If you’re responsible for procuring personal protective equipment (PPE) for your workplace, you know the importance of purchasing the best quality products. Unfortunately, the pandemic has made your job much harder. The PPE shortage has opened the door for poor quality and disreputable suppliers to the industry that have put inferior—and even dangerous—PPE products on the market.
Low-quality gloves are dangerous for both healthcare workers and patients. Gloves made of cheap materials are more likely to rip or tear, allowing for the spread of infectious agents between the healthcare provider and patient.
Budget considerations are always an incentive for going with the lowest bidder. But there are hidden costs of purchasing cheap, low-quality, disposable gloves:
- Increased glove waste results as workers replace faulty gloves or double-glove more often because of repeated glove failure. Waste disposal fees may also increase.
- Inventory costs increase because more gloves have to be purchased and stored to maintain the desired inventory levels.
- Efficiency and productivity are affected when workers have to stop what they’re doing to replace ripped gloves. Patient satisfaction may also decrease.
- Healthcare organizations become more vulnerable to lawsuits when PPE fails to protect healthcare workers and patients.
Low-quality PPE is on the market
Under normal circumstances, medical gloves are regulated by the Food and Drug Administration (FDA). A manufacturer cannot market their disposable medical gloves until receiving a pre-market clearance from the FDA, commonly known as a 510(k).
In response to the COVID-19 public health emergency, the FDA relaxed its enforcement policies to allow more PPE to enter the market quickly. Some groups—especially newcomers to the market—took advantage of this temporary flexibility. As a result, there are some products on the market that do not perform as well as PPE cleared through FDA's pre-market process.
How to verify a distributor is selling quality PPE products
Requesting proof of the manufacturer’s FDA clearance (in addition to FDA registration) is only a starting point for vetting the product—after all, FDA-cleared and approved products are recalled all the time. Here are some other suggestions to help protect your organization:
- Check the reputation and references of the manufacturer and distributor for charges of fraud, sanctions, bankruptcy proceedings, etc. Try to purchase directly from the manufacturer or a well-established distributor—the more middlemen involved, the greater the risk of fraud.
- Beware of any vendor that claims to sell an “FDA approved” Class I medical device. Class I devices like PPE are only cleared, not approved, by the FDA. As well, the FDA doesn’t develop or market any products or “approve” a manufacturer.
- Look for vendors whose products and manufacturing facilities have been independently tested and certified.
- Long-established PPE manufacturers should be able to show proof of industry recognition, awards, and certification of high-quality standards over many years.
- Ask for samples of different products to test. Make sure the sample products meet your exact needs, not just similar to what you will be ordering.
- Beware of PPE priced below-market. Cheap raw materials lead to a cheap, inferior product. Price should not be the only consideration when choosing a supplier.
Ventyv® is your trusted source for PPE
Work with a distributor partner and manufacturer with a proven track record and decades of industry experience. Sri Trang USA is a member of the Sri Trang Group and the manufacturer of the Ventyv® brand of infection prevention products. We are an award-winning, global industry leader in disposable glove manufacturing with production lines that produce 35 billion disposable glove pieces annually. With delivery to more than 140 countries, we meet national quality standards worldwide.Read More