N.J. Admin. Code § 8:43G-8.5

Current through Register Vol. 56, No. 11, June 3, 2024

Section 8:43G-8.5 - Single use medical devices and outsourcing

(a) Single use patient care items shall not be reprocessed except under the following conditions:

1. The manufacturer provides written instruction for cleaning and sterilization of the item and the facility has the resources to meet those specifications; and/or

2. Methods for processing single use patient care items conform with the following Food and Drug Administration regulations:

i. Premarket notification, registration and listing shall comply with 21 C.F.R. Part 807, incorporated herein by reference, as amended and supplemented; and

ii. Quality system regulations shall be as specified in 21 C.F.R. Part 807, incorporated herein by reference, as amended and supplemented; and

3. A quality control program shall be established to ensure the delivery of a safe product as specified in the contract with the third party processor.

(b) Policies and procedures shall be established following OSHA's Bloodborne Pathogens Standard (2011), 29 CFR 1910.1030, available at http://www.osha.gov/pls/publications, incorporated herein by reference, as amended and supplemented, for the transport of contaminated equipment to off-site reprocessing facilities.

(c) Shared reprocessing by multi-hospital reprocessing centers shall meet the following standards:

1. Policies and procedures for all processing protocols shall be approved by all facilities in the network in conjunction with infection control and all sterile processing managers.

2. Instruments and devices transported off site for processing shall be inventoried and pre-cleaned prior to transportation.

3. All decontamination, assembly and sterilization shall be performed according to the device manufacturer's written recommendations.

4. The following records shall be maintained at the processing facility:

i. Sterilization logs shall be maintained for all items sterilized; and

ii. Biological monitoring as specified in 8:43G-8.8(a).

(1) Immediate notification shall be made to the receiving hospital upon a positive biological result.

5. Transport of sterile product shall be performed using disinfected, impervious containers that are either locked or sealed in covered carts.

N.J. Admin. Code § 8:43G-8.5

Amended by 50 N.J.R. 552(b), effective 1/16/2018