Seven Ways to Inspire Innovation in the Health Technology Industry

This article explores ways in which technological innovation can be bolstered in organizations that operate in the health technology industry. We present seven interventions at the team level (employee empowerment, servant leadership, hiring innovators, and scheduling time for innovation) and organizational level (intrapreneurship, flat management, and allowing for failure) that organizations can use to encourage and inspire innovation among employees. Given the increasingly dynamic nature of work within the health technology fields, in terms of both manufacturing processes and clinical developments, creating a culture of innovation and creativity and emboldening employees to regularly engage in such behaviors within these workplaces are critical.

Usability Engineering Recommendations for Next-Gen Integrated Interoperable Medical Devices

This article reports on the development of usability engineering recommendations for next-generation integrated interoperable medical devices. A model-based hazard analysis method is used to reason about possible design anomalies in interoperability functions that could lead to use errors. Design recommendations are identified that can mitigate design problems. An example application of the method is presented based on an integrated medical system prototype for postoperative care. The AAMI/UL technical committee used the results of the described analysis to inform the creation of the Interoperability Usability Concepts, Annex J, which is included in the first edition of the new ANSI/AAMI/UL 2800-1:2019 standard on medical device interoperability. The presented work is valuable to experts developing future revisions of the interoperability standard, as it documents key aspects of the analysis method used to create part of the standard. The contribution is also valuable to manufacturers, as it demonstrates how to perform a model-based analysis of use-related aspects of a medical system at the early stages of development, when a concrete implementation of the system is not yet available.

Quality Fade in Medical Device Manufacturing: Thinness of Airway Breathing Circuit Plastic

Mechanical respirators typically use a plastic circuit apparatus to pass gases from the ventilator to the patient. Structural integrity of these circuits is crucial for maintaining oxygenation. Anesthesiologists, respiratory therapists, and other critical care professionals rely on the circuit to be free of defects. The American Society for Testing and Materials maintains standards of medical devices and had a standard (titled Standard Specification for Anesthesia Breathing Tubes) that included circuits. This standard, which was last updated in 2008, has since been withdrawn. Lack of a defined standard can invite quality fade—the phenomenon whereby manufacturers deliberately but surreptitiously reduce material quality to widen profit margins. With plastics, this is often in the form of thinner material. A minimum thickness delineated in the breathing circuit standard would help ensure product quality, maintain tolerance to mechanical insults, and avert leaks. Our impression is that over the recent years, the plastic in many of the commercially available breathing circuits has gotten thinner. We experienced a circuit leak in the middle of a laminectomy due to compromised plastic tubing in a location that evaded the safety circuit leak check that is performed prior to surgery. This compromised ventilation and oxygenation in the middle of a surgery in which the patient is positioned prone and hence with a minimally accessible airway; it could have resulted in anoxic brain injury or death. The incident led us to reflect on the degree of thinness of the circuit's plastic.

Words Matter: A Commentary and Glossary of Definitions for Microbiological Quality

In the design, control, and regulation of the manufacturing and supply of microbiologically controlled devices (including sterile devices) and drug products (including cleaning, disinfection, and sterilization processing and/or aseptic process manufacturing), different terms and/or definitions are often used for similar processes or applications internationally. With product innovations (including combination products and cell-based therapy) and global regulatory influences, there is a growing need to harmonize these definitions. The objective of the Kilmer Regulatory Innovation microbiological quality and sterility assurance glossary is to clarify and harmonize the practical use of terms employed by the different parts of regulated healthcare product industries internationally and by regulators of the manufacturing and supply of microbiologically controlled healthcare products internationally. The glossary is expected to continue to evolve, and further industry, academic, and regulatory input is encouraged.

