ISO. FDA. CE. They are acronyms used in the medical equipment industry every day. But why are they important to YOU as a doctor, surgeon, or hospital owner? This article explores the reasons why device standards are so important as well as the top 5 reasons why you should buy your medical equipment from an ISO-certified company.
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International medical device standards are important because they require medical device companies to supply equipment that is safe and reliable for healthcare professionals across the globe. In their guide, Medical Device Regulations: Global Overview and Guiding Principles, the World Health Organization outlines the four key reasons why we need standards. They are summarized below:
Buying hospital equipment from an ISO-certified company is one of the best ways for a doctor or administrator to enjoy a superb customer experience. ISO certification is linked to higher quality of service, decreased liability, and ease of device importation and installation. Below are five specific benefits of buying your equipment from an ISO-certified company:
Device companies that are ISO-certified are required to have an approved quality policy to which employees adhere. This policy is usually a few sentences in length and describes the supplier's commitment to delivering the highest quality of product and service. The policy is posted in highly visible locations within the organization and employees are required to know it. Here is an example of a quality policy:
Many countries across the globe have stringent regulations that require hospitals and surgery centers to purchase medical equipment from ISO-certified providers. Narrowing the field of prospective equipment vendors to those with ISO certification eliminates potential roadblocks and delays that can arise during customs clearance and equipment inspections.
Delivering a superb customer experience is a top goal for certified companies. As a doctor or hospital owner who buys surgical equipment from a certified provider, you may notice that your supplier is continually seeking ways to deliver your equipment more efficiently. For instance, you may notice progressively faster order processing times, shorter delays in receiving technical support, and improvements in product functionality or appearance.
ISO certification requires medical device companies to exhibit a strong focus on risk management. Certified companies must provide evidence that they begin managing risks from the moment they begin preparing a device to the post-delivery phase. Purchasing products that were prepared with risk management in mind helps doctors and hospitals reduce liability risks and optimize patient safety.
Knowing that you are purchasing hospital equipment from a company that is committed to patient safety and continued improvement increases satisfaction and peace of mind. You can rest more easily knowing that your hard earned money is being spent on equipment that is designed by a quality-minded provider.
Taking a chance with an equipment company that lacks ISO certification may not produce any consequences. However, you leave yourself at an increased risk for delays, product defects, and failed inspections. Here are some of the risks of NOT buying medical equipment from a certified provider.
Device companies that lack ISO certification are under no formal obligation to develop an efficient quality management system (QMS). In some cases, they may not even have policies and procedures in place to address production hiccups or returned merchandise. This can lead to severe delays in receipt of your equipment and technical support.
Inefficiencies, delays, and poor quality of service all contribute to a poor customer experience. You may find yourself spending all of your time tracking down your equipment supplier in an effort to address product defects or poor service. This could ultimately lead to dollars lost and compromised patient safety.
Few things are more frustrating than paying thousands of dollars for a piece of equipment only to have it confiscated during the customs clearance process. If your country requires ISO certification and you purchase a device from a vendor that lacks certification, you may face lengthy difficulties clearing your equipment.
A growing number of regulatory bodies are requiring doctors and hospitals to purchase equipment from companies with ISO certification. Failure to offer proof that you are working with a certified manufacturer can lead to failed equipment inspections, confiscation of your equipment, and even closure of your hospital or surgery center.
In spite of the many advantages ISO certification offers, there are many medical equipment suppliers that are not certified. Confirming certification is not always as easy as checking a provider's website, and it is up to you as an equipment buyer to find out if you are working with a certified provider. Here are three key ways to find out if you are working with an ISO-certified medical equipment provider"
The simplest way to find out if a company is ISO-certified is to request a copy of the company's certificate. The salesperson with whom you are working should be able to send you a copy of the certificate by or . Here is a copy of an actual ISO : certificate issued in :
ISO audits and certifications are overseen by an official external agency. In the United States, most audits are conducted by NSF International Strategic Registrations (NSF-ISR). If you have access to a copy of the device company's certificate, you can find the name and number of the certifying organization at the bottom of the certificate.
The certificate will also contain a footer that provides the website address for the certifying agency and instructions for anyone who wishes to verify registration. The website will contain a way for you to search for ISO-certified medical device companies. Below is a screenshot of NSF's website, which features this search feature in the lower left corner in orange:
If you would like additional validation that an equipment supplier is certified, you can enlist the support of a third-party organization or auditor to verify certification. This option is sometimes chosen by doctors or hospitals who have hired a consultant to oversee all of their procurement activities.
