Will be interesting to see how the U.S. Food and Drug Administration (FDA), European Commission and others come together in the years ahead to develop a globally harmonized approach to UDI.

What I’ve learned so far is that CS/SPD staff, while often overlooked, play a critical role in a healthcare facility’s operations and the delivery of safe and effective patient care. If you go into a hospital or surgery center for a procedure, you likely won’t meet someone from this profession during your stay, but be aware that they are playing an instrumental role in your treatment.

While there’s been a lot of negative press lately on the role that contaminated surgical equipment plays in hospital acquired infections (HAIs) little credit has been giving to those CS/SPD departments that are doing it right. I interviewed a number of CS/SPD professionals for the article and I was blown away by their commitment to patient care and safety. While many healthcare facilities don’t pay for CS/SPD continuing education and don’t offer higher compensation to those who are certified, the majority of respondents to a recent CS salary survey in HPN (75%) reported being certified, which indicates that many CS/SPD seek out and pay for certification on their own – not to receive higher pay (because most don’t) but because they want to “improve their craft and become experts”, as one supervisor of sterile processing put it.

Check out the survey results and article in the March 2013 issue of HPN. It is entitled: SPD pros making progressive strides.

For the March issue, I interviewed Michele DeMeo, a sterile processing expert who is autistic and dying from Amyotrophic Lateral Sclerosis (ALS) and melanoma. While the interview had nothing to do with her conditions, she was very open and honest about her physical limitations and with what she was experiencing as a terminally ill patient.

While Michele and I corresponded only via email (it’s easier for her than talking on the phone), I could tell she is an amazing individual. She has written a book entitled “The Beauty of a Slow Death” and is making a movie about her relatively short life entitled “Love, Loss & Life.” I encourage you to check both out.  The movie trailer can be found at: http://www.lovelosslife.org.

I am hearing more and more about this issue from both MedTech clients and others in the industry. See the blog post featured in today’s MassDevice Weekly Round-Up entitled “Death of a (MedTech) Salesman.”

Stay tuned for an article by Microline Surgical Chairman and CEO Dr. Jean-Luc Boulnois on this and other issues facing MedTech companies, particularly start-ups, today. It is currently in development and will be published in the new year.

This has been in the back of my mind for months now but I’ve come to the realization that the reason why I can sleep at night is that I’m promoting a technology that has been proven to be better than what is out there – better for doctors, better for patients, perhaps even better for healthcare in general if it cuts down on costly complications and gets people feeling better sooner.

My client, Microline Surgical, is a private company without the big marketing dollars that are driving many of the competitive technologies out there. The technology is not new, it is not well-known but based on my conversations with ENTs throughout the U.S. it is better than what the big guys have to offer – and that’s precisely why I’m proud to say that I am promoting it to not only other ENTs but also to potential patients.

Any PR professional walks a fine ethical line. I worked for a large advertising agency early in my career that would not take on liquor or cigarette companies as clients. I’ve learned to be selective in which clients I represent, turning down business when appropriate, and jumping at the chance to represent promising technology, services and solutions.

Just recently, I began working with a MedTech start-up in the U.K. called GlySure that is developing a continuous blood glucose (CBG) monitoring system for critical care patients.  One of the coolest things is that there is research showing the clinical need for this type of technology. Various companies have tried to develop CBG systems, including some big players in this space, but no one to date has been able to do it right.  Based on the results of an ICU Pilot Trial, it seems GlySure is on the right path. They anticipate starting clinical regulatory trials in the U.S. and Europe this fall.

I certainly don’t want to come across as a saint – those who know me know this isn’t the case (particularly those who were with me on the Nellcor Roadshows back in 2000) – but as hokey as it sounds, I believe PR consultants must be willing to stand behind what they are promoting.

With the proposed rule issued, Jay Crowley, senior adviser on patient safety with the FDA’s Center for Devices and Radiological Health, is no longer being hounded with the question of “when” but is now dealing with questions related to “how” manufacturers can comply with the UDI rule.

Karen Conway, industry relations director at GHX, just published a series of blog posts that do an incredible job of explaining the proposed UDI system, manufacturer requirements and how healthcare providers can begin preparing to use product data standards within their organizations. Here is a link: http://www.ghx.com/product-pages/industry-resources/blog-the-healthcare-hub.aspx

Seems the healthcare industry has been talking about product data standardization for quite some time.  Will be interesting to see activity in this area ramp up now that there is a U.S. regulatory driver behind it.

• Lack of Education: A representative from a hospital stated that lack of education around global data standards enablement has prevented the industry from moving forward. “We may get it, but our C-suite doesn’t get it and how do we get them to invest in something that they know nothing about?”

