ECRI Blog

Recently, 3M™ issued an urgent, voluntary recall of select models and lots of 3M™ Steri-Drape™ Surgical Drapes distributed between October 29, 2021, and August 25, 2022.

How is the drape used?

The Steri-Drape is made from clear polyethylene plastic with a matte finish, which includes an adhesive strip. It is used as a surgical drape for patients during procedures. This drape is intended to absorb liquids with no strike-through to decrease the risk of microbial migration, and function as a barrier to skin.

The effected products include: 3M™ Steri-Drape™ Surgical Drapes, Catalog Numbers 1000, 1000NS, 1000NSD, 1010, 1010NS, 1010NSD, 1020, 1020NS, 1021, 1021NS, 1030, 1030NS, 1033, 1060, 1060NS, 1061, 1061NS, and 1071.

What do you do with a medical device when it reaches the end of its useful life? If the device was used to store, generate, or communicate protected health information (PHI) or other sensitive data, you can't dispose of the device "as is." You'll first need to take steps to minimize security risks. Creating a structured decommissioning process now will help assure that the protections you need are in place when you dispose of medical devices in the future. 

Data security concerns

For any medical device that may contain sensitive data, the decommissioning process needs to account for the proper disposal of that data, regardless of whether the device is to be destroyed, sold, refurbished, reassigned to another location within the facility, or otherwise reused.

NFL football is an American pastime, but fun turned to fear last week as Buffalo Bills safety Damar Hamlin, age 24, collapsed on the field. Cardiac arrest is particularly uncommon for healthy young people. However, athletes may be at greater risk than others when actively competing in sports.

Hamlin is not alone. Every year, about 356,000 people in the US experience cardiac arrest outside of a hospital setting—that’s nearly 1,000 people per day. Sadly, an estimated 90% of these events are fatal.

Despite representing nearly 10% of deaths in the US each year, cardiac arrest is poorly understood by the general public. Unlike a heart attack, in which an artery that provides blood to heart tissue is blocked, cardiac arrest is an electrical issue, and the heart can no longer contract in a coordinated manner. As a result, blood cannot be pumped throughout the body, and heart and brain tissue can begin to die off from a loss of oxygen.

To make more effective and efficient decisions regarding budgeting and managing medical equipment, it’s essential that healthcare organizations focus on capital budgeting, medical equipment selection, and recall management. 

Capital budgeting is the process of allocating funds for the purchase of long-term assets, such as medical equipment. The goal of capital budgeting is to ensure that a healthcare organization has the funds necessary to purchase needed equipment and can do so while maintaining a balanced budget.  

Equipment selection is an area of critical focus during the process. To select the right equipment, healthcare organizations should understand the benefits and drawbacks of the various different types of medical equipment.  

You’ve heard and followed the familiar adage, “consider the source.” And for good reason, since the adage reminds one to verify the trustworthiness of a source before heeding its content. Perhaps nowhere does the saying ring truer than healthcare, where lives are at stake and resources limited.

For health systems, the acquisition of a new medical device can be fraught with a lot of "noise." As a system works to evaluate the potential of a new technology, subjective factors, personal biases, and marketing hype can influence perceptions at a time when identifying trustworthy sources is critical. A lack of sound evidence can further complicate the process.

However, decisions between supply chain and clinical leaders are still possible even when evidence is not conclusive.

In fact, the value analysis process can provide opportunities to engage and educate physicians about acquisition management and the standards and evaluation criteria that will help health systems obtain products that best meet their needs and provide desired clinical outcomes.

Identify biases

A good starting point is to ask your physicians where they get their information and then discuss those sources, so they, as good stewards of institutional resources, become more aware of common biases such as:

In one of the latest challenges for the embattled healthcare supply chain, the U.S. Food & Drug Administration (FDA) reported that there is now a shortage of tracheostomy tubes, especially pediatric tracheostomy tubes.