There are many reasons to purchase your medical equipment from an ISO-certified device company. From outstanding product quality to increased peace of mind, the benefits of buying from an ISO-certified company are numerous and impressive.
To learn more about the advantages of purchasing medical equipment from a certified provider, please contact us at Avante Medical Surgical by at +1-502-244- or by at As an ISO-certified organization, we deliver high quality products and service to clients in over 150 countries. We look forward to becoming your single solution for all of your equipment needs!
Kary VanArsdale is the Director of International Sales for Avante Medical Surgical (formerly DRE Medical). She is also a psychologist and Certified International Commerce Specialist. With over 16 years of experience in the international medical equipment industry, Kary has helped clients from over 150 countries save money on their medical equipment purchases. She also designed the content for the following microsites, which are designed to help medical equipment professionals across the globe make cost-effective purchasing decisions:
When it comes to surgical procedures, the quality of the instruments used can have a significant impact on the outcome. As high-quality surgical instruments can make a difference in precision, accuracy, and ultimately patient safety.
Moreover, the surgical instruments that come with high quality will by default come with longer virtual life thanks to the high-end materials and lower need for surgical instrument maintenance.
In this article, we will explore the benefits of using high-quality surgical instruments, with tips, and some other interesting details.
7 Benefits of High-Quality Surgical Instruments:
The benefits you must hear about when searching whether to use or not quality surgical instruments, so you would be able to make the right investment:
1. Precision and Accuracy:The quality surgical instruments are designed with precision and accuracy in mind. They are manufactured with tight tolerances and precise dimensions to ensure that they perform exactly as intended.
This level of precision is vital in surgical procedures where even small deviations can have significant consequences. Thus, surgeons need quality instruments to be able to make smaller, more precise incisions, reducing the risk of complications and improving patient outcomes.
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2. Durability and Longevity:Surgical instruments are designed to be durable. They are made from high-quality materials that resist sterilization, wear, and corrosion. This means that they can stand up for a long time.
Therefore, when investing in high-quality surgical tools, you can expect to see a return on your investment in the long run.
3. Patient Safety:Perhaps the most critical benefit of using quality surgical instruments is the impact on patient safety. As high-quality instruments are less likely to break or malfunction during a procedure, reducing the risk of complications and improving patient outcomes.
Additionally, high-quality instruments are easier to clean and sterilize, reducing the risk of infection and ensuring that they are safe for use in each procedure.
Furthermore, they help reduce the risk of complications, infections, and other adverse events, ultimately benefiting patient recovery and overall health.
4. Comfortable Function:High-quality surgical instruments are designed with comfortable function in mind. They are engineered to fit comfortably in the hand, reducing strain and fatigue for the surgeon.
This quality improvement will lead by default to increased precision and accuracy during long procedures, reducing the risk of errors and improving patient outcomes.
5. Training and Education:Using excellent surgical instruments can have a positive impact on the training and education of medical professionals. As they can provide a consistent and reliable platform for training, allowing medical professionals to develop their skills with confidence.
Moreover, using high-quality instruments in training can help to ensure that medical professionals are prepared for real-world surgical procedures, improving patient outcomes and safety.
6. Cost-Effectiveness:While high-quality surgical instruments may have a higher upfront cost, yet, their durability and reliability can lead to long-term cost savings. Investing in quality instruments reduces the need for frequent replacements or repairs, minimizing operational expenses over time.
While, on the other hand, if you invest in low-quality tools, you may have to replace them in a short time, leading to increased long-term expenses.
7. Enhanced Surgeon Satisfaction:Surgeons prefer working with high-quality instruments that offer superior performance and precision.
And using reliable tools enhances surgeon satisfaction, which will cause better efficiency, reduce stress, and improve overall job satisfaction. Moreover, helps you avoid the dangerous surgeon burnout.
Tips for Choosing the Right Supplier for High-Quality Surgical Instruments:
When selecting a supplier for excellent surgical instruments, healthcare facilities should consider the following factors:
To conclude,
Having high-quality surgical instruments is essential if you need to ensure precision, accuracy, durability, patient safety, improved work circumstances, and effective training and education for your team.
Keep in mind, that by choosing superior surgical instrument innovation, medical professionals can provide their patients with the best possible care, improving outcomes and ensuring safety throughout the surgical process.
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