As an associate attending in the Department of Medical Physics and chief of Biomedical Engineering at Memorial Sloan Kettering Cancer Center, Paul Frisch is well aware of the challenges being faced today by biomedical engineers.

HealthCare Business News caught up with Frisch to talk about some of the major themes that are dominating the industry and took center stage at this year’s AAMI Meeting.

HCB News: Is your department becoming more integrated with the hospital's IT department? If so, how?
Paul Frisch: Over the last decade the role of Biomedical Engineering has significantly expanded within healthcare institutions. The traditional role of Clinical Engineering that focused on service, preventative maintenance and regulatory compliance has significantly changed. Clinical Engineering no longer works on stand-alone devices. Medical Devices are typically networked, frequently wireless, and integrate to other medical devices, clinical applications and commercial products, such as tablets, cellular phones and scanners. It is becoming increasing important to healthcare institutions to establish working synergies between Biomed, IT and informatics groups with the institution. Clinical Engineering only represents a portion of the overall scope of Biomedical Engineering in today’s hospitals. Depending on the institution Biomedical Engineering can include the investigation of new and evolving technologies, medical device design, device and application integrations, mechanical design, fabrication and 3D printing, managing the electromagnetic environment of the institution and cybersecurity. All of these roles require strong collaboration with IT.

At MSK Biomedical, Engineering and IT have established a strong working synergy. On the service side, service requests go through the center’s IT help desk, where service requests are distributed both to IT and Biomed staff. Biomedical Engineering is a stakeholder and participant in the IT organizational planning, and committee meetings. As an example, an existing Collaboration committee includes Biomedical Engineering, IT and Clinical Staff to jointly review all projects and planned expansions to delegate and ensure resources, funding and the necessary technical skills are available and appropriately assigned.

HCB News: Do you feel like your department is understaffed or feeling a crunch?
PF: MSK, as are most hospitals, is experiencing increasing patient volume and acuity, driving expansion of patient care facilities and new and increasing technologies within the clinical space. Further complicating staffing issues are the new roles being assigned to Biomedical operations. Since many of these new roles require multidisciplinary skill sets beyond those of traditional clinical engineering, it is becoming increasingly difficult to identify the ideal candidates. In most hospitals space is at a premium, where clinical space or patient care space frequently have priority. Therefore, it is necessary to align increased staffing needs to appropriate space.


HCB News: Are you able to get necessary training, codes and manuals from the equipment manufacturers?
PF: Most equipment manufacturers provide equipment-specific manuals at the time of purchase and training is usually available at a price. Challenges can arise through the equipment planning process. Budgets reflecting training and travel need to be created during the equipment replacement planning stages. Budgeting after the fact makes it less likely that sufficient training and travel dollars would be allocated to ensure optimum training.

New regulations focus on ensuring staff competency, which, for many devices, implies that staff is manufacturer-trained on specific system hardware and applications. MSK has implemented “train the trainer” programs to ensure new staff are internally trained to provide some level of core capability and competency.

HCB News: How involved are you in capital equipment purchasing?
PF: This is an increasing area of concern. It is an expectation of regulatory agencies, and vital that Biomedical Engineering organizations are part of the capital equipment purchasing process for medical devices and clinical applications. MSK is currently creating processes, ensuring Biomedical Engineering will be a participant and contributor in the review and recommendation process. This will focus and drive standardization, service coordination, and advanced knowledge and review of space requirements, staffing, and education and training.

HCB News: What role are you being asked to play in hospital cybersecurity?
PF: Cybersecurity is one of the expanding roles of Biomedical Engineering, as mentioned earlier. Medical devices are increasingly networked and integrated into the hospital network architecture. This enables potential security breaches to start at the medical device and penetrate the hospital-networked applications. Many medical devices are designed to be open systems, specifically designed to provide rapid or continuous access and visibility. Biomedical Engineering is partner to IT cybersecurity for medical devices. Early applications focus on developing detailed device connectivity diagrams to identify the access points on the medical devices or device network. Access can go both ways, from the device to the network and from the network back to the device. Research has already documented the ability to alter functionality of medical devices through breeches in security, which have the potential of putting patients at risk. Biomedical Engineering is also working with IT to develop methods to identify security issues and implement a medical device recovery plan.

HCB News: Are you satisfied with the data you are generating for asset management?
PF: Several years ago, Biomedical Engineering started a project to develop an asset life cycle management system that enhanced our capabilities for evidence-based device assessment, life cycle management, data validation and data mining. The data repository integrates with the Center’s RTLS and passive RFID systems providing location content to the assets, reporting and visualization applications. In the near future the Center’s purchasing and financial systems will be provided life cycle information about the devices enabling enhanced replacement planning. The project is investigating the integration of natural language data mining tools to enhance and expand the user interfaces and search capabilities. These tools enable Biomedical Engineering to review, generate and distribute asset information to a variety of users, including technical users, clinical engineering users, administration and executive staff.

HCB News: Are you happy with the relationship you have with OEMs? How could it be improved?
PF: The relationship with the OEM’s is typically a smooth one. I would note, that it is Biomed’s responsibility to be clear on the expectations and deliverables. The OEM should be clear on how data or PM compliance is reported within the institution, as well as identifying the processes for downloading field service information reports.

HCB News: Do you feel that new standards or regulations are needed to ensure that biomeds and ISOs are safe service for patients at the same level as manufacturers?
PF: I believe it is the role of the internal hospital Biomed organizations to define the standards and expectation for service and support. All supporting organizations should be using Biomed policies and procedures to define service and PM standards. Service standards should be altered based only on evidence-based analysis of a specific institution’s experiences, as defined by Biomed organizations.