If you’ve ever read anything online about tourniquets or first aid, you’ve probably seen the keyboard commandos spouting off about this or that certification, recommendation, or approval that a particular tourniquet has or doesn’t have. With so many opinions, it can be difficult to determine what’s actually the truth. So we’ve gone ahead and put the information together here so you can figure it out.
COTCCC Recommendation: During most discussion online there is the inevitable person who says, “If it’s not CoTCCC recommended, then it’s garbage.” The problem with that is that it’s simple untrue, and those people generally are ignorant to the process of how a specific tourniquet became recommended. CoTCCC recommended tourniquets are based on Department of Defense (DOD) studies that were conducted by the U.S. Army during the early 2000’s. At that time, there were very few commercial pre-hospital tourniquets on the market, so only a percentage of the tourniquets available today were able to be included into the study. Therefore, until the DOD or its affiliate military branches do another tourniquet study, there won’t be any new or updated recommendations for tourniquets.
Now let’s go one step further. No organization is beyond reproach or the existence of possible conflicts of interest. You should never just turn your brain off and say; “Well this organization says it’s ok, so its ok, I don’t have to do my own research or testing.” Historically, that logic has been proven to be wrong; for example:
Do the CoTCCC recommended products have merit? Yes. Does the CoTCCC do good work, and set good evidence based guidelines? Yes. Should you question or experiment outside of their recommended product? Yes.
COTECC: The CoTECC is the civilian counterpart to the CoTCCC. A major difference in this committee is that they do not recommend particular products, because they do not want to have any conflicts of interest, and they believe that the evidence based practices and products speak for themselves. Furthermore, they believe that recommending products would stifle innovation and advancement of new product development. What you can gain from this organization is evidence based training and best practice guidelines that you can tailor to your needs. The CoTECC recognizes that there are many ways to do something correctly, and allowing the users to integrate their information with others creates a net gain and advancement of the doctrine as a whole.
ISO 9001: Is the International Organization for Standardization (ISO) is an international standard setting body for manufacturing. ISO 9001 is a quality management system certification that strives for continuous improvement. This certification is the minimum requirement for tourniquet manufacturers to make and sell tourniquets in the USA and some other countries. If the tourniquet manufacturer doesn’t have this certification or is not using a contract manufacturer with this certification you would be wise to keep your distance. IE counterfeit tourniquets.
ISO 13485: Is another certification from the International Organization for Standardization. ISO 13485 is specific to medical devices, because it represents that a particular product is manufactured consistently every time. It also includes traceability, which means that Lot and Batch codes are standard, and more importantly that all components and parts are traceable so in the event of any type of failure they can identify which products are defective, where they were sold, and they can process a recall or advisory promptly. ISO 13485 is also a requirement to sell internationally as many countries will not accept the bare minimum of ISO 9001. This is also something you as a customer and user must decide. Is ISO 9001 enough for you regarding quality management or do you want ISO 13485? Having both is probably the best.
GMP: Good Manufacturing Practices (GMP) is a requirement of all manufacturers.
FDA Registrations: All medical device establishments that sell in the USA are required to register and pay the annual establishment registration fee in order to do business. This is the most important, and in actuality the certification / approval / recommendation that actually matters regarding tourniquets. Registration allows the FDA to monitor companies and periodically audit them to ensure they are doing what they should be doing to make safe products. FDA sends inspectors from time to time to audit medical device company quality management systems, and records to verify compliance. This is a good thing, because it makes sure that companies are not selling unsafe products to consumers. FDA registered establishments will have an establishment registration number and an owner operator number. For example:
So how do you verify that a company is FDA registered? Log on to the FDA website page - Establishment Registration & Device Listing – to search the database. You can enter as little or as much information as you like.
Establishment or Trade Name: Enter the name of the company.
Owner / Operator Name: Enter the owner / operator name if doing business under name different than establishment.
Proprietary Name: Enter the proprietary name.
Product Code: Nonpneumatic tourniquet product code is GAX.
Establishment State: Enter company state location, if known.
Registration or FEI Number: Enter registration or FEI number, if known.
Owner / Operator Number: Enter owner / operator number, if known.
Classification Device Name: Class 1, or nonpneumatic tourniquet.
Establishment Type: The majority of companies will fall into 3 of the 12 categories:
Establishment Country: Enter country, via drop-down menu.
*If you can't find the company in the database, you may want to steer clear.
FDA Compliant Quality Management System: All medical device companies are required to have an FDA compliant quality management system that has at least one internal audit performed annually, and is open to FDA audit at any time.
Contract Manufacturers: Are factories / facilities that have the required quality management system certifications and good manufacturing practices in place to manufacture medical devices.
Specification Developers: Are companies or individuals that create the specifications for medical devices. They utilize contract manufacturers to make their medical devices, and can be identified in the device labeling by the manufacturer symbol accompanied by the phrase, “Manufactured For.”
Medical Device Representation: In order to sell medical devices internationally some countries require you to have in-country representation. These companies have access to product technical files, specifications, SOPs, and the like. They assist in notifying international countries in recalls, product advisory, and processing of reports promptly.
Counterfeit Tourniquets: Counterfeit tourniquet is a broad term used to describe tourniquets that are made outside of medical device regulations, quality management standards, federal regulations, good manufacturing practices, and safety. Just because a company can make something doesn’t mean it is safe. That is why the aforementioned documentation, and processes are required to verify and validate that medical devices are safe. Counterfeit tourniquets or other medical devices for that matter that don’t conform are not safe. The FDA guidelines specifically state that if a company is not registered, has a compliant quality management system, scientific evidence to support claims, records, etc. then all products that are in-stock or have been sold are nonconforming and cannot be sold, and the company in violation will be hit with hefty fines, and likely shut down.
Of course, there is little you can do to stop international companies in some countries like China from taking your design, even if you have intellectual property for protection. That’s more of a company issue than a customer / consumer issue. What you can do to protect yourself is don’t buy $8 tourniquets from E-bay, even if a doctor or someone tells you to in a news article. Any physician who tells you buy what is a counterfeit tourniquet on E-bay or the like should probably be reprimanded. Counterfeit tourniquets are dangerous because of all the previous things mentioned, but they are also dangerous because they generally break and fail on first use. Now imagine exposing that tourniquet to sun, sand, saltwater, heat, cold, and other forces; how well do you think it’s going to work?
CE Mark: CE is a French abbreviation for, “Conformité Européene." CE marking represents that a product conforms to the EU health, safety, and environmental protection standards. It is required to sell in the EU.
Class 1 Medical Device (Low-Risk): These devices present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Examples include enema kits and elastic bandages. 47% of medical devices fall under this category and 95% of these are exempt from the regulatory process. Tourniquets are part of this class.
Class 2 Medical Device: Most medical devices are considered Class II devices. Examples of Class II devices include powered wheelchairs and some pregnancy test kits. 43% of medical devices fall under this category.
Class 3 Medical Device: These devices usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category.