March 2024 
Health Tech Hazards
Exploring the Executive Brief from ECRI

Introduction

Medmarc provides coverage for manufacturers and distributors of medical devices, pharmaceuticals, biotechnology, and more. This ProAssurance line of business provides Products/Completed Operations Liability (“Products Liability”) and Manufacturers’ Errors and Omissions Liability (“E&O”) for medical technology and life sciences companies. While Medmarc is a part of ProAssurance Group, it does accept applications from other carriers. Medmarc uses an open-market distribution network, meaning that any properly licensed broker may place coverage with them. If you are looking for more information on Medmarc’s services, you can follow this link to explore their resources.

Summary

With the increase of in-home care, the use of at-home devices like infusion pumps and ventilators have increased as well. The at-home devices allow for more comfortable and convenient care; however, the devices were not necessarily designed for those who may lack the knowledge to operate and use them properly. Severe harm can result if patients or caregivers do not fully understand how to troubleshoot or handle the equipment. To minimize possible risks, choose devices that are well matched for patients, caregivers, and their environment as well as provide support for home users in using the medical devices successfully.

Medmarc Resource

“Checklist for Safety Information for Home-Use Products”: Medmarc provides a checklist for safety information for life sciences manufacturers and medical technology companies with home-use products. Their checklist includes looking at how warnings and labels are designed, the messaging used within the instructions and labels, as well as the symbols and pictorials used for messages. They also provide resources for organizations as they are creating labels, instructions, and warning messages for their medical technology.

Summary

Not properly cleaning, disinfecting, and sterilizing reusable medical equipment between uses can potentially lead to the spread of infection or device damage or other forms of harm. The eclectic differences between reprocessing instructions makes it challenging to successfully reprocess medical devices. Many reusable medical devices and healthcare items have incomplete, impractical, or onerous reprocessing instructions. Due to the inconsistency, healthcare workers who perform reprocessing can find it difficult or even impossible to complete the task effectively or could suffer harm. Healthcare organizations should address this issue before purchasing medical devices.

Medmarc Resource

Webinar “Medical Device Design and Infection Prevention”: A growing concern for healthcare providers is the expanding universe of drug-resistant microbes and the hospital-acquired infections that can result in complications, mortality, and morbidity. Infection prevention is critical for medical device manufacturers, as medical devices have been known to harbor drug-resistant microbes and transmit device-related infections even after the devices have been appropriately disinfected. The FDA has addressed the infection rates associated with reprocessed devices like duodenoscopes by placing new and additional obligations on manufacturers to verify that new product designs reduce the contamination rate. 

Summary

Drug compounding is necessary when a commercially available formulation does not come in a “ready-to-administer” form or does not meet patients’ needs in another way. Any potential error made while compounding injectable medications can be severe if not deadly, if the error is not caught before administering to the patient. Accurate compounding is key for all preparations, but it is especially crucial for injectable preparations because of their need to be sterile, the frequency of compounding required, the opportunities for error, and potential for significant harm.

Medmarc Resource

Pharmaceutical Compounding: From the time a 2012 fungal meningitis outbreak that was tied to a compounding center was exposed for the common misuse of pharmaceutical compounding, compounding has grown to be the center of media and governmental attention. While there are concerns, compounding has several legitimate and necessary uses in healthcare. Legitimate compounding is done on a patient-by-patient basis although there are exceptions for animals and children if a dosage of an approved drug may not be suitable. Areas to consider when discussing compounding include traditional vs. nontraditional methods, oversight and regulation, the concerns of compounding, and why drugs are compounded.

Increased Burn Risk with Single-Foil Electrosurgical Return Electrodes

Summary

Adult patients are placed at an unnecessary risk of burns during electrosurgery when single-foil conductive return electrodes are used instead of safer options. Alternatives include the use of dual-foil conductive return electrodes, capacitive return electrodes, or other treatment modalities. ECRI challenges return electrode manufacturers to cease the manufacture and sale of single-foil conductive return electrodes, particularly for adult patients.

Surgical Fires

The term “never event” was coined in 2001 to describe medical errors that should never happen. The National Quality Forum (NQF) now lists 29 types of never events (also referred to as “serious reportable events” by NQF and “sentinel events” by The Joint Commission). Surgical fires are among the most common sentinel events reported by hospitals.

Surgical fires occur in a wide variety of medical settings, from solo practices to large hospitals. Surgical fire prevention depends mostly on fire risk awareness and communication among the members of the surgical team. Any team member can prevent or contribute to a surgical fire because elements of the fire triangle—air (oxygen), fuel (prepping solution, drapes, patient skin), and ignition source (electrosurgical units)—are generally overseen by different members of the surgical team. Therefore, all team members should think about how their actions might inadvertently complete the fire triangle and should communicate with other team members about fire risk status throughout the surgery.

