Firm reps present during surgery

The Herald has found half of the 5000 metal-on-metal implants used in New Zealand have been subject to safety alerts. Photo / Thinkstock

Hospital says medical device company staff allowed in theatres without patient consent if expertise needed.

Staff working for companies producing artificial hips, pacemakers and other medical devices are being allowed into surgeries at public hospitals without the consent of patients.

The practice has emerged during Herald inquiries into an investigation by the Health and Disability Commission, which accepted a surgeon's assurances he had told a patient he was bringing into the operating theatre a staff member from the company which had designed the faulty part he was removing.

The hospital board for which the surgeon was working has since told the Herald there was no consent and none was required for device manufacturing company staff whose clinical skills were needed.

Hip replacement patient Lynne McKay complained to the HDC after safety issues with the double metal hip implants she had. The Herald has found half of the 5000 metal-on-metal implants used in New Zealand have been subject to safety alerts.

A complaint to the commission by Ms McKay resulted in a finding that there were issues with her treatment, which resulted in her receiving six replacements in six years.

During the first revision surgery in July 2012, a Stryker representative was among the gowned and masked surgical team preparing to operate. Ms McKay said she had no idea there was someone present from the company she blamed for years of agony.

Documents show as part of its inquiry, surgeon Rocco Pitto assured the HDC he had told Ms McKay the Stryker representative was present. As part of his assurance, he sent a copy of medical notes for a November 2012 revision which stated: "Manufacturer can be in theatre w/pt (with patient) consent (and) discussion w/patient."

Even though there was no information sent about the July 2012 surgery, deputy health and disability commissioner Theo Baker said she had accepted Mr Pitto's assurances it was standard to have medical company representatives in theatre. Ms Baker was also provided with a copy of the health board policy which said it was "the responsibility of the clinical staff" to discuss the presence of medical company representatives in operating theatres "and to obtain patient consent for the representative to be present".

When the Herald quizzed the health board about the case, a spokeswoman said Mr Pitto "did not obtain consent as the representative was required to be in theatre as part of the specialist team".

Further, the board's deputy chief medical officer, Dr Wilbur Farmilo, said it was common to have "equipment experts" from medical companies in surgery because of their expertise with the devices being used. "They are an integral part of the team and therefore not routinely discussed with the patient or separately consented." Consent was also not required to remove the defective parts, the board said.

The commission, after being approached by the Herald, stood by the investigation. Ms Baker said a copy of the policy governing medical company representatives had been received.

The commission said the focus on the inquiry was on whether "there was a lack of reasonable care and skill in Ms McKay's care". The commission finding was that Mr Pitto and the health board's care was satisfactory.

Hospital policy

• Hospital policy says patients must give consent if medical company staff present in operating theatres.

• But the hospital tells the Herald consent is not necessary if those staff are needed to help.

• Hip replacement patient says she never knew company representative was in surgery.