• No Business Case for Standards Adoption: It seemed that everyone in the audience agreed that there is currently no proven business case for standardizing healthcare data. How do you get C-level executives to invest in data standardization if there is no proof of ROI?

• Internal Complexity and Costs: A representative from a medical device manufacturer stated that product data standardization (transitioning from internal, proprietary product numbers to an industry standard) would impact every aspect of her organization (IT, inventory, distribution network, packaging, marketing, etc.). “Getting everyone moving in one direction is a costly, complex process and I don’t even know who would lead this effort internally.”

Everyone knows that data standardization has the potential to improve patient care and reduce costs by ensuring that the right products are delivered to the right locations in the right quantities at the right prices – reducing errors and the cost/labor required to address supply chain discrepancies in business transactions between trading partners. But within an industry struggling with so many challenges – increased costs (supply, labor etc.), dwindling reimbursements, healthcare reform requirements – few have the time and resources to tackle data standardization – especially when there is little evidence that these efforts will significantly cut costs.

Representatives from GHX shared information on a number of initiatives that should help get healthcare data standards back on track. They include:

• GS1 White Paper: GS1 recognizes that healthcare providers and suppliers need a solid business case for standards that they can present to the C-suite to secure resources for data standardization within their organizations. GS1 is currently developing a white paper that presents the benefits that other industries (e.g. retail, consumer packaged goods) have derived from data standardization and how healthcare can take lessons learned from these industries to develop a business case and roadmap to industry-wide adoption.

• C-Suite Messaging: While most supply chain teams within healthcare provider and supplier organizations recognize how data standardization can increase efficiency, reduce costs and improve patient care, selling standards enablement to the C-suite is an uphill battle because of lack of knowledge around standards and the lack of a solid business case for standards adoption. GS1 is working to develop messaging geared to the C-suite that supply chain managers can use to help gain support for data standardization within their organizations.

• Technology: GHX is working with its members to understand what they need to support standards enablement so that it can offer solutions that simplify data standardization and synchronization between trading partners. This includes the development of a single consolidated data feed to support not only e-commerce, but also emerging regulations, such as the U.S. Food & Drug Administration’s Unique Device Identification (UDI) system.

“Part of the reason why so many people are in the room today is that we realize standards are definitely needed,” said one medical device manufacturer. “But we’ve got to find ways to get the knowledge and benefits from standardized data without having to rip out everything that we already have in place.”

This trend came into play during a conversation that I had earlier this week with an otolaryngologist (ear, nose and throat doctor) in California for a public relations campaign that I’m launching for one of my medical device clients.

I knew this ENT had been having success with my client’s technology, which is designed to perform tonsillectomy and other ENT procedures with minimal tissue damage, but I had no idea that patients were banging on his door to undergo procedures with this device.

The ENT moved his practice from Wisconsin to California just three months ago, and during that short period of time, two patients have actively tracked him down because he is the only surgeon in the area to use this particular technology – one who was willing to drive two hours to seek this treatment!

The most recent patient, an adult in need of a tonsillectomy, told this ENT that he had actively searched on the Internet to find out which technology/technique used for tonsillectomy resulted in the least pain and bleeding and the fastest recovery time, reading through clinical studies and watching graphic procedure videos. When he determined that my client’s technology was the best solution, he contacted the company to find an ENT nearby who could use the device to perform his tonsillectomy – and that’s what led him to this particular ENT.

While pharmaceutical companies and other healthcare suppliers have long known and used consumer marketing to drive patients to drive their doctors to prescribe brand name drugs, I feel the medical device industry has lagged in this area.  I mean, how many consumers actively research which instrument used in a surgery will provide the best outcomes? As a PR professional working with device companies, I have to admit that I always check to see which brand of pulse oximetry sensor is on my finger when I’m in the hospital, but does the average consumer?

I’ve always been adverse to using scare tactics to drive patients to seek out a specific medical technology. I once interviewed for a PR position with a device manufacturer who notoriously used this approach to push its monitors on ORs only to have the monitors sitting unused gathering dust. As “goody two-shoes” as it sounds, I couldn’t bring myself to take the job because it felt wrong.

But I find it interesting that patients are taking it upon themselves to do the research. Particularly since my client is a rather small company with limited marketing dollars that, as the ENT pointed out, is up against larger competitors that gain market share not because their technology is better but because they speak louder and carry a bigger stick.

I guess it is one thing to force a new device on clinicians through patient pressure but another thing to have something so great that patients will actively seek it out on their own….