of a premarket approval (PMA) application.”1

Most fall into these two categories: 

Class I Medical Devices
A Class I medical device are those devices that have a low to moderate risk to the patient and/or user. Today, 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process. If a device falls into a generic category of exempted Class I devices, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, the manufacturer is required to register their establishment and list their generic product with FDA.

Class II Medical Devices
Class II medical devices are those devices that have a moderate to high risk to the patient and/or user. 43% of medical devices fall under this category. Most medical devices are considered Class II devices.2

Here’s a quick reference chart:3Now that you understand the FDA guidelines, you understand that all surgical devices are classified. Anything over a Class I is considered a patient safety risk to have modified. If a company says they can modify your device, ask them a few questions: 

  1. What does your liability insurance look like? 
  2. What does your modification approval process look like? (If they don’t have a process, that should raise a red flag to you.)
  3. If you can’t modify the specific device in question, why? And what is your professional recommendation to guide us in getting this item replaced, or getting something like it to help keep our surgeons satisfied? 

If the company you choose to partner with meets the above criteria and has historically been a good organization to work with, you are in good hands. Before you send that item off to be modified, be sure to check that the specific item does not have pitting or damages, or that it is like new, meaning it hasn’t been previously altered or sharpened, which can change the length of that specific instrument. 

Several things can happen if you send that item off for a modification. First, the company will be able to bring it back to standard then make modification. Second, if the company isn’t detail-oriented, you will be paying to have a modification done on a device that has no business being modified and should be replaced. Third, the company will receive that item and reject the modification, costing you time. 

The moral of the story is your surgeons have unique needs, but they are also tasked with patient safety being the highest priority. It is the goal of any department, healthcare provider, and facility as a whole to achieve a great surgical outcome. Before you partner with any vendor, ensure that that organization has a strict approval process in place, liability insurance, and that they will not modify any device above a Class I. In-house maintenance/facilities and biomedical teams may have the tools to fire up the welding machine and go to town to achieve the precise angle your physician wants. It’s cheaper, it’s faster, and it’s much less of a process. But it’s not best practice and it is a liability waiting to happen. Shy away from that as a viable option at all costs, because no amount of convenience or cost-effective remedy is worth a class action lawsuit or patient being harmed. Let’s all work together to educate, inform, and keep our patients safe.

 

References:

1. https://www.fda.gov/about-fda/cdrh-transparency/515-program-initiative

2. https://www.innovatum.com/2014/12/understanding-difference-class-class-ii-medical-devices/

3. https://www.bmpmedical.com/blog/whats-difference-fda-medical-device-classes-2/


Rebecca Kinney has been working to improve patient safety in the medical arena for more than 13 years. She provides educational content on LinkedIn to help sterile processing and medical professionals gain knowledge as it relates to surgical devices, and her articles have appeared in Outpatient Surgery magazine. Her articles focus on the practical, hands-on knowledge operating room professionals can benefit from—never lacking in entertainment as she unfolds the true reality and struggles that are faced every day in the operating room setting. She is also a small business owner of a startup sales and marketing consulting agency.

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