As the senior director of biomedical engineering at the Children's Hospital of Philadelphia, Andrew Rich oversees a 32-person biomedical department that supports approximately 32,000 devices.

Needless to say, he is no stranger to the challenges hospitals face with managing medical equipment. HealthCare Business News spoke to Rich about current trends impacting the profession, challenges and best practices for acquiring new equipment and what the “Rodney Dangerfield effect” has to do with the current shortage of biomedical engineers.

HCB News: At CHOP, are you seeing the convergence of the IT and biomedical departments?
Andrew Rich: Absolutely. There's a long history with biomed departments and where they fit into organizations over the years, and I think we’re witnessing the next iteration of that. As more and more medical devices need to have their information in the patient's EHR, the greater the need and driver for biomeds and IT to work closely together.

As of 2½ years ago, our department reports directly to IT, but that close relationship started several years before as we began doing a lot of device integration projects. Reporting to IT has worked out well.

We needed to support IT in the integration of data from medical devices, which is not cut and dry like other IT devices, but we also needed to build up the relationships and help IT understand what medical devices are, how they're used and the challenges faced with connectivity.

It's not unusual at some hospitals for IT and the biomed department to not know who is responsible for what. That's more the norm, I think, and that's what I tried to avoid by integrating our work with IT. We were able to keep that wedge from being formed, so when an IT project manager wants to bring resources together for integration, we have a seat at the table.

HCB News: How involved are you in capital equipment purchasing?
AR: We're very involved with [the] acquisition of new medical devices. There are many systems we have in place to evaluate those requests, and we're a part of that evaluation process – whether it's a committee-based request or a clinical engineer doing a technical assessment of a device and making recommendations. We're very involved in that.

On the software side, it's more of a shared effort on medical devices between IT and biomed.

HCB News: Do you feel like your department is understaffed or feeling a crunch?
AR: I wouldn't say we're understaffed. We've been staffed appropriately over the years partly because of our support at CHOP and our place within the organization, but our stress level is more related to growth of the organization and keeping up by hiring good, quality people. Having the right staff is more challenging than having enough staff.

It's tough because the educational pipeline has gotten much smaller for biomeds than it was 10 or 15 years ago, so it's difficult to recruit and positions are open six months to a year sometimes before you find someone.

HCB News: What do you attribute that to?
AR: We've always been faced with an identity crisis where people don't know who we are and what we do. I'm on the path to retirement right now and working remotely, but when I was in Philadelphia, I was an adjunct teacher at a local community college trying to get more students interested in a biomedical engineering career.

We just don't have a great pathway because nobody really knows what we do, even though we're listed as one of the up and coming career opportunities for people. We have that Rodney Dangerfield effect. We don't have any respect.

Hopefully, it's starting to turn around with schools like the Community College of Philadelphia helping us get the word out and attract some good, quality people.

HCB News: Are you satisfied with the data you are generating for asset management?
AR: We’ve used a CMMS from MediMizer for a long time. We use it to manage medical device inventory, asset management and preventative maintenance and repair management. With all the changes recently with [the] Joint Commission, we have to follow manufacturer procedures so we incorporated the procedures within the CMMS, and most biomed departments will tell you that's what they do.

HCB News: What role are you being asked to play in hospital cybersecurity?
AR: It varies a lot depending on the organization. At CHOP we have some involvement, but we're struggling a little bit because, in many respects, the device manufacturers want to handle it on their own while we have an IT department that wants to manage it. This gets complex because with medical devices we don't live in a world where you're running off a common operating system like Windows or Linux or whatever it may be. Instead, you're dealing with proprietary devices that don't make it easy to patch or monitor the way you can in the regular world of IT.

Since our IT department has over 500 people and does so many things in the hospital, it isn’t something the biomeds are highly involved with. But there are other hospitals where biomeds are more involved and it's certainly one of those top five items that biomed departments are struggling with.

HCB News: Have you experienced challenges when it comes to obtaining the necessary service training, codes and manuals from equipment manufacturers?
AR: It depends. We work on building relationships with vendors up front when we purchase equipment. As it relates to imaging equipment, a community hospital might struggle to work with Siemens, Philips and GE, but we are able to work successfully with them.

If we buy a PET scanner we negotiate for technical training for our staff so that they can get the certification and manuals, things they need for preventative maintenance.

Some companies do prevent that from happening and a big area is clinical lab equipment. They don't tend to train or provide the information we need. We can occasionally get information from other sources, but there are hospitals [that] really struggle with this.

Through the supply chain process we're able to document our requirements and pressure the vendors to provide what we need. If they say they don't train for a device, we're not happy about it, but we shouldn't be servicing a system we're not educated on, although we may fight for preventative maintenance capabilities.

Some places have it more difficult than we do. We are just set up fairly effectively to avoid that happening most of the time. The argument that's out there right now, with biomeds sort of being considered as a third party, is not new in our industry and there are a lot of different viewpoints.

When manufacturers sell you a piece of equipment, they make their capital profit in that equipment and then they make their money on service. I've done enough service contract negotiations to know that their profit margins are pretty significant on the service side, so they have a vested interest in holding on to that. I'm sure some have concerns about the quality of the individuals servicing their equipment and I would say for some third parties that concern may be valid, but it's not a reason to license or put other restrictions on people servicing equipment.

HCB News: Do you feel that new standards or regulations are needed to ensure that biomeds and ISOs are ensuring patient safety at the same level as manufacturers?
AR: We need to know, from the manufacturer’s perspective, what are they looking for that they don't see from an in-house biomed department? What are their concerns? The statistics and the data show that there have been a fractional percentage of medical device failures that have occurred because of poor service and resulted in injury, illness or death to a patient. There is not enough data out there to show that it's a problem.

So, if that's the case, and the information and data is true, what have manufacturers seen that has caused them to have these concerns? Once that’s established, the third parties and ISOs can try to answer to it.

There are some very big, well structured ISOs out there with solid policies and procedures, and a lot of these ISOs are beginning to grow. Many of these companies can provide documentation on training and competencies, so you need to get the right people around the table, which is something I know AAMI is trying to do, and have these discussions to find out where the gap is, and where is the data to back up the concern.