Assessing Detergent Residuals for Reusable Device Cleaning Validations

Cleaning chemistries are detergent-based formulations that are used during the processing of reusable medical devices. Manufacturers are responsible for demonstrating the safety of cleaning formulations when they are used during a device processing cycle, including the risk of device-associated cytotoxicity over the concentration ranges for recommended use and rinsing during cleaning. However, no regulation currently exists requiring manufacturers to demonstrate such safety. Although manufacturers' safety data sheets (SDSs) provide information on the safe use of chemicals for users, this information may not provide sufficient detail to determine the risks of residual chemicals on device surfaces. SDSs are not required to contain a comprehensive list of chemicals used, only those of risk to the user. They should be supplemented with information on the correct concentrations that should be used for cleaning, as well as instructions on the rinsing required to reduce the levels of chemicals to safe (nontoxic) levels prior to further processing. Supporting data, such as toxicity profiles or cytotoxicity data that support the instructions for use, would provide medical device manufacturers and healthcare personnel with the necessary information to make informed decisions about selection and correct use of detergents. In the current work, cytotoxicity profiles for eight commonly used cleaning formulations available internationally were studied. Although all of these products are indicated for use in the cleaning of reusable medical devices, results vary across the serial dilution curves and are not consistent among detergent types. The information presented here can be leveraged by both medical device manufacturers and processing department personnel to properly assess residual detergent risks during processing. This work also serves as a call to cleaning formulation manufacturers to provide this information for all chemistries.

Selecting a Passive Network Monitoring Solution for Medical Device Cybersecurity Management

The number of cyberattacks and information system breaches in healthcare have grown exponentially, as well as escalated from accidental incidents to targeted and malicious attacks. With medical devices representing a substantial repository of all the assets in a healthcare system, network security and monitoring are critical to ensuring cyber hygiene of these medical devices. Because of the unique challenges of connected medical devices, a passive network monitoring (PNM) solution is preferred for its overall cybersecurity management. This article is intended to provide guidance on selecting PNM solutions while reinforcing the importance of program assessment, project management, and use of leading practices that facilitate the selection and further implementation of PNM solutions for medical devices. The article provides a detailed introduction to connected medical devices and its role in effective care delivery, an overview of network security types and PNM, an overview of the National Institute of Standards and Technology Cybersecurity Framework and its application for program assessment, essentials of project management for PNM solution selection and implementation, key performance indicators for measuring a solution's ability to meet critical cybersecurity needs for medical devices, and lessons learned from the author's professional experience, selective literature review, and leading practices. Rather than describing a complete list of guidelines for selecting PNM solutions, the current work is intended to provide guidance based on the author's experience and leading practices compiled from successful medical device cybersecurity programs.

Determining EMC Test Levels for Implantable Devices in Bipolar Lead Configuration

Certain low-frequency magnetic fields cause interference in implantable medical devices. Electromagnetic compatibility (EMC) standards prescribe injecting voltages into a device under evaluation to simplify testing while approximating or simulating real-world exposure situations to low-frequency magnetic fields. The EMC standard ISO 14117:2012, which covers implantable pacemakers and implantable cardioverter defibrillators (ICDs), specifies test levels for the bipolar configuration of sensing leads as being one-tenth of the levels for the unipolar configuration. The committee authoring this standard questioned this testing level difference and its clinical relevance. To evaluate this issue of EMC test levels, we performed both analytical calculations and computational modeling to determine a basis for this difference. Analytical calculations based upon Faraday's law determined the magnetically induced voltage in a 37.6-cm lead. Induced voltages were studied in a bipolar lead configuration with various spacing between a distal tip electrode and a ring electrode. Voltages induced in this bipolar lead configuration were compared with voltages induced in a unipolar lead configuration. Computational modeling of various lead configurations was performed using electromagnetic field simulation software. The two leads that were insulated, except for the distal and proximal tips, were immersed in a saline-conducting media. The leads were parallel and closely spaced to each other along their length. Both analytical calculations and computational modeling support continued use of a one-tenth amplitude reduction for testing pacemakers and ICDs in bipolar mode. The most recent edition of ISO 14117 includes rationale from this study.

Thermal Disinfection Validation: The Relationship Between A0 and Microbial Reduction

Validating a thermal disinfection process for the processing of medical devices using moist heat via direct temperature monitoring is a conservative approach and has been established as the A0 method. Traditional use of disinfection challenge microorganisms and testing techniques, although widely used and applicable for chemical disinfection studies, do not provide as robust a challenge for testing the efficacy of a thermal disinfection process. Considerable research has been established in the literature to demonstrate the relationship between the thermal resistance of microorganisms to inactivation and the A0 method formula. The A0 method, therefore, should be used as the preferred method for validating a thermal disinfection process using moist heat.