The case studies below address examples of surgical adverse incidents that involve surgical fires. Consider how the various surgical team members could have prevented the fires.

• Case Study: Electrocautery Ignites Supplemental Oxygen
• Case Study: Electrocautery Ignites Alcohol-Based Surgical Prep
• Case Study: Electrocautery Ignites Aerosolized Anesthetic

Summary

Damage to an infusion pump can affect its ability to accurately deliver fluids or medications, which may result in dangerous medication administration errors. Pump damage also can distract staff as they look for a replacement device and may ultimately delay therapy for the patient. Furthermore, if the damage goes unnoticed or uncorrected, multiple patients can be put at risk. ECRI challenges manufacturers to advance the technology by designing models that, for example, have fewer damage-prone components, can more reliably prevent gravity flow, and are made from materials that can withstand cleaning with a greater variety of chemicals.

Medication Administration Errors

A recent article by the Institute for Safe Medication Practices highlights the importance of implementing strategies to prevent persistent medication errors and hazards. From the article:

“The Five Rights” are broadly stated expectations set forth with the desire to achieve safe medication practices. The belief is that the five rights will ensure the right patient is given the right medication, at the right dose, at the right time, and via the right route. However, the five rights must be recognized for what they are, merely desired outcomes for safe medication practices. … Ultimately, prevention of medication errors relies on the integrity of several complex, interrelated systems designed with high-leverage safety practices and strategies to reduce risks and limit harm, coupled with clearly defined processes and behavioral expectations.

According to the World Health Organization (WHO), medication errors cause at least one death every day and injure approximately 1.3 million people annually in the United States. Globally, the cost associated with medication errors has been estimated at $42 billion annually.

The case study below highlights the importance of medication management, which includes documentation, reconciliation, and communication.

• Case Study: Negligent Medication Management Alleged for Seizures and Brain Damage

Summary

A high number of defective single-use medical devices are present in the supply chain. That broad concern remains, but for the current year we’ve focused on one specific product group: implantable products intended for use during orthopedic procedures. The prevalence of quality control (QC) issues related to these products and the potential for significant harm warrant particular attention. Implantable orthopedic products range from simple items—such as bone screws, rods, and plates—to complex ones, like knee and hip prostheses. Defects in these products can delay or prolong surgery and can lead to other harm, including persistent pain or infection, that may not become evident until long after the patient’s surgery. ECRI challenges manufacturers of implantable orthopedic products—and all single-use medical devices—to strive for zero defects in their manufacturing and packaging processes.

Medical Device Defects

Each year, the U.S. Food & Drug Administration (FDA) receives several hundred thousand medical device reports of suspected device-associated deaths, serious injuries, and malfunctions. The ECRI advises healthcare organizations to instruct medical device users to look for and report signs of medical device defects prior to use, tracking defects that are reported and holding manufacturers and distributors accountable, using the organization’s leverage to push for improvements.

The case study below highlights an incident in which the defendant neurosurgeon failed to detect that a patient’s shunt was malfunctioning. A plaintiff’s expert testified the physician was negligent for failing to order a diagnostic test that would have shown the shunt was malfunctioning.

• Case Study: Failure to Detect VP Shunt Malfunction Results in Bilateral Optic Neuropathy

We are committed to responsible pricing that reflects the current risk environment. After a recent review of our rate plan and rating factors, we have updated our rate strategy for new and renewal accounts in Oregon. The following changes, which have been filed and approved, may impact NORCAL insureds:

• 5% Base Rate Increase
• Revised Separate Limits Entity Factors: Increased Separate Limits Entity factors for 2+ group size
• Revised Physician Specialty Class Factors:
  • Increase: Bariatric Surgery, Cardiovascular Surgery, Emergency Medicine (with Trauma), General Surgery, Neurosurgery, Orthopedic Surgery (including Spinal Surgery), Physician NOC (Major Surgery), Thoracic Surgery, Vascular Surgery
• Revised Physician Specialty Class Assignments:
  • Increase: Dermatology (Major Surgery), Emergency Medicine, Hospitalist (including ER), Hospitalist (including Minor Surgery), Hospitalist (No Surgery), Ophthalmology (Minor Surgery), Otolaryngology (Major Surgery), Pain Management (Interventional), Plastic Surgery, Radiology (Diagnostic), Radiology (Interventional), Urology (Major Surgery)
  • Decrease: Infectious Disease, Pediatrics (Minor Surgery)

These changes go into effect April 1, 2024, and are applicable to new and renewal accounts. We will notify affected policyholders of the changes.