Isolation Technology News

At the December 2005 Midyear Clinical Meeting of the American Society of Health-System Pharmacists, Darryl Rich, PharmD., a surveyor for the Joint Commission on the Accreditation of Hospital Organization ("Joint Commission"), gave a presentation on updates to Joint Commission standards. At the conclusion of his prepared remarks, Dr. Rich was asked a question about the USP 797. Although the question was outside the scope of Dr. Rich's remarks, and indeed , his area of expertise, he answered the question based upon information he received outside the Joint Commission on USP 797 and its impact on barrier isolators. Unfortunately, Dr. Rich's statements were inaccurate and his response misleading, and he sincerely regrets any confusion it has caused to health ISO Class 5 air quality standards.

The sole responsible entity for USP 797 and its interpretation is United States Pharmacopeia ("USP"). According to Susan de Mars, USP's Chief Legal Counsel, USP 797 (2004) does not require a positive pressure isolator that provides at least ISO Class 5 quality air to be operated within a cleanroom.

Darryl Rich, PharmD, is a valued employee of the Joint Commission, One function the Joint Commission provides is to disseminate accurate information on health care issues. The Commission believes that Dr. Rich has always attempted to satisfy this function.