Dr. Lanny Johnson, a pioneering orthodpedic surgeon, remarked that “The foundation of business is innovation, and its foundation in medicine is clinical observation.” For medical-device development, the most important place is in the hospital, or better yet, the operating room, watching actual procedures. Another is in the wet lab.

The problem is that operating rooms are inaccessible to the average person, and for good reasons. This is a place where life and death decisions are routinely made, liability risks are high, and dedicated, busy people are working together, sometimes at high speed by strict rules that they don't have time to explain to an outsider. The facility and the surgical team simply cannot afford to have someone in the room who does not know how to follow sterile procedure, patient privacy regulations, and myriad other written and unwritten rules. Where does one begin to learn some of these rules and gain access to the OR?

Medical-device companies typically interface with the customers in the OR through their sales force. Sales reps then feed information to their counterparts in sales and marketing and these observations finally filter (sometimes second-and-third hand) to design and engineering departments. Device companies could help themselves by giving designers, engineers, and product managers the opportunity to see their products at work in the hands of users in real-life situations and on actual patients. Some companies do this well. Others can improve.

The person that can help you get into an OR is a surgical sales rep that works in the area of your surgical specialty. They can help orient you to the local rules and possibly sponsor you into an OR to do your clinical observation. Another might be to sponsor a supportive surgeon or surgical physician's assistant (PA). Just remember: Access as an observer in the OR is by invitation only, and you must know the proper decorum and protocol ahead of time to avoid embarrassing or dangerous mistakes.

A primer on OR etiquette

Lynne Bass RN, medical director, Bascom Surgery Center, San Jose, Calif., has been especially helpful to me in understanding some of the rules of the OR, (and diligent in letting me know of my infractions.) She has put together a helpful basic primer on OR etiquette. “I taught medical students and reps coming into the OR years ago,” she says. “The primer was partially born as a result of that experience.” Here are Bass' 10 OR commandments:

1. Do not go into the OR until the patient is prepped and draped.

2. Make certain that your head and facial hair are completely covered with proper attire.

3. Keep your hands behind your back. Touch nothing!

4. Stand away (4 ft) from the surgical (sterile) field. This includes the back table, mayo tray, and the draped surgical field.

5. Stand 2 to 3 feet away from any member of the surgical team (those fully attired in sterile surgical garb).

6. Even if you have permission to take pictures, do not lean over the sterile field with your camera.

7. Keep conversation to a minimum. Ask a team member if you can ask them a question. It may not be appropriate to initiate conversation at particular times during the surgical procedure. Be sensitive to challenges the surgeon and surgical team may be experiencing.

8. Do not open sterile items requested by the team. That is the circulating nurse's responsibility.

9. Be respectful of the employee lounge. Do not linger there. Food and space is budgeted for the employees.

10. Update your immunization records and have a copy available.

A few correlations to the rules could include:

Be especially aware of the sterile field. Never get between the sterile field and sterile instruments or the gowned team. The sterile field is from the draping on the OR table up, 3 ft in all directions and 2 ft from a gowned OR team. Never reach, lean, or point over the back table. Skin can shed from your hands or arms onto the sterile instruments and cause contamination. If you need to point at things in the sterile field in a tech support role, use a laser pointer.

Wear flat, comfortable shoes (no heels) and socks. You will need to either put on shoe covers or wear provided shoes/sandals (in many ORs outside the U.S.) Borrow training or procedure videos for prior review so you have a sense of what to expect in the room and during the procedure. When you put on scrubs, tuck in the shirt to help prevent shedding dead skin on to your scrub pants and the floor.

Do not enter the OR without a surgical mask. Most facilities have “redline” areas outside of the actual OR where scrubs, booties, caps, and masks are required. Be aware of these areas. If you don't know, ask. If you can't ask, observe.

Even though you may not have thought of them since high school, immunization records can be important. Some facilities do not require them, however, some require shot records before you can enter their OR. If a facility requires your shot records, they must be complete and up to date, including proof of newer shots such as Hepatitis-B. Find out the requirements in advance. The morning you are set to walk in the OR is not the time.

Get permission from the facility and the patient before taking pictures in the OR. Federal HIPAA (Health Insurance Portability and Accountability Act) Privacy regulations on this are quite strict, and the facility can get in a lot of trouble for violating these guidelines. Do not retain copies of medical information with identifiable patient names. For more information see http://www.hhs.gov/ocr/hipaa/.

Do not use devices without an FDA clearance or IRB approval from the facility. Further, do not use devices without validated sterilization, or that contain materials for which you do not have valid biocompatibility data. You are a guest in the OR. You have a strict ethical responsibility to avoid doing anything that puts the patient, the surgeon, or the facility at risk. Some facilities have strict rules for bringing any new products into the OR. Check with the facility's materials management department.

Do not take used or “red bag” contaminated disposable devices out of the OR. It may be tempting to take your product back for evaluation. But don't, unless you have a have an approved protocol in place with the facility to do so.

Each facility has its own variation of these rules and may even add a few of its own. For instance, many facilities let reps and observers change into scrubs in the surgeon locker room. Others do not. Some have a place to secure valuables (wallets, purses), while others do not. You may need to take a small bag to keep your street clothes and wallet with you. Again, check ahead of time, and be flexible to adjust to the local practices.

When observing surgeries in another country, be sure to orient yourself to the customs, culture, and conventions of that location. These may be considerably different from those in the U.S.

Labs and courses

If you have the opportunity, offer to help with a surgical-skills lab for your company. This can be an invaluable experience. Whether in a dedicated facility, university, or trade show setting, each lab has its own protocol, in terms of how specimens are handled to how representatives from industry may interact with the attending surgeons. Be aware and respectful of the fact that there may be sponsoring companies involved.

At the beginning of cadaver wet-lab courses, such as those held at the Orthopedic Learning Center in Rosemont, Ill, attendees are given a detailed orientation to the OHSA regulations. These are for the safety of the attendees and staff, and to prevent biological contamination of the non-wet lab areas. If you attend a course similar to the OLC, be sure to arrive in time for this important information, and carefully follow the safety rules. There are also rules on how to clearly identify yourself as an industry representative.

Another place to gain experience in clinical observation is in the pre-clinical animal lab. If you have the opportunity, offer to help assist in these studies as well. Depending on the study, many of the same sterile field rules apply.

Putting observations to work

The Stanford Biodesign Fellowship program uses a system of observation to teach the development of medical-device innovation. It is a method that you can use to collect and leverage your clinical observations.

Fellows are assigned to work at Stanford Hospital as surgical techs for the summer prior to the start of the program. They keep a detailed notebook of observations, paying special attention to what does and does not work, and keeping an eye out for “high quality problems.” These “bug lists” of hundreds of problems are compiled and ranked. Out of this comes a short list of important problems that can be solved with an innovative medical device. The problem list becomes the basis of thesis projects for the Biodesign Fellowship teams.

OR access training credentials

Future access to the OR by persons without basic training may become even more restricted. Since 2007 the Association of periOperative Registered Nurses (AORN) and the American College of Surgeons (ACS) have begun forumlating rules and guidance on credentialing for industry representatives in ORs, and to allow access only to those with proper basic training credentials. On-line training materials available for a fee for sales reps that work in the OR. For more information see: http://www.imda.org/news/update/200711.htm#vendor

The assistance of Lynne Bass, RN, Robert Bruce, PA, and Lee Fagot is gratefully acknowledged in the preparation of this article.