FDA Warns Puerto Rican Health Providers About Customed Packs

Health care staffers should not use the company's convenience packs and trays for any surgical procedure because adequate testing hasn't been completed, according to the agency.

The U.S. Food and Drug Administration has posted a warning to staffers working at health care facilities or hospitals in Puerto Rico that they should not be using Customed surgical convenience packs and trays for any surgical procedure, including general hospital, dental, and obstetrical and gynecological procedures, because the integrity and safety of their contents -- such as exam gloves, absorbent towels, suture bags, surgical table covers, and drapes -- cannot be assured because adequate testing has not been completed.

Edwin Ramos, director of the Compliance Branch in FDA's San Juan District Office, sent a Warning Letter on Dec. 9, 2014, telling Customed's president and owner that FDA's mid-2014 inspection turned up problems and the company's responses to them were unsatisfactory. FDA reports that the sterility of the company's products is in question, and it cannot prove that endotoxin and ethylene oxide levels are within safe limits, that package integrity can withstand stresses during transport, and that the products will be effective up to their expiration dates.

"These deficiencies pose a risk of serious adverse health consequences, such as infection and death," according to the agency.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Get the Ultimate Guide to OSHA Recordkeeping

    When it comes to OSHA recordkeeping there are always questions regarding the requirements and in and outs. IndustrySafe is here to help. We put together this page with critical information to help answer your key questions about OSHA recordkeeping.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We put together a guide that’s easy to digest so you can ensure you're complying with OSHA's training standards.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Industry Safe
comments powered by Disqus