All lubricants Are Not created Equally.
Over the years, the lubricating jelly market has changed and has been subject of detailed investigation by the FDA and other regulatory agencies. As with many medical device items, market pressures have driven the pricing down and we have seen these pressures negatively affect product quality. In today’s healthcare environment, a company can’t expect to pay a low, low price and expect to buy quality product.
Since 1931, the Holland Rantos Company manufactured the “premium” HR Lubricating Jelly. When HR left the market in the early 2000s, Surgilube became the predominant product on the market and gained market share once owned by HR Lubricating Jelly. As pricing pressures in the 2000s became even stronger, many “commodity” type products surfaced. During this same time, many companies began sourcing products overseas in an effort to keep the costs down.
Many lubricants contain a significant amount of water as the primary ingredient. Recently, there has been a flurry of publicity regarding the inferior water quality in China and Korea; it is understandable that this fact may stir one to question what kind of water may be going into lubricants that are manufactured overseas.
It’s no secret that during the past few years the FDA has been extremely busy chastising a few companies that make lubricating and ultrasound jelly, all centering around quality. When companies are indicted, it is usually as a result of the company either not following cGMP, and/or using inferior ingredients.
When evaluating a lubricant for use, one should consider a few questions:
1. Is the product sterile?
2. Is the product made in the USA?
3. How long has the product been on the market and has there ever been an FDA recall?
4. Does the manufacturer follow cGMP?
5. Does the manufacturer follow ISO 9001:2008 production standards?
6. Does the manufacturer follow ISO 13485:2003 standards (specifically for medical devices)?
7. Is the product registered with the FDA and how many Medical Device Registrations does the product maintain?
So, are all lubricants created equally? Hands down, the answer is NO! Furthermore, you don’t have to pay a top dollar for a Premium product. HR Lubricating Jelly is your high quality, premium lubricant that carries a middle of the road price. When you sacrifice quality over a price driven commodity, you leave room for compromise and ultimately the patient may suffer.