No real guidelines for manufacturers of protective garments

Barry T Katzen

There needs to be clear and valid information on every garment that enables comparative decision-making for interventionists. This is desirable as a voluntary initiative from manufacturers; otherwise, the solution may be to move forward with some type of regulatory initiative, writes Barry T Katzen.


Currently, there are no real guidelines for manufacturers of protective garments. They are primarily limited by good manufacturing practice. Part of the current problem regarding the lack of adequate information that they make available stems from the transition from lead which was included in all protective garments to lead equivalents. In the past, since all of these garments were made of 0.5mm lead, there was no real variation in standardisation insofar as thickness was concerned. With the introduction of lead equivalent materials, variation in the make-up of protective equipment began to occur. Currently, there is no requirement for any type of manufacturing labelling on these protective garments. In fact, when you pick up an apron, there will generally not be any type of a label on it that indicates what kind of material is being used, what the thickness of the material is, and what testing may, or may not, have been done to validate its ability to protect. This is the type of information we would like to see on these garments, along with some validation or expectation that this information would be valid.

At Miami Cardiac and Vascular Institute (MCVI), we have an active process directed towards both radiation reduction and protection of workers in and around radiation. The relative risk for physicians and employees is greater, the closer you are to the source and the patient. However, everyone in the room requires protection. Universal precautions, as well as standards of radiation protection include the use of thyroid shields and protective glasses. As was demonstrated at ISET 2016, significant variation of protection has been documented as a result of the angulation of scatter radiation to the operator. Sometimes there is a trade-off in managing radiation protection risks against musculoskeletal risks. We recommend 0.5mm lead aprons, and wraparound types of aprons, for those who have a high likelihood of turning around during the course of a procedure. With personnel who have known back issues, we may choose to use alternatives including tin, however these types of aprons require greater care and are more prone to cracking. Thyroid shields are considered part of routine radiation protection. At this time, routine use of wearable leaded caps is not widespread.

As both a clinician interventionist and executive, I would like to see information on each and every garment that allows us to make comparative decisions, and some documentation that that information is valid. While we are all reluctant to advocate more regulation and complexity, without a voluntary initiative by manufacturers to do so, it may be necessary to move forward with some type of regulatory initiative.

Finally, protection for everyone who works with medical radiation is extremely important, but is also multifactorial. At MCVI, we have made this a performance improvement initiative, to run across the many hospitals and facilities that are performing these procedures, and I am certain we can bring dramatic improvement in risk reduction including reduction in the amount of radiation used and how it is applied on a per procedure basis, as well as optimising protection for everyone who is involved in using it for the important procedures that we do to improve patient care.

Barry T Katzen is founder and chief medical executive of Miami Cardiac & Vascular Institute, and one of the course directors of ISET