Greg Browne

6 Things to Consider in Medical Device Development for the Cardiac Catheterization Laboratory

Interventional cardiology procedures are generally very profitable for healthcare institutions and, after a decade of growth, there continues to be significant investment and technology advancement in the catheterisation laboratory (or cath lab). However in an age of tightening budgets, medical institutions are also seeking further cost and time efficiencies to ensure that current margins are maintained.

Profitability can no longer be guaranteed by the novelty of a technology or device alone and Medical device manufacturers are required to also demonstrate that any new device has been designed with the cath lab use environment and real work protocols front-of-mind.

If insufficient care is taken to ensure that a the new cath lab instrument adequately meets the needs of end-users, there is a danger that workflow efficiency or safety will be reduced, negatively affecting the caregivers focus on patient health and adversely affecting the profitability of the procedure as a result. This can become a significant barrier to the adoption of a new technology.

Context is important too in order to innovate in this space and it is therefore critical for device engineers to deeply understand how the cath lab works. StarFish Medical’s Design Research specialists have spent many hours, as part of the Pathfinder™ Process,  immersed in hospital catheterization laboratories observing and documenting Intravascular Ultrasound (IVUS) and Electrophysiology (EP) procedures and workflow.

Here are six things to consider when developing a new instrument for the cath lab environment:

1.     BE AWARE of the congestion zone at the foot of the cath lab table

  • Because of the requirements of the fluoroscopy c-arm, display banks, and other standard instrumentation, space at the table-side can be difficult to secure and, if available, is usually only around the foot of the cath lab table. In EP procedures this space can be even more limited depending on the positioning of ablation and mapping instrumentation and leads. As a result, even in large, purpose-built cath labs, one finds congestion of equipment, devices, leads and cables at the foot of the table.
  • If your instrument is unable to be positioned at the table side, have you considered how it could still be useful during a procedure? Are your cords and leads of sufficient length to allow the device to be used from a distance? How will the images and outputs reach the physician? Have you considered how sterility will be maintained?

2.     CONSIDER the universal layout characteristics common to all cath lab environments

  • In purpose-built and legacy environments alike, you can always count on the arrangement and orientation of the principle cath lab equipment (the cath lab table, the fluoroscopy c-arm, the display bank and sterile work zone) to be consistent across the board.
  • Knowing that the relationship of the sterile work zone is consistent in relation to where other equipment located can be advantageous when considering the design configuration of a new device for use in the cath lab.

3.     ALWAYS Place connectors, controls and cable features at an easy-to-reach height where users do not have to bend over or stoop.

  • “If I cannot reach it without bending then I am not going use it” (quote from RN in the cath lab)
  • Recurring back pain is a persistent complaint of cath lab staff.
  • Cardiac cath lab procedures involving fluoroscopy at a minimum will take two hours with a minimum of 40 min of fluoro time. Health and safety protocols demand that users wear as much as 18 lb. of lead fluoro protection for the duration of these procedures. These protective garments place a strain on the mobility of users and operators when performing even simple tasks.
  • We have documented many examples of devices that are not used as intended just because they are out of the easy reach of the end-user

4.     Cable management  is ALWAYS an issue

  • We consistently hear from users across the board that cable management is a huge problem in cath labs. With this in mind it seems interesting that device engineers and designers seem to generally place cable management at the bottom of the list of priorities.
  • Do not presume that there will be any cable conduit infrastructure available for your device. StarFish have visited many a newly commissioned cath lab only to find that their conduits are already bursting at the seams.
  • Having cables lying around is not only a safety issue but is unhygienic and makes the setup, take down, cleaning and troubleshooting of devices a particular problem. Exposed piles of tangles cables are also prone to damage from wheeled devices. This typically results in treatment delays, a real issue for hospitals. The reality is that poor cable management is a real pain-point for end-users

5.     NEVER assume that the needs of Physicians are the same the needs of technicians and RNs.

  • Do you really understand who will be the end-users of your new device?
  • While the output of a device is generally focused on helping the physician to make a good clinical decision, this does not mean that they will be the operator of the device. Remember to take the time to understand who will actually be responsible for setting your device up, priming it, managing it during a procedure, taking it down, cleaning it, transporting it, servicing it etc. This will help you to really understand how best to get your product right. Physicians dislike having to wait around for RNs to complete an action for which they are unsure or inadequately trained.

6.     REMEMBER that during a case, the physician’s hands and eyes are probably already busy. How will this understanding impact on the interface design on your new device?

  • “During a case you can be so busy chasing the pony that got out that you’ll never fix the fence” (Quote from an EP Physician)
  • During cath lab procedures Physicians are required to continuously review and parse many different types and styles of information to ensure the well-being of the patient and outcome of a procedure. At the same time they will also be manipulating a catheter and handle in response to the information. It is therefore critical to understand where in the existing workflow your device’s output will fit and to prioritize information output to best knit into existing protocols.
  • Consider the physicians line-of-sight in the design execution of any new interface especially if there is no option to connect to an existing display bank. Complication and distraction are never welcomed in the cath lab. The purpose is to aid decision-making.
  • “Good judgement comes from experience but experience comes from bad judgement” (Quote from an EP Physician)

Image: © Can Stock Photo / zandb1

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