"This supply chain disruption disproportionally affects the pediatric population due to the already limited number of products available for this patient population and the spike in cases of respiratory illnesses in children," says Jillian Hillman, ECRI's senior manager, Functional Equivalents - Device Evaluation.

To help reduce the burden on healthcare providers and promote patient safety, ECRI has issued this functional equivalents report. ECRI will offer updated guidance as this situation unfolds.

The shortage includes the Bivona® tracheostomy tubes manufactured by ICU Medical. The shortage may be related to difficulties in getting the raw materials needed to make the tracheostomy tubes. 

Healthcare organizations are some of the most complex and critical in the world. Supply chain disruptions in healthcare can have a ripple effect on patients, staff, and the community at large. So, whether you are running a health system, hospital network, aging services facility, or ambulatory care center, supply chain disruptions are crucial to understanding your organization as a whole. 

A supply chain is a complex network of individuals and companies that design, manufacture, distribute, and consume healthcare products. Because supply chains are so complex, it's easy for disruptions to occur. Some disruptions are due to labor strikes, transportation issues such as weather-related traffic jams or port closures, supplier bankruptcies, and product recalls. Other reasons could be that a company is sourcing products from a region that's experiencing political instability or if they rely on a limited number of suppliers. 

This can leave you without the necessary supplies or medications that you need to provide the level of care your patients deserve. That being said, there are ways that providers and healthcare facilities can prepare for these disruptions. If you're looking to navigate supply chain changes more effectively, keep reading for tips on preparedness and management strategies you can employ.

While COVID-19 has waned, it has not yet disappeared. Schools, community leaders, and healthcare providers continue to closely “watch the numbers” to ascertain local infection rates and take actions and precautions accordingly. While they do that, business leaders, especially those in the healthcare industry, continue to watch another indicator—the supply chain and its disruptions.

In addition to the pandemic, several other forces have continued to disrupt the supply chain. Recent labor strikes, worker shortages, production slow-downs or stoppages, and war continue to impact the supply chain. To date, the healthcare industry and general public have experienced shortages in personal protective equipment (PPE), baby formula, and now surgical staplers.

Supply chains are frequently discussed, but what is their role in delivering safe and effective care across hospitals, aging care services, and ambulatory care facilities? Awareness of supply chains increased during the COVID-19 pandemic due to the fact that lockdowns were being implemented globally, slowing down the manufacturing of new products, and interrupting the import and export of goods. Supply chains play a role in every industry, but those in healthcare might not have the in-depth understanding of supply chains that they should. No matter what type of health facilities you operate or healthcare services you offer, let's take a closer look at what roles the healthcare supply chain plays in your organization.

What is a healthcare supply chain?

A healthcare supply chain refers to the network of systems, companies, and individuals involved in the healthcare industry and health services. From the raw production of ingredients necessary to make medications to the prescription drugs actually given to patients, everyone plays a role in the healthcare supply chain. Supply chains feature a range of global players, and planning plays a major role in ensuring that everything is operating smoothly. This is why, when faced with a serious illness like COVID-19 that prevented healthcare products from being produced or delivered, the supply chain was able to be impacted so easily. Without the supply chain, the healthcare industry would simply not function.

Recently, Covidien, LLC, a subsidiary of Medtronic, recalled Palindrome and Mahurkar hemodialysis catheters due to a catheter hub defect. Once again, we are reminded that patient safety and supply chain are not separate parts of healthcare that should function independently of each other. Rather, their interdependence is vital to increasing patient safety and optimizing clinical outcomes; creating efficient, safe, and successful working environments; and maintaining the fiscal viability of healthcare facilities, be they large or small, private or public.

The COVID-19 pandemic brought this simmering issue to the surface, and healthcare provider organizations are getting smarter about preparing for the unexpected and strengthening their supply chains. ECRI has long offered such advice and support, and we continue to expand and strengthen our guidance, specifically in the area of providing trustworthy, independent functional equivalent information and  vendor information that is available quickly, easily, and cost-effectively—most importantly, it’s reliable information.