In spite of the wide variety of technology available, practitioners can’t always find equipment they want to use for a treatment or procedure. They may, however, have a piece of equipment that would be perfect with just a little creative engineering…

Perhaps the goal is to make it more effective for its intended use; or you may wish to adapt the equipment so that it can be used in an entirely new way. Alteration does not require changing parts, either; you might just want to change the original factory settings to achieve different results. Is it, then, a mistake, even if your intent is to provide good care to your patient? It can be and often is.

Practitioners have pursued great medical ideas and modified medical devices since the dawn of care; we have come a very long way since the use of flint shards as knives. It is appropriate to put medical creativity into perspective, however, and exercise great care when using medical equipment. Everyday use of office medical equipment involves controlling and centralizing selection and purchase of that equipment; systems for performing periodic inspections, maintenance and repairs; training staff in the use of the equipment; reporting incidents of equipment malfunction to manufacturers and retention of recall notices and appropriate response to them – all of this has to be carefully documented.

The following is an excerpt from an ECRI Institute (ECRI is an evidence-based healthcare research and information organization) Health Devices Journal. This material is specific to device modifications by users:

In general, we recommend against implementing all but the simplest device modifications requested by clinicians. We define modification as the replacing, remounting, adjusting, or adding of components or subsystems to a device to improve safety, reliability, or performance.

Modifications recommended by the manufacturer or other recognized sources should usually be implemented at once. Modifications by a healthcare facility to meet its special needs, on the other hand, should be discussed and approved by the clinical engineering department, administration, risk management, and clinical staff. Whenever such modifications are contemplated, consideration must be given to the possible technical and clinical effects, as well as liability risks and regulatory agency requirements. A healthcare facility should document a well-reasoned need for a device to be modified, including the fact that an equivalent device is not commercially available. It should also document considerations taken and testing performed to ensure the safety and efficacy of the modified device. After modification, the device should be inventoried, and the facility must remain vigilant for any recalls affecting the original device. In addition, it may be necessary to modify the inspection and preventive maintenance activities associated with the original device and to adjust the intervals for routinely performing such activities.

Further, the FDA’s Centers for Devices and Radiological Health offers much guidance on the topic of medical device regulation. Manufacturers of medical devices are defined in FDA’s guidance document on medical device reporting at: http://www.fda.gov/cdrh/manual/mdrman.html#whomust.

A manufacturer [§803.3(n)] is any person who manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological or other procedures. The term includes any person who:

• Repackages or otherwise changes the container, wrapper or labeling of a device in furtherance of the distribution of the device from the original place of manufacture;
• Initiates specifications for devices manufactured by a second party for subsequent distribution by the person initiating the specifications; or
• Manufactures components or accessories which are devices that are ready to be used and are intended to be commercially distributed and intended to be used as is, or are processed by a licensed practitioner or other qualified person to meet the needs of a particular patient

Medical device manufacturers are subject to FDA’s regulations on Premarket notification 510(k) when making significant modifications to a marketed device (http://www.fda.gov/cdrh/devadvice/3143.html). [i]

As noted by ECRI, a great deal of paperwork surrounds device modification. The ECRI document references healthcare facilities, but it is also specific to the individual office. Are you prepared to take special care in inventories, repair and update logs, utilization logs, and required reporting? You will likely need all of this, as well as detailed information on the adjustments made and information on any parts added (including manufacturer, lot and serial number, if available).

As referenced above, when a practitioner re-works a piece of medical equipment, the Food and Drug Administration (FDA) classifies these persons as manufacturers. In that classification they are subject to all manufacturing regulations, especially those which directly apply to medical device production.[ii] To follow these regulations, a practitioner must file appropriate documentation of intent to modify equipment and the purpose for the changes. Though the FDA may grant waivers for some provisions, it is likely that modified equipment would have to undergo tests and be approved; any use on humans would also have to be recorded and tracked. 

The FDA’s regulations are written for manufacturers who will be marketing their equipment, but the agency still expects a solo practitioner who just wants to tweak one piece of equipment to work under their guidance.

A device user who modifies the apparatus also should recognize that all prior manufacturer’s liability is usually nullified by the modification; therefore, if an injury occurs and the device is involved, there will be little chance of success in a third-party claim against the manufacturer. In situations where the equipment has not been modified by the user, manufacturer’s liability has shielded the practitioner from responsibility in cases where a properly utilized device was the cause of injury.

If any equipment modifications are ever considered, the ability of the practice to tolerate greatly increased paperwork and liability must be considered. The safety of your patients and your own professional reputation also hang in the balance. You might have the next great medical equipment idea, but if you are ever going to patent it, or if you are just going to use it safely on your patients, you will need to follow these guidelines; and you should also ensure that you maintain appropriate coverage for this unique liability.