Recalls of home medical devices and defective single-use devices are among the top concerns of the Penn State-based nonprofit’s Top 10 Technology Risks of 2023.
The growing popularity of smart home and home health care technology, including remote patient monitoring software, means there are more medical devices in the home to supervise, either by the care team or by patent. This may lead to problems if the devices are not working.
Tops the challenge of identifying home medical device recalls Top 10 Technology Risks for 2023An annual report issued by ECRIIt is a Pennsylvania-based nonprofit organization focused on safety, quality, and cost-effectiveness in health care. Now at the age of 16y In the year, the report highlights problems associated with healthcare technology, and identifies trends in care delivery that may come as a surprise to both providers and patients.
With medical devices at home, ECRI notes, patients who use these devices at home may be the last to hear about a recall, and may not understand what a recall means or what an address is like.
The report notes, “Device manufacturers rarely have direct contact with home care patients; health care providers may not proactively contact patients about recalls.” “As a result, patients who use medical devices at home may learn about a recall — and the steps necessary to ensure safe use of the device — long after it has been issued, possibly from an unreliable source, such as a television ad for a class action lawsuit or through social media.”
In addition, the recall notice may be filled out in technical language that patients do not clearly understand. They may not understand the risks involved with the device and continue to use it.
“ECRI challenges manufacturers of medical devices that can be used outside of the hospital environment to implement measures such as: providing users with easy-to-follow device registration instructions, writing simple-worded recall notices, maintaining up-to-date device distribution databases, and hiring staff to ensure recalls reach home users.” says the report.
Second on the list is another growing trend in healthcare: the growing number of single-use medical devices, designed to be used once and then thrown away. ECRI indicates that there is an “unacceptably high number of defective single-use medical devices,” which can negatively affect patient care, lead to delays in care or treatment, and even harm patients.
The report notes that “ECRI has received reports of cracked tubes and connectors; sterilization of needles, catheters, and procedure kits; and incorrect product labeling.” “These are just a few examples of product defects that can lead to waste, delay, incorrect treatment, healthcare acquired infection, or other patient harm.”
“The European Commission against Racism and Intolerance is concerned that some device manufacturers are not doing enough to address the problem,” she says. “In fact, rather than seeing improvements over time, we’ve seen a steady increase in problem reports. ECRI urges manufacturers to take decisive steps to improve quality control (QC) processes.”
The rest of the list is as follows:
- Improper use of automated dispensing cabinet bypasses.
- Undetected intravenous needle displacement.
- Failure to manage cybersecurity risks associated with cloud-based clinical systems.
- Inflate by pressure.
- Confusion surrounding respirator cleaning and disinfection requirements.
- Common misconceptions about electrosurgery.
- Excessive use of cardiac telemetry.
- Do not report device-related issues.
Many of the items on this list are caused or exacerbated by the pandemic. Healthcare organizations struggled to maintain operations during the height of the COVID-19 crisis, and most are still dealing with stress, burnout, and staffing issues. In this environment, healthcare providers are more likely to consider workarounds or bypass established procedures to get something done, which can lead to unsafe or dangerous practices. It is inherent in management at this time to stress the importance of safety protocols.
At the same time, the report calls on the medical device industry to be more serious.
“This year we will expand the challenge to our industry colleagues,” the report notes. “We believe that some of the risks described in this report can be mitigated—and perhaps even eliminated—through improved device designs or manufacturing practices. As a general rule, an engineering solution that removes risk will always be better than a training solution that can only warn of a hazard.” With the COVID-19 pandemic leaving healthcare facilities understaffed and healthcare workers stressed, it is more important than ever that medical technologies are designed in ways that help ensure they are used safely.”
The European Commission against Racism and Intolerance has also noted the trends it has identified over the years in its reports that have led to industry-wide improvements. The 1970s helped spur improvements to manual resuscitators to prevent insufficient lung inflation, and the 1980s saw a move toward more secure electrode connections to patient monitoring equipment to prevent electrocution.
In the 1990s, reports prompted the industry to improve bed safety to prevent slipping and choking, as well as adding free-flow prevention mechanisms to infusion pumps to prevent overuse of medication. Since 2000, the organization has urged industry to improve the integration of drug libraries and syringe pumps to prevent drug dosing errors; improving CT scanner dose control techniques to reduce radiation exposure; and improving endoscopic re-treatment procedures and techniques to prevent cross-contamination.
Eric Weklund is HealthLeaders’ Innovation and Technology Editor.