We are seeing an extraordinary rise in the use of technology in clinics. New tools for screening and assessing patients, or tools for managing workloads and streamlining record keeping are just a few. Whatever your pain point is, there is probably a product on the market that could help alleviate your clinic’s challenges.
When you are evaluating a purchase, like most business managers, you are probably asking questions about features, pricing and return on investment. These are all very important variables to the person (or people) responsible for clinical efficiency and fiscal health of a business.
But when considering the introduction of a new biomedical device into your facility, there is an extra set of responsibilities (and therefore, decision factors) that should be a part of your decision-making process.
The questions you should be asking are:
1. Is the product or device intended to be used for medical purposes? And if yes:
2. Is it registered with the appropriate regulatory body?
Why is this important?
If a product you are buying is intended to be used to screen, assess, diagnose or treat a patient, by law it is considered to be a medical device. This means that the product must be registered with the appropriate regulatory body.
If you are using a new technology for medical purposes, there are potential risks that must be identified and mitigated. There is a process for this, which is managed and monitored by the government. In Canada, medical devices are regulated by Health Canada. In the United States, the Food and Drug Administration (FDA) regulates medical devices.
Since the use of medical devices have hazards/risks associated with them, in most of the world medical devices are classified based on their perceived risk. In the U.S., there are three tiers of medical devices:
Class I Medical Devices are those that have been deemed to have the lowest level of risk and therefore are subject to the lowest level of regulatory control.
- Class II Medical Devices are more complex than Class I devices, are considered to be of higher risk than Class I devices and therefore require more stringent regulatory controls to provide assurance of their effectiveness and safety.
- Class III Medical Devices are the most complex and are considered to be of the highest risk to the patient and/or user. Therefore, these have very stringent oversight by the government.
In Canada, this is subdivided a little further to make four classes, but still based on the perceived risks.
For a product to be registered as a medical device, records showing proof of safety and efficacy must be collected, analyzed and presented to the regulatory body before the sale and marketing of the product is allowed in the jurisdiction of interest. Furthermore, the company is subject to audit of their Quality Management System on a regular basis.
As a business owner or clinician, the use of non-approved devices in your clinic to screen or assess patients should be of concern, as the products efficacy and safety have not been demonstrated and risk to both the operator of the equipment and patient have not been ascertained.
Stepscan Technologies is both a Health Canada and U.S. FDA registered medical device manufacturer. The core Stepscan® product is a Class I medical device, primarily used within the research and clinical assessment space.