Health hazard: DRAP clamps down on unregistered stents

Authority urges use of only registered medical equipment

ISLAMABAD: The Federal Inspector of Drugs conducted a snap visit to Shifa International Hospital Islamabad to gauge the use of unregistered stents.

The main pharmacy, satellite pharmacy, cardiac ward and catheterisation lab – where stents are primarily used – were thoroughly inspected for a span of eight hours.

The Drug Regulatory Authority of Pakistan (DRAP) has approved stents of specific companies which include Abbott, Medtronic, Blue Medical Devices, as well as Boston Pharmaceuticals.

An investigation team comprising of the Drap Quality Assurance additional director, Drap Medical Devices director, and the Drap deputy director general conducted a similar raid at Lahore’s Mayo Hospital as well.

The drug regulator has conducted raids and has begun an investigation in the wake of the Federal Investigation Agency unearthing the use of substandard and expired stents in the hospital in Lahore.

Furthermore, Drap has been conducting raids in various hospitals providing cardiac care as well.

The statements of Cardiac Surgeon Shafiq Saqib, several nurses, technicians at Mayo hospital were also recorded.

Inadequate storage practices pertaining to medicines and stents were also observed in older and tertiary care hospitals in Punjab.

Five different types of stents, catheters, balloons, and sutures were seized as they failed to meet the regulatory requirements for registration, packaging and labelling.

The federal drug inspector in Lahore took notice of the alarming storage conditions of a warehouse in a government hospital.

Saving Life Technologies and Pak Punjab Cardiac Medical Systems supplied unregistered stents to Mayo Hospital, allegedly with the knowledge of the hospital’s staff.

The case is being tried at the drug court in Lahore.

Drap has advised doctors and hospitals to only use registered stents.

Published in The Express Tribune, January 25^th, 2017.